DOCSLIB.ORG

TIGER KRX Bio K-New Deal ETF(364970

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
TIGER KRX Bio K-New Deal ETF(364970 [Korea] October 7, 2020 TIGER KRX Bio K -New Deal ETF (364970 KS) Unrivaled growth potential COMPANY ANALYSIS Mirae Asset Daewoo Co., Ltd. Taehee Kim [email protected] Choong-hyun Kim, CFA [email protected] Heightened profile of Korean Biotech companies are among the biggest stocks on the KOSPI biotech firms Samsung Biologics and Celltrion are, respectively, the fifth and seventh largest stocks on the KOSPI by market cap. Just a decade ago, the pharmaceutical/biotech sector accounted for a mere 1% of the KOSPI and 8.2% of the KOSDAQ by market cap. Today, the sector has a 9.1% weight in the KOSPI and a 27.5% weight in the KOSDAQ. The biotech sector includes large, profitable companies as well as smaller, technology-focused firms. Drivers of sustainable growth Korean biotech firms starting to carve out a place in the global market Korean biotech firms have landed a series of out-licensing deals with multinational pharmaceutical companies, proving their enhanced R&D capabilities. In 2020, Korean companies have engaged in not only drug development and technology transfer but also the launch and direct marketing of new drugs in overseas markets. Celltrion and Samsung Bioepis have increased their market shares in the global biosimilars market. Samsung Biologics is solidifying its leading position in the global biologics CMO market, recently announcing a plan to build a fourth production plant. Positive outlook for 4Q20 and Strong earnings growth, R&D momentum, and positive pandemic effects 2021 We project the combined revenue of Celltrion, Samsung Biologics, Hanmi Pharmaceutical, and Yuhan to expand at a CAGR of 18.8% over the next three years. We look for R&D momentum to pick up in 4Q20 and 2021, when many Korean biotech firms plan to publish and present the results of ongoing clinical trials. The COVID-19 pandemic could present promising opportunities for Korean companies; in the absence of a vaccine or effective treatment, they can compete on an equal footing with multinational pharmas. In particular, Korean CMO and diagnostic kit companies have enjoyed strong demand in the wake of the pandemic. TIGER KRX Bio K-New Deal ETF constituents (%) 30 26.3 24.4 25 23.5 20 15 10 8.7 4.8 5 3.8 3.4 2.0 1.8 1.2 0 SK Samsung Celltrion Celltrion Seegene Alteogen Yuhan Hanmi Celltrion Hanmi Biopharm Biologics Healthcare Pharm Pharm Science Source: Mirae Asset Daewoo Research Analysts who prepared this report are registered as research analysts in Korea but not in any other jurisdiction, including t he US. PLEASE SEE ANALYST CERTIFICATIONS AND IMPORTANT DISCLOSURES AND DISCLAIMERS IN APPENDIX 1 AT THE END OF REPORT. October 7, 2020 TIGER KRX Bio K-New Deal ETF C O N T E N T S I. Executive summary 3 II. Unrivaled growth potential 4 1. The pharma/biotech sector’s weight in the KOSPI has increased to 9.1% 4 2. Drivers of sustainable growth 5 III. 4Q20 and 2021 outlook 8 1. Both revenue and operating profit to grow sharply 8 2. A variety of R&D achievements likely 9 3. Benefiting from COVID-19 11 IV. Status check and outlook by segment 14 1. Biosimilars 14 2. In-vitro diagnostics 18 V. ETF overview 21 Diversified exposure to new drugs, biosimilars, and diagnostic kits 21 Mirae Asset Daewoo Research 2 October 7, 2020 TIGER KRX Bio K-New Deal ETF I. Executive summary Biotech companies are among the biggest stocks on the KOSPI Samsung Biologics and Celltrion are, respectively, the fifth and seventh largest stocks on the KOSPI by market cap. The four largest stocks on the KOSDAQ are Celltrion Healthcare, Seegene, HLB, and Alteogen. The pharmaceutical/biotech sector, which just a decade ago accounted for a mere 