2017 Korea Innovative PHARMACEUTICAL Company Potential of Pharmaceutical Industry in Korea
Aging populations and growing interest in health and welfare continue companies have developed therapies in an array of areas including oncology, antibacterial, gastritis, respiratory to drive up the demand for innovative drugs across the world. Globally, infections, duodenal ulcer, diabetic foot ulcer, erectile dysfunction, hepatitis B and hypertension.
R&D spending in the pharmaceutical industry was higher than any Development of innovative drugs targeting other industry (pharmaceutical and bio ranked No. 1 with 150 billion Drug development the global market Early years of drug getting on track 2010’s dollars(2015)), indicating that the future industrial structure is shifting Development of development Local manufacturing of 2000’s finished products and new processes from IT to pharmaceutical business. drug substance 1990’s 1980’s 1960/70’s
Pharmaceutical Industry in Korea Launch of innovative drugs(total of 27) ’99 ’01 ’02 ’03 ’05 ’06 ’07 ’08 ’10 ’12 ’13 ’14 ’15 2016 In Korean, the value of drugs manufactured in Korea was KRW 16.9 trillion in 2015. The annual average growth rate for the past five years was 4.7 percent. In addition, the size of the pharmaceutical market was
KRW 19.2 trillion in 2015. Sunpla EGF Factive Apitoxin Revanex Levovir Pelubi Noltec Pyramax Supect Duvie Riavax Acelex Olita Tab
Milican Peudovaccin Zydena Mvix Kanab Zemiglo Zabolante Size and Market Trends in Pharmaceutical Industry in Korea (Unit: KRW Trillion, %)
Category Production Export Import Balance Market size Sivextro(Tab.) Q-roxin Camtobell Zepeed 2011 15.4 1.9 5.4 △3.5 18.9
2012 15.6 2.3 5.7 △3.4 18.9 Sivextro(Inj.) 2013 16.2 2.3 5.2 △2.8 19.0
2014 16.4 2.5 5.4 △2.8 19.3 Suganon 2015 16.9 3.3 5.6 △2.3 19.2 Drug Development in Korea
Note: 1) Pharmaceutical products include finished products, narcotic drugs, ultra narcotic, psychotropic substance and drug substance [Clinical Trials] Clinical trials grew dramatically from both qualitative and quantitative 2) Numbers in export and import categories are calculated in Korean won and converted US dollar by using annual average exchange rate at Bank of Korea perspectives 3) Market Size= Production-Export+Import Source: Pharmaceutical Industry Statistics, Korea Pharmaceutical and Bio-Pharma Manufacturers Association Already on a clear growth track with its high level of clinical trial capabilities and reliable data, Korea is emerging as Facts & Survey Report, Korea Pharmaceutical Traders Association, Korea Health Industry Statistics System a core clinical trial destination in the pharmaceutical market in Asia. Korea-based 22 major healthcare organizations, including Seoul National University Hospital, Samsung Seoul Medical Center and Asan Medical Center, have won Based on its technological competitiveness and quality drugs, the pharmaceutical industry in Korea has global certifications for their clinical study environment helping the country to build a clinical infrastructure on a taken a stride in strengthening its ability to develop innovative drugs in a short period of time, including R&D, global level. With this advanced infrastructure, Korea became the second largest host city for global clinical trials clinical trials and drug manufacturing. Impressive growth made in the last few years suggests that Korea since 2011. Korea hosted 675 cases in 2015 recording 3.5% increase compared to 652 cases in 2014. based pharmaceutical companies are ready to take a leap forward as global players. The number of multinational regional clinical trials(MRCTs) conducted by multinational pharmaceutical companies in Korea has also increased sharply since the country introduced International Conference on Harmonization Good [R&D] Development of innovative medicines and strong pipelines across various Clinical Practice(ICH GCP) in 2000. Especially, Pfizer formed a partnership with Korea as part of its global clinical therapeutic areas program in 2008, selecting 4 of its 9 global Core Research Sites(CRSs) in Korea.
The local pharmaceutical industry began manufacturing both finished products and drug substances in the [Manufacturing] High level of competitiveness and ability to generate rich pipelines of 1960s, and developed new processes in the 1980s. Following the early phase of drug development in the late innovative drugs 1980s, Korean pharmaceutical industry began to develop innovative drugs in the 2000s. Since then, Korean pharmaceutical industry has been successfully developing one of the most innovative and incrementally Pharmaceutical companies in Korea have been working to ensure that their drug manufacturing facilities meet modified drugs. rigorous global standards. To reflect global trends, the guidelines on Good Manufacturing Practices(GMP) changed Since the introduction of the chemical compound patent system in 1987, the number of innovative drugs from dosage forms to prior approval of individual items in 2008. As the guidelines shifted from management of introduced in the country has also increased at a very fast pace. Korea has seen development of innovative dosage forms to that of individual items based on a step-by-step process through 2010, the quality assurance drugs across various therapeutic areas, from “Sunpla Injection,” a treatment for stomach cancer developed system for domestically manufactured drugs reached a global level. by SK Pharmaceuticals in 1999 to “Olita Tab” developed by Hanmi in 2016. So far, Korean pharmaceutical
2 3 Public-private Partnership for Development of Pharmaceutical Industry Contributing to Global Health
In addition, Korea has the ability to conduct drug R&D for compounds and commercial technologies, including Korea aspiring to transforming itself into one of the top seven pharmaceutical powerhouses organic synthesis, agents and global clinical trials. This ability was gained through development of generics Korea has designated the pharmaceutical industry as one of the future growth engines, In order to foster the industry, and incrementally modified drugs. Korea is also a leader in the pharmaceutical biological technology the Korean government has been placing emphasis on enhancing growth potential through far-reaching policy area. With fruitful results from R&D including development of the world’s first stem cell therapy and measures, ranging from technology innovation to promoting market transparency, boosting global competitiveness xenotransplantation of pancreatic ducts, Korea is in an advantageous position to be a leader in promising of companies, and establishing infrastructure for sustainable development, Moreover, with knowledge and capacity future industries. The level of therapeutic technologies in cardiac surgery and management, and cervical mustered, the government, industry, medical society, and academic community are devoting themselves to make a leap cancer in Korea is the best among other OECD countries, according to OECD Health Data 2009. forward into global markets.
Korea pharmaceutical industry is shifting its focus from the domestic market to the global market, and the Under the circumstance where the Korean population has been aging rapidly, the Korean government has keen interest world now pays attention to Korean pharmas as successful partners. in the pharmaceutical industry, which serves as a foundation for the quality of life of the public, The government introduced “Accreditation of Innovative Pharmaceutical Company” in 2012, and will reinforce its efforts to support the industry every year with a view to reinventing the nation into one of the top seven pharmaceutical titans.
Introduction of Promotion and Support of Innovative Pharmaceutical Company
Korean Pharmaceutical Market Clinical Trial Capability What Company Can Be an Innovative Pharmaceutical Company? KRW 19 Trillion(USD 18 Billion, '15) Special Act on Pharmaceutical Industry Promotion and Support (enacted in March 2011) serves as the legal foundation to ▶ Seoul, the capital of South Korea, ranks #2 for industry ▶ 1.2% of the World Market(14th) sponsored clinical trials among all cities worldwide('16) designate innovative pharmaceutical companies verified to possess high R&D capacity for new drug development and to ▶ Around 2.9% Average Annual Growth('11~'15) ▶ Korea ranked as 7th in the world for Industry sponsored be globally competitive, Those companies are expected to play a leading role in developing the domestic pharmaceutical ▶ Only 25% MNC dominated clinical trials('16) industry into a future growth engine. (reimbursement price based, '12) ▶ 894 manufacturers(285 for finished drugs) World Class GMP & DDS Technology Accreditation Process The Accreditation Screening Committee conducted written and verbal evaluations on candidate pharmaceutical firms New Drug Release Competency ▶ cGMP & EU GMP standard facilities ▶ Innovative Drug Delivery Systems which met the requirements (Article 2 of the Enforcement Decree of the Special Act: investment volume over a certain ▶ 27 New Drugs, 58 IMD products approved • Film-type Viagra and patch-type Alzheimer's and Parkinson’s level), In the evaluations, the committee assessed candidate companies based on specific requirements, such as R&D ▶ 2~3 New drugs coming out to the market every year drugs developed, etc performance in the past, company’s capacity, vision and investment plan, ethical business practice, etc, The results of the evaluations delivered by the screening committee were finalized after the review carried out by the Committee for Top Class Bio-Pharma Competency High Growth in Export Pharmaceutical Industry Promotion and Support, which is chaired by the Minister of Health and Welfare.
▶ High quality bio products (1st stem cell therapy, 1st ▶ '11~'15, 13.7% CAGR for Drug Export biosimilar approved, 21 biosimilar clinical trials undergoing) • US $2,940M export ('15) Composition of Designated Innovative Pharmaceutical Companies ▶ Stem cell (Clinical trials 2nd, Patent 4th, • General pharma firms [35]: 35 leading firms that have marked high scores in terms of R&D investment as well as # of Researcher 5th, SCI Papers 8th in the world) ▶ researchers, manufacturing facilities, patent and license-out, and overseas market advancing plus ten SMEs that have Stable supply of Vaccines Globalization • Self supply for essential vaccines built on expertise in specialized areas such as development of incrementally modified drugs • 5 premium vaccines in Clinical Trials (Phase 1, (PCV, HPV, Rotavirus, Herpes zoster, Cholera)) ▶ Joining PIC/S (’14) and ICH ('16) • Bio venture companies [8]: firms with relatively low sales but highly competitive technology and creative business ▶ 21 WHO PQ products(vaccine) developed (’16) models ▶ Joint worldwide marketing of K-pharma developed drugs with MNCs • Multinational pharma firms [2]: one local company of an MNC considered outstanding in terms of R&D investment (in National Pharmaceutical R&D Support ® • Boryung’s Kanarb for hypertension (Fimasartan) early clinical trials), local production performance, overseas market advancing, etc. • Celltrion’s Remsima® Inj. (Inflixmab) ▶ Total government healthcare R&D : $400M • Hanmi’s Amosartan® for hypertension and ▶ Total government pharm. R&D : $250M • Esomezol® for esophageal reflux disease List of Companies Certified as Innovative Pharmaceutical Companies [45] ▶ Total MoHW pharm. R&D : $130M • JW’s 3 chamber IV solution (June, 2017) Category Name of Company Boryung Pharm, Bukwang Pharm, Celltrion, Chong Kun Dang Pharm, CJ HealthCare, Dae Hwa Pharm, Daewon Pharm, Daewoong Pharm, Dong-A ST, Dong Wha Pharm, GemVax & Kael, Green Cross, HanAll BioPharm, Handok, Hanlim Pharm, Hanmi Pharm, Huons, Hyundai Pharm, IL-Yang Pharm, Isu Abxis, General pharma firms [35] JW Pharm, Kolma Korea, Korea United Pharm, Kuhnil Pharm, LG Life Sciences, Pharma Research Products, Pharmicell, Samjin Pharm, Samyang BioPharm, Shin Poong Pharm, SK Chemicals, ST Pharm, Taejoon Pharm, Yuhan, Yungjin Pharm Bio venture companies [8] BC World Pharm, Bioneer, Corestem, Crystal Genomics, Genexine, Medytox, ViroMed, Tego Science Multinational pharma firms [2] Korea Otsuka Pharm, Sanofi-Aventis Korea
4 5 Pharmaceutical 7 Phase III Technology Technology Phase II Clinical Trials TM Phase I Preclinical BIONEER CORPORATION Han-Oh Park, Ph.D. Molecular Diagnostic, Genomic New Drug, Genomic Science 34302, Daejeon Korea Daedeok-gu, Munpyeongseo-ro, 8-11, www.bioneer.com Development L/O to Yuhan Corp. L/O to Yuhan BIONEER PROGRAMS Supported by Ministry of Health and Welfare Fund grant · Company · CEO Specialty · · Location Homepage· R&D COLLABORATION PROGRAM R&D COLLABORATION Discovery Programs Immuno-Oncology Yuhan Corp. Immuno-Oncology Yuhan Keloids (SAMiRNA) Psoriasis (SAMiRNA) IPF (SAMiRNA) Solid Cancer (SAMiRNA) Lung Cancer(miRNAs) Skin whitening Dengue Hemorrhagic Fever Bioneer, an innovative biotech company since 1992 since company biotech an innovative Bioneer, R&D Pipeline Bioneer currently is developing SAMiRNA-based drugs various in fields of indications, which include Keloids, IPF, immuno-oncology, cancers, skin whitening and alopecia. Some pipelines have been licensed out to the biggest Koreanpharmaceutical company, and the progresses of the earlystage research are being madethein resources. other research our with internally area, SAMiRNA (Self-Assembled-Micelle-inhibitory-RNA) a nontoxic is RNAi nanomedicine, which allows efficient delivery of siRNA/miRNA to target tissues. SAMiRNA a SCE is (single Chemical Entity), manufactured using the solid phase synthesizer, which greatly simplifies the manufacturing and QC processes compared to other RNAi drug candidates. SAMiRNA overcomes majorchallenges that current oligonucleotide-based therapeutics face, such as insufficient delivery and adverse effects. The advantages of SAMiRNA include its flexibility toincorporate siRNA/miRNA sequences against any disease targets. Pre-clinical research data suggest that SAMiRNA would be the most unique and singularly effective RNAi prodrug system developed to date. The company now is moving forward with the human proof-of-concept. total a provide Program Development Drug siRNA/miRNA Bioneer’s within processes integrated Vertically solution for SAMiRNA therapeutics discovery and development, from high-throughput SAMiRNA™ synthesis, HT RT-qPCR screening and preclinical tests to IND filing. With its world’s-best RNAi core technologies and infrastructure, Bioneer the is ideal partner for pharmaceutical and biotechnology companies currently developingRNAi therapeutics, or seeking to enter the RNAi therapeutics space. Bioneer’s research and technical support teams ensure top-quality products and services to meet unique needs of partners. Established1992in based on proprietaryoligonucleotide synthesis and PCR technology,Bioneer the is first biotechnology company of Korea.The company has developedsingle-molecular RNAinanoparticle, SAMiRNA™, which transforms miRNA/siRNA into novel therapeutics. In line with its root in molecular technologies, the company has also developed enabling instruments such as high-throughput oligo synthesizer, fully-automated real time qPCR instrument, and automatic protein synthesizer. Leveraging these unique capabilities, Bioneer wellis positioned to develop the next generation therapeutics and molecular diagnostics that can serve as uniquely-and fully-integrated drug discovery and development platform. By capitalizing on these foundational technologies developed over the past years, 10 Bioneer leading is the innovative RNAi drugs and molecular development. diagnostics siRNABioneer’s SAMiRNA Program using Development Drug Innovation · Value · Discovery · Value Innovation BIONEER CORPORATION CONTACT US CONTACT Woo Lee,Tae Ph.D., P.I., RNAi Therapeutics Center Research • Phone : +82-42-930-8675 • E-Mail : [email protected] Stage Preclinical Preclinical Preclinical Preclinical Preclinical Formulation Formulation Formulation Formulation Phase I (Korea) Products BPH Diabetes Antibiotic Anti-cancer Anti-cancer Anti-cancer Anti-cancer BCWORLD PHARM. CO., LTD. Steve H. Hong · DDS-oriented Pharmaceutical Company · Therapeutic categories such as pain, anesthesiology, neurology, and musculoskeletal diseases 78 Gaepo-ro 22gil Gangnam-gu, Seoul, Korea www.bcwp.co.kr Indications Schizophrenia Hyperlipidemia Psychostimulant · Company · CEO Specialty · · Location Homepage· Mepem Inj., Cilacin Inj. etc. Merogel Gel, BC Itraconazol etc. Tab., Starova BC Tab., Atorvastatin etc. Tab. Pamiron Inj., Risidro Tab. Ibertan Ibertan Tab., Duo Duomax Tab., etc. Tab. Mucopid BC Tab., Ranitidine Inj. etc. Remiba Inj., BC Morphine Sulfate Inj., BC Fentanyl Inj. etc. Item BCWP_Y001 BCWP_D011 BCWP_P001 BCWP_E003 BCWP_E004 BCWP_C001 BCWP_D001 BCWP_D009 BCWP_D003 BCWP_A001 Narcotics GI AgentsGI Anti-Infectives Hyperlipidemia SR SR GRS Anti-Hypertensives Therapeutic Class Prodrug Liposome Antibiotics (Carbapenem) Antibiotics Anti-Osteoporosis Agents Anti-Osteoporosis Category Combination Microsphere Microsphere Microsphere Microsphere R&D Pipeline Main Products BCWORLD PHARM strives to establish its position as a pioneer in developing value-added pharmaceuticals BCWORLD PHARM strives to establish its position release as well as fast-dissolv- immediate/controlled including technology formulation cutting-edge through invest- proactive of way by formulation depot and system gastro-retentive formulation, combined DDS, ing ments in R&D and strategic alliances. (KIPC) Company Pharmaceutical Innovative Korea as certified been has only not PHARM BCWORLD Recently by Korea Center (ATC) but also designated as Advanced Technology by Korea Ministry of Health & Welfare Ministry of Knowledge Economy. BCWORLD PHARM is a technology-driven pharmaceutical company in is a technology-driven pharmaceutical BCWORLD PHARM development enables in formulation and process Korea whose expertise novel formulation generics as well as value-added it to provide quality products.
GRI : A-3, Korea Bio Park, 694-1 Sampyeong-dong, Seongnam-si, Bundang-gu, Gyeonggi-do, Korea Head Office : 78 Gaepo-ro 22gil Seoul,Gangnam-gu, Korea Myung-Kwan Chun, PhD., Director Research Planning Team • Phone : +82-31-628-0921 • E-Mail : [email protected] • CONTACT US CONTACT Kim,David Director Overseas Business Department • Phone : +82-2-2182-0466 • E-Mail : [email protected] • PAMIRON INJ. PAMIRON MEROGEL
CILACIN INJ. BCWORLD PHARM. CO., LTD. BCWORLD Towards Global Standard R&D for Healthcare Products R&D for Healthcare Global Standard Towards 6
Pharmaceutical Pharmaceutical 9
Bukwang Pharmaceutical Co., Ltd. Hee Won Sang Yoo, Hoon Kim Pharmaceuticals and sanitary aids Sangdo-ro,7, Dongjak-gu, Seoul, Korea http://www.bukwang.co.kr · Company · CEO Specialty · · Location Homepage· cap.(clevudine) as the 4th new drug for hepatitis B in the world and licensed out to cap.(clevudine) as the 4th new drug for hepatitis ® cap.(clevudine) : an innovative new drug for chronic hepatitis B virus ® tab.(R-thioctic acid tromethamine) : a new drug for diabetic neuropathy ® evovir was developed by Bukwang and it is the 4th drug developed for HBV infection worldwide, and the 11thevovir was developed by Bukwang and it is the countries in Asia. with pharmaceutical and bio-venture in partnership candidates new drug innovative is developing Bukwang out multinational clinical trial for an anti-diatetes compound companies in Korea and abroad. Bukwang is carrying a targeted anti-cancer drug with LSK US, and co-developing together with Melior Pharmaceuticals in the disease disorder in Parkinson’s movement for candidate a novel in licensed Also, Bukwang US. the in BioPartners Bukwang acquired recently. patients from Contera Pharma in Denmark, which R&D in order to sustain new drug developmentwith the aim of Bukwang are planning to continue investment in improving global health. Bukwang Pharmaceutical Co., Ltd. is one of the innovative pharmaceutical Co., Ltd. is one of the Bukwang Pharmaceutical dedication to development and was founded in 1960 with companies in Korea of novel, outstanding medicines.and commercialization Dexid R&D Pipeline MLR-1023: insulin sensitizer in type 2 diabetes kinase - Lowering blood glucose level by activating Lyn FDA IND - Phase 2a clinical trial currently ongoing in US and Korea, under US FDA and Korea JM-010: candidate for levodopa-induced dyskinesia in Parkinson’s disease patients - Controlling neurotransmitter release from the presynaptic neurons - Completed phase 2a proof-of-concept clinical trial in South Africa Apatinib mesylate: targeted anti-cancer agent known to be involved in - A small-molecule targeted anti-cancer therapy which selectively inhibits VEGFR-2, angiogenesis of tumor cells is planned - Phase 3 clinical trial in Korea to validate efficacy as 3rd line gastric cancer treatment JM-012: candidate for morning akinesia in Parkinson’s disease patients - A special formulation under development to control absorption of L-dopa Bukwang has successfully achieved remarkable growth for over fifty years. Bukwang achieved US$120 million as Bukwang has successfully achieved remarkable of financial year 2016. Bukwang developed Levovir Products Levovir L B virus and it has excellent safety and tolerability profiles. newdrug in Korea. It is potent in suppression of hepatitis Dexid was developed by Bukwang and it is a new drug for diabetic neuropathy. It only contains R-thioctic acid which drug for diabetic neuropathy. Dexid was developed by Bukwang and it is a new exerts better antioxidant effect than S-thioctic acid. To Contribute to Society through Supplying Value-added New Products to New Products Value-added through Supplying to Society Contribute To from disease Suffering Help Patients Ltd. Pharmaceutical Co., Bukwang Phone : +82-2-8288-114 E-mail : [email protected] Levovir CONTACT US CONTACT • • Launch RG ○ PIII PII I P ○ ○ ○ ○ ○ PC ○ ○ ○ ○ RS Boryung Pharmaceuticals co., Ltd. Hong,Tae Choi Full ingredient Pharmaceutical product and substance 136, Changgyeonggung-ro, Chongro-ku, Seoul www.boryung.co.kr with Mexico and 12 other Latin countries (already with Mexico and 12 other Latin countries (already ® BKC 007 BKC 005 BKC 006 BKC BKC 004 BNT 002 BNT 003 BCB 002 BCN 004 BVN 002 BVN 003 Product · Company · CEO · Specialty · Head Office Homepage· NHL Vaccine Vaccine Indication Liver cancer Hypertension Alzheimer's disease Alzheimer's disease by our proprietary technology. After its launch in March 2011, Kanarb recorded Kanarb 2011, March in launch its After technology. proprietary our by ® Hypertension Diabetes Hypertension Hypertension Hyperlipidemia Hypertension Hyperlipidemia CV AN CNS Therapeutic area Biologics (Fimasartan) ® IMD NCE Category 10 million USD sales in the same year, and 18.2 million USD in 2012, 21.8 million USD in 2013 and 34.5 million and 10 million USD sales in the same year, was also recognized for its clinical value in Mexico, which is USD in 2014, making it the No. 1 ARB in Korea. It prescription in Mexican as 1st in cardiologist’s ranked and a country with the highest obesity index worldwide, ARB market in 2015 just a year after its launch. licensed-out Kanarb Boryung has successfully Until now, Boryung has developed Kanarb developed has Boryung R&D Pipeline Products Kanarb Boryung Pharmaceuticals strives to be a company which will continuecompany a be to strives Pharmaceuticals Boryung by preparing for the to the health of mankind’ to practice ‘contributing on challenges with innovation.future and taking high- produce to efforts continuous made and development and research on continually invested has Boryung antineoplastic and antibiotics drugs. As a result, quality products in the specialty areas such as cardiovascular, Megace have become the best selling products and Astrix and our products such as Gelfos M, Yongkaksan, brand in Korea. Boryung has emerged as the most familiar and trusted approved in Mexico, Ecuador, Honduras, Costa Rica, El Salvador, Panama, Colombia), Russia, China and 13 Rica, El Salvador, Honduras, Costa approved in Mexico, Ecuador, Europe, USA, Japan, with discussions licensing business under are we Also countries. Asian Southeast Australia etc. Kanarb Combination drugs Plus in 2013, the Kanarb lineup has extended to other drugs After launching HCTZ combination drug, Kanarb launched in August 2016. A hyperlipidemia combination starting from the Amlodipine combination drug, Dukarb Another hyperlipidemia is also to be launched in December. fimasartan + rosuvastatin) drug (Tuvero, in 2019. combination drug and ARB+CCB+hyperlipidemia combination drug will be launched
[email protected] : 120mg fimasartan 60mg fimasartan Molecular Structure R&D planning team MinJihyun • Phone : +82-2-740-4019 • Contact Information Boryung Pharmaceutical co., Ltd. Boryung Pharmaceutical Lifetime care company Lifetime 8
Pharmaceutical Pharmaceutical 11 A ○ ○ PhIII ○ ○ ○ PhII ○ ○ ○ ○ ○ PhI ○ ○ ○ ○ ○ ○ NC R Chong Kun Dang Pharmaceutical Corp. Young-Joo KimYoung-Joo R&D of new medicine and incrementally modified drug (IMD) Korea Seoul, Seodaemun-gu, Chungjeong-ro, 8, www.ckdpharm.com Cancer Anemia Glaucoma Expectorant Solid cancerSolid Neutropenia Dyslipidemia Dyslipidemia Colon cancer Indication Auto-immune Gastric disorder President & CEO & President Multiple myeloma Multiple · Company · · Specialty · · Location Homepage· Pain, Uremic Pruritus Hypertension/Dyslipidemia Neurodegenerative disease Age-related Macular Degeneration Macular Age-related CKD-519 CKD-516 CKD-701 CKD-702 CKD-351 CKD-841 CKD-581 CKD-333 CKD-508 CKD-506 CKD-504 CKD-497 CKD-495 Project CKD-943* CKD-11101 CKD-12101 CNS Others Oncology Immunology CV Metabolic & Therapeutic area * CKD-943 is an in-licensed product from Cara Therapeutics Inc. Chong Kun Dang Pharmaceutical Corp. (CKD) was established in 1941 with Pharmaceutical Corp. (CKD) was Chong Kun Dang to is dedicating its efforts the best quality medicines and a goal of supplying health and quality of life. for improving human develop novel therapeutics R&D Pipeline Products Chloramphenicol palmitate and sterile ChloramphenicolIn 1968, CKD obtained US FDA approval for Chloramphenicol, FDA approval for raw materials in Korean pharmaceutical industry. sodium succinate. It was the first commemorative US for raw materials such as Oxytetracycline hydrochloride,In addition, CKD has gained additional US FDA approvals CKD is one of the first Korean pharmaceutical and etc. Remarkably, Rifampicin, Demeclocycline Tetracycline, 1970's to develop novel technologies and therapeutics. Throughcompanies to establish a R&D center in the early CKD has launched various products such as Lipilou, Dilatrend,a long history of its own research and development, including Cardiovascular Metabolism diseases and Immuno-suppressant. in different therapeutic areas and Tacrobell in research and development, CKD has successfully launchedInvesting over 12.3% of its revenue (as of 2016) IMDs and fixed dosevarious for diabetes and developed Duvie and cancer for therapeutics, Camtobell novel two CKD is currently under business licensing and Dilatrend SR. Especially, Cantabel combinations such as Telminuvo, discussions to explore overseas markets. Global R&D trials for NCE development. CKD-519, a CETP inhibitor for Currently CKD has opened several global clinical trial in Australia and CKD-506, a HDAC6 inhibitor for treatment treatment of dyslipidemia is under phase II clinical trial in Europe since 2016. of autoimmune disease is under phase 1 clinical trial in US for CKD-504, a BBB-penetrating HDAC6 inhibitor In 2017, CKD is also planning to open phase 1 clinical disease and alzheimer's disease). treating neurodegenerative disease (huntington‘s BINT Medicine R&D Corporation for Terminal Illnesses for Terminal R&D Corporation BINT Medicine Technology) Bio-Info-Nano (BINT: Pharmaceutical Corp.Chong Kun Dang Tab. Anti-Diabetic agent Tab. ® CONTACT US CONTACT Business Development Team • Phone : +82-2-2194-0441 • E-Mail : [email protected] Lipilou tab., anti-hyperlipidemic agent Camtobell inj., anti-cancer agent Duvie
