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EU-Japan Centre for Industrial Cooperation
Opportunities for Cooperation between EU and Japan on Biotechnology in Healthcare: Japan Bioventures Landscape
Tokyo, April 2018
Esther RODERGAS
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Disclaimer The information contained in this publication reflects the views of the author and not necessarily the views of the EU-Japan Centre for Industrial Cooperation, the European Commission or Japan authorities. The author believes that this paper is reliable and reasonably clear. While utmost care was taken to check and translate all information used in this study, the author and the EU-Japan Centre may not be held responsible for any errors that might appear. This report does not constitute legal advice in terms of business development cases. The author can be contacted at [email protected]
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Executive Summary
Japan is one of the major countries that European biotech companies target in their expansion when it comes to internationalisation. This report intends to be a useful source of information for European SMEs and clusters considering potential cooperation with Japan.
In the healthcare sector, and more specifically in the therapeutics development field, partnerships between European and Japanese pharmaceutical companies well established in their respective local markets has typically involved License agreements on co-development and commercialisation rights. The Japanese inlicensor would typically get the rights on a product of European origin to pursue its clinical development in Japan, obtain the local regulatory approval, and commercialise it in the domestic Japanese market. The reverse situation was possible as well, when products developed in Japanese companies pipelines were licensed-out to European based companies.
In an era of open innovation, partnership models are evolving, and can go well beyond pharma licensing deals on co-development and product commercialisation rights. Moreover, European biotech SMEs often present alternatives to the traditional therapeutic product development, and business models are frequently based on discovery platforms and services to facilitate research and drug development.
This report is therefore focussing on public research institutions and academic bioventures in Japan, which may hold great potential for collaboration with European SMEs.
Biotechnology policies in Japan are presented in the first section of the report, exploring the Regulatory mechanisms for approval of regenerative medicines which Japan pioneered (sections 2&ยท3). A brief presentation of Japan science and technology indicators, and major cooperation programs in health with the European Union is given in sections 4&5. The chronology of the evaluation of Academia-Industry relations in Japan, leading to the current situation of academic bioventures is presented in sections 6 & 7.
Section 8 includes an overview of the Japanese biotech academic landscape. A comprehensive description of all the laboratories doing biotech research in Japan was beyond the scope of this report. Major universities and flagship research centres are presented, explaining how relations with industry are organised for each centre. A selection of innovative academic bioventures is provided, linked to the research laboratory which was at the origin of the technology offered by these companies.
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The global health innovative technology fund is presented in section 9, as an interesting model of tripartite collaboration with Japan, potentially interesting to EU biotech companies. Section 10 describes the most active Japanese clusters and innovation hubs with interest on international collaboration biotechnology and healthcare. The report concludes with some practical recommendations for EU biotech companies considering entering the Japanese market.
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List of abbreviations

AMED ALS CiRA CDMO CRO EMA EU ES FDA GDP GHIT GMP HFSP HGF iPSC IFReC IMSUT ICGC IHEC IHMC IMPC IoT JABEX JBA JPY LiC LINK-J MHLW MAB METI MEXT MOTHERS MoU

Agency for Medical Research and Development Amyotrophic Lateral Sclerosis Center for induced pluripotent stem cell Research and Application Contract development and manufacturing organization Contract Research Organization European Medicines Agency European Union Embryonic stem cell Food and Drug Administration (US) Gross Domestic Product Global Health Innovative Technology Fund Good manufacturing Practices Human Frontier Science Programme Hepatocyte Growth Factor Induced Pluripotent Stem Cell The Immunology Frontier Research Center Institute of Medical Science University of Tokyo International Cancer Genome Consortium International Human Epigenome Consortium International Human Microbiome Consortium International Mouse Phenotyping Consortium Internet of Things Japan Association of Bioindustry Executives Japan biotechnology Association Japanese Yen Lifescience Industry Center in Kanagawa Life science Innovation Network Japan Ministry of Health Labour and Welfare Monoclonal Antibody Ministry of Energy Trade and Industry Ministry of Education, Culture, Sports, Science and Technology Market of High Growth and Emerging Stocks (Tokyo Stock Exchange) Memorandum of Understanding

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M&A NEDO NGS NISTEP OECD PMDA PMI QbIC RCAST RMP RPE SMEs

Mergers and Acquisitions New Energy and Industrial Technology Development Organization Next Generation Sequencing National Institute of Science and Technology Policy Organisation for Economic Co-operation and Development Pharmaceuticals and Medical Devices Agency Preventive Medicine and Diagnosis Innovation Program Riken Quantitative Biology Center Research Center for Advanced Science and Technology Regenerative Medicine Product Retinal Pigment Epithelium Small and Medium Size Enterprises

