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Biojapan / Regenerative Medicine Japan 2018 Partnering Data As of November 2018

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Biojapan / Regenerative Medicine Japan 2018 Partnering Data As of November 2018 a BioJapan / Regenerative Medicine Japan 2018 Partnering Data As of November 2018 2019年10月9日(水)〜11日(⾦) Oct. 9WED ー11パシフィコ横浜FRI ――――――――――――――――――October 9–11, 2019 Pacifico Yokohama,Pacifico Japan Yokohama 2019 Japan: the World’s Second Largest Pharmaceutical Market Representing 8% of the world pharmaceutical market in 2016, Japan’s pharma sector remains one of the largest in the world. While Japan is often said to be overly insular, a recent sharp rise in the number of international forays from larger Japanese pharmaceutical companies—including many significant M&A deals and the establishment of new R&D sites around the world—indicates a bright and increasingly international future for the industry. Furthermore, the nation’s ageing population is creating an ever-larger domestic market for medicinal products and services, and in particular the easing of regulatory restrictions is set to turn Japan into a hotbed for regenerative medicine-related R&D. 1200 Japan 1000 Asia-Pacific (Excl. Japan), 800 Africa, Middle East 600 Europe 400 Central / S. America 200 0 N. America 2012 2013 2014 2015 2016 Source:JPMA Databook Domestic Japanese Sales Rankings (Distributor Level, FY2017) Company Sales: USD Company Sales: USD (November 2018 rates) (November 2018 rates) 1 Takeda 6,317,258,929 11 Eli Lilly Japan 2,496,991,071 2 Daiichi Sankyo 5,971,785,714 12 Ono 2,266,526,786 3 Astellas 4,919,303,571 13 Bayer 2,146,785,714 4 Pfizer 4,291,142,857 14 Kyowa Hakko Kirin 2,076,625,000 5 Chugai 4,286,526,786 15 Eizai 1,865,482,143 6 Mitsubishi Tanabe 3,230,785,714 16 Sumitomo Dainippon 1,575,205,357 7 MSD 3,203,116,071 17 AstraZeneca 1,556,473,214 8 Otsuka Holdings 3,036,017,857 18 Nichi-iko 1,490,696,429 9 Novartis 2,702,383,929 19 Santen 1,470,553,571 10 GSK 2,638,955,357 20 Sawai 1,451,696,429 Copyright 2018 JTB Communication Design, Inc. 2 Financial Results of the Leading Japanese Pharmaceutical Manufacturers (Japan FY2016 Consolidated Accounts) Sales: USD Company (November 2018 rates) Takeda 15,464,741,071 Astellas 11,711,205,357 Otsuka Holdings 10,674,526,786 Daiichi Sankyo 8,527,892,857 Eisai 4,813,366,071 Mitsubishi Tanabe 3,785,508,929 Dainippon Sumitomo 3,675,339,286 Kyowa Hakko Kirin 3,062,669,643 Shionogi 3,025,803,571 Taisho 2,497,973,214 Ono 2,185,687,500 Santen 1,777,642,857 Hisamitsu 1,302,901,786 Kyorin Holdings 1,030,116,071 Tsumura 1,026,375,000 Kaken 906,062,500 Nippon Shinyaku 881,973,214 Mochida 869,187,500 Kissei 640,232,143 Zaria 579,017,857 Copyright 2018 JTB Communication Design, Inc. 3 Japanese Drug Discovery Alliances Drug discovery alliances between Japanese and non-Japanese organizations are also on the rise. With over half of new medicines now stemming from biotech companies and startups, Japanese pharmaceutical companies understand the potential in developing these new drugs and bringing them to market. Company Alliance Partner Date Daiichi Sankyo Max Planck Innovation (DEU) 2017 Daiichi Sankyo Bristol-Myers Squibb (USA) 2017 Daiichi Sankyo MD Anderson (USA) 2017 Daiichi Sankyo