1% of the KOSPI, has become one of Korea’s flagship industries. In our view, the industry’s rapid growth is not a bubble but will be sustained over the long term. Drivers of sustainable growth 1) Growing R&D capabilities Korean biotech firms have landed a series of out-licensing deals with multinational pharmaceutical companies, proving their enhanced R&D capabilities. The number of such deals has increased sharply in recent years; in 2015 alone (the year the re-rating of biotech stocks began), Hanmi Pharmaceutical clinched major deals with four global firms (Boehringer Ingelheim, Eli Lilly, Sanofi, and Janssen). Over an eight-month period beginning in Nov. 2018, Yuhan signed major out-licensing deals with Janssen, Gilead Sciences, and Boehringer Ingelheim. 2) Moving beyond technology transfer to direct drug releases Korean biotech companies are currently gearing up to bring their new drugs to market. Notably, SK Biopharmaceuticals will directly market two of its in-house developed drugs in the US: Sunosi (narcolepsy treatment; released in Jul. 2019) and Xcopri (antiepileptic drug; May 2020). We believe Xcopri has strong commercial potential, as it demonstrated superior efficacy to existing treatments in a study (findings were published in a renowned journal). Hanmi Pharmaceutical is also set to release new drugs in the US, albeit through a marketing partner. The firm’s Rolontis (neutropenia treatment) and Oraxol (an oral anti-cancer drug) are expected to receive FDA approval at end-Oct. 2020 and in Feb. 2021, respectively. 3) Korean biotech firms leading the global biosimilars market Korean firms are increasing their dominance in the global biosimilars market. Globally, Celltrion/Celltrion Healthcare and Samsung Bioepis have the largest market shares in a number of biosimilar segments. In Europe, Celltrion’s Remsima and Truxima command market shares of 57% and 40%, respectively, outgrowing their reference drugs. Samsung Bioepis’s Benepali and Imraldi are seeing rapid market share gains. 4) Samsung Biologics, the largest player in the global biologics CMO market Samsung Biologics, which started out with a 30,000-liter plant, became the world’s third largest CMO player when it established a second plant (152,000 liters), and moved to the no. 1 spot by building a third plant (180,000 liters). Recently, the company announced that it would build a fourth plant (256,000 liters), widening its lead over the second and third largest players. Positive outlook for 4Q20 and 2021 We have a positive outlook for 2H20 and 2021. We project the combined revenue and operating profit of four major pharmaceutical/biotech firms—Celltrion, Samsung Biologics, Hanmi Pharmaceutical, and Yuhan—to expand at CAGRs of 18.8% and 53.8%, respectively, over the next three years. Notably, significant licensing deals, a pivotal factor in elevating enterprise value, are expected to materialize, and many Korean firms are planning to present the results of ongoing clinical trials and participate in global conferences in 4Q20 and 2021. In addition, the COVID-19 pandemic is presenting opportunities to Korean biotech players, which are moving as quickly as global rivals to develop vaccines and treatments (with good prospects for commercial results). CMO companies are receiving large-scale supply contracts from capacity-strapped multinational pharmas. In particular, Korean diagnostic kit companies have been able to promote their technologies globally and record explosive earnings growth amid the pandemic. Mirae Asset Daewoo Research 3 October 7, 2020 TIGER KRX Bio K-New Deal ETF II. Unrivaled growth potential 1. The pharma/biotech sector’s weight in the KOSPI has increased to 9.1% Just a decade ago, the pharmaceutical/biotech sector accounted for a mere 1% of the