® Current Status Rabies - Approved by MFDS in 2012 (Republic of Korea) - Approved by EMA in 2013 (Europe) - Approved in 67 countries as of December 2015 - Submitted MAA for EMA approval (Europe) - Approved by MFDS in 2014 (Republic of Korea) Major Indication Breast Cancer (ADC) - Influenza virus infection - Celltrion, Inc. Celltrion, HyoungkiWoosungKee, Kim Biopharmaceutical development and manufacture 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Korea www.celltrion.com and InflectraTM(CT-P13) in Europe, is a biosimilar monoclonal and InflectraTM(CT-P13) ® (infliximab), which is an anti-inflammatory medicine that has been (infliximab), which is an anti-inflammatory medicine that ® Indication · Company · CEO Specialty · · Head Office Homepage· CT-P27 CT-P26 CT-P19 litis, Psoriatic arthritis, Psoriasis Rheumatoid arthritis, Adult Crohn’s disease, Rheumatoid arthritis, Adult Crohn’s disease, Ulcerative colitis, PaediatricCrohn’s Paediatric ulcerative colitis, Ankylosing spondy Non-hodgkin’s Lymphoma, Chronic lymphocytic Chronic lymphocytic Lymphoma, Non-hodgkin’s leukaemia, Rheumatoid arthritis, Granulo matosis with polyangiitis and microscopic polyangiitis Early breast cancer, Metastatic breast cancer, Metastatic breast cancer, Early breast cancer, Metastatic gastric cancer Infliximab Rituximab Project Trastuzumab Target (INN) Target ® TM TM Novel therapeutics Product Truxima Remsima Herzuma antibody developed to be comparable to an already approved biological medicine (also known as the reference product). Theantibody developed to be comparable to an already approved reference product for biosimilar infliximab is Remicade which is the world’s firstwhich biosimilarmAbis tothe receiveworld’s approval from a regulatory agency in coupled with a passion for patient well- expertise, a developed country.Celltrion’sR&D allowed the Company to enter into this highlybeing, is a unique set of capabilities that challenging space. Also, Antibody-Drug Conjugate (ADC) technology and Fc Engineering technology is incorporated to develop bio-better treatmentsis technology Engineering Fc and (ADC) technology Conjugate Also, Antibody-Drug has completedand novel biological drugs such as an antibody for influenza virus infection. The proposed treatment for influenza its global phase I study and is in preparation stage for clinical phase II study. Celltrion focuses on promoting the health and welfare of patients in need of innovative biopharmaceutical products throughCelltrion focuses on promoting the health and welfare state-of-the-art technologies, and establishing quality systems. world-class manufacturing and research facilities, developing Products & Pipeline Biosimilar infliximab, also known as its brand name Remsima Based in Incheon, Republic of Korea, Celltrion, Inc. is a global biopharmaceutical leader of Korea, Celltrion, Inc. is a global Based in Incheon, Republic in biosimilar monoclonal and development (R&D) capabilities with strong research areas, including oncologyand novel drugs for various therapeutic antibodies (mAbs) approval for Remsima EMA Celltrion previously received and autoimmune diseases. approved in Canada, Japan and throughout Europe for the treatment of inflammatory conditions including Crohn's Disease,approved in Canada, Japan and throughout Europe for colitis, rheumatoid arthritis, ankylosing spondylitis, psoriaticpediatric Crohn's Disease, ulcerative colitis, pediatric ulcerative psoriasis and plaque psoriasis. (TNF-alpha), which tumor necrosis factor-alpha has been designed to attach to Infliximab, the active substance in CT-P13, biosimilar infliximab improves inflammation and other diseaseis involved in causing inflammation. By blocking TNF-alpha, product. infliximab was approved by the EMA for all indications of its reference symptoms. In 2013, Celltrion’sbiosimilar infliximab was filed in August 2014 and was based on a comprehensiveThe Biologics Licensing Application (BLA) for biosimilar data, nonclinical data, clinical pharmacology and clinical efficacydata package inclusive of foundational analytical biosimilarity the first biosimilar monoclonal antibody in the U.S. and safety data. If approved, biosimilar infliximab will be
Remsima™
CONTACT US CONTACT Celltrion Headquarters : +82-32-850-5000• Phone : +82-32-850-5057• Fax • E-mail Business : [email protected] Investment : [email protected] :[email protected] Celltrion, Inc. A Global Technology Leader in the Field of Leader Technology A Global Drug Development and Biologic Biosimilar 10
Pharmaceutical Pharmaceutical 13 based on ® Remarks Release(2015.1) Approval(2014.7] • • approval IND (Phase 2016.6) 1, approval IND (Phase 2015.5) 1, NDA Market authorization Clinical IND IND IND Details inj., which contains autologous bone marrow- bone autologous contains which inj., ® IIT(ongoing) Preclinical projet (completed) projet CORESTEM Inc. Kyung Suk Kim Chang & Jin Tae Seongnam-si, Bundang-gu, Pangyo-ro 255beon-gil, 24, Korea Gyeonggi-do, http://CORESTEM.com/en/ is stema cell-based therapy product that induces a Government funded R&DGovernment funded ® Basic Reseach President & CEO & President · Company · · Location Homepage· disease-modifying treatment effect amyotrophic in lateral sclerosis, thereby alleviating deteriorating physical functions in patients. NEURONATA-R ALS (CNS) (CNS) Indication atorphy(CNS) Multiple system Anoxic brain injury (Muscular skeletal) OA/cartilage defect Lupus (Autoimmune) ® Project Allogenirc Allogenirc Allogenirc Autologous chondrocyte derived MSC derived derived MSC derived bone marrow-bone bone maarow- bone
® Product Inj is an Autologous Bone Marrow-Derived Mesenchymal Stem Cell therapy for amyotrophic lateral Inj is an Autologous Bone Marrow-Derived Mesenchymal ineffect treatment disease-modifying a induces that product therapy cell-based stem a is inj., ® ® NEURONATA-R CS10BR05 CS20AT04 CS30MS02 NEURONATA-R Therapeutic area derived mesenchymal stem cells, has effect of improvement of the functional decline through anti-inflammatory andderived mesenchymal stem cells, has effect of improvement neuron death, and prolongation of motor neuron in ALS patients.immune modulatory effects, inhibition of motor NEURONATA-R R&D Pipeline We developed the stem cell therapeutic product for ALS (Amyotrophic Lateral Sclerosis) for the first time in the world, product for ALS (Amyotrophic Lateral Sclerosis) developed the stem cell therapeutic We in July 2014 and began medication Ministry of Food and Drug Safety medicines by Korea’s received the permission of to patients in February 2015. was successful in development of NEURONATA-R By following a strategic development plan, CORESTEM Products NEURONATA-R CORESTEM is a bio-pharmaceutical company that has developing and a bio-pharmaceutical company CORESTEM is diseases. therapy for the treatment of incurable producing stem cell research and outstanding technological skills. reflect our unparalleled technological expertise that is PLUS CellCORESTEM develops stem cell therapy products that treatment efficacy and deliver the best curative value of our products, we In order to maximize and EfficHigh Tech. Tech element technologies that are required for commercialization. select the most suitable stem cells and fully internalizing to make another leap forward to become a specialized globalCORESTEM Inc. is focusing all our energy and resources biopharmaceutical firm. sclerosis. MSCs are capable of differentiating into various cells that constitute the human body; they also secretesclerosis. MSCs are capable of differentiating into NEURONATA-R cytokines. anti-inflammatory and factors neuro-trophic deteriorating physical functions in patients amyotrophic lateral sclerosis, thereby alleviating
Leading Stem CEll Therapy Products, CORESTEM. CEll Therapy Leading Stem Inc. CORESTEM ® CONTACT US CONTACT Sarah Yon Hui Kim, Business Development Group. Executive Director • Phone : +82-70-4707-3544 • E-Mail : [email protected] In-young Chang, Business Development Team, leader Team • Phone : +82-70-4706-9780 • E-Mail : [email protected] NEURONATA-R can help to ® Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Partnering availability Southeast Asia ® ® MKT NDA I.V. solution bag is convenient to use for I.V. PIII ® I.V. solution bag is convenient to use for I.V. ® PII Clinical Trial , HONGSAMJIN GOLD PI is safe and effective in treating anemia of hemodialysis ® ® PC Details DS (Cefpodoxime) tab. & dry syrup, CONDITION ® is a winter drink with an authentic red wine and Korean honey, boasting of sweet and smooth flavors. is a winter drink with an authentic red wine and Korean honey, is an outstanding energy drink produced with 6-yeared red ginseng. ® ® is a healthy natural and zero-calorie beverage with pure and mild flavors. Target Indication Target ® has been launched in 1992 creating a new market of hangover relief drink in Korea. has been launched in 1992 creating a new market of hangover relief drink in Korea. contains the goodness of Hovenia dulcis with its function of liver protection. ® ® Lipid is parenteral nutrition IV solution bag for supplying energy, essential fatty acids and omega-3 fatty acids to patients. Lipid is parenteral nutrition IV solution bag for supplying energy, Amino acid and Glucose to patients. Peripheral is total parenteral nutrition (TPN) IV solution 3 chamber bag for supplying Lipid, is the best choice for MRSA & MRSE. Hand, Foot & Mouth Disease Gastric Acid-Related Disorders IBS-C, NASH Arthritis Rheumatoid Type 2 Diabetes / Hyperlipidemia Hypertension Hypertension/ Hyperlipidemia Hypertension Hyperlipidemia / of Prevention Hand, Foot & Mouth Disease Cancer Renal Anemia ® Inj. is an injectable drug used for the treatment of colorectal cancer ® ® was developed 1st in Korea and 3rd in the world. Epokine has excellent antibacterial effects on MRSA, MRSE and Enterococcus. ® ® Inj. is a chemotherapy RTU (ready-to-use) injectable drug for the treatment of pleural esothelioma and non-small cell lung cancer. Inj. is a chemotherapy RTU (ready-to-use) injectable drug for the treatment of pleural esothelioma ® ® ® CJ HealthCare corporation CJ HealthCare Seok hee Kang ETC (CVs, Antibiotics, IV Solution, Oncology, Endocrinology, Nephrology&Urology, GastroIntestinal, Musculo skeletal,Respiratory, Others) & Health functionalproducts CJ CheilJedang Center, 330, Dongho-ro, Jung-gu, Seoul 100-400, Korea www.cjp.co.kr Description doctors and nurses in hospitals Calmtop CONDITION doctors and nurses in hospitals. As the treatment of vancomycin-resistant Enterococcus faecium infections, Cinezolid Tapocin PEMTA HongSamJin Gold As a fourth-generation synthetic fluoroquinolone antibacterial agent, Moveloxin Saessak Boricha Epokine - Honey Vin Chaud - Honey Vin HutGaeSoo OmapOne OmapOne support their natural defenses during strong chemotherapy. Vancorin patients with end-stage renal disease. cause the Neutropenia. Leukokine Chemotherapy in advanced cancer patients and in acute Leukemia patients can Molecule , HONGSAMJIN, · Company · CEO · Specialty Business · Head Office Homepage· ® Tegoprazan Small molecule Small molecule Atorvastatin, Metformin Candesartan, Amlodipine Valsartan, Amlodipine, Rosuvastatin Valsartan, Amlodipine, Atorvastatin Vaccine Ranibizumab biosimilar Pemetrexed solution Pemetrexed Darbepoetin alfa biosimilar Product Pipeline CJ-12420 CJ-14199 RA CJ-30056 CJ-30059 CJ-30060 CJ-30061 CJ-40010 CJ-40012 CJ-30045 CJ-40001 IMD NCE OmapOne Peripheral Inj. bag (Lipid, Amino acid, Glucose) OmapOne Lipid Inj. bag (Fish/MCT/Soybean/Olive oil) SoutheastAsia EPO, - G-CSF, VancomycinInj., Inj., Teicoplanin Ciprofloxacin Inj., Moxifloxacin Inj.,Irinotecan, Linezolid Inj., Entecavir tab., Ceftriaxone Inj., Ceftazidime Inj. CONDITION Biologicals 7. Calmtop Inj. (Irinotecan) 10. 11. CONDITION (Hangover relief drink) 6. Cinezolid I.V. solution bag(Linezolid) 6. Cinezolid I.V. 4. Tapocin Inj. (Teicoplanin) 4. Tapocin 8. Pemta Inj. (Pemetrexed) 12. HongSamJin Gold (Red Ginseng drink) 5. Moveloxin I.V. solution bag(Moxifloxacin) 5. Moveloxin I.V. 14. Saessak Boricha (Barley sprout Tea) 1. Epokine Inj. (rh-EPO) 15. Chaud (Boiled wine with citrus fruits) Honey Vin 13. HutGaeSoo(Thirst –quenching tea drink) 9. 3. Vancorin Inj. (Vancomycin) 3. Vancorin 2. Leukokine Inj. (rh- G-CSF) R&D Pipeline DS: Discovery, PC: Preclinical Studies, MKT: Market, IMD: Incrementally Modified Drug Global Business China - CONDITION1. 2. Japan - Cefozopran, Cefotiam, Cefmenoxime, Banan 3. 4. The Middle East, Africa and CIS - EPO, G-CSF, Vancomycin Inj., Levofloxacin Inj., Ciprofloxacin Inj., Ceftriaxone Inj., Cefotaxime Inj. 5. Latin America - EPO, G-CSF, Vancomycin Inj., Inj Teicoplanin Products Heal the World, Better Life the World, Heal HealthCare CJ CJ HealthCarestarted its business as Pharmaceutical Division in CJ CheilJedang in 1984. On the of2014, April 1st it was launched as a pharmaceutical-dedicated affiliate of CJ Group in order to grow into a global leading pharmaceutical company through quick responses to the ever-changing climate of the pharmaceutical industrywell as aggressive as investment R&D in activities. CJ HealthCare developing is new drugs indicated for treatment of digestive or inflammatory diseasesbased and cancers, on its own distinguished R&D capabilities. At the same time, it also is sparing no effort to conduct constant R&D activities for the 2nd-generationvaccines, EPOs and developing is and cutting edge incrementally modified drugs (IMDs) and combinations with a focus on chronic diseases including circulatory and endocrine disorders.
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(Mr. Donghee Lee) [email protected] [email protected] (Dr. Sun Park)
Floor 6 Le Thanh St., Ton District th 1, HCMC1, Vietnam • TEL: +84 - 8 - 3911 – 5114 • E-MAIL: [email protected] (Mr. Minki Ku) Vietnam branch office 15 CJ Europe GmbH Ober der Roeth 4 65824 Schwal Germany bach, • TEL: +49 - 6196 - 590128 • FAX: +49 - 6196 - 45418 • E-MAIL: [email protected] (Dr. Young Sun Lee) CJ Japan Corp. 2-7-4, CJ Nishishinbashi, Bldg, 8F, Minato-ku, Tokyo, 105-0003, Japan • TEL: +81-80-1249-0427 • FAX: +81-3-3580-1055 • E-MAIL: [email protected] (Mr. Sungbin Cho) China branch office 12ceng, yidigang yizuo, 20hao, Beijing, Chaoyangqu, Jiushanqiaolu, China, 100016 P.C • TEL: +86 -138 - 1046 - 2758 • E-MAIL:
Contact Information CJ HealthCare, Korea(Headquarters) CJ CheilJedang Center, 330, Dongho-ro, Jung-gu, Seoul 100-400, Korea • Tel: +82-2-6740-2186 • FAX: +82-2-6740-2492 • E-mail: CJ HealthCare Corp. CJ HealthCare Big leap to global pharmaceutical company to global pharmaceutical Big leap 12
Pharmaceutical Pharmaceutical 15 oral paclitaxel solution which oral paclitaxel st (Codename: DHP107), it is world 1 is world it DHP107), (Codename: ® Dae Hwa Pharmaceutical Co. Ltd. Eun-Seok Kim / Byung-Tae Noh Products Medicinal (Seoul Office) 2145 DaeHwa Bldg., Nambusunhwan-ro, Seocho-gu, Korea Gangwon- Hoengseong-gu, Hoengseong-eup, 495, Hanu-ro, site) (Manufacturing do, Korea www.dhpharm.co.kr · Company · CEO Specialty · · Location Homepage· project of DHLASED was Liporaxel project of DHLASED st was approved by MFDS on Sept. of 2016 as new IMD product. Also, by using this DHLASED, lots of new was approved by MFDS on Sept. of 2016 as new market. projects are on-going development for the future ODM/OEM TDDS market share, also controls more over 70% of the domestic And for the TDDS field, DAEHWA reputation by quality. keep in growing the market existence with good domestic pharmaceutical technology. has been providing signpost in the every step of development of DAEHWA accomplished advancement of investment strategy And to prepare the age of limitless competition, DAEHWA of advanced countries. in R&D of new pharmaceutical products by building a global system at the level is on-going diversify the business area to the plastic surgery cosmetics and medical devices Also, DAEHWA as DH- and other new business to be the global corporation. Also, has the 4 subsidiary company named (Hospital IT Horim (Pharmaceutical whole-saler), RedoxBio (API synthesizing, and HA related products), SMED (Pharmaceutical and cosmetics with peptide technology and others). service) and C-Tri DAE HWA has developed all kinds of medicines ranging all kinds medicines from ulcer peptic of has developed HWA DAE adult treatments and cancer, a assistant including to preventive medicines disease, etc.related Ever since, have continued to attain established in1984, was a robust mid-sized innovative company. DAEHWA company with continuous trade surplus in the global market. strong growth and have sprang to a global biotech 150 pharmaceutical products, and currently produces about As listed on KOSDAQ (Since 2003), DAEHWA of Food and Drug Safety). Also, exporting more over approved products are around 300 from MFDS (Ministry it will be expanded to the more over 40 name for 20 countries, furthermore, 60 products with its multi-brand by multi-brand names. countries with 100 kinds of products in the world Asia, South America and Africa, then newly main overseas markets are South-eastern DAEHWA’s Currently, so would be extended its business area to the whole world. launched products in Eurasian countries and USA, manufacturing finished product from as the specialized pharmaceutical company has technology of DAEHWA specialized in DDS (Drug Delivery System) technology field. active pharmaceutical ingredients, also, especially call it as DHLASED (Dae Hwa Lipid-bAsed Self- newly developed platform technology DAEHWA Firstly, or non-absorbable non-soluble turning be would this technology technology), Drug delivery Emulsifying medicines to well soluble and absorbable medicines. 1 The Healthful WORLD, Dynamic DAEHWA! WORLD, Dynamic Healthful CO., LTD PHARMACEUTICAL DAE HWA Tel: 82-2-6716-1073 e-mail:[email protected] Tel: 82-2-6716-1074 e-mail:[email protected] Tel: 82-2-6716-1071 e-mail:[email protected] Tel: 82-2-6716-1072 e-mail:[email protected] Regulatory Affair • Claire Kim • Rachel, Cha CONTACT US CONTACT Overseas Business • Hanwoong, Seo • Paul Cho Resnalin patch Kebanon plaster Rivamensa Patch Loxona Cataplasma DDL Plaster soft cap. Top-Roll
Ph III Ph II Ph I Preclinical Staph aureus Preclinical CrystalGenomics, Inc. Joong Myung Cho, Ph.D. Discovery and Development of Novel Therapeutics Novel of Development and Discovery Korea A Tower, 5th Bio F., Park, 700 Daewangpangyo-ro, Bundang-gu, 463-400 Gyeonggi-do, Seongnam-si Korea www.crystalgenomics.com DEVELOPMENT STATUS: Discovery Specialty Business · Company · CEO · · Head Office Homepage· MDS MDS MRSA Indication AML, MCL, CLL Immuno-Oncology Pancreatic cancer cancer Pancreatic Out-licensed to Aptose Biosciences (NASDAQ: APTO) in a licensing deal worth potentially up to $303 million (June 2016)
Fab I inhibitor (enoyl-[acyl-carrier-protein] (ACP) reductase) Fab I inhibitor (enoyl-[acyl-carrier-protein] HDAC inhibitor inhibitor Dual BTK-FLT3
Dual Cyclooxygenase-2 and Carbonic Anhydrase Inhibitor Dual Cyclooxygenase-2 and Carbonic Anhydrase Area Cancer Cancer Cancer Cancer Cancer Cancer AML, MCL & CLL ABSSSI and other serious infections associated with ABSSSI and other serious infections associated MDS, etc.) and Hematologic Cancers (Pancreatic Cancer, Solid Tumors Various Osteoarthritis
: Phase 1b/2 clinical trials ongoing for pancreatic cancer and MDS Phase 2a completed (USA) Approved in Korea (2015) Infectious Disease
Acelex (polmacoxib) is a novel NSAID with a unique mode of action, approved for the relief of signs and symptoms ofand signs of for the relief approved of action, unique mode a with NSAID a novel is Acelex (polmacoxib) forpartner commercial CrystalGenomics’ 2015 and is being sold by Dong-A ST, in osteoarthritis. Acelex was launched where TR-Pharm would be agreement with TR-Pharm of Turkey Korea. In 2016, CrystalGenomics had signed a supply and the MENA region. countries covering Turkey responsible for sales and marketing of Acelex in 19 CG400549 is a novel antibacterial its walls, cell bacterial of ingredient an are acids fatty Since synthesis. acid fatty in enzyme essential an (fabI), drug candidate that inhibits enoyl-[acyl-carrier-protein] synthesis is critical for the survival of bacteria. (ACP) reductase CG ‘806 is a once daily, oral, first-in-class FLT3/BTK inhibitor. This small molecule demonstrates potent inhibition inhibitor. oral, first-in-class FLT3/BTK CG ‘806 is a once daily, tyrosine receptor mutations of the and or ITD, duplication, tandem internal (including FLT3 forms of mutant of and represents kinase domain), eliminates AML tumors in the absence of toxicity in murine xenograft models, AML. Likewise, CG’806 demonstrates potent, a potential best-in-class therapeutic for patients with FLT3-driven developed for non-covalent inhibition of the Cys481Ser mutant of the BTK enzyme, suggesting the agent may be CLL and MCL patients that are resistant/refractory/intolerant to covalent BTK inhibitors CG200745 is an anti-cancer agent that deactivates HDAC, an enzyme that catalyzes the histone deacetylation. BasedCG200745 is an anti-cancer agent that deactivates HDAC, an enzyme that catalyzes the histone deacetylation. showedon a series of anti-cancer efficacy tests using various cancer cell lines and xenograft animal models, CG200745 Co. (approved). superior profile when compared to other compounds in the same class of drugs such as Zolinza of Merck & 2 3 1 4 5 DRUG TARGET: DRUG INDICATION: STATUS: TARGET: DRUG DRUG TARGET: DRUG INDICATION: STATUS: INDICATION: PARTNERING STATUS: INDICATION: STATUS: TARGET: DRUG No.
- - - · CG200745 (Potentially Best-in-Class HDAC Inhibitor for Solid Tumors) -
R&D Pipeline · CG400549 (Potentially First-in-Class Fab I Inhibitor for MRSA) CrystalGenomics is developing several drug candidates for various therapeutic areas and has an approved product. CrystalGenomics is developing several drug candidates for osteoarthritis which has been approved by the MFDS of Acelex (polmacoxib) is a next generation NSAID antibiotic for MRSA and other a first-in-class is CG400549, Korea in 2015. The second therapeutic program third therapeutic The U.S. in the study 2a phase a completed successfully had which infections staph serious in studies 1b/2 phase ongoing two with therapeutic anti-cancer targeted molecular a CG200745, is program syndromes (MDS). In addition to the aforementioned programs, Korea for pancreatic cancer and Myelodysplastic stages. in preclinical and discovery CrystalGenomics has several other therapeutic programs Products · Acelex (Polmacoxib, Next Generation NSAID for Osteoarthritis) CrystalGenomics, Inc. is a commercial stage biopharmaceutical company dedicated to dedicated company biopharmaceutical stage a commercial is Inc. CrystalGenomics, the R&D and commercialization of pharmaceuticalsnovel to address significant unmet medical needs in the therapeutic area of infectious disease, oncology and inflammatory headquartered is diseases. The Company and has in a subsidiary in Korea California, traded the on publicly studies, is clinical andit multi-national of the management for U.S. exchange. KOSDAQ · CG026806 (First-in-Class dual BTK-FLT3 inhibitor for AML, MCL & CLL)
Steven Kim, R.Ph., MBA, Business Development Director, : +82-31-628-2720• Phone • E-mail : [email protected] CONTACT US CONTACT CrystalGenomics, Inc. CrystalGenomics, Commercial Stage Biopharma Company with a Robust Pipeline and Proven with a Robust Pipeline Company Stage Biopharma Commercial of Novel Drugs Commercialization in R&D and Record Track 14
Pharmaceutical Pharmaceutical 17 M M M ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ PIII PIII PIII PII PII PII PI PI PI ○ Pre Pre Pre Development Status Development Status Development Status R R R ○ ○ ○ tablet suspension indication Glabellar lines Description Description Antiulcer program Antiulcer Lyophilized powder Lyophilized Spinal fusion device X-ray contrast agent Upper Limb SpasticityUpper Limb 250/300/500mg Tablets fixed dose combination dose fixed fixed dose combination dose fixed Oral fungicidal program fungicidal Oral Dental sinus lifting graft Oral mucositis, spray type Acute wound healing (OTC) chewable tablet formulation Diabetic foot ulcer, spray type Neuropathic pain, Cancer pain Lung cancer, pancreatic cancer pancreatic cancer, Lung PLGA polymer encapsulated depot Pen type injector + Liquid Cartridge Generic of Glibec (100mg: BE, 400mg P1) Daewoong Pharmaceutical Co., Ltd. Wook Jong Lee, small-molecule new drugs, biological drugs, value-added chemical drugs 163-3, Samsung-dong, Kangnam-gu, Korea Seoul, www.daewoong.com Biosimilar, RecombinantBiosimilar, Human Erythropoietin · Company · CEO Specialty · · Head Office Homepage· EGF EPO hGH type MOA MOA BMP-2 Iohexol Imatinib Sildenafil Sildenafil Fungicidal Leuprolide PRS inhibitor Ursodeoxycholic acid Ion channel blocker Dioctahedral smectiteDioctahedral Botulinum toxin type A Olmesartan + Rosuvastatin APA (Acid Pump Antagonist) Ranitidine + Bismuth + Sucralfate Albis URSA Eposis Easyef Code Olostar Nabota Nurigra Dihecta Brand Brand Novosis Luphere Imatinib DWJ205 DWJ209 DWJ208 DWJ206 &D Pipeline Omnipure Caretropin Nurigra Chew Value-added Generics & Generics Generics & Value-added Biologics Daewoong Pharmaceutical is the pharmaceutical company with the No. 1 with the No. Pharmaceutical the pharmaceutical is company Daewoong drugs prescription of market. insales the Korean and innovative pharmaceutical South Korea, Daewoong Pharmaceutical offers high-quality Established in 1945 in Seoul, top market leaders in Korea. products and is one of the providing better health for people through its total dedication toFor over 60 years, Daewoong Pharmaceutical has been for new drug development to meet diverse medical needs andhealthcare. Daewoong has built strong core competency enhance human life. has involved in becoming a global healthcare group byBuilding on our core strength, Daewoong Pharmaceutical mission to have an inspiring with global partners. We operating our foreign branches in SE Asia and by collaborating to improving the quality of life for people worldwide. become a top 50 global healthcare company which contributes The reinforcement of the R&D capacities through the establishment of R&D center in the USA, China focused on developing new chemical entities, biologics,Daewoong Lifescience Research Institute has been and India. APIs. Daewoong has also been studying to find solutionsincrementally modified drugs and high-value added disease as well as other innovative pain disease, Alzheimer’s for the unmet therapeutic needs of neuropathic Daewoong is operating several overseas offices in China, Vietnam, programs like anticancer gene therapy. and has R&D centers in China, India and America.Indonesia, Thailand, Philippines, USA, and India R New Chemical Entities Pharmaceutical Company with the No.1 Company Pharmaceutical Drugs in Korea Prescription Sales of Pharmaceutical Co., Ltd. Daewoong +82-31-270-8576 Ms. Gyeongsug(Kay) Nam, Team Leader, Strategy Planning Team Mr. Doyoung(Brian) Kim, Team Leader, Global Strategy Dept. CONTACT US CONTACT Early Stage Collaboration and License In/Out • • Phone : • E-Mail : [email protected] BusinessGlobal Development and License Out • • Phone : +82-2-550-8112 • [email protected] : Stage Phase III Phase III Pre-clinical Application submitted Daewon Pharmaceutical Co., Ltd. Baek, Seung Ho / Baek, Seung Ryel Drug manufacture and sales 386 Chunhodaero, Seongdong-gu, Seoul, Korea www.daewonpharm.com Epilepsy Indication Hyperlipidemia Hyperlipidemia · Company · CEO · Specialty · Location Homepage· new medicine by KoreanFood and Drug Administration.It is Hyperlipidemia, Hypertension th Project DW8486 DW0929 DW1501 DW10558 NCE Tech. Type Tech. Combination Combination Sustained Release a highly effective NSAIDs for pain relief which has less side effects than existing NSAIDs products. It has been improved further with our incrementally modified drug Pelubi CR tab, a patented technology applied product that controls drug absorbing area. R&D Pipeline Oramin Capsule Oramin World’s favorite multivitamin, Oramin Cap., by Daewon contains high quality Korean Ginseng and royal jelly as sortswell as all of vitamin and minerals necessary for vital daily life. Oramin, our representative global brand, demonstrates the superiority of Korean ginseng over all the world, being ranked first out of multivitamin brands in 4 countries. Pelubi, Pelubi CR tablet (the 12thnew medicine in Korea) The Pelubi tablet, a series of NSAIDs, was developed in the whole process from raw materials to end product onlyby Daewon Pharm and Certificated asthe 12 Products Be a partner who protects healthy life of human beings based on reliability and reliability human on based beings of life a partnerBe healthy protects who customers. trustof Since the establishment in 1958 with a founding idea of “realization of Daewon human health.”, Pharm. Co., Ltd. has made the best efforts for human health and happiness through manufacturing and providing specialized medicines. produceWe reliable and safemedicines by securing world-classmanufacturing facilitiesand superior R&D capabilities. Daewonpharm producesboth vitamins toimprove human healthand other specialized medicine forcirculatory, respiratory, antibiotic, chemotherapy and psychoneurosis uses. can find You information about our products on our website(www.daewonpharm.com). Please visit our website for the details. With its first export to Vietnam in 1994, Daewon Pharm has made eye-opening achievements of exports. Now, we export our products to 40 countries such as China, Latin America, Middle East, CIS, and Africa. Daewon exportingis about 50 products and expanding is its export volume with products such as Pelubi tablet, a new chemical entity, and Oramin Capsule, multivitamin supplement with Korean Ginseng.
