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Directory of Korean Pharmaceutical Industry 2016

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Directory of Korean Pharmaceutical Industry 2016 2016 Directory of Korean Pharmaceutical Industry Contents 1. Greeting ������������������������������������������������������������������������������������������������������������������������������������������� 4 2. Overview of the Korean Pharmaceutical Industry ������������������������������������������������������������ 6 1) Current Status 2) Production Management System 3) Development of New Drugs 4) R&D Reinforcement 5) Biopharmaceuticals 6) Globalization 7) Korean Pharmaceutical Industry Vision - PHARMA 2020 3. Directory of Pharmaceutical Companies �������������������������������������������������������������������������� 13 · Regular Members(2015. 4) A~D ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 14 E~J ��������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 66 K~P �������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 110 R~Y �������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 158 · Associated Members(2015. 4) C~G ��������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 200 4. Korean Pharmaceutical Company List ����������������������������������������������������������������������������� 206 4 2016 Directory of Korea Pharmaceutical Industry Welcoming Message Greetings to all! I am Kyeong-Ho Lee, Chairman of the Korea Pharmaceutical Manufacturers Association, On behalf of about 200 KPMA member companies making efforts for continuous development of Korean pharmaceutical industry and for better and healthier life of people, I would like to express my welcoming message to all the readers of this book. Korean pharmaceutical industry produces safe and quality medicines by strictly complying with domestic Pharmaceutical Affairs law as well as international regulations including ICH guidelines from developing stage of medicines to manufacturing, distributing and consuming stage. As a result of the effort, the Ministry of Food and Drug Safety, Korean regulatory authority for safety and quality management of medicines, joined the membership of PIC/S (The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) in 2014 together with Japan, which is a proof that the quality and safety of medicines made by Korea is globally recognized. As of 2016, a total of 26 new drugs(New Chemical Entities) have been developed by Korean pharma industry, and Korea ranks 10th in the world based on the standard of US FDA approval. Combined with excellent biotechnology infrastructure and clinical study capability(Seoul is the best city in the world based on the number of clinical study) and advanced IT technology, Korea now is one of the global powerhouses in terms of biopharmaceuticals. The market size of Korean pharmaceutical industry accounts for about 20 billion dollars and with this confidence, Korean pharma industry is knocking on the global market though vigorous export and direct overseas investment such as constructing manufacturing site overseas. 5 The purpose of this directory book is to provide you with practical support for your business by presenting the detailed information of competitive Korean pharma companies who are ready to go global as well as brief picture of Korean pharma market. I truly understand that when trying to enter into overseas market including Asian market, it is difficult to select appropriate potential partners and to make a real contact with the person in charge. Therefore, this directory consists of KPMA member company list, the actual contact point and main business area, flagship product, technology, size and recent status of the company, I hope this book helps you understand better of Korean pharma companies and also conduct business exchange more actively. Thank you Dr. Kyeong Ho Lee Chairman Korea Pharmaceutical Manufacturers Association 6 2016 Directory of Korea Pharmaceutical Industry Overview of the Korean Pharmaceutical Industry Korea’s pharmaceutical market is worth approximately USD 17billion as of 2014, accounting for about 1.5% of the global pharmaceutical market worth USD 1.06 trillion. As of 2014, the number of pharmaceutical companies in Korea stands at 894. Among them, manufacturers of finished pharmaceutical products are 285 with a combined workforce of 78,259 employees. The actual output of pharmaceutical products, including finished pharmaceutical products (USD 12.2billion), amounts to roughly USD 16 billion. unit : USD 1million Category 2010 2011 2012 2013 2014 Productrion 13,676 13,562 13,668 14,222 14,422 Export 1,555 1,707 2,029 2,036 2,223 Import 4,487 4,784 5,032 4,529 4,713 Trade balance -2,933 -3,077 -3,003 -2,492 -2,490 Market size 16,608 16,639 16,671 16,714 16,912 As of the end of 2014, Korea has manufactured 11,854 ETC drugs(worth USD 10,104.6 million) and 6,164 OTC drugs (worth USD 2,132 million).USD 15,801million USD 15,801million 7 Production Management System Equipped with production infrastructure conforming to CGMP regulatory standards Joined PIC/S in 2014 The Korean pharmaceutical industry has invested over USD 2.6billion to build a production infrastructure that conforms to U.S. CGMPs through the GMP advancement project initiated in the mid-2000s. The joining of PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) by the Ministry of Food and Drug Safety in 2014 is also expected to further increase the global standing of the Korean pharmaceutical industry and bolster its exports. Development of New Drugs 26 new medicines(NCE) and 52 incrementally modified drugs Through 2015, Korea has succeeded in developing 26 new medicines since the inception of Sunpla Injection (SK Chemicals) in 1999, an anti-cancer medicine and Korea’s very first locally developed new medicine. As many as eight pharmaceutical products have been locally authorized as botanical drugs as of late 2015. Korea also produces 52 incrementally modified drugs (through 2015), including Hanmi Pharmaceutical Company’s Esomezol – a reflux esophagitis medicine and Korea’s first incrementally modified drug that gained FDA approval in 2013 for sales in the U.S. USD 15,801million 8 2016 Directory of Korea Pharmaceutical Industry R&D Reinforcement A continued increase in R&D investment (8.25% of sales invested) A total of 671 products in the pipeline The Korean pharmaceutical industry continues to expand its investment in R&D each year to boost the development of new medicines. The R&D expenses of Korean pharmaceutical companies equipped with labs and research- dedicated departments have demonstrated continued growth. As of 2013, the ratio of R&D expenses to sales stands at 8.25%, equivalent to USD 1.06billion. As a result, Korean pharmaceutical companies have 671 new medicines currently in the pipeline (as of late 2013). Among these new medicines, 25 have already been approved by FDA to begin clinical tests, completed all the steps to gain final approval, or gained final approval for sales. Biopharmaceuticals Developed the world’s first stem-cell therapy product Producing four of five globally commercialized stem-cell therapy products Korea is rising as a global biopharmaceutical power based on its outstanding biotechnology infrastructure, advanced clinical study, and world-class IT technology. Korea’s Hearticellgram-AMI (Pharmicell) is the world’s first stem-cell therapy product to gain approval for marketing. In 2012, Hunterase (Green Cross) became the world’s second medicine developed to treat Hunter syndrome and has been designated as an orphan drug by FDA. Currently, four out of five globally commercialized stem-cell therapy products have been developed and manufactured by Korean companies (Hearticellgram-AMI, Cartistem, Cupistem, and Neuronata-R). Korea also boasts advanced production facilities for biopharmaceuticals. The production facilities within the Incheon Free Economic Zone, with a current capacity of 330,000 liters a year, will be upgraded to an annual capacity of 510,000 liters by 2018. This upgrade is expected to help the Incheon Free Economic Zone emerge as the world’s largest biopharmaceutical production base. The Korean government has been providing strategic support for biopharmaceuticals, including its investment of USD 291million in 2015, in an aim to release and commercialize five biopharmaceutical products globally by 2017. 9 Globalization Exports reaching USD 2.4 billion Increased export of medicine development technology Direct overseas investment reaching USD 150 million The Korean pharmaceutical industry is advancing into the world in earnest as evidenced by its increasing export of finished products, drug substances, and technology as well as its soaring foreign direct investment (for the construction of production plants, etc.). The total exports of pharmaceutical products sold in 188 countries in 2014 stand at USD 2.40349 billion, a 14% increase from the previous year. Pharmaceutical product exports have demonstrated an impressive yearly growth rate of 19.7% since 2006. In 2016, pharmaceutical exports are projected to exceed the
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