KOSPI and 8.2% of the KOSDAQ by market cap. Today, the sector has a 9.1% weight in the KOSPI and a 27.5% weight in the KOSDAQ. Samsung Biologics and Celltrion are, respectively, the fifth and seventh largest stocks on the KOSPI by market cap. And notably, after the three-way merger of Celltrion, Celltrion Healthcare, and Celltrion Pharm (under a plan recently announced by Celltrion Group; combined market cap of W52tr), the merged entity stands to be the third largest stock on the KOSPI after Samsung Electronics and SK Hynix. Newly listed biotech stocks have contributed to the market weight expansion of the pharmaceutical/biotech sector in the KOSPI, but strong share rallies by existing companies have been the core driver. The KRX Healthcare Index has soared a whopping 211% since 2015, outperforming the KOSPI by 188%p. The sector has also outperformed this year due to the pandemic. Figure 1. Pharma/biotech sector’s weight in the KOSPI Figure 2. Pharma/biotech sector’s weight in the KOSDAQ (%) (%) 10 35 9.1% 9 30 27.5% 8 7 25 6 20 5 15 4 3 10 2 5 1 0 0 00 02 04 06 08 10 12 14 16 18 20 00 02 04 06 08 10 12 14 16 18 20 Source: Quantiwise, Mirae Asset Daewoo Research Source: Quantiwise, Mirae Asset Daewoo Research Figure 3. Relative performances of the KOSPI and KRX Figure 4. Relative performances of the KOSPI and KRX Healthcare Index since 2015 Healthcare Index since 2020 (P) (P) 400 KOSPI KRX Healthcare Index 200 KOSPI KRX Healthcare Index 350 180 160 300 140 250 120 200 100 80 150 60 100 40 50 20 0 0 1/15 1/16 1/17 1/18 1/19 1/20 1/20 2/20 3/20 4/20 5/20 6/20 7/20 8/20 9/20 10/20 Source: Quantiwise, Mirae Asset Daewoo Research Source: Quantiwise, Mirae Asset Daewoo Research Mirae Asset Daewoo Research 4 October 7, 2020 TIGER KRX Bio K-New Deal ETF Aside from improved fundamentals, the Korean pharmaceutical/biotech sector’s outperformance can be attributed to investors’ high expectations for new drug pipelines. Going forward, we expect companies’ enhanced technology and tangible R&D achievements (e.g., licensing deals and new drug commercialization) to drive sector-wide growth and share rallies.
Load more

Recommended publications
  • FTSE Korea 30/18 Capped
    2 FTSE Russell Publications 19 August 2021 FTSE Korea 30/18 Capped Indicative Index Weight Data as at Closing on 30 June 2021 Index weight Index weight Index weight Constituent Country Constituent Country Constituent Country (%) (%) (%) Alteogen 0.19 KOREA Hyundai Engineering & Construction 0.35 KOREA NH Investment & Securities 0.14 KOREA AmoreG 0.15 KOREA Hyundai Glovis 0.32 KOREA NHN 0.07 KOREA Amorepacific Corp 0.65 KOREA Hyundai Heavy Industries 0.29 KOREA Nong Shim 0.08 KOREA Amorepacific Pfd. 0.08 KOREA Hyundai Marine & Fire Insurance 0.13 KOREA OCI 0.17 KOREA BGF Retail 0.09 KOREA Hyundai Merchant Marine 1.02 KOREA Orion 0.21 KOREA BNK Financial Group 0.18 KOREA Hyundai Mipo Dockyard 0.15 KOREA Ottogi 0.06 KOREA Celltrion Healthcare 0.68 KOREA Hyundai Mobis 1.53 KOREA Paradise 0.07 KOREA Celltrion Inc 2.29 KOREA Hyundai Motor 2.74 KOREA Posco 1.85 KOREA Celltrion Pharm 0.24 KOREA Hyundai Motor 2nd Pfd. 0.33 KOREA Posco Chemical 0.32 KOREA Cheil Worldwide 0.14 KOREA Hyundai Motor Pfd. 0.21 KOREA Posco International 0.09 KOREA CJ Cheiljedang 0.3 KOREA Hyundai Steel 0.33 KOREA S1 Corporation 0.13 KOREA CJ CheilJedang Pfd. 0.02 KOREA Hyundai Wia 0.13 KOREA Samsung Biologics 0.92 KOREA CJ Corp 0.11 KOREA Industrial Bank of Korea 0.22 KOREA Samsung C&T 0.94 KOREA CJ ENM 0.15 KOREA Kakao 3.65 KOREA Samsung Card 0.08 KOREA CJ Logistics 0.12 KOREA Kangwon Land 0.23 KOREA Samsung Electro-Mechanics 0.81 KOREA Coway 0.36 KOREA KB Financial Group 1.78 KOREA Samsung Electronics 25.36 KOREA Daewoo Engineering & Construction 0.12 KOREA KCC Corp 0.12 KOREA Samsung Electronics Pfd.