Pelubi, Pelubi CR tablet SinHo Choi SinHo • Phone : +82-2-2204-6975 • E-mail : CONTACT US CONTACT Andy Lee • Phone : +82-2-2204-6971 • E-mail : [email protected]
Oramin Capsule Daewon Pharmaceutical Co., Ltd. Daewon Pharmaceutical Reliable Partner for Human Health Partner for Human Reliable 16
Pharmaceutical Pharmaceutical 19 Stage Novosci(MENA) Signed Agreement with DONG WHA PHARM. CO., LTD. Ji Hoon Sohn Antibiotic1) 2) Cancer 3) New Herbal Drug 98, Huam-ro,19F, Seoul, Korea www.dong-wha.co.kr compared to existing quinolone antibacterial asthma Disease Indication breast cancer · Company · CEO · Specialty · Location Homepage· ulcerative colitis Acute Exacerbations of irritable bladder syndrome Chronic Obstructive Pulmonary Korea Project Phase Ⅰ Preclinical Preclinical Preclinical completed Launched in S. pneumoniae and H. influenza Tablet (New Quinolone Antibiotic: Zabofloxacin D-aspartate Hydrate) Project DW1018 DW2005 DW2008 DW2007 ® Zabofloxacin(DW224) Quinolones Antibiotics agents. Best-in-class activity against - Rapid symptom relief compared to Moxifloxacin - Good safety profile: No serious adverse events, no QT prolongation, no phototoxicity, no rash, no dysglycemia - Launched in Korea 2016 in - Signed ‘Distribution and License Agreement’ with Novosci Healthcare MENA (12 regions) in Jan. 17th, 2017. R&D Pipeline Dong Dong Wha Pharm, as first Korea’s and oldest pharmaceuticalthe development is pharmaceutical which industry, pursuingof theultimate goal company, is drugs. new of Whal Myung Su, Korea’s first western-style medicine, by integrating the advantages of Western medicine into the royal court’s secret recipe the first in 1897, year of The Great Korean Empire. Furthermore, many pharmaceutical products such as Fucidin ointment, Lacteol and Pancold A etc., have been developed after Dong- Wha Pharmaceutical Research Institute was founded in 1973. Since present state-of-the-art laboratory building was built in 2010, it now is set to become a global hub for new drug development. The Chungju Industrial Complex (established2009)in equipped is with equipment and facilities that satisfy Current GoodManufacturing Practice (cGMP) Regulations A. D. In addition, of US F. the plant has been evaluated as a world-class pharmaceutical company by the installment of high-tech plant automation system. Utilizing multi-component resources, Dong Whastrategizes to develop numerous superior medicines, the most advanced drugs and new pharmaceutical products. Products Zabolante - Indication : Acute Exacerbation of Chronic Obstructive Pulmonary Disease -
Human & Happiness Human & PHARM. CO., LTD. DONG WHA
® CONTACT US CONTACT Yoon Kyung Kim, Manager, General Global Business Team • Phone : +82-2-2021-9341 • E-mail : [email protected] Zabolante Tobira SKK (JP) Partner Eurofarma, Geropharm Meiji Seika Meiji Seika MSD, Bayer Luye, Alkerme, KR KR US/EU/KR Market US/EU Late Dev. Erectile Dysfunction Erectile Functional dyspepsia Functional US US JP US CN/IN/LatAm/RU Stage JP/EU Early dev. QD EU US JP Acute bacterial skin and skin structure infection Preclinical Dong-A ST Min Seong, Jang / Kang Hyoung, Soo Ethical(ETC) drug specialized company 64, Cheonho-daero, Dongdaemun-gu, Korea Seoul, http://www.donga-st.com(Korean) http://en.donga-st.com (English) Discovery · Company · CEO Specialty · · Head Office Homepage· Indication Wet AMD*** Wet Type 2 diabetes, etc Type Overactive bladder Cancers, etc Breast cancers Reumatoid arthritis Anemia Skin infection Lung infection 2 diabetes Type NASH** Functional dyspepsia Diabetic neuropathy disease Parkinson’s ® 100mg & 200mg 30min. : 1hr to 2 hours before sexual activity, 50mg & 75mg : QD TID before meal TID QD(for 6 days) Prevention of NSAIDs-induced gastritis, Acute&chronic gastritis Acute&chronic gastritis, NSAIDs-induced of Prevention Type 2 Diabete Mellitus Dosage Administration & in the US. Suganon : Evogliptin 5mg, Sugamet XR : (Evogliptin/Metformin) 2.5mg/500mg, (Evogliptin/Metformin) XR : 2.5mg/850mg, Sugamet 5mg, 5mg/1000mg Evogliptin : Suganon Artemisia Argyfolium 95% ethanol viscous ext. 60mg [Eupatilin 0.48~1.44mg, jaceosidin 0.15~0.45mg] Udenafil 50mg, 75mg, 100mg, 200mg Usage & Indications Corydalis tuber & pharbitis seed ext. 30mg Usage & Indications Usage & 200mg Indications phosphate Tedizolid ® Description Anti-VEGF mAb GPR119 agonist M3 antagonist (Novel IO target) Trastuzumab BS Trastuzumab Adalimumab BS Darbepoetin α BS DPP4 inhibitor CCR2/5 antagonist Herbal extracts Herbal extracts Herbal extracts Antibiotics (oxazolidinone) ® / Sugamet XR (Tab/Inj) ® ® ® ® ® ® ® Code DA-3131 DA-1241 DA-8010 DA-4501 DA-3880 DA-9801 DA-9805 Sivextro Suganon Motilitone Suganon Sivextro Stillen Zydena DMB-3111 DMB-3113 Motilitone Cenicriviroc* * In-licensed from Tobira ** Non-alchohlic steatohepatitis *** Age-related macular degeneration Dosage Administration & • • Dosage Administration & Dong-A ST targets to generate KRW 1 trillion of sales by 2020, with 30% contribution from overseasR&D, business. each laboratory In of the Dong-A ST Research Center has set different strategies. The DrugLaboratories Discovery Researchcarries out global R&D, while the Pharmaceutical Product Research Laboratories concentratedeveloping will IMDs. R&D pave will on the way to realize the company’s vision of becoming a “respected and leading global company developing innovative new and 2017 be drugs”, will the year to make a big step forward. Active Ingredients Active Products • Ingredients Active Usage & Indications Dosage Administration & • Ingredients Active Dong-A ST an is Ethical (ETC) drug specialized company within Dong-A Socio Group. Its major business areas are ETC products, overseas business, as well as medical equipments and diagnostics. Dong-A ST has three subsidiaries,Dong-A Participacoes Ltda, Dong-A America Corp. and Dong-A Brasil Farmaceutica Ltda as of the end of Dong-A2015. Participacoes Ltda, a subsidiary in Brazil, was established in 2013 to target new markets by formulating local investment plans and developing new business. Together with Dong-A Brasil Farmaceutica Ltda, a subsidiary company that handles regulatory approvals, marketing, and sales, Dong-A Participacoes Ltda acts as headfor office Dong-A ST Latin in America. Dong-A America Corp. Dong-A is ST’s US sales subsidiary, handling production and sales of Bacchus • Active Ingredients Active Usage & Indications Ingredients Active Dosage Administration & R&D Pipeline An R&D-driven that has industry been leading the healthcare company in years. 80 over for Korea
Deputy general manager, Pricing & Deputy manager, general Public Affairs Team • Phone : +82-2-920-8341 • E-mail : [email protected] CONTACT US CONTACT Hyung-Shik Kang, Pelubi tablet Pelubi tablet Pelubi tablet
Pelubi tablet Dong-A ST An R&D-driven company that has been leading the that has been company An R&D-driven years. for over 80 industry in Korea healthcare 18
Pharmaceutical Pharmaceutical 21 III (KR) (EU, KR) (KR) (EU) (EU, KR) (EU, KR) II Clinical Phase Clinical (EU) I US IND preparation Development Stage Pre- clinical clinical Re- search hyFc is derived from hybridization of non-cytosolic hyFc is derived from hybridization of non-cytosolic Therapeutic vaccine is prepared by introducing antigen Therapeutic vaccine is prepared by introducing Anemia Diabetes Solid tumorsSolid Solid Tumors Solid 2/3 and CIN 3 only Short Bowel Syndrome HPV Persistent Infection Primary Indication Adult Growth Hormone Deficiency Chemotherapy-Induced Neutropenia Chemotherapy-Induced Pediatric Growth Hormone Deficiency Hormone Growth Pediatric Cervical Grade Intraepithelial Neoplasia Cervical Cancer with Checkpoint Inhibitor IL-7 EPO GLP-1 GLP-2 G-CSF Vaccine Compound Bi & Tri specificBi & Tri Long-acting hGH DNA Therapeutic y–Long-actingTechnology: Fc-based Genexine, Inc. Genexine, H.Michael Keyoung, MD, Ph.D & You-Suk Suh, Ph.D Cancer orphan immunotherapy, diseases Korea of 13488, Republic Gyeonggi-do Seongnam-si, Bundang-gu, Bldg.B, Park Bio Korea 700 Daewangpangyo-ro, www.genexine.com GX-I7 GX-E2 GX-H9 GX-H9 GX-G8 GX-G6 GX-G3 hyFc IO GX-188E Product Product munotherapy: Multi Target Target Multi · Company · CEO Specialty · · Location Homepage· Orphan HPV DNA immunotherapy targeting HPV pre-cancer and cancers (cervical cancer and head & neck cancer) via HPV DNA immunotherapy targeting HPV pre-cancer based therapeutic DNA vaccine CD8+ T-Cell and twice- (weekly acting long best-in-class with patients Pediatric and Adult in Deficient Hormone Growth monthly) growth hormone in Phase II in EU & KR Autoimmune disorders Short Bowel Syndrome and Several preclinical assets for orphan diseases, from Biobetter Biobetter Oncology/ Category Immunotherapy Genexine(KOSDAQ, 095700)is a clinical stage biotechnology company focused on the development and a clinical stage biotechnology company focused Genexine(KOSDAQ, 095700)is Our goal is long-acting biologics. novel immunotherapeutics and next generation commercialization of innovative that will transform their lives. to bring to patients medicines drugs for multi-billionproprietary our 2 therapeutic areas with Focus Areas: dollar market 1) Cancer Im - - Long-acting interleukin-7 for cancer immunotherapeutics Diseases:2) Orphan - - Platform Technology hyFc Technolog 1) site-directed mutagenesis. This hybridization combination gives immunoglobulin Fc portions of IgD and IgG4 without of drug candidate and prevents adverse immunogenicity and flexible hinge that minimizes the loss of bioactivity and superior long-acting characteristics less side-effects applicability, by enzymes. hyFc thus has broad cleavage to the drug candidates. Technology: 2) DNA-basedImmunotherapy Vaccine & When administered, it induces expression vector. gene and dendritic cell targeting gene into high-efficiency then eliminates HPV- The killer CD8+ T-cells HPV specific T-cells. antigen-specific immune response and activates infected expressing cells. R&D Pipelines Hybrid Fc (hyFc) Technology & Therapeutic DNA & Therapeutic (hyFc) Technology Hybrid Fc Pioneer Vaccine Genexine CONTACT US CONTACT Planning/DevelopmentBusiness Jin J. Lim, Senior Manager • Phone: +82-31-628-3352 • E-mail: [email protected] Approval Phase III(IND 2014) Phase IIb III a marketing and ® Phase Phase II II Phase I Phase Pre-clinical Pre-clinical Pre-clinical Pre-clinical Pre-clinical kills cancer kills cells to is elicit combined CD4+/CD8+ T ® Pre-clinical GemVax & KAEL Co., Ltd. Sang Jae Kim Developing, Manufacturing, Commercializing Therapeutics Biological Korea Gyeonggi-do, Seongnam-si, Bundang-gu, Unjung-ro, 146 www.gemvax.com Screening · Company · CEO Specialty · · Head Office Homepage· in pancreatic cancer has been investigated and confirmed number in of ® Disease Indication Hyperplasia Inflammation Viral Infection Ocular Disease Prostate Cancer Benign Prostatic Pancreatic Cancer markedly prolonged the survival a group in ofpatients having high serum eotaxin level were confirmed in over 1,000 patients. The key finding obtained from trial the TeloVac Neurodegenerative Alzheimer’s Disease Urogenital Disorders ® ® TM is the is “first-in-class” immunotherapeutic drug for the treatment of patients with pancreatic cancer. a Peptide is drug derived from human telomerase that abundantly is expressed in most of human ® ® GV1001 Novel Peptide Novel Description (>81.02pg/mL). manufacturing authorization Korea in as a treatment of locally advanced or metastatic pancreatic cancer patients whose serum level higher is than 81.02pg/mL combination in with Gemcitabine/Capecitabine. RIAVAX cell responses, thereby inducing tumor eradication as well as long term memory. The safety and efficacy/ Immunogenicity of RIAVAX Completed Planned On-going R&D Pipeline Products RIAVAX GemVax & KAEL Co., Ltd. is an innovative company dedicated to innovative company dedicated Co., Ltd. is an & KAEL GemVax of immunotherapeutic and commercialization research, development, drugs. drug and peptide-based In September 2014 Korean 15, Ministry of Food and Drug Safety (MFDS) granted RIAVAX cancers. Briefly, the mechanism by which RIAVAX previous thirteen clinicaltrials. In a large-scale phase the triallll safety TeloVac, andimmune-modulating effect of RIAVAX was that RIAVAX
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® Jiyeon Yoo, Deputy General Manager, Planning & Management • Phone: +82-2-544-3221 • Fax: +82-2-3443-4997 • E-mail : [email protected] Contact Info
RIAVAX GemVax & KAEL Co., Ltd. & KAEL Co., GemVax A Global leader in innovative drug development leader in innovative A Global 20
Pharmaceutical Pharmaceutical 23 Information HanAll BioPharma Co. Ltd. SungwukDr. Kim SeungkookDr. Park Oncology1) & Fibrotic Disease 2) Infectious Diseases 3) Immunology 4) Endocrinology Sincheon-dong,11-10 Songpa-gu, Seoul, Korea www.hanallbiopharma.com · Company · CEO Specialty · · Location Homepage· HL009, adenosylcobalamin liposomal gel, has three different potential mechanisms of actions for the also it dermatitis; (NO) which causes HL009 can bind to nitric oxide dermatitis. treatment of atopic From an immunology synthase (iNOS) to further reduce NO levels. nitric oxide can inhibit inducible perspective, HL009 can activate T regulatory cells which excrete IL-10 and TGF-beta suppressing immune response. Adenosylcobalamin has low permeability through skin due to its large molecular size and relatively topical product utilizing liposomal Thus, HanAll has formulated adenosylcobalamin high hydrophilicity. Benefits of liposomal formulation technology include improved stability, formulation technology. and reduced skin irritation by using lipids with enhanced skin penetration due to increased lipophilicity, proven safety. *KR Phase II (complete) / US Phase II (complete) (Aug. 2013) HL036 is TNF-alpha receptor fragment for the treatment of local inflammatory diseases caused by TNF- by caused diseases inflammatory local of treatment the for fragment receptor TNF-alpha is HL036 anti-TNF drugs’ limitations include small alpha such as uveitis, dry eyes, and AMD. Current systemic to high dosage. Therefore, by utilizing fragment, volume of distribution and adverse drug events due topically administered when distribution of volume greater have will fragment receptor TNF HanAll’s via Furthermore, size. molecular larger having products anti-TNF-alpha marketed currently to compared allow smaller doses and increase the efficacy. protein engineering, HL036 will have greater affinity to will be found in targeted ocular areas when It is anticipated that higher concentrations of HL036 to utilize this unique property of HL036 preventing systemic ADEs. HanAll aims administered topically, solution. for the indication of dry eyes by developing ophthalmic *Preclinical Stage (Aug. 2013) antibodies targeting the Fc Neonatal Receptor HanAll is currently developing fully human monoclonal by IgG autoantibodies. (FcRn) for the treatment of autoimmune diseases caused a salvage pathway that prevents lysosomal FcRn plays an essential role in IgG homeostasis by regulating in the circulation. While FcRn-mediated half-life degradation of IgG, thus contributing to a long half-life pathogens, it also prolongs the serum half-life extension is beneficial for IgG antibody responses against in autoimmune diseases. of IgG autoantibodies and thus promotes tissue damage by blocking FcRn, leading to reduced levels of Hence, HL161 will reduce overall concentration of IgG pathogenic IgG. *Preclinical Stage (Aug. 2013) HL156Can, a mitochondrial primer, is a New Chemical Entity (NCE) targeting cancer metabolism, inhibiting is a New Chemical Entity HL156Can, a mitochondrial primer, depletion, which increases metabolic stress This inhibition leads to ATP mitochondrial OXPHOS system. cells with defected AMPK signaling functionin cancer cells. HL156Can exhibits cytotoxic effect in cancer potential confirmed has HanAll function. signaling AMPK normal with cells cancer in effect cytostatic and HanAll is of selected cell lines. Currently, efficacy of HL156Can to overcome resistance in number xenograft model, Braf V600E inhibitor resistantconducting in-vivo experiments with LKB1 -/- (NSCLC) model. melanoma xenograft model, and lapatinib resistant xenograft *Preclinical Stage (Aug. 2013) HL040, a fixed dose combination product, is composed of atorvastatin and losartan for the treatment of and currently conducting phase III hyperlipidemia and hypertension. HanAll finished the phase I study, trial in Korea and phase I study in US. *KR Phase III (In-progress) / US Phase I (complete) (Aug. 2013) HL009 HL040 HL036 HL161 Product HL156CAN HanAll BioPharma is a R&D-oriented pharmaceutical company, currently HanAllR&D-orienteda is pharmaceutical company, BioPharma (KOSPI). Exchange Stock the Korean listed on R&D Pipeline Innovative Medicines to Improve the Quality of Improve the Quality Medicines to Innovative Human Life Co. Ltd. HanAll BioPharma CONTACT US CONTACT Soonim Lee, Director • Phone : +82-2-2204-1753 • E-mail: [email protected] US BRANCH S. Oh, T. Director : +1-301-738-3980• Phone • E-mail: [email protected] HPI. Inc. 9605 Medical Center Drive, Suite #290 Rockville, MD, 20850 KR KR KR Marketed US NDA/BLA CN US/CA Ph III US Ph II Ph I US CA NC Anthrax Anthrax pertussis Varicella Varicella deficiency deficiency Indication Tuberculosis Tuberculosis Colon Cancer Cancer Colon Hemophilia A Hemophilia Hemophilia A Hemophilia Breast cancer cancer Breast Green Cross Corp. Cross Green Huh, Eun Chul Plasma Derivatives & Recombinant Proteins, Vaccines, ETC& Korea Gyeonggi-do, OTC Products Yongin-si, Giheung-gu, 30beon-gil, Ihyeon-ro 107, www.greencross.com Hunter syndrome syndrome Hunter Hemophilia A & B Seasonal influenza Seasonal influenza Severe infection/PID Severe infection/PID Severe infection/PID Congenital fibrinogen Congenital Tetanus and diphtheria Tetanus, diphtheria and circulating blood volume blood circulating after liver transplantationafter liver Restoration/maintenance of of Restoration/maintenance Prevention of HBV recurrence recurrence HBV of Prevention · Company · CEO Specialty · · Location Homepage· Project GC1107 GC1109 GC1102 MG1111 GC5101B GC1111B GC5111A GC1101D GC1101D GC1118A GC3111A GC5113A GC5107A GC5107B GC5112A GC3107A GC3106A MGAH22 MG1113A GCFLU-Quadrivalent Vaccine Category Plasma Derivatives Derivatives Plasma Recombinant Protein/Ab R&D Pipeline Products Plasma Fractions & Recombinants 1971, Green Cross currently manufactures more than 12 first Albumin production in Starting from the nation’s Recent innovations factors, and anti-thrombin factor. plasma fractions including immunoglobulin, anti-hemophilic recombinant Factor VIII for hemophilia A treatment.include ‘rhFVIII (GreenGene F)’, a 3rd Generation of Vaccines first epidemic hemorrhagic third Hepatitis B vaccine in 1983, the world’s to develop the world’s succeeded We useQuadrivalent was approved for GCFLU in 1988. The quadrivalent inactivated influenza vaccine, fever vaccine single-dose vial was approved in December 2016. in Korea in 2015, and WHO PQ(pre-qualification) for ETC& OTC Medicines medicines in the field of cardiovascular disease, metabolicGreen Cross has provided a broad range of ethical alsowe products), OTC core of our (one with patches hypertensive disease. Along including diabetes, disease dermatology and immunology. have provided OTC products in respiratory, A leading global R&D institute conducting research of plasma- institute R&D of research conducting A leading global antibodies. and therapeutic proteins recombinant vaccines, derivatives, such as vaccines, plasma-derivatives, pioneered in the field of biopharmaceuticals, Green Cross Corp.(GCC) has been well known for the R&D and proteins and therapeutic antibodies. GCC has diagnostics, recombinant first epidemic hepatitis B vaccine, ‘Hantavax’, a world’s biggest selling commercialization of ‘Hepavax B’, a world’s chicken pox vaccine. A complete flu pipeline includes second hemorrhagic fever vaccine, and ‘Suduvax’, a world’s and etc. GCC is also pursuing opportunities in rare diseasesseasonal flu vaccine, H1N1 vaccine, avian flu vaccine In 2015, GCC earned $807 million in revenue recording it asdeveloping therapies for Hunter syndrome (Hunterase). $90 million in R&D (11.2% of Sales).3rd largest Korean pharmaceutical company and invested
HG, Beak manager General Business Development • Phone : +82-31-260-9337 • Fax : +82-31-260-9417 • E-Mail : [email protected] Woo-Jin Lee/Director Overseas Business • Phone : +82-31-260-9370 • Fax : +82-31-260-9491 • E-Mail : CONTACT US CONTACT Devotion to healthy lives of people to healthy lives Devotion Corp. Green Cross 22
Pharmaceutical Pharmaceutical 25 Phase I Phase I Phase III Phase III Phase II/III Pre-phase III Development stageDevelopment
AMD
HANLIM PHARM. CO., LTD. JAE YOON, KIM R&D and manufacturing of API/BPIs, pharmaceutical product 42, 52 Seochodaero, Gil, Seocho-Gu, Seoul, Korea http://www.hanlim.com Indication osteoarthritis Surgery area marker Mixed hyperlipidemia Allergic rhinitis, pruritus Acute/Chronic bronchitis Acute/Chronic Specialty Business · Company · CEO · · Location Homepage· Anti-allergic rhinitis agent (Mometasone furoate 0.5mg, Azelastine HCl 1.4 mg) HL151 HL237 HL-PIF HL217 HL301 HL-LMN Products Anti-osteoporosis agent including VitaminD (Sodium Risedronate 35mg, Cholecalciferol 5,600IU) Digestives (Pepsin 25mg, Papain 50mg, Diastase 15mg, Cellulase 15mg, Pancreatin 50mg, Pancrelipase 13mg, UDCA 25mg) drugs New drugs New Category Incrementally modified modified Incrementally Increase tear production R&D Pipeline With the corporate mission of protecting the precious human from various life protecting the precious of the corporateWith mission the to improve diseases, HANLIMforms endeavored of has consistently the leading of grown one to become have andwe standards people, health of incompanies Korea. completed together with the founding of the central research In 1993, the future-oriented GMP factory was we continue to make a great investment scheme of the company, As a part of the long-term investment center. manufacturing facilities lately to enhance the health of in accumulating advanced technologies and reorganizing mankind as a leading pharmaceutical company. Products [1] T-SPORIN EYE DROPS : Agent for dry eye (Cyclosporin 0.5mg) - - Minimize droplet size by Nano-emulation - Reduced eye irritation [2] NASAFLEX NASAL SPRAY : - Perennial allergic rhinitis [3] RISENEX PLUS TAB : - Treatment and prevention of postmenopausal osteoporosis and prevention of postmenopausal - Treatment of osteoporosis in men - Treatment [4] DAGES CAP. : - Insufficiency of gastric, enteric and pancreatic secretion irregularity - Anorexia, meteorism, flatulence, steatorrhea, fermentative, dyspepsia with intestinal - Dyspepsia in cholecystectomized patient - Superalimentation during convalescence and fattening diets - Insufficiency of biliary secretion - Cholelithiasis, cholecystitis, cholangitis, jaundice RISENEXPLUS TAB DAGES CAP T-SPORIN EYE T-SPORIN DROPS NASAFLEX NASAL SPRAY Thinking of the Human Health and the Future of the Human Health Thinking CO., LTD. HANLIM PHARM. E-Mail : [email protected] Contact Information SO-JUNG, KIM (Managing director / Global business) • Phone : (822) 3489-6127 • Remarks Genexine partnered CMG Pharm. Partnered Medical device Medical Phase III Small molecules Phase II Phase I Biologics HANDOK Inc. Kim YoungJin Pharmaceutical product(ETC, OTC), Medical device & diagnostics, Healthcare products & service 132 Teheran Street Gangnam-gu Seoul 06235 Korea www.handok.co.kr Preclinical · Company · CEO Specialty · · Location Homepage· Discovery IMD* device Medical Category Biologics Chemical Chemical Chemical Cancer Alopecia Diabetes Diabetes Resistant Glaucoma Indication Deficiency Hypertension +hyperlipidemia Growth Hormone DENEX Project HL1550 HL5101 HL3501 HL2356 HL5945 TA CV QOL Orphan Oncology Diabetes / Diabetes Ophthalmic Metabolism *IMD : Incrementally Modified Drug Modified Incrementally : *IMD R&D Pipeline Main Products Tenelia M(Teneligliptin + Metformin HCl) rate target HbA1c achievement - provides powerful blood glucose control with high Release Micro-coating Technology) (Dual - minimized the pill size by applying DRM Technology use - improves medication adherence rate with once-daily Amaryl M(Glimepiride + Metformin HCl) and metformin HCl in Korea - The first fixed dose combination of glimepiride profile - provides glycemic control with favorable safety - registered 59 countries and exported to 8 countries Amaryl Mex(Glimepiride + Metformin HCl) metformin HCl in the world combination of glimepiride and - The first patented sustained-release fixed dose 2009) (Winner of Korea New Drug Award, Technology) - applied by DRM technology (Dual Release Micro-coating - registered by 43 countries and exported to 5 countries Ketotop Plaster (Ketoprofen) pain in Korea - No. 1 sales* plaster for osteoarthritis and muscular - Patent in 5 countries and Launched in 4 countries *Data on file : Based on IMS data, 1996-2016 HANDOK (CEO & Chairman Young-Jin Kim), a leading innovation-driven Kim), & ChairmanHANDOK Young-Jin (CEO pharmaceutical/health-care manufactures in company develops, Korea, and human and quality life. the health of to improve distributes solutions healthcare skeletal, psychoneurotic disease, muscular focus in diabetes, cardiovascular, Handok has a core business founded in 1954, grew as a joint health. Handok, and consumer diagnostics devices, medical human vaccines, from 1964 to 2012. Handok has also established strategic collaborations venture with Hoechst/Aventis/Sanofi companies. For more information, please visit in several areas with multiple multinational pharmaceutical www.handok.co.kr.