Glycotope (DEU) 2017 Daiichi Sankyo Puma Biotechnology (USA) 2017 Astellas Universal Cells (USA) 2017 Astellas Ogeda (BEL) 2017 Astellas Affinivax (USA) 2017 Astellas Auration Biotech (USA) 2017 Astellas Ironwood (USA) 2017 Astellas Ganymed Pharmaceuticals (DEU) 2017 Astellas Medicines for Malaria Venture (AUS) 2017 Eisai Arena Pharmacuticals (USA) 2017 Otsuka Jansen (BEL) 2017 Otsuka X-Chem (USA) 2017 Otsuka Mylan (USA) 2017 Otsuka R-Pharm (RUS) 2017 Otsuka Neurovance (USA) 2017 Otsuka Akebia (USA) 2017 Otsuka Teva (ISR) 2017 Taiho Jansen (USA) 2017 Takeda PvP Biologics (USA) 2017 Takeda ARIAD Parmaceuticals (USA) 2017 Takeda Exelixis (USA) 2017 Takeda Maverick Therapeutics (USA) 2017 Takeda Finch Therapeutics (USA) 2017 Takeda Harrington Discovery Institute (USA) 2017 Takeda BioSurfaces (USA) 2017 Takeda TESARO (USA) 2017 Takeda Cardurion Pharmaceuticals (USA) 2017 Takeda Molecular Templates (USA) 2017 Takeda HemoShear Therapeutics (USA) 2017 Takeda Portal Instruments (USA) 2017 Takeda HemoShear Therapeutics (USA) 2017 Takeda NuBiyota (CAN) 2017 Takeda GammaDelta Therapeutics (GBR) 2017 Takeda Medicines for Malaria Venture (CHE) 2017 Takeda Biological E (IND) 2017 Takeda Zydus Cadila (IND) 2017 Ono Merck (USA) 2017 Ono X-Chem (USA) 2017 Ono Numab Therapeutics AG (CHE) 2017 Ono Array Biopharma (USA) 2017 Ono Karyopharm Therapeutics (USA) 2017 Ono Neurimmune Holding (CHE) 2017 Ono Cyclenium Pharma (CAN) 2017 Copyright 2018 JTB Communication Design, Inc. 4 Sources: Company Website Company Alliance Partner Date Ono Schrödinger (USA) 2017 Chugai JW Pharmaceutical (KOR) 2017 Mitsubishi Tanabe NeuroDerm (ISR) 2017 Santen Regenerative Patch Technologies (USA) 2017 KYORIN Merck & Co., Inc. (USA) 2017 BinhDinh Pharmaceutical and KYORIN 2017 Medical Equipment JSC (VNM) TEIJIN PHARMA Merck & Co., Inc. (USA) 2017 TEIJIN PHARMA Merz Pharma GmbH (DEU) 2017 TEIJIN PHARMA Neuronetics,Inc. (USA) 2017 TEIJIN PHARMA SRETT (France) 2018 Astellas Potenza (USA) 2018 Astellas Juventas Therapeutics (USA) 2018 Astellas FibroGen (USA) 2018 Astellas Cytokinetics (USA) 2018 Astellas Quethera (GBR) 2018 Astellas Merck (USA) 2018 Astellas Aquinox Pharamaceuticals (CAN) 2018 Astellas Genetic (USA) 2018 Astellas Mitobridge (USA) 2018 Astellas Vical (USA) 2018 Eisai Bristol-Myers Squibb (USA) 2018 Eisai Eurofarma (BRA) 2018 Eisai CY Biotech (CHN) 2018 Eisai Broad Institute / Colorado St.Univ. (USA) 2018 Otsuka Proteus Digital Health (USA) 2018 Otsuka Visterra (USA) 2018 Taiho Arcus Biosciences (USA) 2018 Taiho Servier（FRA） 2018 Taiho Helsinn (CHE) 2018 Takeda Verily (USA) 2018 Takeda Ambys Medicines (USA) 2018 Drugs for Negelected Diseases initiative Takeda 2018 (CHE) Takeda Valeant (IRL) 2018 Takeda Unipharm (USA) 2018 Takeda Denali Therapeutics (USA) 2018 Ono Merus (NLD) 2018 Chugai Eli Lilly and Company (USA) 2018 Taisho UPSA (FRA) 2018 FUJIFILM Irvine Scientific Sales Company (USA) 2018 FUJIFILM Yestar Healthcare Holdings (CHN) 2018 KYORIN FAES FARMA (ESP) 2018 KYORIN Yissum (IRL) 2018 TEIJIN PHARMA Nox Medical ehf (ISL) 2019 Taiho Cullinana Pearl (USA) Copyright 2018 JTB Communication Design, Inc. 5 Sources: Company Website Regulatory Changes Make for Faster Access to Market for Regenerative Medicine Regulatory Changes Two acts were enacted in Japan in November 2014 that