    [Show full text]
  • Holdings-Report.Pdf
    The Fund is a closed-end exchange traded management Investment company. This material is presented only to provide information and is not intended for trading purposes. Closed-end funds, unlike open-end funds are not continuously offered. After the initial public offering, shares are sold on the open market through a stock exchange. Changes to investment policies, current management fees, and other matters of interest to investors may be found in each closed-end fund's most recent report to shareholders. Holdings are subject to change daily. PORTFOLIO HOLDINGS FOR THE KOREA FUND as of July 31, 2021 *Note: Cash (including for these purposes cash equivalents) is not included. Security Description Shares/Par Value Base Market Value (USD) Percent of Base Market Value SAMSUNG ELECTRONICS CO 793,950 54,183,938.27 20.99 SK HYNIX INC COMMON 197,500 19,316,452.95 7.48 NAVER CORP COMMON STOCK 37,800 14,245,859.60 5.52 LG CHEM LTD COMMON STOCK 15,450 11,309,628.34 4.38 HANA FINANCIAL GROUP INC 225,900 8,533,236.25 3.31 SK INNOVATION CO LTD 38,200 8,402,173.44 3.26 KIA CORP COMMON STOCK 107,000 7,776,744.19 3.01 HYUNDAI MOBIS CO LTD 26,450 6,128,167.79 2.37 HYUNDAI MOTOR CO 66,700 6,030,688.98 2.34 NCSOFT CORP COMMON STOCK 8,100 5,802,564.66 2.25 SAMSUNG BIOLOGICS CO LTD 7,230 5,594,175.18 2.17 KB FINANCIAL GROUP INC 123,000 5,485,677.03 2.13 KAKAO CORP COMMON STOCK 42,700 5,456,987.61 2.11 HUGEL INC COMMON STOCK 24,900 5,169,415.34 2.00 SAMSUNG 29,900 4,990,915.02 1.93 SK TELECOM CO LTD COMMON 17,500 4,579,439.25 1.77 KOREA INVESTMENT 53,100 4,427,115.84
    [Show full text]
  • Korea Morning Focus
    December 23, 2019 Korea Morning Focus No English report summaries this morning Major Indices Close Chg Chg (%) KOSPI 2,204.18 7.62 0.35 KOSPI 200 295.31 1.00 0.34 KOSDAQ 649.73 1.88 0.29 Turnover ('000 shares, Wbn) Volume Value KOSPI 637,639 5,021 KOSPI 200 75,360 3,446 KOSDAQ 929,806 4,198 Market Cap (Wbn) Value KOSPI 1,481,267 KOSDAQ 234,817 KOSPI Turnover (Wbn) Buy Sell Net Foreign 2,004 1,848 156 Institutional 986 847 139 Retail 1,961 2,283 -322 KOSDAQ Turnover (Wbn) Buy Sell Net Foreign 518 418 100 Institutional 172 164 8 Retail 3,484 3,568 -84 Program Buy / Sell (Wbn) Buy Sell Net KOSPI 1,813 1,611 203 KOSDAQ 485 406 79 Advances & Declines Advances Declines Unchanged KOSPI 437 366 105 KOSDAQ 609 601 134 KOSPI Top 5 Most Active Stocks by Value (Wbn) Price (W) Chg (W) Value Samsung Electronics 56,000 0 676 Hynix 95,000 1,400 263 KODEX Leverage 14,145 65 183 Jooyon 804 31 161 KODEX Kosdaq150 8,005 85 150 Leverage KOSDAQ Top 5 Most Active Stocks by Value (Wbn) Price (W) Chg (W) Value HLB 102,200 3,300 205 Energy Solutions 25,850 2,750 170 BRIDGE 54,300 -8,100 140 BIOTHERAPEUTICS SyntekaBio 15,100 650 113 ESA 2,060 -635 103 Note: As of December 20, 2019 This document is a summary of a report prepared by Mirae Asset Daewoo Co., Ltd. (“Mirae Asset Daewoo”) and published on our website.