CONTACT US CONTACT SoHyun Kwon Head of Corporate & Business Development • E-mail : Ketotop Plaster Amaryl Mex Amaryl M
Tenelia M Tenelia HANDOK Inc. The Health Innovator The Health 24
Pharmaceutical Pharmaceutical 27 P1 P3 P2 Clinical Remark Pre-Clinical Pre-Clinical Pre-Clinical Pre-Clinical Pre-Clinical Pre-Clinical Indication Trehalose 3% Trehalose - Solution”) Clacier eye-drop HA Dermal Filler ON Rivastigmine 9mg, 18mg Ascorbic acid 250mg/2mL Esomeprazole 20mg, 40mg IBD Sepsis Sodium hyaluronate 20mg/2mL Heparin sodium 25,000unit/5 mL Melasma Fatty Liver Indication Cholecalciferol 5mg(200,000I.U)/1 mL Atorvastatin 10mg, 20mg, 40mg, 80mg Dry eye syndrome Acute low back pain wrinkle alleviating effect Lidocaine HCl 36mg with Epinephrine bitartrate /1.8mL Hemorrhoidal, Phlebitis & Varicose Prep. Hemorrhoidal, Phlebitis & Varicose man - Medicati Temporary improvement of glabellar lines Temporary Osteoarthritis (Single injection treatment) HU To reduce the depth and length of the skin wrinkle, inhibit To the destruction of collagen in the skin tissue and excellent HU-017(NCE) HUONS CO., LTD. Um, Key An Korea of Republic Gyeonggi-do, Seongnam-si, 253, Bundang-gu, Pangyo-ro, C, 902 innovalley Pangyo 100, Biovalley-ro, Jecheon-si, Chungcheong-buk-do, Republic of Korea www.huons.com Composition Elravie High Inj. Botulinum toxin type A New combination drug Merit D Inj. HU-018(Honeybush Ext.) NSAID combination drug Vitis vinifera Extract 50mg Vitis S-EMPRA Tab. Composition HL-09 Magnoliae Cortex Ext. Clacier eye-drop Cyclosporine combination drug Sodium hyaluronate 60mg/3mL Moisview eye-drop HSP23 Lonicera Japonica T. Ext. HSP23 Lonicera Japonica T. Pine Inj. 25,000units Huons Rivastigmine Patch · Company · CEO · Head Office Factory · Homepage· Cholecalciferol 5mg(200,000I.U)/1 mL Huons Atorvastatin 10mg, 20mg, 40mg, 80mg Medicaine Inj. 2% (1:80,000), (1:100,000),(1:200,000) ment IMDs Dietary supple- Biologics New Drug Category Global business · Exclusive Distribution Agreement with Alcon, US (Korean Branch) for Kynex and Clacier eye drop · Exclusive Distribution Agreement with Spectra, USA for Lidocaine Inj. & Sodium Chloride Inj · Exclusive Distribution Agreement with Nipro, Japan for Lidocaine Ctg. · Co-promotion with Kabi, Germany (Korean Branch) for Fresofol MCT Injection · Exclusive Distribution Agreement with Biosyn, Germany for Selenase Huons, started as Kwang Myung Pharm in 1965, has grown to a competent Myung started PharmHuons, in 1965, as Kwang and medicine essential original andeffective producing company, global 50years. over and innovation through products, continualmedical challenges Huons,total healthcareinnovator has grown tocompetenta globalcompany, producing original and effective essential medicine and medical products, through continual challenges and innovation over 50years. Huons built new factory in 2009 with state-of-the art manufacturing facility in compliance with Korea, US and cGMP. Huons, having obtained many patents as the results of its research, not is becoming complacent and working is hard for development of new medicines, with the global pharmaceutical market entrance. Huons Sodium chloride injection had been approved as 510(K) US-FDA. in Huons dental cartridge and Plastic ampoule products had been approved Japan in PMDA. Foundation · In 1965 (Established as a name of Kwang Myung Pharmaceutical) · In 2003 (Changed its name as HUONS which means ‘ Main Products R&D Pipeline HEALTHCARE INNOVATOR HEALTHCARE LTD. HUONS CO., ELRAVIE filler ELRAVIE DERMASHINE BALANCE CLACIER eye drop MEDICAINE Inj. CONTACT US CONTACT Han Seok, Ko (General Manager / Export team) • Phone: +82-2-854-4700 • Fax: +82-2-6455-0740 • E-mail : [email protected] KYNEX Eye-drop ® TM TM ) 3 Exd4] DM & Obesity /P2 GCSF] Neutropenia/P3 1 ( LAPS LAPS
efpeglenatide [ olmutinib NSCLC/P2* Rolontis [ poziotinib Breast cancer/P2 Oraxol Breast cancer/P3** Luminate DME/P2 l a c i lin C TM Hanmi Pharmaceutical.co.,Ltd Hanmi JongSoo Woo, SeChang Kwon products pharmaceutical based R&D Wiryeseong-daero,14, Songpa-gu, Seoul, 05545, Korea www.hanmipharm.com Insulin115] Diabetes/P1 GLP/GCG] DM & Obesity /P1 hGH] GHD/P2 LAPS LAPS LAPS HM12470 [ HM12525A [ HM95573 Solid tumor/P1 Oratecan Solid tumor/P1 KX2-391 Solid tumor/P1 HM71224 RA/P2 efpegsomatropin [ B B ) · Company · CEO Specialty · · Location Homepage· 0 1 ( l a c i lin c - argeted Program n o N Insulin combo] Diabetes Diabetes/Obesity Program LAPS Kinase T Epigenetics Program Stem Cell Therapy Program Rare Disease Program HM14220 [ Immuno-oncology Program : Pentambody Platform (2) Autoimmune Disease Program (2) Others Obesity Diabetes Oncology Auto-immune R&D Pipeline Established in 1973, Hanmi Pharmaceutical is the No.1 pharmaceutical Hanmi Pharmaceutical is Established in 1973, new drug development in terms of R&D spending and company in Korea achievements. Hanmi Pharm. Co., Ltd. is based in Korea, and has a strong focus in new drug R&D, specifically in 3 majorHanmi Pharm. Co., Ltd. is based in Korea, and long-acting peptides. Key therapeutic areas are diabetesfields: 1) Biologics: LAPSCOVERY platform applied platform applied bispecific antibody pipelines. Key targeting areas are targeted and obesity; 2) PENTAMBODY 3) NCE: Mainly oncology and auto-immune disease targetedimmuno-oncology and autoimmune disease; and combination programs for approved drugs. In addition, thepipelines. Hanmi Pharm also has strong fixed-dose in various co-development and collaboration projects. Hanmicompany also works closely with global partners efforts through its "Open Innovation Strategy" ofcontinues to expand its drug discovery and development teaming with potential partners for innovative solutions.
Duted
Phone : +82-2-410-9087 [email protected] : Phone : +82-2-410-9291 E-mail : [email protected] Phone : +82-2-410-0462 E-mail : [email protected] Development • • Information / In Licensing Management Kyoung Woo Lee eR&D/Licensing Leader, Team • • Export (Finished Products/APIs/CMO Business) Steven Cho Part Leader • • CONTACT US CONTACT Licensing out Yang Joshua Global Leader, Businesseam Rosuzet Amosartan Tab Esomezol Cap. Hanmi Pharmaceutical. Co., Ltd. Hanmi Pharmaceutical. R&D Driven Pioneer for Innovation in Life Sciences Innovation in Life Pioneer for R&D Driven 26
Pharmaceutical Pharmaceutical 29 Marketed NDA Ph III Ongoing Ongoing Ph II Ph I Ongoing IL-YANG PHARMACEUTICALIL-YANG CO., LTD. DONG YEON, KIM Urology, GI, Dermatology, Oncology, Vaccine, Biopharmaceutical Hagal-ro,110, Giheung-gu, Yongin-si, Gyeonggi-do, Korea www.ilyang.co.kr in Asia) Pre Ongoing Ongoing st · Company · CEO Specialty · · Location Homepage· USA China Korea Korea Korea Korea Korea Korea Korea Korea Korea Korea Korea Country in the world, 1 Korea, China th NERD GU / DU GERD / EE and NERD Application 1st line1st CML-CP line1st CML-CP 2nd line CML-CP H.pylor eradication Antiviral IY7640 agent Flu Quadrivalent Vaccine Avian Flu Vaccine (H7N9) Respiratory Syncytial Virus Syncytial Respiratory Seasonal Flu agent vaccine Flu Quadrivalent Vaccine(Child) H. Pylori s New Drug developed in Korea (4 New Drug developed in Korea generation BCR-ABL1 tyrosine kinase inhibitor(TKI) for the treatment of Philadelphia chromosome th th line therapy for newly diagnosed CML-CP has been approved Korea in by MFDS and has been launched on FEB, 2016. nd st st Virology - Low frequency serious adverse events adverse serious frequency Low - - Superior effect on Severe GERD/EE patients - Low reoccurrence - Reduces symptoms of night time heartburn - Low DDI 1 2 positive(Ph(+))CML 1 Noltec a Proton is Pump Inhibitor (PPI) that controls the secretion of gastric acid for the treatment of DU, GU, GERD/EE, Radotinib Ilaprazole Compound 5) Key features Key 5) - High, fast and deep response - High overall survival rate 2. Noltec (API: Ilaprazole) 1) 14 2) 3) Indication: Ph(+) chronic myeloid leukemia (CML) in chronic phase (CP) 4) 2) Respect humanity, promote human’s health, and improve welfare through welfare and improve health, human’s promote humanity, Respect pharmaceutical advanced products. of and development research continuous PHARM. IL-YANG CO., has LTD., been exerting its intended efforts manufacturing in superior pharmaceutical products for the past 70 years. Since its first supply of pharmaceutical products in Korea has 1946, in IL-YANG been own advancing its established into a top-ranking pharmaceutical IL-YANG Biopharmaceutical. company and the in world Virology, with developments Vaccine, Oncology, in the areas Gastroenterology, of Urology, vaccine plant in April with 2011 theproduction capacity of 60mil has doses been per exporting IL-YANG year. a variety of pharmaceuticals to approximately 30 countries including USA and established Europe. IL-YANG two joint ventures in China, PHARM. YANGZHOU IL-YANG CO., and LTD., HEALTH TONGHUA IL-YANG PRODUCTS CO., for LTD., manufacturing and distribution of finished pharmaceuticals in China. Since their establishment, the sales and business are expandingexponentially. In Sept. 2014, had YANGZHOU completion IL-YANG ceremony for newly built GMP plant which compliance is to EU-GMP standard. Product Supect1. (API: Radotinib) 1) 18 R&D Pipeline 3) Expert Opinion: “Ilaprazole, developed to overcome the limitations of currently available PPI’s” features Key 4) 3. Anti-Viral agent IY7640 has been announced at American Society for Virology on 22 2012 that July, it 20~30 is times potent than Tamiflu Respect Humanity, Promote Human’s Health, Human’s Promote Humanity, Respect Welfare Improve CO., LTD. PHARMACEUTICAL IL-YANG E-Mail : [email protected] Noltec Supect CONTACT US CONTACT Young Hwi KO BD Global / Manager General • Phone : +82-2-570-3804 • Fax : +82-2-570-3708~9 • NDA Poli HDP HRA Teva Bayer MTPC Dompe Takeda Novartis Ph III Astrazeneca Company Bausch &Lomb Ph II Ph I PC Indication DS Breakthrough cancer pain Allergy Acute and Chronic Bronchitis Chronic and Acute Hemorrhage during surgery Supplement (OTC) Emergency Contraceptive Emergency Vaginal Infection Hypertension Hemorrhage during surgery Anti-Dementia Acute and Chronic Bronchitis Chronic and Acute Antidepressant Anti-Parkinson Emergency Contraceptive Emergency Coronary Heart Disease Hypertension Hypertension Type GPCR 11 betaHSDI 11 Anti-oxidant Mucos-active Natural compound Natural compound Peripheral antitussive Composition Voltage-gated sodium channels Antiulcerant Mucosal Protection Mucosal Antiulcerant fentanyl citrate fentanyl pemirolast potassiumpemirolast levodropropizine ascorbic acid, beta-carotene, etc. beta-carotene, acid, ascorbic ulipristal acetate estriol, lactobacillus nisoldipine aprotinin,collagen, fibrinogen, thrombin collagen, fibrinogen, thrombin galantamine hydrobromide acebrophylline pramipexole dihydrocholoride paroxetine HCl paroxetine levonorgestrel anhydrous lisinopril atenolol/atenolol&chlorthalidone valsartan/valsartan and HCTZ Hyundai Pharmaceutical Co., Ltd. Chang Hyun, Yoon Research and Development of new medicine and incrementally modified drug(IMD) Hyundai Pharm Bldg, Bongeunsa Street 135, Gangnam-Gu, Seoul, Korea http://www.hyundaipharm.co.kr CNS Obesity Epilepsy Bronchitis Indication Type2 Diabetes Type2 Diabetes Type2 Cough Suppressant OCUVITE TACHOSIL Gastroduodenal Ulcer Gastroduodenal SYSCOR ER · Company · CEO Specialty · · Location Homepage· MIRAP TAB ZESTRIL TAB TACHOCOMB ELLAONE TAB TAMIRINE TAB Chronic Renal Insufficiency NORLEVO 1 TAB Product name ACTIC ORAL TAB SURFOLASE CAP TAREG/CO-TAREG ALEGYSAL DRY TAB GYNOFLOR VAG TAB LEVOTUSS SYR/TAB PAXETIL TAB/CR TAB TENORMIN/TENORETIC HT-003 HD-003 BPS-015 BPS-006 HOB-051 HOB-047 HOB-060 HOB-046 HOB-048 Products IMD NCE Central nervous system Women’s health Hemostatics Ophthalmologicals Cardiovascular disease Respiratory Criteria Therapeutic Class R&D Pipeline With the long history since 1965, Hyundai Pharmaceutical (here Group after history 1965, since the long With in pharmaceutical R&D the best company has been growing for up HDP) Asia. beyond heading to the world and now Korea Products HDP is committed to creating the best value for mankind through its innovative product development, humanisticHDP is committed to creating the best value for mankind relentless pursuit of innovative effort, we have been givenmanagement and social responsibilities. Through by Korean Management Association in 1984, the Bestfor several renown awards such as Best Enterprise and in National Safe in Korea in 1997, the President Award Productivity Company among all listed companies and innovative as the Advanced technology center (ATC) Quality Management in 2005 and 2009 and lately selected With these recognitions, as well as our strengths inpharmaceutical company in 2012 by Korean government. hasHDP products, pharmaceutical innovative develop to capabilities and resources human qualified manufacturing, Asian border ourselves and with our esteemed global partners. demonstrated and is now fully ready to go beyond
Edward Kim Edward Manager Business Development Team • Phone : +82-2-2600-3848 • E-Mail : CONTACT US CONTACT Hyundai Pharmaceutical Co., Ltd. Hyundai Pharmaceutical The Company Which Has Dream of Healthy Society Dream of Healthy Which Has The Company 28
Pharmaceutical Pharmaceutical 31 MKT NDA P3 P2 Clinical Trials P1 Product Group Pre- Clinical Discovery 1. Carbapenem Antibiotics 2. Amino Acid Solutions & Other Sterile Solutions Solutions 3. General I.V. 4. Antimicrobial & Antifungal Agents 5. Gastrointestinal Agents 6. Topical 7. Multivitamins 8. Agents for Antibiotics 9. Miscellaneous 1. Carbapenem Antibiotics: Imipenem/Cilastatin, Meropenem 2. Anti-fungals: Ketoconazole, Itraconazole, Fluconazole Acid 3. Chiral Products for Custom Synthesis & Specialty Amino 4. Miscellaneous BPH HBV MM OAB Gout AML Nocturia Diabetes Diabetes Brain cancer Indication Rheumatoid arthritis Rheumatoid Renal cell carcinoma Hepatocellular carcinoma Dyslipidemia/Hypertension ® ® ® ® ® JW Pharmaceutical Corp. Lee Ha Kyung and gastrointestinal,nephrology/antianaemic,anticancer cardiovascular, antibiotic, solutions, I.V- (IMD) drug modified neuropsychiatryincrementally Nambusunhwan-ro,2477 Seocho-gu, Korea Seoul, www.jw-pharma.co.kr ® Type URC102 CWP291 Guardlet Product Livalo-V™ GuardMet Desonix ODF Desonix CreaVax BC CreaVax RA tenofovir IMD tenofovir CreaVax RCC CreaVax HCC dutasteride tablet fesoterodine IMD fesoterodine was approved as pharmaceuticals for export ® · Company President· Specialty · · Location Homepage· Small Small Finished Product API (Active Pharmaceutical Ingredient) Biologics Molecule CreaVax RCC Category ※ JW Group provides pharmaceuticals vital for maintaining the lives of patients maintaining pharmaceuticals of vitalJW for the lives provides Group into a leading and as has drugs anticancer developed such and antibiotics, Solutions. manufacturer I.V. and global pharmaceutical of company For 70 years ever sinceits foundation 1945, in JW Pharmaceutical focuses on healthcare, ETC, OTC, diagnostics and medicalequipment. Based on new technologies and services for healthy lives of human beings, JW Pharmaceutical hasbuilt up strong sales network across the country gout. and and superior solutions, pipelines rheumatology, in I.V. endocrinology, oncology,cardiology, antibiotics, ExportMajor Products R&D Pipeline JW is focusing on developing Small Molecules as well as Biologics in the area of oncology andplatforms endocrinology by employing its novel JW Pharmaceutical Corp. JW Pharmaceutical Contact Information BD & Licensing Zi-Ho Yeom Business Development • Tel: +82-2-840-6885 • E-mail: [email protected] Export (APIs/Finished Products/CMO Business) Manager Lee, Senior Hojong Global Sales Team, Global Business Division • Tel: +82-2-840-6719 • E-mail: [email protected] Planning Research DaeKyung Koh R&D Strategic Planning • Tel: +82-2-840-6089 • E-mail: [email protected] Marketed Phase III Phase II Phase I Development Status Preclinical Discovery Indication Cancer (Solid Tumor) Hemoglobinuria Cancer Immunotherapy B Hemophilia Gaucher Disease Fabry Disease Anti-thrombotic Paroxysmal Nocturnal ® ® ® ISU305 ISU106 ISU104 ISU304 ISU Abxis Co., Ltd. Lee Joo Seok Biological pharmaceutics development based on the technology Gyeonggi- platform Seongnam-si, Bundang-gu, for Daewangpangyo-ro 22, 712beon-gil, biologics Fl., 5th C and animal Bldg. cell culture Center, R&D Global do, 13488, Korea www.abxis.com Fabagal Clotinab Product Abcertin (Imiglucerase) (Abciximab) (Abciximab) (Agalsidase beta) ® ® ® Drug Drug Novel Novel Orphan Orphan Biosimilar Category R&D Pipeline Products Abcertin Since 2001, ISU Abxis has established its own platform technologies and product pipeline with a desire of Since 2001, ISU Abxis has established its own as its name stands for (ABXIS = AntiBody + aXIS). Beginning being an axis of all therapeutic antibody industry Abxis ISU in 2006, antibody therapeutic first ISU’s of launch market and development successful the with 2013 in Consequently biobetters. and biosimilars in specialized industry biopharmaceutical Korean led has ISU Abxis has biotherapeutics for Gaucher and Fabry. and 2014, ISU Abxis has launched two rare disease full development and through the QC/QA management and class manufacturing world the accumulated compliance. manufacturing experiences in the globally harmonized are Mexico, Iran and Venezuela, including Turkey, three products, supplied to around 30 countries ISU Abxis’s products in the world. Furthermore, ISU Abxis operates available as the only alternatives against the original Mexico, as obtained the GMP certificates from Turkey, the mammalian production dedicated cGMP facility America and Middle East. Colombia and a number of major countries in Latin of providing global and local potential partner excellent expertise in biotechnology is capable ISU Abxis’s (2-5g/L), (2) development management system enabling the with (1) the higher productivity at CMO level within 24 months, and (3) higher biosimilarity to its original first-in-human IND from the cell line development optimization and preclinical and clinical development of product. ISU Abxis also has excellence in screening, drugs for cancer and hemophilia B. Besides the internal novel monoclonal antibody and recombinant protein and provide orphan drugs for Korean patients suffering development activities, ISU Abxis strives to import from the lack of treatment options. based business for difficult-to-treat and rare diseases both ISU Abxis will expand its advanced technology domestically and worldwide. ISU Abxis is the Korean leading biopharmaceutical company which leading biopharmaceutical company Abxis is the Korean ISU succeeded in development on the first therapeutic antibody in Korea. ISU America and and Latin world-class products to MENA Abxis provides the with the US and its business portfolio by collaboration continues to expand EU based pharmaceutical companies. · Indication: Enzyme Replacement Therapy (ERT) for Gaucher Disease (GD) · Indication: Enzyme Replacement Therapy (ERT) Imiglucerase second the world’s · The first treatment for GD developed in Korea and Iran, and etc. · Launched in 2013 in Korea and exported to Mexico, Fabagal · Indication: Adjunct to Percutaneous Coronary Intervention (PCI) second Abciximab · The first therapeutic antibody developed in Korea and the world’s etc. Colombia, and · Launched in 2007 in Korea and exported to twelve countries including Turkey, · Indication: Enzyme Replacement Therapy (ERT) for Fabry Disease (FD) · Indication: Enzyme Replacement Therapy (ERT) Agalsidase beta second the world’s · The first treatment for FD developed in Korea and 2017 · Launched in 2014 in Korea and global phase III clinical trial will be initiated in 2Q Clotinab · Company · CEO Specialty · · Location Homepage·
[email protected] [email protected] ® ®
® E-Mail : E-Mail : Clotinab Fabagal Abcertin Esther Park Administration & Planning Staff • Phone : +82-31-696-4616 • Fax : +82-31-696-4691 •
CONTACT US CONTACT Jisoo Park, MBA Director, Head of Global Commercial Business • Phone : +82-31-696-4643 • Fax : +82-31-696-4690 • ISU ABXIS Research Based Biotechnology Company Developing Therapeutic Company Based Biotechnology Research Disease Patients to Rare and Providing Treatments Proteins 30
Pharmaceutical Pharmaceutical 33
, ® , Busulfex , ® , Samsca , ® , Mucosta , ® Korea Otsuka Pharmaceutical Co.,Ltd. Sung-hoMoon, The manufacture, sale, import and export of pharmaceutical products 770-9 Yeoksam-dong, Gangnam-gu, Seoul, Korea www.otsuka.co.kr . We are faithfully carrying out the mission of faithfully carrying out the mission are We . ® , Pletaal , ® · Company · CEO Specialty · · Location Homepage· : World’s first development of new dosage form : World’s ® and Abilify Maintena and ® : World’s first approval in Tourette’s disorder first approval in Tourette’s : World’s ® a Otsuka Pharmaceutical has production facilities based in Korea, contributing to its exports to 31 countries, - Pletaal SR (28.5 Billion won in 2014, 43.8 billion won in 2015, 46.6 billion won in 2016) As a Korean company exporting its products to overseas, Korea Otsuka Pharmaceutical has made a great great a made has Pharmaceutical Otsuka Korea overseas, to products its exporting company Korean a As Korea Otsuka Pharmaceutical has amplified the advantages of clinical development environment of Korea- of Korea- Korea Otsuka Pharmaceutical has amplified the advantages of clinical development environment healthcare China-Japan, improved the efficiency of new medication development and contributed to better service for Asian by developing a cure for endemic disease in relevant country country Korea Otsuka Pharmaceutical has developed medications best suited for the - Abilify a 'company contributing to Korea's healthcare industry' not only in the sale ofa 'company contributing to Korea's R&D, manufacturing and exportsmedicines, but also in the areas of Deltyba 4) 4) Korea Otsuka Pharmaceutical is a branch of Otsuka Group International, is a branch of Otsuka Korea Otsuka Pharmaceutical supplies excellent and innovative We in Korea in 1982. which was established Abilify such as medicines, Business Kore including 10 Asian countries (Japan, China, Philippine, Finland,etc) and Italy,21 European Denmark, countries etc). ( UK, In fact, Germany, the a high-level companyFrance, of technology, has and successfully produced exported a medicine this to Japan in 2011. forglobal clinical trials, which requires role: differentiated clinical development, exports and its Korea Otsuka Pharmaceutical’s 1) model 2) A development center for anti tuberculosis drug and diagnosis/medicine-taking 3) Korea otsuka Pharmaceutical (KOP) was started with the construction of the Hyangnam Plant back in 1989. Korea otsuka Pharmaceutical (KOP) was started Practice) and BGMP(Bulk Good Manufacturing Practice) The Plant acquired KGMP(Korea good Manufacturing Cambodia, Philipines, have exported products to China, Indonesia, Taiwan, recognition in1990 and 1999.We Japan and Hong Kong, starting from the re-export to out parent company headquartered in Malaysia, Vietnam and production capacity with EU-GMP for out outstanding in Europe recognition In 2014, we gained in 1991. to Asia for the foremost base of Otsuka Pharmacetical. While expanded the scope of exports to Europe in addition Korea depend on imports from their respective domestic markets, most multinational Pharmaceutical companies in economic growth through the export of outstanding medicines. Korea Otsuka Pharmaceutical contributes to Korea with Japan and China from the phase1 undertaking of the Korea Otsuka Pharmacetical has worked in cooperation business strategy of Otsuka Group and, in doing so, contributed clinic study in 2007 according to the global clinic of new medicines. industry and development to the advancement of the korean clinic development on February 28,2014) with MOUs(1st in September,2009/2nd Plus, Otsuka Pharmaceutical(Japan)signed two 10-year and medicines of development and research in cooperation for Welfare and of Health Ministry Korean the of growth the promoting while diseases of treatment the research to won) billion 200 investment(worth facilities. and expansion of manufacturing pharmaceutical industry through the installation eam t ® Otsuka-people Creating New Products for BetterNew Products for Creating Otsuka-people Health Worldwide Pharmaceutical Co.,Ltd. Korea Otsuka ® ® ® Abilify Abilify Maintena Mucosta CONTACT US CONTACT R&D/Export/Product Taegyu Han Development • Phone : +82-2-3287-9203 Others Kim Taejin Planning Team • Phone : +82-3287-9124 Pletaal Phase I Phase I Phase I Non-clinical Non-clinical Non-clinical Non-clinical Non-clinical Non-clinical Development stage chnology. chnology. http://www.kolmar.co.kr Kolmar Korea Co., Ltd. Hak Bae Choi Pharmaceuticals/Cosmetics/Health Foods Functional CNI BD 1596-3 Seocho-Dong Seocho-Gu Seoul Korea Obesity Asthma Antidots Indication Antiallergics Osteoporosis Antithrombotics Antithrombotics Antithrombotics Ulcerative Colitis · Company · CEO · Specialty · Location Homepage· KKM 162 KKM-162 KKM-172 KKM-152 KKM-153 KKM-154 KKM-164 KKM-165 KKM-171 Candidate Category Incrementally Modified Drug New Herbal Drug ince founded in 1990 as a joint venture company with Nihon(Japan) Kolmar, Kolmar has grown to the biggest a joint venture company with Nihon(Japan) Kolmar, ince founded in 1990 as R&D Pipeline olmar Korea has its roots in the world-wide Kolmar Group. The Kolmar Group based on Kolmar Americas Inc., Kolmar on based Group Kolmar The Group. Kolmar world-wide the in roots its has Korea Kolmar has 1921, in Wisconsin, Milwaukee, in established was and Group Kolmar of organization parent the is which Korea, and China, showing off the vast scale in the world. the world-wide network including Kolmar Japan, information continuous the know-how, R&D 100-year-old with equipped Kolmar of network global the In and academic activities by affiliated research group exchanges are carried out through the regular symposium may be shared as well as technologies. Also Kolmar Korea members, so that latest data concerning marketing cosmetic history. world-wide pharmaceutical and takes the initiative in the development history of Products Kolmar Korea has a cutting-edge technology called ‘LIDCAPS’ that enables liquids to fill into hard-shell capsules. are Lidsen cap.(naproxen), cough-zero cap.,of the technology The representative products taking advantage extract of the unsaponifiable fraction of Zea mays L.), which have been approved by Denti-lid cap.(Titrated assuch areas therapeutic the all virtually covers line-up product Korea’s Kolmar Besides, Korea. in first KFDA cap.), cardiovascular system (Amlodapine tab.), dermatologicals (Mitra cap.), genito-urinary system (Taminal respiratory system (Pellium syrup.), alimentary treat (Panto-K tab.) and metabolism (Glimepirid tab.), etc. Kolmar’s CMO Service on Pharmaceutical Business CMO Service on Kolmar’s service do to analytical service and clinical Trial All integrated services from the pharmaceutical development Kolmar as it provides fast formulation development, scale updistribution channel could be collaborated with manufacturing, strict quality control and just-in-time delivery. Global Kolmar Leading Korean Pharmaceuticals CMO company including Cosmetics andCosmetics including company CMO Pharmaceuticals Korean Leading Foods.Functional Health S manufacturer. Korean Pharmaceutical contract service with customers who want to outsource theirKolmar Korea has provided customized contract manufacturing foods to be more competitive and to develop new formulationspharmaceutical products, cosmetics and healthcare feasible in the market. R&D and development, grafting 100 years’ Kolmar Korea reinvests more than 6% of net sales into its research and leading the latest trend by developing world- worth of R&D know-how into research and development, and cosmetics. Kolmar Korea has been approved not only in class pharmaceuticals, health functional foods its great and predominant te domestic market but in international market for
Fax : +82-2-515-1532 E-mail : [email protected] Fax : +82-2-515-1532 E-mail : [email protected]
Contact Information Moon-Su Pyo Director / Global Business Dept. • Phone : +82-2-3485-0497 • • Ms. Elena Ryu Regional Manager / Global Business Dept. • Phone : +82-2-3485-0397 • • Kolmar Korea Co., Ltd. Kolmar Korea Creating the Value of Health and Beauty of Health the Value Creating 32
Pharmaceutical Pharmaceutical 35 - - Launch Launch P3 P3 P3 Phase III Major Export Country Japan 8.3m$ * Export, 2011Y: Japan/Vietnam/Philippine 14.0m$ * Export, 2011Y: Malaysia/Singapore/Vietnam 0.5m$ * Export, 2012Y: Philippine, Vietnam 0.06m$ * Export, 2012Y: Vietnam 0.04m$ * Export, 2012Y: Phase II P1 Phase I Content melatonin Amoxicillin Tazobactam Pot.clavulanate Thiocolchicoside Formerol Dry Syr. Formerol Dry Syr. Ampicillin Sodium Amorphous aescin Sulbactam Sodium Sulbactam Sodium Piperacillin sodium Piperacillin Sodium Amoxicillin Sodium Eodolac Micronized Formoterol fumarate Calcium polycarbophil QOL Budesonide micronized Dental Saccharomyces boulardii Omega-3-acid ethyl esters Oncology Preclinical Preclinical Preclinical Preclinical Preclinical Preclinical Cardio Vascular Preclinical Insomnia Indication Periodontitis Dyslipidemia Dyslipidemia Dyslipidemia Kuhnil Pharmaceutical Co., Ltd Joong Young Kim Development, Manufacturing, and Distribution of Various Pharmaceutical ProductsDosage including Forms, Oral Injectables, Inhalers, etc. 100-120 Korea, Seoul, Jung-gu, Jeongdong-gil, 14, B/D, OhSong www.kuhnil.com Product Tabaxin inj. Tabaxin Stomach Cancer Pancreatic Cancer Omacor Cap Circadin Tab Wellcon Tab. Wellcon Pentacillin Inj. Acibactam Inj. Piperacillin Inj. Thiosina Tablet Bioflor 250 Pow Formerol Dry Syr. Formerol Dry Syr. Night Eating Syndrome Premature Ejaculation Pulmican Respule Formoterol fumarate Female Sexual Desire Disorder Lodine kuhnil Cap/Tab/SR Tab Lodine kuhnil Cap/Tab/SR Amocla/Amocla Duo Tab/Syr/inj Specialty Business · Company · CEO · · Head Office Homepage· KI 239 KI 208 KI 251 KI 1001 KI 1105 KI 1106 KI 1107 KI 1209 KI 0501 KI 0508 Product Hypnotics Antibiotics Respiratory Cardio Vascular Gastrointestinal Muscle relaxants R&D Pipeline Kuhnil Pharm continues to strive to become an unique research-focused global to strive to become an unique Kuhnil Pharm continues global biopharmaceuticals, development of innovative company through to improve in an effort and combination drug products DDS pharmaceuticals, patients. quality of life in which is the world's only insomnia treatment with the ingredient ofIn 2014, Kuhnil received sales approval of 'Circadin' Kuhnil has also adopted an unique strategy of advancing into a new melatonin to the Ministry of Food and Drug Safety. as development of a world's first approval of Omacor's new indica and niche areas of pharmaceutical development such indication in the treatment of ulcerative inflammation of the smalltion called IgA nephropathy as well as developing new intestine, for a novel GI drug. for innovative biopharmaceutical, TheraCIM, in the treatment ofIn 2005, Kuhnil participated in the clinical program Japanand Korea in cancer gastric for trial 3 phase the initiate to Daiichi-Sankyo with collaborating subsequently NSCLC, with foreign CROs for the development of interferon-ß biosimilar. in the 2nd half of 2012. In addition, Kuhnil has partnered specializes in penicillin formulation manufacturing. With the opening of Kuhnil's new Penmix, A subsidiary Company, market reaching company CMO global a become to envisions Kuhnil facility, manufacturing formulation injectable cGMP utilizing Kuhnil's know-how in the areas of lyophillization process. abroad including Japan and EU, particularly, Products in a wide selection of therapeutic areas including antibiotics, circula Kuhnil Pharm possesses pharmaceutical products Penmix, a subsidiary company of Kuhnil and endocrinology. CNS, respiratory, gastrointestinal, anti-inflammatory, tory, exportation to all over the world including Japan, Malaysia,Pharm, was recognized for excellence in quality through and etc. Singapore, Vietnam, Amocla/Amocla Duo Tab/Syr/inj inj. Tabaxin Piperacillin Inj. Pentacillin Inj. Pulmican Respule Thiosina Tablet Global pharmaceutical company committed in committed company Global pharmaceutical of life for people. better quality providing Co., Ltd. Kuhnil Pharm., CONTACT US CONTACT Jang YongNam R&D Center Manager / Team • E-mail : [email protected] Tab., Tab., ® (Antitussive) NDA Clinical Trial CR Tab., Kalomin CR Tab., Tab, Tab, ® Stage of Developmen ® Remark CR ® CR, Kalomin ® Use Pain caused by rheumatism (Antiinflammatory Analgesic drug) Ischemic symptoms, Thrombosis (Antithrombotic drugs) Acute coronary syndrome (Antithrombotic drugs) Gastrointestinal symptoms associated with functional dyspepsia(brash, nausea, vomiting) CR Tab in 2015. CR Tab Duo Cap., Cilostan ® ® Antitussive Antithrombotic drugs Tab5/100, Gastiin Tab5/100, · Growth Rate from 2015 to 2016 : 9.2% · Growth Rate from 2015 : 810 (Feb. 28, 2017) · Number of employees · Sales : $160M (2016) · Improved dosing regimen from b.i.d. to q.d. · Less side effects of gastrointestinal · Indication : · Indication : · Improved dosing regimen from b.i.d to q.d. · Reduced side effects of headache & tachycardia · Indication : Upper respiratory tract infection · Indication : · Improved patient compliance · Improved patient compliance for adults · Improved dosing regimen from t.i.d. to q.d. · Indication : Hypertension (Anti-hypertensive drugs) · CCB+ARB in ONE tablet · Patent protected unique formulation · Indication : ® Duo Cap, Cilostan KUP was nominated as Forbes’ ‘Asia’s 200 Best Under A 200 Best Under KUP was nominated as Forbes’ ‘Asia’s ® CR Tab., Calvixin CR Tab., ® CR Tab.. In addition, KUP has well balanced R&D portfolio KUP has well balanced R&D portfolio In addition, CR Tab.. ® KUP invested about 12% of net sales and 10% of total employees KUP invested about 12% of net sales and 10% of Code Tab5/50, Losasc Tab5/50, CR, Clavixin Korea United Pharm. Inc. Kang Duk-Young Manufacture, Marketing & Sales of Pharmaceuticals and Other Healthcare Korea Products Sejong, Jeondong-Myeon, 25-23, Nojanggongdan-Gil, http://www.kup.co.kr ® ® UI04LDP090CT UI03SPG300CT KUP is aiming to be not only a local leader but also global leading company KUP is aiming to be not only a local leader but also Clanza Losasc Tab. ® CR Tab. CR Tab CR Tab. Duo Cap. ® ® ® ® Specialty Business · Company · CEO · · Location Homepage· Tab5/100, Gastiin Tab5/100, Tab5/50, 5/100 Tab5/50, ® ® 4. Kalomin 6. Gastiin 1. Clanza 2. Cilostan 3. Clavixin Fixed Dose Combination) CR Tab. New Dosage Formulation) 5. Losasc CR Tab. ® ® (Clopidogrel 75mg and Aspirin 100mg / Product (Ingredient/Formulation) Unigril Tab5/50, Losasc Tab5/50, Levotics (Pelargonium Sidoides(as dry extract) 20mg / and Losartan 100mg Dual Layer Anti-Oxidant) ® Compound Name (Mosapride 15mg/ Controlled Release Formulation) (Cilostazol 200mg / Controlled Release Formulation) (Aceclofenac 200mg/ Controlled Release Formulation) (Amlodipine 5mg and Losartan 50mg/Amlodipine 5mg &D Pipeline(IMD Pipeline) in R&D continuously. KUP is successful developing innovative drugs and commercializing them. As a result, KUP is successful in R&D continuously. KUP has launched several IMDs including Clanza Billion’ over two consecutive years. KUP is one and only pharmaceutical company in Korea nominated by the by nominated Korea in company pharmaceutical only and one is KUP years. consecutive two over Billion’ A Billion’ over two consecutive years (2009~2010). KUP 200 Best Under Forbes magazine as one of the ‘Asia’s in Korea for Cilostan was awarded the Best Drug Research Award by offering wide range of generics as well as differentiated products, incrementally modified drugs. products, incrementally by offering wide range of generics as well as differentiated countries 32 to items different 416 exports and products 307 of portfolio balanced well and broad has KUP and has business alliances facilities in USA, Vietnam, through global marketing, and overseas manufacturing KUP established manufacturing facility in Alabama, US for manufacturing with oversea companies. Especially, in 2003. This facility have allowed KUP to expand markets and distrubuting drugs and health functional foods regulatory processes. in US, Japan, and Europe with know-hows of FDA Losasc including differentiated products of anti-neoplastic, Anti-hypertensive, and Antithrombotic Drugs. Anti-hypertensive, and Antithrombotic including differentiated products of anti-neoplastic, · Business Activities : Manufacture, Marketing & Sales of Pharmaceuticals and Other Healthcare Products Other Healthcare and Marketing & Sales of Pharmaceuticals · Business Activities : Manufacture, : about 307 items · Number of registered products of net sales (2016) · Investment in R&D : 12.8% · Incrementally Modified Drug : Company Profile 3, 1987 · Establishment Date : Dec. R Main Products (IMD Products) KUP is export-oriented is KUP company. Research&Development. in investedKUP KUP acknowledged been abroad. at has home and
Tab. Tab. Tab. CR Tab. Duo Cap.