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Table of contents
Disclaimer .............................................................................................................................................2 Executive Summary ..............................................................................................................................3 List of abbreviations .............................................................................................................................5 Table of contents...................................................................................................................................7 List of Bioventures/companies mentioned in the report: ......................................................................9 List of Figures.....................................................................................................................................11 List of Tables.......................................................................................................................................12 1. Introduction...............................................................................................................................13 2. Japan Biotechnology Policies ...................................................................................................15 3. Regulatory policies for the promotion of Regenerative Medicine ........................................17 4. Japan Science and Technology Indicators ..............................................................................21 5. European Union-Japan Cooperation on Health.....................................................................24 6. Industry- Academia Collaborations in Japan.........................................................................26 7. Entrepreneurship and policies supporting Bioventures in Japan ........................................30 8. Japan Academic Landscape- An Overview.............................................................................34
Internationalization of Japan Universities: Japan Top Global Universities Project ................................................. 34 World Premier International Research Center Initiative (WPI) ............................................................................... 35 Industry-Academia track record of collaborations................................................................................................... 37 University start-up creation: Accumulated number of academic ventures............................................................... 37 The University of Tokyo.......................................................................................................................................... 38 The Institute of Medical Sciences of the University of Tokyo (IMSUT) ................................................................. 38 The Translational Research Initiative by the University of Tokyo........................................................................... 39 The Research Centre for Advanced Science and Technology (RCAST) ................................................................. 41 The University of Tokyo- Organisation of the Collaborations with Industry .......................................................... 42 Support to venture companies at the University of Tokyo ....................................................................................... 42
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Kyoto University ..................................................................................................................................................... 48 Center for iPS Cell Research and Application (CiRA) ............................................................................................ 48 Institute for Integrated Cell Material Sciences (ICeMS) ......................................................................................... 50 Kyoto University: Industry-Academia Collaborations Organisation ....................................................................... 50 Osaka University ..................................................................................................................................................... 58 The Immunology Frontier Research Center (IFReC) .............................................................................................. 58 Osaka University: Industry-Academia Collaborations Organisation ....................................................................... 59 Examples of Academic bioventures from other Universities (Hiroshima, Nagoya, Hokkaido, Kyushu, Kurume, Keio, Saitama) ......................................................................................................................................................... 63 RIKEN Research Institutes...................................................................................................................................... 66
9. Global Health R&D fund (GHIT): An alternative public-private partnership model .......78 10. Industrial Clusters and Innovation Hubs...........................................................................79
Life Science Innovation Network Japan (LINK-J) TOKYO .............................................................................. 80 Life Innovation Centre (LiC) in Kawasaki, Kanagawa Prefecture .......................................................................... 82 The Shonan Health Innovation Park, Kanagawa ..................................................................................................... 84 Kobe Foundation for Biomedical Research and Innovation .................................................................................... 85 Osaka Bio ................................................................................................................................................................ 87
11. Academic Societies and Associations ..................................................................................87 12. Tradefairs and Organisations..............................................................................................90 13. Recommendations and Conclusion .....................................................................................90 Annexes ..............................................................................................................................................92
Annex 1: Japanese bioventures exhibiting at Japan Healthcare Venture Summit 2017 ........................................... 92 Annex 2 List of National Universities ..................................................................................................................... 94
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List of Bioventures/companies mentioned in the report:

Company name Ambicion AnGes Brightpath Biotherapeutics Co Ltd Cellink Chiome bioscience Chordia therapeutics Chromocenter Inc. Cyfuse biomedical KK DNAform Edigene Epigeneron Inc. Epsilon Molecular Engineering Funpep GlyTech Inc. HanaVax Inc Healios Human Metabolome Technologies iHeart Japan Jisak bioengineerng JTEC corpo K Pharma Kinopharm Kotai Biotechnologies Inc. Kyoto drug discovery KDDD Matrixiome Inc. Medinet MegaKaryon Corporation Metcela Molcure Myoridge NB Health Laboratory Co. Ltd

Originating from University/ Institution RIKEN Osaka Kurume, Fukuoka Kyoto RIKEN Kyoto Osaka Kyushu RIKEN Tokyo Osaka Saitama Osaka Tokyo Tokyo RIKEN Keio Kyoto, CiRA Tokyo Osaka
Kyoto Osaka iFReC Kyoto Osaka iFREC Tokyo IMSUT Kyoto, Tokyo Keio Tokyo Kyoto Sapporo University

Cluster/ innovation hub/area
LiC & Fukuoka Bio incubation KU innovation hub, EU LiC Kanagawa Shonan Park, Kanagawa Tokyo U entrepreneurs plaza Venture plaza Yokohama Cambridge,MA, USA Saitama
Tokyo Tokyo, EU/US
Shonan Park, Kanagawa Kyoto innovation hub
Tokyo Yokohama Osaka Kyoto LiC Kanagawa KU pharma research institute Hokkaido

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Noile Immune Nuprotein Organ technologies Peptidream Peptistar PharmaBio RegCell ReproCell Rhelixa Rikenbio SCAD SCI Scohia Pharma Inc. TagCyx biotechnologies Thyas Two cells

Yamaguchi University Nagoya RIKEN Tokyo RCAST Tokyo RCAST Tokyo Kyoto, Osaka Kyoto iCeMS Tokyo RCAST RIKEN Kyoto ICeMS Kyoto Takeda RIKEN Kyoto Hiroshima

Shonan Park, Kanagawa Nagoya University Incubation
LiC Kawasaki LiC Kawasaki Tokyo
LiC Kanagawa /EU/USA Tokyo
Shonan park Kanagawa Tokyo Komaba open lab
Hiroshima

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JapanReportCompaniesUniversityBioventures