    [Show full text]
  • Samsung Electronics Co., Ltd. and Its Subsidiaries NOTES to INTERIM
    Samsung Electronics Co., Ltd. and its Subsidiaries NOTES TO INTERIM CONSOLIDATED FINANCIAL STATEMENTS 1. General Information 1.1 Company Overview Samsung Electronics Co., Ltd. (“SEC”) was incorporated under the laws of the Republic of Korea in 1969 and listed its shares on the Korea Stock Exchange in 1975. SEC and its subsidiaries (collectively referred to as the “Company”) operate four business divisions: Consumer Electronics (“CE”), Information technology & Mobile communications (“IM”), Device Solutions (“DS”) and Harman. The CE division includes digital TVs, monitors, air conditioners and refrigerators and the IM division includes mobile phones, communication systems, and computers. The DS division includes products such as Memory, Foundry and System LSI in the semiconductor business (“Semiconductor”), and LCD and OLED panels in the display business (“DP”). The Harman division includes connected car systems, audio and visual products, enterprise automation solutions and connected services. The Company is domiciled in the Republic of Korea and the address of its registered office is Suwon, the Republic of Korea. These interim consolidated financial statements have been prepared in accordance with Korean International Financial Reporting Standards (“Korean IFRS”) 1110, Consolidated Financial Statements. SEC, as the controlling company, consolidates its 256 subsidiaries including Samsung Display and Samsung Electronics America. The Company also applies the equity method of accounting for its 41 associates, including Samsung Electro-Mechanics.
    [Show full text]
  • Morning Focus
    January 3, 2018 KOREA Morning Focus Company News & Analysis Major Indices Close Chg Chg (%) POSCO (005490/Buy/TP: W450,000) KOSPI 2,479.65 12.16 0.49 Earnings to continue to climb higher KOSPI 200 326.00 1.26 0.39 KOSDAQ 812.45 14.03 1.76 Sector News & Analysis Turnover ('000 shares, Wbn) Volume Value Auto (Overweight) KOSPI 230,256 4,601 Auto sales end 2017 on a disappointing note KOSPI 200 70,198 3,653 KOSDAQ 977,967 6,567 Market Cap (Wbn) Value KOSPI 1,613,508 KOSDAQ 287,930 KOSPI Turnover (Wbn) Buy Sell Net Foreign 1,149 1,019 130 Institutional 937 1,080 -143 Retail 2,448 2,475 -27 KOSDAQ Turnover (Wbn) Buy Sell Net Foreign 448 361 87 Institutional 262 355 -93 Retail 5,861 5,840 21 Program Buy / Sell (Wbn) Buy Sell Net KOSPI 1,051 956 96 KOSDAQ 198 203 -5 Advances & Declines Advances Declines Unchanged KOSPI 498 305 76 KOSDAQ 834 337 80 KOSPI Top 5 Most Active Stocks by Value (Wbn) Price (W) Chg (W) Value Samsung Electronics 2,551,000 3,000 432 KODEX KOSDAQ150 20,440 640 264 LEVERAGE Daum Communications 146,500 9,500 193 SAMSUNG BIOLOGICS 389,500 18,500 156 Hynix 76,600 100 154 KOSDAQ Top 5 Most Active Stocks by Value (Wbn) Price (W) Chg (W) Value SillaJen 102,500 9,000 670 Diostech 29,250 6,750 356 Celltrion Healthcare 106,700 -1,900 295 Sky Newpharm 7,580 1,340 269 Celltrion 225,900 4,800 261 Note: As of January 2, 2018 Mirae Asset Daewoo Research POSCO (005490 KS) Earnings to continue to climb higher Steel 4Q17 preview: Earnings improvement to continue Earnings Preview For 4Q17, we see POSCO’s non-consolidated operating profit coming in at W853bn January 3, 2018 (+18.1% QoQ, +74.7% YoY).