® CR Tab. ® ® ® Contact Information Ahnjihyun • Phone : +82-2-558-8612 • E-mail :[email protected] Cilostan Clanza Kalomin Clavixin
GastiinCR Tab. Korea United Pharm. Inc. Korea United KUP is a Glabal Pharmaceutical Company All Company Glabal Pharmaceutical KUP is a World around the 34
Pharmaceutical Pharmaceutical 37 Medytox HyunJung Ho Botulinum toxin products, Medical aesthetics, Bio-pharmaceuticals 641-4 Gak-ri, Ochang-eup, Cheongwon-gun, Chungbuk 363-883, Korea www.medytox.com · Company · CEO Specialty · · Location Homepage· Medytox’s core business area manufacturing is botulinum toxin type A biopharmaceuticals, Neuronox. It is widely used not only in the cosmetic field, including facial wrinkle reduction, but also in the therapeutic field, for people with blepharospasm, cerebral etc. palsy, Medytox’s hyaluronic Neuramis acid filler, currently is being used in the field of cosmetics to smoothen deep and fixed wrinkles on skin tissue. Also, it used is as therapeutic agent for surgery and for treatment of arthritis. As a partner product, it could maximize a synergy effect along with Medytox’s core product Neuronox. Botulinum Type A product Toxin 2. Hyaluronic Acid Dermal Filler R&D Pipeline Fueled by the success of Nueronox, we plan to perform a basic study for the development of innovative bio pharmaceuticals to heal degenerative arthritis,senile ocular disease, skin disease and cancer. have We strengthened base technology in protein engineering, antibody engineering and cell biology by recruiting talented personnel. As the first achievement, we have completed basic verification studies on degenerative arthritis and senile ocular disease (MT202 and MT401). It appears that they would enter into the pre-clinical phase in 2013. plan We to keepmaking investments with a long-term vision to be a global biopharmaceutical leader through development of innovative drugs. We are at the forefront of Korean biopharmaceutical industry, thanks industry, biopharmaceutical Korean to our of are the forefront at We and to our our on based top-tier biotechnologists, capabilities R&D excellent to are going we Moreover, facilities. state-of-the-art and production operations courage and passion our to due biotechnology of field the intrailblazer a become challenges. to global embrace SinceBotulinum Type NeuronoxA Toxin (Neuronox also is being sold worldwide under different brand names such as Siax, Botulift, Cunox and Meditoxin) was launched in 2006, Medytox has shown a dramatic growth. Since 2009, we have ranked No. 1 market share in Korea and reached near 40% of market share. As more diverse indications are added, it appears that our market share would further increase. Our company has successfully developed the fourth botulinum toxin biopharmaceuticals in the world. are We exporting the products to about 50 countries, including Japan, Thailand, India and Brazil. are We also expecting to be a leading global biopharmaceutical company after entering the North America and EU markets in 2016. ProductsMain 1. Toxin, Filler and Even More Filler Toxin, Medytox [email protected] ® Nueronox CONTACT US CONTACT Headquarters/MicrobialOchang Toxin R&D center • Phone : +82-43-717-6300 • Fax : +82-43-217-1557 • E-Mail : OfficeSeoul • Phone : +82-2-6901-5403 • Fax : +82-2-3471-8374 • • • NDA
• P III P • • • P II Clinical Trial • • • P I PC • • • • • • • • • DS LG Chem, Ltd Jin-Soo Park Diagnostics Biosimilar, Vaccine, New chemical entity, LG Gwanghwamun Bldg.92, Sinmunno-2ga, Jongno-gu, Seoul, Korea www.lgchem.com Indication · Company · CEO · Specialty · Location · Homepage Autoimmune disease Autoimmune disease deficiency growth hormone Pediatric Pneumonia prevention Pneumonia Osteoarthritis Pneumonia prevention Pneumonia DTP/HepB/Hib/IPV prevention prevention Poliomyelitis Aesthetic Filler Aesthetic Type 2 Diabetes 2 Type Diabetes/Dyslipidemia Myocardial infarction colitis Ulcerative Diabetes 2 Type Type 2 Diabetes 2 Type
Product LBEC0101 LBAL Eutropin PentypeEutropin New vaccine pipelines vaccine New Synovian combo. Synovian Improved Pneumonia Improved LBVE LBVC LBVD Next-generation Filler Immune Cell therapy Stem Cell therapy Zemimet ZemiStatin LC280126 LC541239 LC510255 LC65AOD5 New targets High molecular weight hyaluronic acid viscosupplement made by microbial fermentation for low side- High molecular weight hyaluronic acid viscosupplement effect, quality proven by EMEA and CE marking - Recombinant FSH, used in the treatment of female infertility in controlled ovarian hyperstimulation to induceRecombinant FSH, used in the treatment of female infertility reproduction program as well as anovulation the development of multiple follicles in a medically assisted ® The right choice for managing short stature recombinant human growth hormone with proven efficacy andThe right choice for managing short stature recombinant safety since 1993 Combined Diphheria, Tetanus, whole cell Pertussis, Hepatitis B and Haemophilus influenza typeB. whole cell Pertussis, Combined Diphheria, Tetanus, injection Eupenta can prevent five different childhood with a single A novel dipeptidyl peptidase IV (DPP IV) inhibitor for T2DM with good efficacy and safety profiles. A novel dipeptidyl peptidase IV (DPP IV) inhibitor for Approved by the KFDA in June, 2012 - - Human recombinant erythropoietin, safe and effective treatment for anemia of chronic renal failure - Human recombinant erythropoietin, safe and effective - - - ® ® - Fast Active, the most potent quinolone antibiotic in the world, commercialized in over 30 countries worldwide - Fast Active, the most potent quinolone antibiotic in ® ® ® ® Class Vaccine Biologics Chemicals R&D Pipeline *NME: New Molecular Entity IMD: Incrementally Modified Drug CRF: Chronic Renal Failure NASH: Nonalcoholic Steatohepatitis Espogen Hyruan Plus Products Factive Eutropin The First Pioneer in Korean Pharmaceutical R&D Products in Korean Pharmaceutical R&D The First Pioneer contributing chemical company, LG Chem has served as Korea's representative Since its foundation in 1947, quality of life through continuous national economy and the enhancement of the to the development of the based on its stable growth. new product introduction, and quality innovation technological development, business expanding our abroad, and home at networks R&D and sales, production, the established have We company that provides innovative materials and into the global market, aiming to become a world-class in high-value added core businesses while expanding new solutions by sharpening our competitive edge and Energy Solutions. business opportunities in IT & Electronic Materials Chem in order to strengthen a former subsidiary of LG In addition, we have recently merged LG Life Sciences, and expand its business in Life Science area. on nurturing as a new growth engine of the future, LG In the business area which LG Chem has focused interferon by applying genetic engineering technologies Chem became the first in Korea to develop gamma drug from U.S. Food and Drug Administration (FDA) with in 1989 and the first to receive approval for a new competitiveness secure to continue will Chem LG 2003. in antibiotic) "Factive"(quinolone of development its of its R&D capabilities based on its investment and enhancement in the global market through aggressive the drugs. technological prowess that has succeeded in commercializing Zemiglo Follitrope Eupenta
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® ® Synovian Eupenta Zemiglo Eutropin Pen Factive Jong-heon Won, Manager Won, Jong-heon Business Development Team • Phone : +82-2-6924-3233 • E-Mail : [email protected] CONTACT US CONTACT LG Chem, Ltd. LG Chem, Leading Global Life Science Company Global Life Science Leading 36
Pharmaceutical Pharmaceutical 39
Approved PhaseIII Phase II Phase I Investigator Initiated Trial Pre-Clinical GvHD SCI Respitory Failure Kidney transplant Liver Cirrhosis(US) Liver Cirrhosis (KR) IPF CLI , Cellgram- Parkinson’s Disease Hemorrhagic Stroke Erectile DysfunctionErectile AMI Critical Leg Ischemia - IS Acute Stroke Ischemic ® Chronic Cardiac Disease LC Ovarian/Prostate Cancer Chronic Spical Cord Injury Acute Myocardial Infarction Myocardial Acute , Cellgram- Breast/Kidney/Ovarian Cancer is active is pharmaceutical ingredients to enhance stability of therapeutics such as growth DC ED Pharmicell Co., Ltd. Hyunsoo Kim, Seonglae Kim stemcell therapy products,cell therapy products, PEGs, API, flame retardantsstem 7th cell cosmetics, floor, Ssangbong etc B/L, Unju-ro, Gangnam-gu, Seoul, Republic of Korea www.pharmicell.com Glio-blastoma/Malignant Melanoma Glio-blastoma/Malignant Commercialization Steps
Cancer Cellgram- Liver Disease Cellgram- Neuro Disease Cellgram- Pulmonary Disease Cellgram- Etc. Cellgram- Etc. Cardiac Disease Cellgram -AMI · Company · CEO Specialty · · Location Homepage· ® (DC) (MSC) Class Stem Cell t was approved from Ministry of Food and Drug Safety and in July became 2011 the world’s first commercialized stem Polyethylene glycol(PEG) Polyethylene hormone, and insulin. PEG supplied is to internationally well know pharmaceutical companies as Merck and Roche. DNA diagnostic kits and therapeutics’ core material of Nucleoside are supplied to Thermo Fisher and Sigma-Aldrich. Cellgram Also, various clinical trials are being conducted for such diseases of stroke, spinal cord injury, liver cirrhosis, erectile dysfunction, and critical ischemia. limb The efficacyof Pharmicell’s stem cell therapy product was introduced via local and international mass communication which gives high reliability of the product. Especially, to precede clinical trials in US for liver cirrhosis,the Pre-IND meeting with US FDA was completed in 2014. The clinical trials begin will during second half of 2017. celltherapy product.As can be seen from the attached file, theproduct was approved for improving rapidly decreased cardiac function(Ejection Fraction) and MACE(Major Adverse Cardiac Events) from acute myocardial infarction patient. I Dendritic Cell Mesenchymal Mesenchymal R&D Pipeline Pharmicell further is committed to technological innovations that involve the commercialization of stem cells through bio-based businessand cosmetics. Since the company’s founding in 2002, Pharmicell has been driven by passiona for innovative research and technology, coupled with its commitment to improving the quality of life by pioneering safe, deliverable, new, revolutionary treatment products. At the forefront of Pharmicell operational strategy its is unrelenting focus on ensuring the quality of life on a globalscale by offering holistic and sustainable solutions to unmet medical needs through stem cell research and product distribution. Most importantly, Pharmicell sets itself apart in the bio technology industry by practicing generosity. Over the past fifteen years, Pharmicell has become an asset to the stem cell treatment industry onredefining a global scale bythe boundaries of science orderin to create more innovative solutions for medical issues, thus cultivating global dependency and demand for Pharmicell’s products. ProductsMain 1. 2. API(Active Pharmaceutical Ingredients) The world The best thefirst beyond world world stem cell therapyproduct withparadigm technology. bio-chemical shiftof Pharmicell a bio-pharmaceutical is and bio-chemical research and development company that specializes producing in stem cell therapy products and active pharmaceutical ingredients, innovating stem cell banking technology.
Pioneer of stem cell industry and Bio-company with cutting and Bio-company of stem cell industry Pioneer edge technology Co., Ltd. Pharmicell [email protected] CONTACT US CONTACT Seunghwan Samuel Lee directorTeam / Strategy and Planning team • Phone : +82-2-3496-0145 • Fax : +82-2-3496 0159 • E-Mail : Cellgram Box Cellgram product
Activity test Activity test Human studyHuman Approval Process Approval Formulation studyFormulation Approval Process Approval Formulation studyFormulation 2 Phase clinical trial Development StageDevelopment Indication Anti-aging Joint Health Ulcer osteoarthritis Beauty Beauty Anti-adhesion cosmeticsAnti-aging PharmaResearch Products Co., Ltd. Ahn Sang-Soo, Jung / Won-Joon, Anti-aging and QOL(quality of life) products based on Regenerative medicine Bundang-gu, Seongnam-si, Gyeonggi-do, Korea / (Office) 74, Pangyo-ro 255beon-gil, (Factory) 77-19, Gwahakdanji-ro, Gangneung-si, Gangwon-do, Korea www.pr-products.co.kr Project Name Nucleic acid Supplement Joint Health Therapeutic peptide PRM-002 PRM-003 PRM-0011 peptide Functional cosmeticsAnti-aging utilizing DNA fragment Optimizing technology. · Company · CEO · Specialty · Location · Homepage ®
Drugs injection (Sodium Polydeoxyribonucleotide) devices Medical ® Cosmetics Classification ® Eye drops (Sodium Polydeoxyribonucleotide) ® Health Supplement creating a value for a better and longer life. creating a value Moreover, PharmaResearch Products diversified the product pipelines for regenerative medicine on license-in, PharmaResearch Products diversified Moreover, competitiveness of techniques and continuous R&D, co-developments and strategic investments. Through extension in both domestic and global. Also, starting from PharmaResearch Products is promoting market overseas business. China and Japan, PharmaResearch Product is practicing PharamResearch Products is a R&D focused biopharmaceutical company Products is a R&D focused biopharmaceutical PharamResearch anti-aging and for products healthcare developing and researching been has Products PharmaResearch in regenerative medicine going to become a leading healthcare company are We improving Quality of Life. through DNA fragment optimizing technology(DOT). as the first pharmaceutical consulting firm for introducing PharmaResearch Products was established in 1993 in Korea. Through the consulting business, PharmaResearch and registering new drugs and medical devices experience about new technology and products. In 2007, Products get to have enough information and regenerative medicine company by developing endogenous PharmaResearch Products stood up as a leading repair stimulator PDRN R&D Pipeline Satisfying both skin regeneration and filler effect 1) Skin elasticity improvement 2) Dermis density and thickness improvement Products Over the Counter Drugs (OTC) Re-an Cornea and conjunctiva regenerative eye drop diseases due to the lack of nutrition 1) Nutrition supply to cornea and conjunctiva with ulcerative caused by external stress such as contact lenses etc. 2) Applicable to micro injuries of cornea and conjunctiva Ethical Drugs (ETC) Rejuvenex Wound healing and tissue regenerative injection healing Wound and tissue restoration for skin graft healing 1) Wound Medical device Rejuran Total healthcare company Practicing Regeneration medicine for medicine Practicing Regeneration company healthcare Total and Longer Life a Better Ltd. Products Co., PharmaResearch injection ® ® Eye drops ® Re-an Rejuvenex Rejuran CONTACT US CONTACT KimManSeok • Phone : +82-31-8039-1561 • E-Mail : [email protected] 38
Pharmaceutical Pharmaceutical 41 Approved Marketed Marketed Marketed Marketed Non-clinical Non-clinical Non-clinical Clinical (Phase I) Clinical (Phase II) Ready to Approval Under development Development Status Comment Japan (PMDA) Japan (PMDA) Germany (BGV) Germany (BGV) Australia (TGA) Inspection Authorty · Launched in EU (Working as CMO) · Launched in EU (Working · Launched in EU (Registered in DE, BG, RO, UK) & Japan · MRP running for other EU members · Launched in Korea · Approval process ongoing in Iran · Launched in Korea · Launched in Korea · Launched in EU & Japan(Working as CMO) · Launched in EU & Japan(Working · All dossiers are ready for approval procedure · Launched in Korea · Cremophor-free, Ethanol-free formulation · Cremophor-free, · Launched in Korea & Georgia · Tween-80 free formulation (No diluent vial) · Tween-80 · CEP completed · CEP completed · KDMF completed · KDMF completed · Reduced API (66%) with same PK as original · Reduced API (50%) with same PK as original ® ® Goserelin Capsaicin Celecoxib Paclitaxel Products Pemetrexed Fentaderm DemenCure Temsirolimus Lenalidomide Buprenorphine 100mg 500mg 3.5 mg EP, USP EP, USP EP, in-house in-house 4mg / 5mL 20mg, 80mg 200mg/40mL 30mg, 100mg Docetaxel-PNP, Voriconazole-PNP Docetaxel-PNP, 1000mg / 40mL Strength / Grade 20mg, 100mg, 250mg 4.6mg/day, 9.5mg/day 4.6mg/day, 20mg/1mL, 80mg/4mL 140mg/7mL, 160mg/8mL 5mg/10mL, 100mg/20mL /hr, 50㎍/hr 25㎍/hr, 12㎍/hr, Paclitaxel, Docetaxel, Pemetrexed, Bortezomib 30mg / 5mL, 100mg / 16.7mL 100mg / 4mL, 500mg / 20 mL Samyang Biopharmaceuticals Corporation. Eom Taeung Oncology, GMP Manufacturing(APIs, Injections, Patches), DDS Technology 13488, Korea Gyeonggi-do Seongnam-si, 295 Bundang-gu, Pangyo-ro, www.samyangbiopharm.com 150mg / 25mL, 300mg / 50mL Product Paclitaxel (API) Docetaxel (API) Diclofenac Patch Oncology Injections Active Fentanyl · Company · CEO · Specialty · Head Office Homepage· Paclitaxel Paclitaxel Paclitaxel (API), Docetaxel (API), Docetaxel Docetaxel Oxaliplatin Bortezomib Pemetrexed Pemetrexed Rivastigmine Temozolomid Ingredient Zoledronic acid TDS Synthetic Paclitaxel (API), Pemetrexed (API) Liquid form Confidential ® Paclitaxel Docetaxel ® BA enhancing Bortezomib Pemetrexed M S ® Plant Cell Culture PM Polymeric Micelle Organic Synthesis ® ® ® Polymeric Nano-Particle Long Acting Micro-Particle Technology Description Technology (Refrigiated and RT condition) Generic Generic Zolenic Pemed Products Fentaderm Nanoxel (Transdermal Drug Delivery System) (Transdermal DemenCure Genexol Year 2010 2013 2014 2015 API Oral API Oral Patch Injection Injection Category Trans-dermal Category Samyang Biopharmaceuticals Corporation, with its central research center is engaged in Corporation, with its central Samyang Biopharmaceuticals and medical devices. marketing of novel drug delivery systems the development and as its core strategic business of the Corporation is focusing its efforts on healthcare Samyang Biopharmaceuticals for the is developing proprietary and unique core technologies Samyang Biopharmaceuticals Corporation 21st century. novel drug delivery systems. development of world class Main Products GMP Certifications R&D Pipeline Innovative Specialty Pharmaceutical Company Specialty Pharmaceutical Innovative BiopharmaceuticalsSamyang Corporation. [email protected] [email protected] CONTACT US CONTACT Overseas Pharmaceuticals Sales Mr. Sung-Seup Shin Overseas Leader, BusinessTeam Team • Phone : +82-2-2157-9857 • E-mail : API Sales Mr. Ryan Jae Yoon Kim Senior Manager, Overseas Business Team • Phone : +82-2-2157-9861 • E-mail : [email protected] Business development Mr. Sukwon Yoon Senior Manager, Business Strategy Team • Phone : +82-2-2157-9813 • E-mail : IMD NCE NCE IMD NCE NCE NCE NCE NCE NCE NCE NCE Aptamer Category Clinical Clinical Preclinical Preclinical Preclinical Biological Testing Biological Testing Biological Testing Biological Testing Biological Testing Biological Testing Biological Testing Preclinical Clinical / Development Stage Oral Oral Oral Oral Oral Oral Oral Oral Oral Oral Eye drop Injection Oral / Topical Route of Administration HIV Cancer Cancer Cancer Cancer Cancer Alzheimer Samjin Pharmaceutical Co., Ltd. Sung Woo, Lee Manufacture, Marketing and Distribution of Pharmaceutical Products (Finished Products 121,Wausam-ro,Mapo-Gu,Seoul,Korea and APIs) www.samjinpharm.co.kr Indication Hyperlipidemia Dry eye syndrome Dry eye syndrome Sjogren syndrome Alzheimer, Diabetes Alzheimer, Platelet aggregation Platelet · Company · CEO · Specialty · Location Homepage· Code SA001 SJP002 SJP003 SJ-3366 SJ-3902 SJP1610 SJP1601 SJP1602 SJP1604 SJP1603 SJP1605 SJP1701 GMP Factory Since its establishment in 1968, Samjin Pharm Co., Ltd. has always strived in 1968, Samjin Pharm Co., Since its establishment and to invest in research pharmaceutical products to produce high-quality of company philosophy, of new drugs on the basis for the development life”.“Respect for human R&D Pipeline The manufacture of pharmaceutical products, which demands the utmost precision and professionalism, is The manufacture of pharmaceutical products, which The level of manufacturing facilities, therefore, industry. one of the most important parts in the pharmaceutical In order to maintain the high precision company. can be a standard to evaluate the level of pharmaceutical which is eligible for all kinds of qualification control, Samjin in the manufacture of pharmaceutical products, processes with the scientific and automated system. Pharmaceutical has been operating all manufacturing technology as well. have supported its advanced The manufacturing facilities of Samjin Pharmaceutical Products andmanufactures develops, which company pharmaceutical a comprehensive is Pharmaceutical Samjin market. The most representative products of Samjinmarkets both finished products and APIs in the worldwide have occupied significant market share in analgesic Tablet”, and “PLATLESS Pharmaceutical, “GEWORIN Tablet” Also, Samjin Clopidogrel Bisulfate (crystal form 1) as API has and antiplatelet agent markets in Korea, respectively. properties for the direct compression such as narrowincreasing market share by its excellent physico-chemical Samjin Pharmaceutical has continuously been bulk density. particle size distribution, good flowability and good pharmaceuticalIMD and generic with profits and sales in increase potential for strategy marketing a developing products as well as APIs.