made revolutionary changes to the regulatory system for regenerative medicines: the Pharmaceuticals and Medical Devices Act and the Act on the Safety of Regenerative Medicine. Pharmaceuticals and Medical Devices Act Under the Pharmaceuticals and Medical Devices Act, a new category for medicinal products called “Regenerative Medical Products” was defined, in addition to the categories of “pharmaceuticals” and “medical devices.” This allows regenerative medical products to be evaluated based on their own unique characteristics. Additionally, a new approval system for regenerative medicine products, diagrammed above, was also introduced as part of this Act. This new system has cut the time required to commercialize regenerative treatment products down to as little as two to three years, making Japan’s approval system the fastest in the world. Copyright 2018 JTB Communication Design, Inc. 6 Japan creates fastest approval system for regenerative medicines in the world Act on the Safety of Regenerative Medicine It is now possible to contract the manufacturing and processing of cells to external enterprises. The culture and processing of cells and tissues for regenerative medicine using human cells could only be conducted by medical institutions under the supervision of the physicians sponsoring the clinical research. Regenerative Medicine Japan It is with the developments that are set to take place thanks to these new regulatory changes in mind that Regenerative Medicine Japan was first held in October 2016. Organized in collaboration between the Forum for Innovative Regenerative Medicine (FIRM), the Japan Bioindustry Association (JBA), and JTB Communication Design, the new exhibition is co-located with BioJapan, sharing both an exhibition space and partnering system to maximize cross-field collaboration and encourage open innovation. Copyright 2018 JTB Communication Design, Inc. 7 Japanese Outbound M&A Deals Japanese pharmaceutical companies are Besides this, many larger companies have becoming more global and strengthening recently been establishing and expanding their pipelines through M&A. To name just R&D sites in countries around the world. one of many, Takeda Pharmaceuticals, Notable examples include Chugai, who are the market leader in Japan, is reported to set to invest almost 500m USD into their have earmarked as much as $20 billion to Singapore research institute over the spend on overseas acquisitions of coming years, and Eisai, who established companies developing cancer, GI, and their first European research site in the CNS drugs in particular. UK in 2009. Company Takeover Candidate Deal Value (USD) Date Takeda Shire (UK) 62billion TBD Mitsubishi Tanabe NeuroDerm (Israel) 1.1 billion Jul. 2017 Sawai Upsher-Smith Laboratories (US) 1 billion Apr. 2017 Pharmaceutical Hitachi Chemical PCT, LLC, a Caladrius (US) 75 million Mar. 2017 Takara Bio WaferGen (US) 35.9 million 2017 ROHTO Ophthalmos (Brazil) Undisclosed Oct. 2016 Duoc Hau Giang Pharmaceutical Taisho Undisclosed Jul. 2016 (Vietnam) Nichi-Iko Sagent Pharmaceuticals (US) 736 million Jul. 2016 Eisai Liaoning TianYi (China) 78 million Nov. 2015 ReproCELL Biopta (UK) 8 million Nov. 2015 Astellas Ocata Therapeutics (US) 379 million Nov. 2015
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