    [Show full text]
  • Assessment Report on Extension(S) of Marketing Authorisation
    19 September 2019 EMA/CHMP/548703/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment Report on extension(s) of marketing authorisation Remsima International non-proprietary name: infliximab Procedure No. EMEA/H/C/002576/X/0062 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure ............................................ 11 1.1. Submission of the dossier .................................................................................... 11 1.2. Steps taken for the assessment of the product ....................................................... 11 2. Scientific discussion .............................................................................. 12 2.1. Problem statement ............................................................................................. 12 2.2. About the product .............................................................................................. 13 2.3. Type of Application and aspects on development .................................................... 14 2.4. Quality aspects .................................................................................................
    [Show full text]
  • Truxima (Rituximab-Abbs) – New and Expanded Indications
    Truxima® (rituximab-abbs) – New and expanded indications • On May 23, 2019, the FDA approved Teva and Celltrion’s Truxima (rituximab-abbs), for the treatment of adult patients with previously untreated diffuse large B-cell, CD20-positive non-Hodgkin’s lymphoma (NHL) in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens; and with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC). • Previously, Truxima was approved for the following: — Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent — Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy — Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy. • Truxima is a biosimilar to Genentech and Biogen’s Rituxan® (rituximab). — Rituxan is also approved for the treatment of adult patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis, and pemphigus vulgaris. • Similar to Rituxan, Truxima carries a boxed warning for fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. • The most common adverse reactions (≥ 25%) with Truxima use in NHL were infusion-related reactions, fever, lymphopenia, chills, infection and asthenia. • The most common adverse reactions (≥ 25%) with Truxima use in CLL were infusion-related reactions and neutropenia. • The recommended dose of Truxima in the expanded NHL indication is 375 mg/m2 as an intravenous infusion on day 1 of each cycle of chemotherapy, for up to 8 infusions.
    [Show full text]
  • Truxima Prescribing Information
    HIGHLIGHTS OF PRESCRIBING INFORMATION TRUXIMA® (rituximab-abbs) injection, for intravenous use These highlights do not include all the information needed to use TRUXIMA safely and effectively. See full prescribing information for TRUXIMA. • The dose for RA in combination with methotrexate is two-1000 mg intravenous infusions separated by 2 weeks (one course) every 24 weeks or based on clinical TRUXIMA® (rituximab-abbs) injection, for intravenous use evaluation, but not sooner than every 16 weeks. Initial U.S. Approval: 2018 Methylprednisolone 100 mg intravenous or equivalent glucocorticoid is recommended TRUXIMA (rituximab-abbs) is biosimilar* to RITUXAN® (rituximab) 30 minutes prior to each infusion (2.5). WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS • The induction dose for adult patients with active GPA and MPA in combination with REACTIONS, HEPATITIS B VIRUS REACTIVATION glucocorticoids is 375 mg/m2 once weekly for 4 weeks. The follow up dose for and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY adult patients with GPA and MPA who have achieved disease control with induction See full prescribing information for complete boxed warning. treatment, in combination with glucocorticoids is two 500 mg intravenous infusions • Fatal infusion-related reactions within 24 hours of rituximab infusion; separated by two weeks, followed by a 500 mg intravenous infusion every 6 months approximately 80% of fatal reactions occurred with first infusion. Monitor thereafter based on clinical evaluation (2.6). patients and discontinue TRUXIMA infusion for severe reactions (5.1). DOSAGE FORMS AND STRENGTHS • Severe mucocutaneous reactions, some with fatal outcomes (5.2). Injection: 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution in • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant single-dose vials (3) hepatitis, hepatic failure, and death (5.3).