® ® PLATLESS Ferbon Tab Tiroxin Neutoin NEUSTATIN-A
CONTACT US CONTACT Bum Kyu, Shin Manager, General Overseas Business Department • Phone : +82-2-3140-0673 • Fax : +82-2-392-5315 • E-Mail : Samjin Pharmaceutical Co., Ltd. Samjin Pharmaceutical For the Health Life and Fruitful Future Life and Fruitful For the Health 40
Pharmaceutical Pharmaceutical 43 NCE NCE NCE NCE NCE NCE Classification Stage Phase 1(Korea) Phase 1(Korea) Phase 2 (Korea) Phase 1 (Europe) Preclinical(Korea) Preclinical(Korea) Lead optimization Preclinical(Europe) Phase Marketed Marketed Marketed Marketed Marketed Marketed SHIN POONG PHARM.CO.,LTD SHIN JEI MAN RYU Manufacture and Sales of the pharmaceutical products YOKSAM-RO,161 KANGNAM-GU, SEOUL, 06246, KOREA www.shinpoong.co.kr Anti-stroke Indication Anti-platelet Heart failure osteoporosis Osteoarthritis Osteoarthritis Atherrosclerosis Fracture healing/ Dermal/body filler · Company · CEO · Specialty Business · Head Office Homepage· Indication Anti-malaria Anti-malaria Hypertension Osteoarthritis Hyperlipidemia Adhesion Barrier TM TM TM SP-8203 SP-8008 SP-8232 SP-8356 SP-35454 Products HyalONE Freewink Hyal ONE ® Tablets. ® Tablets. Granules ® ® Name Medicurtain EzeRosu Tablets NCE NME Pyramax Pyramax Hyal Forte Injection. CandeAmlo Category R&D Shin poong is the pharmaceutical company in pursuit of human health. pharmaceutical company in pursuit Shin poong is the South Korea, in Seoul, headquartered company pharmaceutical is a multinational Co., Ltd (SPP) Shin Poong Pharm. and presence in more than 45 and Philippines) Vietnam, (China, Sudan, Myanmar, with 5 overseas subsidiaries countries. manufacturing from active ingredients to finished Shin Poong is specialized in one-stop KGMP/EU-GMP-compliant as well-exemplified by supplier and drug development partner, products. Shin Poong has been a reliable worldwide through bank since mid-1980’s, business such as WHO and World Praziquantel via collaboration with public sector with MMV. a recently EMA-approved new malaria drug, Pyramax® industry awarded the Order of Civil Merit from Korean Indeed, SPP is the first company in pharmaceutical R&D pipelines include 1) 7 novel NCEs with health. Shin Poong’s government for such endeavor devotion to public and musculoskeletal diseases, need in CNS, cardiovascular, novel mechanism of action addressing unmet medical value-added formulations/combinations, and 3) innovative 2) de-risked high quality Ethical drugs (ETC) including knowhow and technology platforms. Shin Poong is undertaking biomaterial products based on its unique CMC focused internal R&D. institutions in addition to numerous collaborations with world-renown academic Main Products ® ® pharmaceutical company with the Top-level company pharmaceutical market in the Surgery prescription drugs sales of Pharm.Co.,Ltd Shin Poong ®
® ® Tablets.& Granules. Tablets.& CandeAmlo Pyramax Medicurtain Hyal Forte EzeRosu CONTACT US CONTACT Contact Information Su Mi Oh, Director • Phone : +82-2-2189-3500 • E-mail : [email protected] sanofi-aventis Korea sanofi-aventis Kyung-Eun (Kay) Bae Diabetes, Oncology, Cardiovascular Disease, Internal Medicine, Central Nerve System, arthritis Rheumatoid and Infectious Disease, +82-2-2136-9000 +82-2-2136-9099 235, Banpo-daero, Seoch-gu, Seoul www.sanofi.co.kr ® ® ® Founded Sanofi Established Sanofi Korea Established sanofi-aventis Group Established clinical R&D unit under direct control of corporate headquarters Started sanofi-aventis Korea Launched Cenovis, the consumer healthcare brand Started Sanofi Group Integrated Management Committee Received Family-Friendly Company Accreditation by MOGEF Received Innovative Pharmaceutical Company by MOHW Re-accredited Family-Friendly Company by MOGEF Acquired Consumer Health Care from Boehringer Ingelheim ® ® · Company · CEO Specialty · · Tel Fax · · Location Homepage· 1991 2004 2005 2006 2010 2012 2013 2014 2016 2017 History 1973 Diabetes Aprovel Essential hypertension, Renal disease type in 2 diabetes with hypertension Eloxatin Colorectal cancer, stomach cancer, pancreatic cancer Taxotere Breast cancer, stomach cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, esophageal cancer prostate and cancer R&D Pipeline Myelofibrosis, Articular cartilage defects, Muscular atrophy, Diabetes, Rheumatoid arthritis, Dyslipidemia, Atopic dermatitis and Asthma Products Plavix Atherosclerosis symptoms Lantus SANOFI IS A GLOBAL HEALTHCARE LEADER FOCUSED ON LEADER HEALTHCARE GLOBAL A SANOFI IS NEEDS PATIENTS’ atWe Sanofi work passionately, every to understand day, and solve healthcare needs of people across the world. Sanofi engaged is in the research, development, manufacturing and marketing of innovative therapeutic solutions. It has core strengths in diabetes solutions, human vaccines, innovative drugs, rare diseasesand consumer healthcare. Sanofi headquarteredis in Paris, France and listed in Paris (EURONEX:SAN) and New (NYSE:SNY). York In Korea, Sanofi has three legalentities in the areas of pharmaceuticals and consumer healthcare (Sanofi- aventis Korea), vaccines (Sanofi Pasteur) and rare diseases (Genzyme Korea). Sanofi-aventisKorea has been contributing to Korea healthcare industry to move advance through ‘open innovation’. Accredited as Innovative Pharmaceutical Company in 2014, Sanofi-aventis Korea has established and looked forward to seeking out partnerships with promising pharmaceutical companies, bio-techs, clinical research centers as well as academia in Korea to bring innovation where high unmet patient needs exists, while continuously investing in clinical development of new medicines and help Korean partners go global.
® ® ® ® Global BusinessGlobal Development Mr. Min Ryoo Head of Business Development &License • Phone: +82-2-2136-9012 • E-mail : [email protected] CONTACT US CONTACT R&D Collaboration GwangDr. Hee Lee &Development Research of Head • Phone: +82-42-863-9204 • E-mail : Taxotere Eloxatin Aprovel Lantus Plavix sanofi-aventis Korea sanofi-aventis We Fulfill Your Healthy Dreams Fulfill Your We 42
Pharmaceutical Pharmaceutical 45 HCV/Phase I TB/Marketed HIV/Marketed Goal HCV/Marketed HBV/Marketed Diabetes/Marketed Antifungal/Marketed Antibiotics/Marketed Indication/Stage for clinical trial for clinical trial for clinical trial Phase I in 2017 Phase I in 2017 Non-clinical trial MRI contrast/Marketed Released in 2017 Released in 2018 Released in 2021 Released in 2024 Anticoagulant/Marketed Hyperlipidemia/Marketed Various RNA therapeutics/Clinical Various JP US/EP/JP Customer Domestic/RoW Domestic/JP/RoW Domestic/JP/RoW S.Africa/Germany/CIS Originator (Worldwide) Originator (Worldwide) Originator (Worldwide) Originator (Worldwide) Originator (Worldwide) Originator (Worldwide) TB HIV Cancer evelopment and scale-up optimization. Diabetes Diabetes Anti-viral Anti-viral Project Anticoagulants Anticoagulants MRI Contrast Media ST Pharm Co., Ltd. Geun-Jho Lim CMO (New Drug APIs & Intermediates), Generic APIs, Oligo APIs and New Drug Development 7F MSA Bldg., 891-43, Daechi-dong, Gangnam-gu, Seoul, Korea http://www.stpharm.co.kr HCV drug HCV drug Terizidone Gadobutrol Clopidogrel Atorvastatin Voriconazole Products Diabetes drug Chiral epoxide Antibiotics drug Chloro-(L)-sugar Nucleoside monomers · Company · CEO Specialty · · Location Homepage· CMO New Drug Category Generic APIs Category New Drug APIs Generic APIs Pharmaceutical Intermediates With highly experienced technical teams and synergistic collaboration with a parent company, Dong-A synergistic collaboration with a parent company, With highly experienced technical teams and supportive with intermediates and APIs generic to pipelines product the extends Pharm ST Pharmaceutical, market. enter domestic and global DMFs and high-spec quality control required to timely “ST Pharm provides reliable and timely custom manufacturing services for reliable and timely custom Pharm provides “ST the with communication close and system quality API following stringent clients.” Samchully Pharmaceutical) has been offering excellent custom Founded in 1983, ST Pharm (formerly known as their use in ediates to meet clients’ high expectation for manufacturing service of APIs and their interm cGMP requirements. Our reliability in service, which is well- pharmaceutical development in compliance with with many big pharmas and biotech clients, is the essence of our proven through decades of business relationship strength along with our expertise in process d Main Products 1. Custom Manufacturing 1) New Drug APIs & Intermediates 2) GMP-Oligonucleotides (for RNA therapeutics) 2. Generic APIs & Intermediates Products List (selected) R&D Pipeline (selected) World Leader in API Custom Manufacture Leader in API World Co., Ltd. ST Pharm CONTACT US CONTACT Seong-Soo Oh Chief Researcher R&D Planning Team R&D center • Phone : +82-31-488-1409 • E-mail : [email protected] Phase I Phase I Phase I Status Phase III Phase III Marketed Marketed Marketed Screening Screening Screening Preclinical Preclinical Preclinical Registration Registration Registration Approved in US, EU (Licensed out) Information Quadrivalent cell culture influenza vaccine st Korean new chemical entity Korean new herbal drug Korean cell culture influenza vaccine st st st Vaccine Vaccine Vaccine Vaccine Vaccine Vaccine Anti-cancer agent *The 1 Patch formulation with anti-inflammatory Cartilage protective agent *The 1 Orally dissolving film formulation (ODF) forerectile dysfunction (ED) treatment disease exporting worldwide Patch formulation for Alzheimer’s Prevention for influenza virus *The 1 Prevention for influenza virus 1 *The World Bio-better (Bio-better) Description Plasma product BA enhancing tech Botanical / chemical New Chemical Entity New Chemical Entity New Chemical Entity New Chemical Entity Orally dissolving film SK Chemicals Co. Ltd. Mahn-hoon, Park Specially chemicals and life science business 463-400 Gyeonggi-do, Seongnam-si, Korea Bundang-gu, Pangyo-ro, 310, www.skchemicals.com Chemical, combination drug Chemical, controlled release Recombinant Plasma protein · Company · CEO Specialty · · Location Homepage· - - Fibrosis Epilepsy Product Varicella Varicella Diabetes Hemophilia Indication Haemophilia Herpes zoster Endometriosis Multiple sclerosis Overactive Bladder Erectile dysfunction Pneumococcal diseases Seasonal cell culture flu Chronic arterial occlusion Stroke, systemic embolism Hepatitis B immunoglobulin NBP NBP SID125 SID142 SID143 NCE401 NCE403 NCE406 NCE407 NBP601 NBP602 NBP604 NBP606 NBP607 NBP608 SID1601 THVD201 Product Sunpla injection (3rd generation platinum complex anti-cancerdrug) Joins (Clematis mandshurica, Trichosanthes Killilowii, Joins (Clematis mandshurica, Trichosanthes Prunella vulgaris ext) Rivastigmine patch SKYCellflu Trast patch (Piroxicam) Trast Mvix (Mirodenafil) SKYCellflu Quadrivalent Main Products SK Chemicals contributes to enhance human health and the quality of life to enhance human health SK Chemicals contributes vaccines and innovativepremium drugs, synthetic by developing new manufacturing technologies. industry in 1999, when it new chapter in the history of the Korean pharmaceutical SK Chemicals opened a world's first third generation platinum complex cancer drug. succeeded in launching SUNPLA, Korea's and the a novel erectile dysfunction agent in Korea. In PDE5 inhibitor, In 2007, the company launched the world's fifth world first orally dissolving film (ODF) formulation containing 2011, it also succeeded in commercializing the the PDE5 inhibitor. manufacturing not only ODF formulation but also transdermal patch the platform technology of In particular, in developing incrementally modified formulation drugs. As a formulation had made SK Chemicals as a leader approved for sale in Europe. SK Chemicals is actively result, dementia patch called SID710 was successfully marketing and exporting the product to major markets. R&D of range wide a possesses now Chemicals SK activities, R&D its to investment ceaseless of virtue the In the Particularly, drug. protein recombinant to products derived plasma and vaccines premium from portfolio vaccine, it succeeded in obtaining the Korea's first marketing next generation technology of cell-culture based vaccine. As a part of continuous commitment to vaccine authorization of cell-culture technology based influenza As a result, the vaccine manufacturing plant in Andong city. R&D, it also completed building a state-of-the-art organizations. licensing agreements with multinational company already entered into a couple of major R&D Pipeline SK Chemicals focuses on developing premium vaccines, new chemical entities, and biopharmaceuticaldrug in therapeutic areas with high unmet medical needs.
Jeeho HEO General Manager General
Rivastigmine patch SKYCellflu Quadrivalent prefilled syringe SKYCellflu prefilled syringe Trast Patch Trast Mvix ODF Joins Tab. Sunpla Inj. Name : CONTACT US CONTACT
• Phone : +82-2-2008-2819 • E-Mail : [email protected] SK Chemicals Co. Ltd. SK Chemicals Developing Premium Vaccines, New Chemical Entities, Biopharmaceutical Drugs Entities, Biopharmaceutical New Chemical Premium Vaccines, Developing 44
Pharmaceutical Pharmaceutical 47 NDA III II Clinical I Investigator’s trial under way Investigator’s degree burn and chronic skin ulcer. It degree burn and chronic skin ulcer. nd Pre- Clinical defects degree burn. Wrinkles rd Oral mucosal Indications Corneal defects Rotator-cuff tear Rotator-cuff Cartilage defects Cutaneous wounds TEGO SCIENCE, INC. SCIENCE, TEGO Saewha Jeon Develops and markets products in regenerative medicine, Stem cell and alternative testingDaerung spaces Technotown Gasan III, digital 1fl., 115 2-ro, Gumcheon-gu, Seoul 08505, Korea www.tegoscience.com Chemokine Chemokine · Company · CEO Specialty · · Location Homepage· Category is a cultured skin autograft. Its commercialization was Korea's first and world's second. The patient’s and world's second. The patient’s was Korea's first is a cultured skin autograft. Its commercialization is an allogeneic cultured skin sheet indicated for deep 2 is an allogeneic cultured skin sheet indicated for designates a group of human skin models consisting of live human cells. Any or all layers of the of live human cells. designates a group of human skin models consisting ® ® ® Dermal fibroblasts (auto) Mucosal keratinocytes(auto) Dermal fibroblasts (auto/allo) Mucosal keratinocytes (auto/allo) Kaloderm human skin can be replicated in vitro, making it possible to test the safety and efficacy of cosmetic/therapeutic possible to test the safety and efficacy human skin can be replicated in vitro, making it animal testing. substances without resorting to inhumane and expensive own skin cells are cultured and exponentially expanded to produce grafts that are transplanted back on the to produce grafts that are own skin cells are cultured and exponentially expanded wound. It is indicated for large 3 patient’s promotes healing of the wound and minimizes scar formation. Since source cells are from another human, it can formation. Since source cells promotes healing of the wound and minimizes scar types of acute/chronic wound duration. It can be used on all be manufactured ahead and stored frozen for long It is a globally unique product and dermatology markets. and has promising applications in the cosmetic surgery Sales have so far been over potential overseas competitions. that has cost, therapeutic and shelf-life advantages introduce it to overseas markets. limited to South Korea, but work is under way to Neoderm * Lines indicate current progress with KFDA. * Phase III trials are not required for autologous products. A World Leader in Cell Therapy & Advanced Regenerative Medicine Advanced Therapy & Leader in Cell World A wound for therapy cell skin regenerative in specializing company biopharmaceutical Seoul-based a is Science Tego allogenic cultured skin grafts widely cell therapy market with autologous and Korea’s healing. It has pioneered technologies in cell culture, skin-graft chief strengths have been leading-edge Tego’s used in burn and ulcer clinics. into wider regenerative medicine areas involving musculo- manufacturing and cryopreservation. It is now evolving been has Science Tego expansion. overseas for plans with targets, dermatological and ophthalmological skeletal, listed in KOSDAQ since 2014. Products Holoderm R&D Pipeline
At the leading edge of cell therapy edge of cell At the leading INC. TEGO SCIENCE, [email protected] ® ® ® Neoderm Holoderm Kaloderm CONTACT US CONTACT Seung-wun Baek, Manager Business Development Team • Phone: +82-2-818-2932 • Fax: +82-2-2107-3173 • E-mail : Pre-clinical Pre-clinical 2016 2009 2010 2011 Year Current Status Phase 3 ~ Pre-clinical 2010, 2013, 2014 2008, 2011, 2014, 2017 1995, 2010, 2011, 2012, 2014 Dry eye Indications Bacterial conjunctivitis Ophthalmic/GI indications Facility Taejoon Pharmaceutical Co., Ltd. Young LeeTae / Joon Lee Youb agents Gastrointestinal media, Contrast therapeutics, Ophthalmic 8 Daesagwan-ro 31-gil, Yongsan-gu, Seoul, Korea www.taejoon.co.kr/en/ Ophthalmic solution Sterile ophthalmic solution Sterile ophthalmic solution Sterile ophthalmic solution Sterile ophthalmic solution · Company · Co-CEO Specialty · · Location Homepage· Vendor audit for sterile ophthalmic solution Vendor audit for sterile ophthalmic solution Vendor Product Name GMP KGMP Combination or Improved drugs EU GMP Anvisa GMP US FDA Audit NAFDAC GMP Dry eye product (New Chemical Entity) Antibiotic product (New Chemical Entity) Vendor Audit (EU) Vendor Vendor Audit (Italy) Vendor Indication: Myelography, angiography, urography, contrast enhancement of computerized tomography. urography, angiography, Indication: Myelography, contrast enhanced computed arteriography, Indication: For cerebral angiography and peripheral and intravenous excretory urography. venography, tomographic imaging of the head and body, the heart, central nervous system including the brain,Indication: MR imaging for the whole body excluding patients (2 years of age and older). spine and associated tissues in adults and pediatric Indication: For the reduction of IOP in patients with open-angle glaucoma, chronic angle-closure glaucoma Indication: For the reduction of IOP in patients with or ocular hypertension Indication: For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure Indication: For the temporary relief of burning, irritation further irritation. to wind or sun. May be used as a protectant against Indication: Increase tear production in patients whose tear production is presumed to be suppressed due toIndication: Increase tear production in patients whose sicca. Increased tear production was not seen inocular inflammation associated with keratoconjunctivitis drugs or using punctual plugs patients currently taking topical anti-inflammatory 1 2 3 4 5 6 7 - - - - - - No. R&D Pipeline GMP Certification List Main Products Ophthalmic therapeutics Preservative Free) •XALOST SUD (API: LATANOPROST, •MC FREE (API: SODIUM CARBOXYMETHYLCELLULOSE) •CYPORIN N (API: CYCLOSPORINE, Nano-technology) Contrast Media •IOBRIX INJ. (API: IOHEXOL) •RADISENSE INJ. (API: IOPAMIDOL) DIMEGLUMINE) •MRbester INJ. (API: GADOPENTETATE Taejoon Pharmaceutical Co., Ltd. is a leading specialty pharmaceuticalPharmaceutical Co., Ltd. is a leading Taejoon and gastrointestinal agents contrast media, company in ophthalmology, Pacific Asia Europe, America, of States United the in presence global a with Region Africa.and
Xalost SUD Cyporin N
CONTACT US CONTACT Jun Hee Lee / Business Development • Phone: +82-2-799-0072 • E-mail: [email protected] Taejoon Pharmaceutical Co., Ltd. Pharmaceutical Taejoon Leading Biotech Company for Better Life Biotech Company Leading 46
Pharmaceutical Pharmaceutical 49
clinical Phase 2 Phase 3 Phase 3 Phase 3 Phase 3 Phase 2 Phase 1/2 Phase 1/2 preclinical Preclinical Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Lead discovery Current stage Current Indication Yuhan CorporationYuhan Lee hee, Jung Pharmaceutical Seoul Dongjak-gu, Noryangjinro 74 http://www.yuhan.co.kr/Eng/index.asp IMD IMD IMD IMD IMD NCE NCE NCE NCE IMD NCE NCE NCE NCE NCE NCE NCE NCE Type siRNA siRNA Herbal Biologics Biologics Biologics Biologics Biologics · Company · CEO Specialty · · Location Homepage· Supply of nutrition Treatmentfor hypertension and hyperlipidemia newborns of syndrome distress respiratory for Treatment Antibiotics Antiacidic functions Anti-inflammatory agent Alleviation of heartburn & indigestion Keloid NASH NASH NASH NSCLC Asthma Otitis media Otitis Solid cancerSolid cancerSolid cancerSolid cancerSolid cancerSolid cancerSolid Solid cancerSolid Solid cancerSolid Solid cancerSolid Solid cancerSolid Periodontitis Hypertension Indications Diabetic retiopathy Diabetic Graves’ orbitopathy Graves’ Diabetic neuropathy Periodontitis, arthritis Chronic constipation, IBS Hyperlipidemia diabetes / Hyperlipidemia hypertension / Product name Product YH-BIO YH-BIO YH-BIO YH-BIO YH-BIO YH1177 YH-NCE YH-NCE YH-NCE YH-NCE YH-NCE YH-NCE YH-NCE YH-NCE YH-NCE YH-NCE YHD1119 YH14755 YH12852 YH22162 YH26153 YH25724 YH24931 YHP1604 YH23537 YH25448 3-Chamber TNA (Total Nutrient Admixture) Duowell Tablet Newfactan Tablet Yucla Almagate Suspension Antiphalmine Lotion S Willogel Double Action Suspension Projects Gastrointestinal disorders Metabolic cardiovascular & disorders Immunology inflammation & disorders Cancer As a leading global producer and distributor of pharmaceuticals, APIs/ and distributor producer of As a leading global toimprove is mission intermediates and consumer Yuhan’s goods, products innovative high quality, offering by and well-being health efforts to progress. supportand social services with ongoing in parallel Formulation Plant employ the latest cutting edge technology withOur large-scale Shihwa Synthetic Plant and Ochang General these plants allow us to deliver active pharmaceutical ingredients manufactured full FDA, EMEA and PMDA approval. Together, to the highest standards to our partners across the globe. medicinal chemistry through to process innovation and clinicalWith full spectrum drug-development capabilities from consumer products to improve is relentlessly committed to delivering precision medicines and quality trials, Yuhan first acid-pump antagonist of have yielded Revanex, the world’s health and quality of life. Our focused R&D efforts hepatitis a number of new drug entities for antibiotics, cancer, its class designed to treat gastric ulcers, as well as filled with new pharmaceutical is committed to taking the lead toward a future C, arthritis, and osteoporosis. Yuhan cardiovascular and metabolic disorders, and inflammatory diseases. discoveries, with ongoing research in oncology, you to join us in our journey to create a healthier and more prosperous society. welcome We Products R&D Pipeline Best Partner Best Yuhan Best Partner Yuhan Corporation Yuhan CONTACT US CONTACT QuartersHead 74 Noryangjinro Dongjak-gu, Seoul, 06927, Korea • Phone : +82-2-828-0181 • Fax : +82-2-828-0300 Phase II (Active) Phase III (Active) Phase III (Active) Phase II (Planned) Phase III (Ongoing) Phase II (Approved) Phase II (Completed) Development Stage USA USA USA China China Korea Korea Country DNA DNA DNA Protein Catheter DNA+Virus DNA+Virus Technology DNA + Injection ViroMed Yongsoo Kim 1) DNA/protein-based biopharmaceuticals biopharmaceuticals DNA/protein-based 1) Phytotherapeutics2) (botanical drugs/nutraceuticals) 5th Bldg 203, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Korea www.viromed21.com ViroMed ongoing is a phase III clinical trial for diabetic peripheral neuropathy
Specialty Business Breast Cancer · Company · CEO · · Head Office Homepage· Thrombocytopenia Target Disease Target ViroMed successfully completed a phase I/II trial for amyotrophic lateral sclerosis After successful phase I trial for coronary artery disease (VM202-CAD), a phase II study Coronary Artery Disease Chronic Diabetic Foot Ulcer Amyotrophic Lateral Sclerosis Diabetic Peripheral Neuropathy Phase III clinical trial of chronic non-healing ischemic foot ulcers diabetes in patients (VM202- Peripheral Artery Disease (Critical limb Ischemia)
VM501 VM206 Product VM202-ALS VM202-PAD VM202-PAD VM202-DPN VM202-CAD PAD) initiated is in the US. ④ approvedis and running for subject who have had medical treatment for acute myocardial infarction prior in Korea. VM206 – Therapeutic Cancer Vaccine VM206 a therapeutic is cancer vaccine delivered through intramuscular injection and induces an immune response against the tumor-associated antigen Her2/neu, found in several types of cancers such as breast cancer. A phase I clinical study for breast cancer has been successfully completed in Korea, showing that he administration of VM206 would effectively induce both humoral (antibody) and cellular (CTL) immune responses against tumor. The product is being developed for patients who have received surgery and/or chemotherapy. A phase II trial planned is for Korea. VM501 – Recombinant Protein for Chemotherapy-Induced Thrombocytopenia (CIT)The only drug approved for CIT by the US protein FDA a recombinant is called Neumega. interleukin Its (IL-11) use 11 has been highly limited because of serious side effects associated with the drug. VM501 a genetically is engineered designed to produceinterleukin a high level (IL-11) of efficacy, 11 but with improved safety. After successful phase I and II studies, a phase III clinical study currently is ongoing in China. VM202 – New and Innovative Drug for Cardiovascular and Neurological Diseases VM202 a DNA-based is medicine designed to express two isoforms of hepatocyte growth factor (HGF) gene. HGF has been extensivelyresearched and learned to induce the formation of new collateral blood vessels and the growth and regeneration of damaged peripheral nerve cells. Currently, VM202 under is clinical trials for 4 indications in cardiovascular and neurological disease categories. In these studies, VM202 delivered is through intramuscular injection around the affected regions. ① (VM202-DPN) in the US.② (VM202-ALS), also known as Lou Gehrig’s disease then approved phase II IND targeting84 subjects from US FDA. In May of 2016, the program received Fast designation Track from US FDA. VM202-ALS already has received orphan drug status in 2014. ③ Representative (Clinical trial) Product – Biologics ViroMed Co., Ltd. (“ViroMed”), a leading biologics company focusing on developing novel and innovative drugs,innovative and novel developing on focusing company biologics leading a (“ViroMed”), Ltd. Co., ViroMed tradedpublicly a is Atlanta. ViroMed office in a US and Korea 1996, headquartered in Seoul, in established was has assembled a diverse yet ViroMed KOSDAQ stock exchange (084990) from 2006. company listed on the therapeutics targeting cardiovascular and linked pipeline of new and innovative technologically and conceptually runs several clinical and China. ViroMed and immune disorders in the US, Korea, neurological diseases, cancers, chronic diabetic neuropathy, (diabetic peripheral III clinical trials phase active 2 This includes trials internationally. lateral sclerosis) in phase II clinical trial in the US. Anfoot ulcer) and an approved rare disease (amyotrophic in Korea. In China, a phase III clinical trial is underway foradditional phase II (coronary artery disease) is ongoing cow to also runs a botanical therapeutics program as a cash chemotherapy-induced thrombocytopenia. ViroMed balance the long-term biologics programs. ViroMed Co., Ltd. ViroMed Leading Biotechnology Company Targeting Cardiovascular Disease, Cardiovascular Targeting Biotechnology Company Leading Disorder. Immune-related Cancer and Neuropathy, Seungshin Yu, Ph.D. Director Strategic Business Development • E-mail : [email protected] Contact Information 48
Pharmaceutical 51 1. Products Expected to Export 2. Technology Transfer 3. Certifications from Health Authorities Supplement
h e t
Reg/Pricing Futur Grow
III IMD) 2017 st generic in Korea) st (Clinical study in USA) Merged with ‘KT&G Life Science’ 2016 II
Certified as “Innovative drug company” in Korea
2015
I 2013 Development Status Tarimin tab (bepotastine, YJP’s 1 Omaron cap(omega-3-acids,1 ‘$50M Export Prize’ awarded by KITA
2011 New Cephalosporin plant in Namyang factory Pre-Clinic Yungjin Pharm. Co.,Ltd. Su Jun Park Cephalosporins API Formulation & Korea Seoul, Songpa-gu, Olympic-ro35da-gil, 13, Office : Head www.yungjin.co.kr 2010
Opast tab (limaprost tab) Harmonilan sol. (No. 1 EN drug in Korea) Alvityl I syr (main product for export)
‘$20M Export Prize’ awarded by KITA 2006
Research
New Jeonju factory for API production 2000 · Company · CEO Specialty · · Location Homepage·
1989 Factory for finished products in Namyang Indication 1984 COPD / (Asthma) Mitochondrial Disease Diabetes Spinal stenosis / SR BPH with erectile dysfunction Neuropathic pain / SR Type II DM MRSA Vaccine Prostate Cancer Rheumatoid ArthritisRheumatoid / (OA) The world’s first Bacampicillin synthesis t; an pl
1974
API
Area st r Fi Introduction of penicillin to domestic market Respiratory Metabolic Disorder Metabolic Disorder CV Urology CNS Metabolic Disorder Immunology Oncology Immunology Therapeutic Therapeutic
Botanical Drug Botanical New Chemical Entity Biological Drug Combo, SR, etc. lishment ab st 1952 Importing medicine from JP & US E Name IMDs Project YPL-001 KL-1333D YPP-2022 YLS-1501 KL-1333M YSA-2021 YNP-1807 YBH-1603 YRA-1909 New Drug YDM-2020 R&D Pipeline History Yungjin Pharm. Co., Ltd has been playing a major role as a forerunner in the Korean pharmaceutical industry forerunner in the Korean Co., Ltd has been playing a major role as a Pharm. Yungjin from diseases with relieve the suffering of mankind mission statement, "To since 1952. With our inspiring successful contribution our and safe pharmaceutical products", we have shown our innovative, effective 25 awards including total of globally as well. As a result, we have received not only within Korea, but and Industry Award Development, the Prime Minister Award, for Superior Product the President Award commitment to the development of demonstrate our sustainability, many others. These accomplishments In addition, through overseas and domestic segments. innovative products and business excellence in both business globally. our experience and expertise, we are leading CMO/CDMO
Cefpodoxime proxetil tab. / gran. Meropenem inj. Propacetamol inj. Limaprost alfadex tab. Limaprost alfadex tab. Cefcapene pivoxil tab. / gran Imipenem cilastatin inj. Jeffrey Park International Division Business • Phone : +82-2-2041-8244 • E-mail : [email protected] CONTACT US CONTACT
The medicine for your life The medicine Yungjin Pharm. Co.,Ltd. Yungjin 50
Pharmaceutical Supplement 53 ® ® Peri Note Lipid Generic Generic of Smof of Smof Kabiven Global Global country Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Expected bag) bag) CNS Non- Product Therapy Antiviral Oncology Oncology Stem cell Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine G.I Agents anesthetic Anticancer Antibiotics Anticancer Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics IV Solution Biologicals Biologicals IV Solution (3-chamber (1-chamber Category Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Bronchodilator Antispasmodic Small molecule Cancer Cancer Anemia Infection Infection Infection Infection Infection Anorexia Anesthesia Anti-cancer Anti-cancer Anti-cancer Indication Neutropenia Osteoarthritis Anti-diabetics Anti-diabetics Gastric cancer Gehrig’s disease) Gehrig’s Food Supplement Anti-hypertensives Parenteral Nutrition dysentary syndrome Immunosuppressant Chronic renal failure Hepatitis B infection Alzheimer's dementia tonsillitis, pharyngitis etc. disease or Parkinson's disease Total Parenteral Nutrition (TPN) Parenteral Nutrition Total Symptomatic treatment of severe relapse period of chronic gastritis Respiratory distress caused by airway dementia associated with Alzheimer's amyotrophic lateral sclerosis(ALS, Lou obstruction of bronchial asthma, acute media, mastoiditis, paranasal sinusitis, and spasmodic colic, intestinal colic and Bronchiectasis, bacterial pneumonia, otitis Gastric and duodenal ulcer, acute gastritis, Gastric and duodenal ulcer, Renal and urinary colic hepatic, gall bladder Symptomatic treatment of mild to moderate bronchitis, chronic bronchitis, or emphysema Glucose Imatinib Propofol charcoal Linezolid Entecavir Filgrastim Docetaxel Irinotecan Metformin Tacrolimus 37.5, 75mg Teicoplanin Polmacoxib Amlodipine Soybean oil Pemetrexed Vancomycin Triglycerides Gemcitabine Moxifloxacin Ciprofloxacin Lobeglitazone Erythropoietin Candesartan + Medium-Chain oral adsorptive lysinate 500mg marrow derived Lobeglitazone + Olive oil, Fish oil Autologous bone Krill Oil Omega-3 Lipid, Amino acid, Roxatidine acetate Megestrol Acetate Paclitaxel 10mg/ml Methylol cephalexin Phloroglucinol 80mg Active Ingredient Rivastigmine 9, 18mg Tulobuterol 0.5, 1, 2mg Tulobuterol mesenchymal stem cell
® Duvie Acelex Gemtan solution Megex-I Leukivec Omega-3 TacroBell Belotaxel Cantabell OmapOne Pemta Inj. BR Krill Oil Renamezin Tapocin Inj. Tapocin Epokine Inj. Duvimet XR Citopcin Inj. Calmtop Inj. Gastric Cap. Freefol MCT Vancorin Inj. Vancorin Enteone Tab. Leukokine Inj. Liporaxel Oral Peripheral Inj. Neuronata-R FLOSPAN Tab. FLOSPAN Moveloxin Inj. Resnalin Patch Rivamensa Patch Product name Cinezolid Tab&Inj. Cepharmethyl Cap. OmapOne Lipid Inj. CJ Inc Inc. Corp. Chong Pharm pharm co.,Ltd. Crystal- Boryung Daewon EUTICAL CO., LTD. aceutical aceutical Corestem DAEHWA Kun Dang Genomics, PHARMAC Company HealthCare corporation ------Listed Note marked on WHO EUAL/CE CE marked CE marked CE marked CE marked Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global Global US, EU, country Expected Middle East Non- Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine probiotics Molecular Molecular Molecular Molecular Molecular Molecular Molecular Molecular RNAi drug RNAi drug RNAi drug Category siRNA drug siRNA drug siRNA drug Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Diagnostic Kit Diagnostic Kit Diagnostic Kit Diagnostic Kit Diagnostic Kit Diagnostic Kit Diagnostic Kit HIV-1 Scars Alopecia Narcotics Narcotics Heartburn Antibiotics Antibiotics MERS-CoV Anti-cancer anti-obesity Solid cancer Indication Gastric ulcer Hypertension Hypertension Hypertension Hypertension Skin whitening Antineoplastics Antineoplastics Hepatitis B virus Hepatitis C virus Gastric Hyperacidity Well-being products Well-being Humanpapillomavirus Lipid-Lowering agents Essential Hypertension New Influenza A (H1N1), Mycobacterium tuberculosis, IPF (Idiopathic Pulmonary Fibro sis) IPF (Idiopathic Pulmonary Fibro Zika, Dengue and Chikungunya viruses Keloid Treatment and Removal of Keloid Keloid Treatment Multidrug-resistant tuberculosis (MDR-TB) siRNA siRNA siRNA Phospate Lafutidine Imipenem, Cilnidipine Oxaliplatin Fimasartan Amlodipine Doxorubicin PCR reagent PCR reagent PCR reagent PCR reagent PCR reagent PCR reagent PCR reagent PCR reagent Tamiflumate Rosuvastatin Meropenem 1g siRNA , miRNA siRNA , miRNA siRNA , miRNA Fimasartan with Fimasartan with Cilastatin sodium Remifentanyl HCl Morphine Sulfate Colloidal Aluminum Lactobacillus gasseri Atorvastatin Calcium Active Ingredient Fimasartan with HCTZ
- - ® ® ® -IPF HPV HBV HCV TM TM New -Skin HIV-1 HIV-1 - Lung ® ® ® ® ® ® ® ® ® TM -Cancer ® ® TM ® TM TM Kit Tab. Plus 500mg target BNR17 Besto Kanarb Keloids PCR Kit PCR Kit PCR Kit Oxalitin Gelfos Todula Tuvero Dukarb Kanarb Morphine Alopecia ADmycin Sinraci Inj. Sulfate Inj. Remiba Inj. whitening Vitamin Inj. Vitamin AccuPower AccuPower AccuPower Time PCR Kit Time SMAiRNA SMAiRNA Mepem Inj. 1g Mepem Inj. 1g cancer target BC Atorvastatin Genotyping Kit TB&MDR Real- Multiplex Real- SMAiRNA Time RT-PCR Kit RT-PCR Time Time RT-PCR Kit RT-PCR Time A Real-Time RT- A Real-Time Quantitative RT- Quantitative RT- MERS-CoV Real- Quantitative PCR SMAiRNA Product name Inf A (H1N1) &Inf AccuPower AccuPower AccuPower AccuPower SMAiRNA AccuPower ZIKV(DENV, CHIKV) CHIKV) ZIKV(DENV, SMAiRNA LTD. BIONEER BIONEER Pharm co.,Ltd. Boryung BCWORLD aceutical CORPORATION CORPORATION PHARM. CO., Company 1. Products Expected to Export Expected to 1. Products 52
Supplement Supplement 55 WHO Note US FDA PQ from Designation Orphan Drug granted from - Asia Asia China China China South Japan China, Taiwan, Taiwan, America USA, EU USA, EU USA, EU USA, EU USA, EU, country East Asia Australia, East Asia, India, U.S., Japan, EU, Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Expected Japan, East Japan, East Canada, EU, Japan, South- OTC Food Food Food Food & Food & Plasma Plasma Plasma Plasma Plasma Product Product Vaccines Vaccines Beverage Beverage Derivatives Derivatives Derivatives Derivatives Derivatives Category supplement supplement supplement Recombinant Recombinant EU pre-phase I Phase I Growth Phase II Phase III Immunity Pre-clinical Pre-clinical Pre-clinical Pre-clinical Pre-clinical Indication Intestinal health Clostridium tetani exposure to HBsAg Hangover remedies Hangover remedies 5) Kawasaki Syndrome 4)Guillain-Barre Syndrome enzyme replacement therapy 1)-/Hypogammaglobulinemia patients with liver transplant For treatment of hemophilia A For prophylaxis against Varicella severe bacterial or viral infections severe bacterial or viral infections For patients with Hunter Syndrome For patients with Hunter Syndrome myelosuppressive anti-cancer drugs For the Prophylaxis against Influenza For the Prophylaxis against 1) For prophylaxis of hepatitis B after 2)Combined therapy with antibiotics in 2)Combined therapy with antibiotics 3)Idiopathic Thrombocytopenic Purpura 3)Idiopathic Thrombocytopenic For prophylaxis of tetanus and reduction (Mucopolysaccharidosis II, MPS II) as an (Mucopolysaccharidosis II, Arthritis, muscle pain, anti-inflammation immunization against infection caused by of tetanus symptoms by providing passive a patient treated with chemotherapy using 2) For prophylaxis of hepatitis B in neonates For prevention of recurrence of hepatitis B in For decreasing the duration of neutropenia in IBD Human Curcumin Curcumin Factor VIII Bronchitis Ketoprofen Osteoporosis Osteoporosis Idursulfase-ß Degeneration adminstration Human G-CSF Type A (H1N1) Type A (H3N2) Type Zinc gluconate erythematosus Type B-Victoria Type Systemic lupus for intravenous Human Tetanus Human Tetanus Immunoglobulin Immunoglobulin Human Hepatitis Type B-Yamagata Type B Immunoglobulin Immunoglobulin-G lactic acid bacillus Calcium carbonate Human Hepatitis B Purified Inactivated Purified Inactivated Purified Inactivated Purified Inactivated Purified Inactivated Human Coalugation Rheumatoid arthritis Age-related Macular Active Ingredient Mixed-hyperlipidemia Varicella Vaccine(Live) Varicella Influenza Virus Antigen Antigen Influenza Virus Antigen Influenza Virus Antigen Influenza Virus Antigen Influenza Virus Pegylated Recombinant IMD IMD Herb Hutos GCFLU GCC inj. Stem cell Hunterase Hepabig.inj Sero-Tet inj. Sero-Tet Neulapeg inj. Green VIII inj. Nadossukssuk I.V.Hepabig inj. I.V.Hepabig READY Q Drink Small molecule Small molecule Small molecule Small molecule READY Q Chew Hutos Probiotics Quadrivalent inj. KETOTOP Plaster Product name Varicella Vaccine- Varicella Hutos Joateunteun I.V.-Globulin SN inj. I.V.-Globulin Corp. Cross Green PHARM. HANLIM CO., LTD. Company Handok Inc. PAHO Note through WHO & PQ from Procured WW WW USA, WHO Brazil ASIA) ASIA) ASIA, Japan INDIA) INDIA) EGYPT, EGYPT, MENA) MENA, MENA, CHINA) JAPAN, JAPAN, LATAM) AFRICA, AFRICA, (RUSSIA, country WW (EU, WW (EU, WW (EU, worldwide worldwide worldwide worldwide worldwide worldwide Worldwide Worldwide Expected USA, ROW) MALAYSIA) Russia, CIS) CHINA, CIS) USA, China, INDONESIA, WW (SYRIA, (AUSTRALIA, WW (NORTH WW (NORTH WW (JAPAN, WW (JAPAN, WW (LATAM, WW (LATAM, WW (LATAM, WW (LATAM, ETC ETC Generics Generics Generics Generics Generics Generics Generics Generics Vaccines biologics biologics biologics biologics biologics biologics Product t Biologics Medicine Antibiotic Generics & Generics & Generics & Generics & Generics & Generics & Generics & Generics & Category Prescription Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Value-added Recombinant New chemical medical device puberty Indication Tuberculosis spinal fusion Acute wound Gallstone etc Hemophilia A Antiulcer program Pancreatic Cancer CT contrast media Pulmonary Disease Erectile Dysfunction Erectile Dysfunction Dental sinus lift graft Growth hormone deficiency Growth hormone deficiency diseases, Acute/Chronic diarrhea medical device - adhesion barrier Gastric & duodenal ulcer, gastritis Gastric & duodenal ulcer, Anemia in end stage renal disease Anemia in end stage renal glabellar lines, upper limp spasticity For the Prophylaxis against Influenza esophageal-gastric and large intestinal Liver & bile disease including cholestasis, For the prevention and control of bleeding Relif of painful symptoms associated with Acute Exacerbation of Chronic Obstructive Diabetic foot ulcer, oral mucositis, wounds ulcer, Diabetic foot episodes and preoperative management in Prostate cancer, Endometriosis, Precocious Prostate cancer, Concomitant hypertension and dyslipidemia EGF EPO APA hGH EGF Type B Type BMP-2 BMP-2 chitosan Sildenafil Sildenafil Iopromide Sucralfate Leuprolide Somatropin Cycloserine Tertomotide Tertomotide Zabofloxacin Rosuvastatin Olmesartan + hydrochloride Type A (H1N1) Type A (H3N2) Type VIII, recombinant poloxamer, gelatin, poloxamer, Purified Inactivated Purified Inactivated Purified Inactivated D-aspartate Hydrate Ursodeoxycholic acid Active Ingredient Dioctahedral smectite (AcidPumpAntagonist) Botulinum toxin type A Influenza Virus Antigen Influenza Virus Antigen Influenza Virus Antigen Influenza Virus Ranitidine + Bismuth + Blood coagulation factor inj. ® Albis URSA Eposis Olostar Nabota Nurigra DW206 Novosis Luphere Dehecta Neovest Zabolante Mediclore GCFLU inj. RIAVAX Easyef Spray Novosis – OS Nurigra Chew Closerine Cap. Growtropin Inj. Easyef Ointment Product name Green Gene F inj. Caretropin 22.5 IU Ltd. Corp. Cross Pharm Green Pharm Co. LTD aceutical. KAEL Co., GemVax & GemVax Dong Wha Daewoong Dong-A ST Company 54
Supplement Supplement 57 ------Note Release Release Release Controlled Controlled Controlled Fixed Dose Fixed Dose Fixed Dose Formulation Formulation Formulation Formulation Combination Combination Combination New Dosage Asia, Brazil, Global Global Global Global Global Global Global Russia MENA, MENA, MENA, Russia, Mexico, country ROW, etc ROW, Southeast worldwide worldwide worldwide worldwide worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Expected US, EU, etc Mexico, Brazil Eastern Europe Southeast Asia Active Active Active Active product product product Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Biological Biological Biological Ingredients Ingredients Ingredients Ingredients Category Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription uct (Prescrip- tion medicine) Medical device Medical device Medical device Pharmaceutical Pharmaceutical Pharmaceutical Pharmaceutical Biological prod- Wrinkles and gastritis Antibiotics Antibiotics Antithrombotic Antithrombotic Infertility Indication Hypertension Hypertension Antihyperlipidemia Joint arthritis Angiotensin II blocker Wrinkle correction Treatment of Osteoporosis Treatment Drug for bronchial asthma HMG-CoA reductase inhibitor HMG-CoA reductase inhibitor Gastrointestinal symptoms Pain caused by rheumatism Pain caused by Cardiovascular system drugs Cardiovascular system drugs Growth hormone deficiency Ischemic symptoms, Thrombosis Treatment of gastroduodenal ulcers Treatment Upper respiratory tract infections cerebral palsy, Glabellar wrinkles cerebral palsy, Anemia in chronic renal disease Acute coronary syndrome (antiplatelet) Blepharospasm, Focal spasticity in pediatric ext. APIs APIs APIs APIs Omega-3 + Omega-3 + Teicoplanin Budesonide Rebamipide Vancomycin Atorvastatin Rosuvastatin Erythropoetin Aspirin 100mg Losartan 50mg Cholecalciferol Hyaluronic acid Hyaluronic acid Hyaluronic acid Losartan 100mg Mosapride 15mg Cilostazol 200mg recombinant FSH human Somatropin Aceclofenac 200mg Amlodipine 5mg and Amlodipine 5mg and Clopidogrel bisulfate Atorvastatin Calcium Active Ingredient Pelargonium sidoides Clopidogrel 75mg and Alendronate sodium + Botulinum toxin type A Tab. ® CR Tab. CR Tab. CR Tab. Duo Cap. Tab5/50 ® Tab5/100 ® ® ® ® ® EPO hGH rFSH Tablet Tablet 500μg Yvoire Calcium Calcium Neuramis Neuronox Omega-3/ Omega-3/ medoxomil Clopidogrel Olmesartan Pitavastatin 200/400 mg Rosuvastatin 500/1000 mg Kalomin NEUSTATIN-A NEUSTATIN-A Clanza Gastiin Losasc PLATLESS Tablet PLATLESS BAMEDIN Tablet Cilostan bisulfate (form 1) Product name Atorvastatin mini Losasc AIDBONE PLUS D Rosuvastatin mini Hyruan plus/SIHA Pulmican respules Clavixin Teicoplanin for Inj. Teicoplanin capsule 2000/5mg Vancomycin for inj. Vancomycin capsule 2000/10mg Inc. Ltd. Korea Kuhnil United Samjin Co.,Ltd LG Life Samjin Pharm- Pharm Pharm- Co., Ltd. Co., Ltd. Medytox aceutical aceutical aceutical Sciences, Pharm. Inc. Company ------Note Generic BE study Modified EU EU EU EU, EU, Any Any Asia Asia Asia Asia Asia Asia Latin Asia Asia North Africa Africa Global Global Global Global Global Europe Vaccine America, America, country Asia, US, Northeast South-East South-East Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Expected Middle Eas Southwest South-East Middle East Middle East Middle-East EU, Oceania, Except Korea Asia, Europe, Southeast asia, Southeast asia, Latin america Latin america South America CV Drug Drug Drug Drug Drug Drug Premix system Urology Urology Urology Vaccine Vaccine medicine medicine medicine medicine Medicine Medicine Medicine Musculo- Urogenital Category Respiratory Respiratory Prescription Prescription Prescription Prescription prescription Prescription Prescription Prescription Prescription prescription Prescription I.V. Solution I.V. Prescription I.V. Solution I.V. I.V. Solution I.V. I.V. Solution I.V. OTC Product Prescription Orphan Drug Orphan Drug Orphan Drug Raw Material Cardiovascular Skeletal system BPH Atopy ED, BPH ED, BPH Epilepsy Antibiotics Esophagitis Indication Hypertension, Fabry Disease Anticoagulant Anti-thrombotic Improves Health Antihypertensive Gaucher Disease Psoriasis vulgaris Influenza Vaccine Influenza Vaccine Dry eye syndrome line of CML(chronic myeloid Nocturnal enuresis Anti-obesity Agents nd Improves performance Lipid based IV solution Essential Hypertension Amino Acid IV Solution Amino Acid IV Solution Amino Acid IV Solution Lercanidipine HCL 10mg postmenopausal women leukemia)-CP(chronic phase) Gastric ulcer, acute gastritis, acute gastritis, Gastric ulcer, Prevention of osteoporosis in and 2 acute aggravation of chronic acute acute aggravation of chronic Hypertension, Chronic heart failure st Cough : acute and chronic bronchitis Cough : acute and chronic bronchitis Gastric Ulcer, Duodenal Ulcer, Erosive Duodenal Ulcer, Gastric Ulcer, 1 Myocardial infarction, Shock by sepsis Antifungal, acute/chronic tracheitis etc., 5mL 5.01g 10mg Orlistat Heparin Tadalafil nebivolol Radotinib Ilaprazole Abciximab Amlodipine electrolytes Dutasteride Imiglucerase 0.1%, 0.03% 0.1%, 0.03% virus antigen virus antigen Levitiracetam Valsartan and Valsartan bitartrate 8mg acebrophylline Korea Ginseng 15 amino acids Norepinephrine Valsartan 80mg Valsartan Agalsidase beta 8 amino acids, 3 Amlodipine 5mg levodropropizine Trivalent purified Trivalent sodium25,000IU/ Lercanidipine HCL electrolytes & etc. Cyclosporin 0.05% 15 amino acids & 4 Rebamipide 100mg Refined soybean oil ibandronate sodium Tacrolimus Ointment Tacrolimus Tacrolimus Ointment Tacrolimus inactivated Influenza inactivated Influenza Azithromycin hydrate Quadrivalent purified Active Ingredient Tamsulosin +Tadalafil Tamsulosin desmopressin acetate Taurine, Multi Vitamin Taurine, Amolodipine + Tadalafil + Amolodipine ® ® ® Gugu Duted Premix Lipision 25000IU Amolafil ointment Fabagal Ointment Freamine Clotinab Abcertin Gugutams Tacrolimus Tacrolimus Noltec tab. Calmio gel, Supect cap. Hepatamine Nephramine Drovan (Tab) Uremin (Tab) ZERO-X Cap. Levitiracetam Pine injection Nebolmin (Tab) Lercapin Tablet Valsarex Tablet Valsarex Surfolase (Cap) Clacier Eye drop MAXFORGE Tab. MAXFORGE Tab. Azimax dry syrup Product name WONBI-D LIQUID Noreprin injection Mucoramin Tablet ILYang Flu Vaccine Flu Vaccine ILYang ILYang Flu Vaccine Flu Vaccine ILYang GINSENG ENERGY Levotuss (Tab, SYR) Levotuss (Tab, Pre-filled Syringe inj Pre-filled Syringe inj. JW Korea Hanmi Pharm- Pharm. Kolmar Pharm IL-YANG IL-YANG Co., Ltd. Hyundai HUONS PHARM- Co., Ltd. CO., LTD. aceutical CO., LTD. aceutical ISU Abxis ACEUTICAL Company 56
Supplement Supplement 59 Note testing methods to animal Alternative EU, Asia EU, Asia country Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Expected World Wild World World Wild World World Wild World East, Africa, US, EU, Asia US, EU, Asia US, EU, Asia US, EU, Asia US, EU, Asia US, EU, Asia Asia, Middle, CIS and so on CV CV CNS CNS Product Product medicine medicine medicine medicine medicine medicine medicine medicine Research Medicine) Medicine) Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics Category Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Cell Therapy (Prescription Cell Therapy (Prescription Tester Kit for Tester ETC Medicine ETC Medicine ETC Medicine ETC Medicine OTC Medicine OTC Medicine OTC Medicine Dry eye Infection Infection Infection Infection Infection Infectioin Antibiotics examination Indication of newborns Angiography degree burn(2005.03) Conjunctivitis Hyperuricemia Anti-glaucoma Anti-glaucoma Anti-glaucoma hyperlipidemia Spinal stenosis nd Supply of nutrition Antiacidic functions degree burn over 30% of TBSA Anti-inflammatory agent nd Diabetic Foot Ulcer(2010.06) Anti-inflammatory, Analgesic Anti-inflammatory, degree burn over 10% of TBSA Deep 2 rd Treatment for htypertension and for htypertension Treatment 3 Alleviation of heartburn & indigest Deep 2 Anti-inflammatoryAntipyretic, Analgesic For cosmetics testing and drug discovery Bowel cleansing for x-ray and endoscopic Bowel cleansing for x-ray and Gastric & duodenal ulcer, erosive gastritis Gastric & duodenal ulcer, Treatment for respiratory distress syndrome for respiratory Treatment Iohexol Linezolid Almagate Limaprost L-menthol acid+Lipid Potassium Allogeneic Febuxostat Loxoprofen lol maleate Autologous Telmisartan Telmisartan Latanoprost Latanoprost Human Skin Cyclosporine Rosuvastatin HCl+Na2CO3 Propacetamol Keratinocytes Keratinocytes Cefotiam HCl/ Glucose+Amino Sodium alginate Olopatadine HCl Sodium Alginate Reconstituted 3D Cefditoren Pivoxil Methyl Salicylate Cefcapene Pivoxil Bovine Lung Surfa Polyethylen Glycol Calcium carbonate Ceftizoxime Sodium Sodium bicarbonate Cefmetazole Sodium Active Ingredient - Latanoprost plus Timo Amoxicillin Clavulanate ® ® ® Free Iobrix Lotion Xalost Granule) Granule) Willogel Alpadine (API, Inj.) (API, inj.) Coolprep Lamina G Cyporin N Neoderm TNA (Total TNA (Total Kaloderm 3-Chamber Holoderm Xalost Plus Newfactan Suspension Ceftizoxime Opast (Tab.) Yucla Tablet Yucla Cefmetazole DoubleAction Linezolin (tab.) (API, Tab., Fine (API, Tab., Fine (API, Tab., Duowell Tablet Antiphlamine S Febuxostat (API) Loxoprofen (API) Product name Cefditoren Pivoxil Cefcapene Pivoxil Denogan (API, inj.) Cefotiam (API, inj.) Xalost Preservative Xalost Preservative NutrientAdmixture) AlmagateSuspension INC., TEGO Yuhan Yuhan Pharm. Yungjin Yungjin Co.,Ltd. Co., Ltd Taejoon Taejoon ceutical Pharma- SCIENCE, Company Corporation - - - - - PQ etc free free RTU to EU Asian Note Already Generic Generic Generic to some to India, to India, in Korea in Korea in Korea in Korea in Korea for WHO Same PK No patent Thailand, countries Exporting China etc Exporting Exporting exporting Approved Approved Approved Approved Approved Tween-80 Tween-80 Lower API Lower API Cremophor & same PK & same PK infringement formulation Preparation formulation South- Russia, EU, US, America America America America America America America America America, country Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Expected CSI, Africa, US, EU etc. US, EU etc. US, EU etc. US, EU etc. US, EU etc. east, Latine east, Latine east, Latine east, Latine east, Latine Asia, Latine Asia, Latine Asia, Latine Asia, Latine Asia, Latine Middle east America etc. Asia, Middle Asia, Middle Asia, Middle Asia, Middle Asia, Middle America, etc. API API API API API (ODF) (ODF) Vaccine medicine medicine medicine medicine medicine medicine medicine medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Medicine Category Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription Prescription OTC product (Blood product) (Blood product) (Blood product) others Asthma Asthma Dementia Anti-cancer Anti-cancer Anti-cancer Anti-cancer Anti-cancer Severe pain Anti-Cancer Anti-Cancer Anti-Cancer Indication Anti-malaria Anti-malaria Anti-dhesive Hypertension Osteoarthritis anti HIV/AIDS Anti-coagulant Hyperlipidemia anti Tuberculosis Metabolic disease Hypo-albuminemia Erectile dysfunction Erectile dysfunction Alzheimer’s disease Alzheimer’s Agammaglobulinemia Osteoarthritis, Tenosynovitis, Myalgia & Osteoarthritis, Tenosynovitis, post-exposure prophylaxis HBV infection Prevention for influenza virus (Cell culture) & HES Fentanyl Tadalafil & others Piroxicam Paclitaxel Ezetimibe Paclitaxel Docetaxel Docetaxel Stavudine Terizidone Anhydrous Oxaliplatin Artesunate Artesunate Bortezomib Bortezomib Mirodenafil Pemetrexed Montelukast Candesartan Montelukast Rivastigmine Rivastigmine Temozolomid Palonosetron Lenalidomide Amlodipine & Pyronaridine & Pyronaridine & Rosuvastatin & Zoledronic acid Human albumin immunoglobulin Influenza vaccine Sodium hyaluronate Atovastatin Calcium Clopidogrel Bisulfate Active Ingredient Clematis mandshurica Human anti-hepatitis B Human immunoglobulin