    [Show full text]
  • Samsung Electronics Co., Ltd. and Its Subsidiaries NOTES
    Samsung Electronics Co., Ltd. and its Subsidiaries NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS 1. General Information 1.1 Company Overview Samsung Electronics Co., Ltd. (“SEC”) was incorporated under the laws of the Republic of Korea in 1969 and listed its shares on the Korea Stock Exchange in 1975. SEC and its subsidiaries (collectively referred to as the “Company”) operate four business divisions: Consumer Electronics (“CE”), Information technology & Mobile communications (“IM”), Device Solutions (“DS”) and Harman. The CE division includes digital TVs, monitors, air conditioners and refrigerators and the IM division includes mobile phones, communication systems, and computers. The DS division includes products such as Memory, Foundry and System LSI in the semiconductor business (“Semiconductor”), and LCD and OLED panels in the display business (“DP”). The Harman division includes connected car systems, audio and visual products, enterprise automation solutions and connected services. The Company is domiciled in the Republic of Korea and the address of its registered office is Suwon, the Republic of Korea. These interim consolidated financial statements have been prepared in accordance with Korean International Financial Reporting Standards (“Korean IFRS”) 1110, Consolidated Financial Statements. SEC, as the controlling company, consolidates its 252 subsidiaries including Samsung Display and Samsung Electronics America. The Company also applies the equity method of accounting for its 46 associates and joint ventures, including
    [Show full text]
  • Approved and Pending Biosimilar Applications* *Based on Publicly
    Approved and Pending Biosimilar Applications* Biosimilar Reference Product Marketing Litigation Status (Active or Pending) Name: Zarxio® Name: Neupogen® Approved by U.S. Supreme Court (filgrastim-sndz) (filgrastim) FDA on opinion issued on March 6, 2015. June 12, 2017. Manufacturer: Sandoz Manufacturer: Amgen Commercial U.S. Court of Appeals BLA: 125553 BLA: 103353 launch by for the Federal Circuit Sandoz/Novartis en banc opinion Indications/Uses: Treats in September issued on neutropenia by increasing 2015. December 14, 2017. production of white blood cells. Often used Litigation in the U.S. for patients taking District Court for the chemotherapy treatments Northern District of or after bone marrow California; summary transplantation. judgment of non- infringement entered on January 1, 2018; on appeal to the U.S. Court of Appeals for the Federal Circuit. Name: Inflectra® Name: Remicade® Approved by Litigation initiated in (infliximab-dyyb) (infliximab) FDA on April 5, the U.S. District Court 2016. for the District of Manufacturer: Celltrion, Manufacturer: Janssen Massachusetts. Inc. Biotech, Inc. Commercial (at- risk) launch by Grant of Celltrion’s BLA: 125544 BLA: 103772 Pfizer/Celltrion motion for summary in November judgment currently on Indications/Uses: 2016. appeal to the U.S. Inhibits tumor necrosis Court of Appeals for factor-alpha to reduce the Federal Circuit. inflammation in patients with the following autoimmune diseases: rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and ankylosing spondylitis. *Based on publicly available information as of the date of this publication. Last revised December 13, 2018 – FOR INFORMATIONAL PURPOSES ONLY. Approved and Pending Biosimilar Applications* Name: Erelzi® Name: Enbrel® Approved by Litigation in the U.S.