In- ® ® ® ® Patch M ® ® S PM ® ® ® ® Tablets Granules ® ® API API API API API (SN) Patch SN inj jection Tablets Tablets Albumin Ezerosu Oncology Temozol Joins tab. (trivalent/ Pemed SKYCellflu Injectables Injectables Trast patch Trast Liv-Gamma Fentaderm Nanoxel Protezomib Candeamlo IV Hepabulin quadrivalent) Tadalafil ODF Tadalafil Genexol Mvix tab./ODF Oncology Orals Medicurtain Product name Montelukast ODF Pyramax Rivastigmine patch DemenCure Pyramax SK Pharm. Co.,Ltd Co. Ltd. Co., Ltd. Samyang ST Pharm aceuticals Chemicals Biopharm- Company Shin Poong Corporation 58
Supplement Supplement 61 - - Note Asia China Japan Global Global Global Global Global US/EU US/EU MENA US/EU US/EU USA/EU USA/EU USA, EU USA, EU USA, EU, country worldwide worldwide worldwide US/China/ Targeted Targeted Worldwide Worldwide Worldwide Worldwide Worldwide World wide World wide Japan, EU, East - - - - - IND (EU) (EU) (US) (US) Phase 2 Phase 2 Phase 2 Phase 2 Phase 2 planned, launched launched launched Ph I com- Ph I com- Ph I com- Ph III on- going (JP) Ph II com- pleted (EU) pleted (JP), pleted (JP), US pre-IND Overseas and Phase I Preparation pleted (US), Global Ph III Phase 1b/2a Preparing PK Ph I on-going Ph III planned Ph III planned IND approved EU pre-Phase I O IND Phase I Phase I Korea Phase 2 Phase II Phase 2 Phase 2 Phase II Phase 2 Phase 2 Phase 2 Phase III Development StatusDevelopment launched launched launched Launched Marketed preclinical Pre-clinical Pre-clinical Preparation Phase 1b/2a Phase 3 ended IBD disease Anemia Anemia pertussis Lumbargo Bronchitis Neoplasia solid tumor HPV Cancer Indication Neutropenia Colon cancer AGHD/PGHD Degeneration Breast cancer Gastric cancer etythematosus Systemic Iupus pharyngitis etc. Type 2 diabetes Type Hunter syndrome deficiency (PGHD) deficiency (AGHD) sinusitis, tonsillitis, Overactive Bladder Diabetic Neuropathy Age-related Macular mastoiditis, paranasal Varicella Vaccine(Live) Varicella Adult growth hormone Cervical Intraepithelial Diabetic foot ulcer, oral Tetanus, diphtheria and Tetanus, pneumonia, otitis media, media, otitis pneumonia, Bronchiectasis, bacterial mucositis, acute wounds acute mucositis, Anemia in end stage renal Pediatric growth hormone Growth deficiency hormone Osteoarthritis, Rheumatoid, Osteoarthritis, Rheumatoid, biosimilar) ® biosimilar) ® Herb Hybrid Vaccine Vaccine DA-3880 biologics biologics Biologics Biologics Biologics biologics Stem cell Analgesic DMB-3111 Antibiotics Anticancer Category Fc Technology Small molecule Biologics (ADC) Small molecule Biologics (EGFR) DNA Vaccine Technology DNA Vaccine DA-9801 (Botanical drug) DA-1241 (GPR119 agonist) DA-8010 (M3 receptor antagonist) (Trastzumab, Herceptin (Trastzumab, (Darbepoetin alfa, Aranesp Inc. Ltd. Green Pharm Co. LTD Daewon PHARM. HANLIM EUTICAL CO., LTD. CO., LTD. DAEHWA Genexine, aceutical. aceutical. Dong-A ST PHARMAC Company Daewoong Daewoong Cross Corp. Pharm. Co., Handok Inc. ------NCE IMD IMD IMD IMD IMD Note Vaccine Biosimilar Biosimilar use) liquid RTU(ready-to- Japan Global Global Global US / EU US / EU US / EU US / EU East Asia country Worlwide Worlwide Worlwide Worlwide Targeted Targeted Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worlwide Worlwide Worlwide Worlwide Worlwide ROW & China ROW & China ROW & China LATAM, South- LATAM, ------
N/A N/A N/A N/A N/A N/A N/A N/A N/A (USA) Phase 1 Phase 1 Phase IIa Australia) Launching Launching completed Overseas Phase 1/2a (Completed) (Netherland) - - - Korea Phase I 2 ready Process Phase 3 Phase 3 Phase 1 Phase 1 Phase III Phase III Phase III Development StatusDevelopment Phase Ib/ Launched Launched Launched Preclinical Preclinical Preclinical Preclinical Launching Launching Preclinical Preclinical Pre-clinical Pre-clinical Phase 1/2a Phase 1/2a Non-clinical Non-clinical Non-clinical Non-clinical development Process development Process Process development Process Process development Process GERD (MSA) Cancer Cancer Cancer Anemia Anemia Diabetes Oncology Anticancer Leukopenia AMD, DME Indication Dyslipidemia Colon Cancer Hypertension Hypertension Hypertension Hypertension Schizophrenia Degeneration Renal enemia Osteoarthritis hyperlipidemia systemic lupus & Hyperlipidemia & Hyperlipidemia Multiple myeloma Parkinson’s Disease Parkinson’s erythematosus (SLE) Rheumatoid Arthritis Cancer (hematologic) Autoimmune Disease Age-Related Macular (OA/cartilage defect) ABSSSI, Osteomyelitis and other serious Staph multiple system atrophy Hand Foot Mouth disease infections including MRSA Hyperlipidemia & Diabetes Biologic Biologic CKD-701 Oncology CJ-12420 CJ-30060 CJ-30059 CJ-30061 CJ-40001 CJ-30056 candidate candidate RTU (pemetrexed) Category CKD-11101 technology)) ® (voglibose+metformin) small moleculesmall moleculesmall Small molecule Small molecule Small molecule ® (ARB: Fimasartan) CJ-40010 (Vaccine) CA20AT04(BM-MSC) New Chemical Entity CS10BR05(BM-MSC) CS30MS02(cartilage) (atorvastatin+metformin) Beta biosimilar candidate (candesartan+amlodipine) Pemta CKD-519 (Small Molecule) CKD-506 (Small Molecule) CKD-516 (Small Molecule) CKD-504 (Small Molecule) CKD-581 (Small-Molecule) manufacturing technology) manufacturing technology) (darbepoietin α biosimilar) Hyaluronic acid (cell bank & Botulinum toxin (cell bank & VogMet CKD-760 (Adalimumab) biosimilar (ranibizumab biosimilar candidate) CJ-40012 (Ranibizumab biosimilar) CKD-12101 (Pegfilgrastim) biosimilar Methoxy Polyethylene Glycol-Epoetin (amlodipine + valsartan + atorvastatin) (amlodipine + valsartan + rosuvastatin) HPV vaccine (cell bank & manufacturing (Darbepoetin- alfa biosimilar candidate) CJ Inc. Inc. Corp. Pharm co.,Ltd. Crystal Boryung PHARM. CO., LTD. aceutical aceutical Corestem Genomics, BCWORLD Chong Kun Company HealthCare corporation Dang pharm 2. Technology Transfer 2. Technology 60
Supplement Supplement 63 ------Safe Note Better P2Y12 patient release release polymer inhibitor Biologics Solubility Solubility Marketed Sustained Sustained enhancing enhancing, based DDS compliance XO inhibitor Gene delivery Antibody biosimilar - Any Global Global Global US, EU US, EU US, EU US, EU US, EU US, EU US, EU US, EU Europe country Asia, US, Targeted Targeted Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Middle EastMiddle Asia, Europe, ------ N/A N/A N/A N/A N/A N/A Ph 2 Asian Clinical Clinical US Ph 2 America) (a part of Launched Iran MAA Preclinical and South in Mexico, completed in progress Overseas 3 completed 3 Middle East population Ph population Ph 1 Ph 2 Ph 1 Korea Phase 1 Phase 1 Phase 1 Phase 1 Phase 1 Development StatusDevelopment Launched Launched Launched Launched Discovery Discovery launching Preclinical Preclinical Launched Launched Preclinical Preclinical Preclinical Laucnched Laucnched Laucnched Laucnched (completed) Pre-clinical (completed) (completed) (completed) IND (’17 1Q) Clinical Trial Clinical Trial NDA approved line of nd HCC CNS Gout Gout phase) Cancer Oncology Oncology Oncology Analgesic AML/MM Antitussive Antitussive Anti-cancer Anti-cancer Anti-cancer Severe pain Indication and 2 GI modulator Fabry Disease st Antithrombotic Antithrombotic Antithrombotic Hemoglobinuria Anti-viral agent Gaucher Disease 1 Neuropathic pain Dryeyesyndrome Anti-hypertensive Sjogrensyndrome Dry eye syndrome Atherothrombosis Cancer (Solid Tumor) Rheumatoid arthritis Rheumatoid CML(chronic myeloid leukemia)-CP(chronic Paroxysmal Nocturnal Glabellar wrinkles, etc. Gastric Ulcer, Duodenal Duodenal GastricUlcer, Ulcer, ErosiveUlcer, Esophagitis ® ® NCE NCE tech. tech. SA001 SA002 ISU305 ISU104 SJP1601 Fabagal Biologics TDS tech. TDS tech. Abcertin Category SiRNA DDS polymer-based polymer-based polymer-based parenteral DDS parenteral DDS Immunotherapy Small moleculeSmall Small moleculeSmall Tumor-targeting Cell Therapeutic long-acting DDS tech. Prescription Medicine Prescription Medicine Prescription Medicine Fixed Dose Combination Fixed Dose Combination New Dosage Formulation Controlled Release Formulation Controlled Release Formulation Controlled Release Formulation Controlled Release Formulation Controlled Release Formulation Biologics (Botulinum toxin product)
JW Inc. Ltd. Korea United Samjin LG Life Pharm- IL-YANG IL-YANG PHARM. PHARM. Co., Ltd. Samyang Medytox Corporation aceuticals Biopharm- aceutical aceutical ISU Abxis Sciences, Corporation Company Pharm. Inc. Pharmaceutical - - IMD Sanofi Sanofi process process Note ZAI Lab Athenex Athenex Athenex Company ex. Korea, ex. Korea, Bi-specific Genentech to Janssen WW rights Technology Eli Lilly and Licensed to Licensed to Licensed to to Spectrum to Spectrum - WW rights -China rights Manufacturing Manufacturing Licensed from Pharma Group WW rights ex. WW rights ex. WW rights ex. WW rights ex. China licensed China licensed Simplification of Simplification of Japan licensed licensed to Luye Pharmaceuticals Pharmaceuticals Pharmaceuticals China (incl. Hong Korea, China and rights licensed to Korea licensed to Korea licensed to Korea licensed to Kong and Macau) Antibody Platform EU Asia Asia CIS, EU America USA, EU USA, EU country Targeted Targeted Worldwide Worldwide Japan, East Japan, East - - - Phase I Phase I Phase I Phase II Phase II Phase II Phase II Phase II Phase III Phase III Discovery Overseas PC PC Korea Phase I Phase I Phase II Phase III Development StatusDevelopment Phase III Discovery Marketed Preclinical completion Pre-clinical Pre-clinical Pre-clinical Development GHD disease arthritis Epilepsy diseases Diabetes Diabetes Rheumatoid Indication Neutropenia Solid tumors Solid tumors Solid tumors Osteoporosis Osteoporosis Breast cancer Breast cancer Hypotensive agent Diabetes & Obesity Diabetes & Obesity Rheumatoid arthritis Essential Hypertension Mixedhyperipidemia Protective agent of the Gastroesophageal reflux Oncology & Autoimmune Non-small cell lung cancer gastric mucous membrane inhibitor) HM30181A) HM30181A) GCSF analog) RAF inhibitor) dual inhibitor) GI PENTAMBODY kinase inhibitor) IMD IMD long-acting hGH) CNS Poziotinib (Pan-HER Oraxol™ (Paclitaxel + long-acting GLP/GCG) Olita™ (olmutinib; 3rd- LAPSGCSF; long-acting Category HM14220 (LAPSInsulin/ Oratecan™ (Irinotecan + HM71224 (BTK inhibitor) LAPSGLP-1 Combination) generation EGFR tyrosine long-acting GLP-1 analog) Rolontis™ (eflapegrastim; HM95573 (2nd-generation long-acting Insulin analog) efpeglenatide (LAPSGLP-1; HM12470 (LAPSInsulin115; HM12470 (LAPSInsulin115; Small molecule Small molecule HM12525A (LAPSGLP/GCG; HM12525A (LAPSGLP/GCG; KX2-391 (Src kinase/tubulin efpegsomatropin (LAPShGH; Prescription Drug Prescription Drug Prescription Drug New New (NCEs) Entities Technology Biologics Chemical Hanmi Pharm. Pharm- HUONS Co., Ltd. Hyundai PHARM. HANLIM CO., LTD. CO., LTD. aceutical aceutical Company 62
Supplement Supplement 65 Note Supply company APIs to a Company Japanese scheduled scheduled products to a Japanese Supply bulk- KGMP PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA J GMP ANVISA EU GMP EU GMP EU GMP WHO PQ WHO PQ WHO PQ Thai GMP Thai GMP Inspection Inspection Inspection Inspection Inspection Inspection Inspection Inspection Inspection Japan GMP Japan GMP Japan GMP Japan GMP Japan GMP certification certification certification certification certification certification International Philippines GMP Philippines GMP Infection Infection Infection Infection Infection Infection Infection Infection Infection Oncology Antibiotiecs Antibiotiecs Antibiotiecs Antibiotiecs Indication Tuberculosis Antihistamine Antihistamine Cardiovascular Cardiovascular Antihypertension pancreatic cancer Immunosuppressant Growth hormone deficiency For the Prophylaxis against Influenza For the Prophylaxis against Influenza Inj. Inj. Inj. Inj. Inj. Inj. Inj. API API API API API API Vial Vial Tab. Syrup Tablet Tablet Capsule injection Capsule. Injection Injection Vial, AQ, Pen Vial, dosage form Type B Type Linezolid Linezolid Alacepril A (H3N2) A (H3N2) A (H1N1) A (H1N1) B-Victoria Tacrolimus Fimasartan Cycloserine Somatropin Doxorubicin Pitavastatin B-Yamagata Moxifloxacin Moxifloxacin Cefotiam Hcl clavulanate Fexofenadine Fexofenadine Cefopodoxime Cefopodoxime Cefozopran Hcl Cefazolin sodium Cefmenoxime Hcl Ambroxol HCl (API) Purified Inactivated Purified Inactivated Purified Inactivated Purified Inactivated Purified Inactivated Purified Inactivated Purified Inactivated Sesquihydrate (API) Active Ingredient Pantoprazole Sodium Influenza Virus Antigen Influenza Virus Amoxicillin/Potassium Tertomotide hydrochloride Tertomotide Bacampicilin hydrochloride Ceftriaxone Sodium hydrate Influenza Virus Antigen Type Antigen Type Influenza Virus Antigen Type Influenza Virus Influenza Virus Antigen Type Antigen Type Influenza Virus Influenza Virus Antigen Type Antigen Type Influenza Virus Influenza Virus Antigen Type Antigen Type Influenza Virus Influenza Virus Antigen Type Antigen Type Influenza Virus ® ® ® ® tab. ® dry syrup ® GCFLU Pengood Alacepril RIAVAX Closerine First-Sin Kmoxilin GCFLU inj. Best-Call Tacrolimus GFLU multi Fimasartan Ceftriaxone Doxorubicin Pitavastatin Rasenazolin Banan Cinezolid Inj. Pan-Sprorin Fexofenadine Fexofenadine Moveloxin Inj. Moveloxin Inj. Cinezolid Inj. Growtropin Inj. Quadrivalent inj. Product name Banan CJ Ltd. Corp. Green Chong Pharm Pharm pharm co.,Ltd. Boryung aceutical aceutical Kun Dang KAEL Co., GemVax & GemVax Dong Wha Dong-A ST HealthCare Company corporation Cross Corp. 3. Certifications from Health Authorities from Health 3. Certifications ODF ODF Fund) Note Oral BA (Korea Drug and Welfare) and Welfare) and Welfare) and Welfare) enhancing Development KOREA KDDF KOREA MOHW KOREA MOHW KOREA MOHW KOREA MOHW (Ministry of Health (Ministry of Health (Ministry of Health (Ministry of Health supported Project supported Project supported Project supported Project supported Project Latin Latin Latin Japan USA, EU, country worldwide worldwide Targeted Targeted Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide Worldwide US, EU, Asia, US, EU, Asia, US, EU, Asia, ------N/A (IND (IND) Phase2 (Active) (Active) (Active) Phase II Phase III Phase III Phase III approved) Screening Preclinical Preclinical Preclinical Preclinical Preclinical Preclinical Clinical(P1) Overseas ALS - Phase II ------NDA Lead Phase I Phase I Korea Phase1 (Active) Phase II Development StatusDevelopment Launched Launched Launched (trivalent) Screening Phase 1/2 Phase 1/2 Preclinical Preclinical Preclinical Preclinical Preclinical Pre-launch preclinical Clinical(P1) Clinical(P2) optimization (quadrivalent) Phase3 ended virus NASH wound Asthma Diabetes Sclerosis Oncology Anti-stroke Hemophilia Neuropathy Indication Anti-platelet BPH with ED GI prokinetics GI Heart failure COPD/Asthma Spinal Stenosis Fibrotic disease /Osteoporosis Fracture healing Osteoarthrosis prostate cancers Neuropathic pain Atherosclerosis Multiple Sclerosis Dermal/body filler Thrombocytopenia Diabetic Peripheral Erectile dysfunction Amyotrophic Lateral Endometriosis, uterine Chemotherapy-induced Prevention for influenza Coronary Artery Disease Burn, Diabetic Foot Ulcer myoma, BPH and breast / Peripheral Artery Disease Stroke, systemic embolism and various acute& chronic TM TM CV CNS SID143 Urology NBP604 NCE407 SP-8008 SP-8232 SP-8356 SP-8203 SP-35454 SKYCellflu HyalONE Category Respiratory FreeWink Cell Therapy Plasmid DNA Plasmid DNA Plasmid DNA Plasmid DNA Tadalafil ODF Tadalafil ALK5 inhibitor GPR40 agonist GnRH antagonist Montelukast ODF Recombinant Protein New chemical entity New chemical entity Recombinant protein Recombinant (Autologous & Allogeneic Keratinocytes) SK INC TEGO Yuhan Pharm. Co.,Ltd Pharm. Co.,Ltd Pharm. Yungjin Co.,Ltd. Co. Ltd. Co., Ltd. ViroMed ViroMed SCIENCE, Chemicals Company Shin Poong Shin Poong Corporation 64
Supplement Supplement 67 ------GMP GMP 2017 2013 2014 2015 2013 2012 Note Certification Certification Peru FDA) GMP Japan PMDA PMDA PMDA Russia Ukraine Council) EU GMP EU GMP GCC (Gulf FDA GMP FDA GMP Colombia, Certificate WHO GMP WHO GMP PIC/S GMP Non-sterile Quasi-Drug Turkey, Iran, Turkey, certification certification certification certification certification PMDA GMP PMDA GMP PMDA GMP PMDA GMP certification PMDA GMP Cooperation ANVISA GMP MFDS (Korean Iran, Colombia US FDA (510K) certification Turkey, Mexico Turkey, CE certification COFEPRIS GMP COFEPRIS GMP International Philippines FDA Jordan, Pakistan lungs diabetes Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics Indication Hypertension Hypertension Hypertension Hypertension Joint arthritis Anti-thrombotic Fungal Infection Fungal Infection Gaucher Disease Hepatits B vaccine Dental Anesthetics DTP-HepB-Hib vaccine Diluent for injectable drug glucose supplement during Growth hormone deficiency Vitamin, Mineral & Nutrition Vitamin, intravascular access devices. tubing system and in dwelling Hypokalemia, cardiac collapse, hypoglycemia, Cerebral edema, symptoms of seasonal allergies Flushing compatible intravenous Gastroesopha geal reflux disease Shock, Cardiac disease, Non-oral supplement of water, Diagnosis of supplement of water, Treating high blood pressure in the Treating asthma symptoms and to relieve the API API Solid Solid Solid Bottle Tablet Tablet Tablet Tablet Plastic Plastic Tablets Tablets Tablets Capsule Injection Injection Injection Injection Injection Injection Injection Injection Ampoule cartridge Ampoule Ampoule (injection) (injection) (injection) (injection) Dispersion formulation formulation Eye bath drops Eye bath drops dosage form Glucose Bosentan Lidocaine, Abciximab Losartan K Losartan K Losartan K Adrenaline Itraconazole Itraconazole tetrahydrate Imiglucerase Gemcifloxacin Hyaluronic acid Sodium chloride Sodium chloride Cilastatin sodium Cilastatin sodium Hepatits B vaccine human Somatropin Taurine 2000, others Taurine Montelukast sodium Active Ingredient Amlodipine camsylate Amlodipine camsylate Amlodipine camsylate DTP-HepB-Hib vaccine Meropenem trihydrate Meropenem trihydrate Esomeprazole strontium Imipenem monohydrate and Imipenem monohydrate and ® ® hGH 1.8mL Factive Euvax B Mixture Mixture injection 5/100mg 5/100mg Clotinab Abcertin IYEN2000 Imipenem Cozaar XQ Amosartan Hyruan plus Meropenem 20mg, 40mg Euforvac-Hib Tab. 5/50mg, Tab. Tab. 5/50mg, 5/50mg, Tab. Toracona tab. Toracona Prepenem Inj. Pospenem Inj. Bosentan Tab. injection 0.9% Itrazonazole SD Amosartan Tab. Esomezole Cap. Isotonic Sodium Sodium chloride Epilido cartridge chloride solution 20% Glucose for Product name Montelukast tab. JW Ltd. Hanmi Pharm. LG Life IL-YANG HUONS CO., LTDl PHARM- ISU Abxis Corporation CO., LTD. Sciences, ACEUTICAL ACEUTICAL Company Pharmaceutical 2012 2012 2012 2009 2012 2015 Note cancelled Launching FDA Syria PIC/S (ANVIS) (ANVIS) EU GMP Authority Ivory Coast Kazakhstan Kazakhstan Yemen FDA Yemen Oman MOH Jordan MOH Saudi Arabia Ethiopia FDA Uganda NDA Taiwan FDA - Taiwan Tanzania FDA Tanzania Colombia FDA Colombia FDA Peru Authority Ukraine- PIC/S certification (Germany BGV) Brazil Authority Brazil Authority International Epilepsy Indication Hypertension Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Type II diabetes Type Antithrombotic agent Edema., Hypertensionos Gastroesopha geal reflux disease Corticosteroid-responsive dermatoses form form form form form form form form form form from form form form form form form form form Solid Tablet Tablet Capsule Semi-solid formulation dosage form Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Solid dosage Eye bath drops dosage form Clobazam Losartan K Furosemide tetrahydrate Glibenclamide Desoxymethasone Active Ingredient Amlodipine camsylate Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Glimepiride Metformin Esomeprazole strontium Clopidogrel napadisilate 10mg tablet 2mg + 2mg + 0.25% 500mg 500mg 2/500mg 2/500mg 2/500mg 1/250mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 2/500mg 5/100mg Lasix tab. Prolonged- Prolonged- Daonil tab. Amosartan Frisium tab. AMARYL M Pidogle Tab. 20mg, 40mg Amaryl M IR Amaryl M IR Amaryl M IR Amaryl M IR Amaryl M IR Amaryl M IR Amaryl M IR Amaryl M IR METFORMIN METFORMIN Tab. 5/50mg, Tab. Amaryl M SR Amaryl M SR GLIMEPIRIDE Amaryl M SR Amaryl M SR Amaryl M SR Amaryl M SR Amaryl M SR release tablet release tablet 500mg coated Esperson oint. AMARYL MET coated tablets + METFORMIN Amaryl Met XR Glamaryl combi Esomezole Cap. IR GLIMEPIRIDE 2mg/500mg film Product name Glimepiride 2 mg Hanmi Pharm. Company Handok Inc. Handok Inc. 66
Supplement Supplement 69 Note PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA PMDA USFDA, TGA USFDA, TGA, USFDA, TGA, USFDA, EDQM certification International ------CV Infection Infection Infection Infection Infection Infection Infection Infection Indication ------Inj. API API API Capsule API, Tablet API, Tablet Fine Granule API, Injection API, Dry syrup dosage form PMH API 2 API 3 Cefdinir Ribavirin Cilostazol Voglibose Piperacillin Levofloxacin Cefotiam HCl Cefditoren Pivoxil Ceftriaxone Sodium Cefmetazole Sodium Active Ingredient Candesartan Cilexetil Cefcapene Pivoxil HCl Cefaclor Monohydrate Caftazidime Pnetahydrate PMH API 2 API 3 Cefdinir Cefaclor Ribavirin Cefotiam Cilostazol Voglibose Cefditoren Cefcapene Piperacillin Ceftriaxone Caftazidime Levofloxacin Cefmetazole Candesartan Product name Yuhan Pharm. Yungjin Yungjin Co.,Ltd. Company Corporation - - - - API API 2015 2016 2015 2016 2015 2015 2010 2014 2015 2013 Note API API API GMP GMP GMP GMP GMP GMP GMP GMP IRAN China China KGMP KGMP EU GMP EU GMP EU GMP EU GMP & EU GMP China, USA CE Marking certification certification certification certification certification certification certification certification certification certification certification Certification Germany(EU) Germany(EU) EU(Germany) EU(Germany) EU(Germany) PMDA GMP- Japan(PMDA) Japan(PMDA) Japan(PMDA) JGMP(PMDA) JGMP(PMDA) Japan(PMDA) US FDA GMP- TGA GMP-APITGA certification ANVISA GMP- Preparing cGMP CE certification Australia (TGA) International TBSA Dry eye NSAIDs Medicine Medicine Anti-ulcer Anti-cancer Anti-cancer Anti-cancer Anti-cancer Anti-cancer Anti-cancer Anti-cancer Indication Antimalarial Anti-malaria degree burn(2005.03) anti HIV/AIDS anti HIV/AIDS anti HIV/AIDS anti HIV/AIDS anti Anti-glaucoma Anti-glaucoma Medical device nd Anti-Neoplastics degree burn over 30% of nd Alzheimer’s disease Alzheimer’s Anti-adhesion barrier Glabellar wrinkles, etc. Glabellar wrinkles, Anti-hypertensive agents Diabetic Foot Ulcer(2010.06) degree burn over 10% of TBSA Deep 2 rd Deep 2 3 - - API API API API API API API API Vial Vial Patch Sheet Sheet Tablet Tablet Plaster Solution Solution Solution Injection Injection Injection Injection Nutrition Granules supply to and tissue Temporary Temporary cornea and conjunctiva (lyophilized) correction of regeneration Blood product facial wrinkles dosage form Wound healing Wound Sodium Sodium maleate Oncology Oncology Oncology Valsartan Paclitaxel Paclitaxel Paclitaxel Docetaxel Docetaxel Diclofenac Injectables Injectables Injectables Zidovudine Zidovudine Zidovudine Zidovudine Omeprazole Latanoprost Pemetrexed Autologous Rivastigmine Sodium CMC Keratinocytes diethylammonium Imatinib Mesylate Synthetic Paclitaxel Active Ingredient Sodium Polynucleotide Botulinum toxin type A Botulinum toxin Polydeoxyribonucleotide Polydeoxyribonucleotide Latanoprost plus Timolol Latanoprost plus Timolol Pyronaridine & Artesunate Pyronaridine & Artesunate Sodium Hyaluronate & HES Allogeneic Keratinocytes
® ® ® ® - - - - eye drop ® Patch Patch Xalost Active OMED Plasma product) MC Free injection Rejuran Biologics Oncology Oncology Oncology Ingredient Diclofenac Kaloderm Injectables derivatives Injectables Injectables Holoderm Xalost Plus Rejuvenex Coated Tab. Rivastigmine Divaltan Tab. Divaltan Tab. Pyramax Tab. Pyramax Tab. Paclitaxel(API) Paclitaxel(API) Pyramax Gran. Docetaxel(API) Newtinib Filim- Pharmaceutical Medicurtain Inj. (Botulinum toxin (Botulinum toxin Re-an Product name
SK Inc. INC., TEGO Pharm. Co.,Ltd Co. Ltd. Co., Ltd Taejoon Taejoon ceutical Co., Ltd. Pharma- Pharma- Co., Ltd. Samyang Products Medytox aceuticals Biopharm- Research SCIENCE, ST Pharm Chemicals Corporation Shin Poong Company 68
Supplement memo 71 70 memo PB 72 memo