    [Show full text]
  • CELLTRION Inc. CT-P13 3.5
    CELLTRION Inc. CT-P13 3.5 A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis 24th March 2019 Statistical Analysis Plan Part 2 – Final Version 4.0 Prepared by: XXXXXXXXX XXXXXXXXXXXXXXXXXXX XXXXXXXXXXXX XXXX XXXXXXX Prepared by: ____________________________ Date: ____/____/____ XXXXXXXXXXXX XXXXXXXX XXXXXXXXXX Approved by: ____________________________ Date: ____/____/____ XXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXX Upon review of this document, including table, listing and figure shells, the undersigned approves the final statistical analysis plan. The analysis methods and data presentation are acceptable, and the table, listing and figure production can begin. I Confidential Confidential CELLTRION, Inc. Statistical Analysis Plan, Part 2 – Final Version 4.0 CT-P13 3.5 Date Issued: 24th March 2019 TABLE OF CONTENTS 1. ADMINISTRATIVE STRUCTURE .......................................................................... 6 2. INTRODUCTION........................................................................................................ 6 3. STUDY OBJECTIVE .................................................................................................. 7 3.1. Primary Objective .................................................................................................. 7 3.2. Secondary Objectives............................................................................................
    [Show full text]
  • Victory Fund Holdings Victory Vif Sophus
    VICTORY FUND HOLDINGS As of June 30, 2021 VICTORY VIF SOPHUS EMERGING MARKETS MATURITY TRADED MARKET TRADED MARKET SECURITY DESCRIPTION DATE VALUE (BASE) VALUE (BASE) % ALIBABA GROUP HOLDING LTD ADR 1,972,532.44 4.25% BAIDU, INC. ADR 501,186.20 1.08% CEMEX DA - ADR 425,787.60 0.92% BANCO DE CREDITO E INVERSIONES 42.24 0.00% BANCO DE CHILE 222,461.14 0.48% CONTROLADORA VUELA CIA-ADR 252,035.20 0.54% VALE SA 519,202.93 1.12% GRUPO FINANCIERO BANORTE SAB DE CV 53,844.63 0.12% ALSEA SAB DE CV 191,300.90 0.41% PETROBRAS DISTRIBUIDORA SA 280,040.22 0.60% HDFC BANK, LTD. ADR 295,770.40 0.64% INFOSYS TECHNOLOGIES ADR 917,463.43 1.98% JD.COM INC 462,259.52 1.00% MYTILINEOS HOLDINGS SA 231,598.89 0.50% ASM PACIFIC TECHNOLOGY LIMITED 289,896.61 0.63% WALSIN TECHNOLOGY CORP 358,898.56 0.77% HINDUSTAN PETROLEUM CORP LTD 420,901.59 0.91% LIC HOUSING FINANCE LTD 347,677.95 0.75% TATA STEEL LTD 279,822.18 0.60% NMDC LTD 371,024.87 0.80% DB INSURANCE CO LTD 248,435.54 0.54% CJ CORP 218,169.43 0.47% CHINA AIRLINES LTD 237,394.11 0.51% NANYA TECHNOLOGY CORP 437,286.77 0.94% LG UPLUS CORP 400,318.87 0.86% INBODY CO LTD 147,250.34 0.32% EVERGREEN MARINE CORP TAIWAN LTD 550,999.17 1.19% FORMOSA PLASTICS CORP 266,092.71 0.57% FOSCHINI GROUP LTD/THE 78,224.61 0.17% SIAM COMMERCIAL BANK P-NVDR 302,348.74 0.65% MEDIATEK INC 586,318.72 1.26% SAMSUNG SECURITIES CO LTD 272,600.80 0.59% DR.
    [Show full text]