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1 (updated:2015/5/18)

2 Rapid Growth of the Japanese Regenerative Medicine Industry Japan is the second-largest pharmaceutical market (2012) in the world after the United States. METI estimates the market size for regenerative medicine at about US$10 billion in 2030 (Japan), which promises enormous economic benefits. Market Forecasts for Regenerative Medicine (Japan) 2012 US$ 90 mil US$ 950 mil US$ 10 bil. (Million US Dollars) US$ 950 million 2030 US$ 10 billion Others Immune Cell Blood Pancreas Liver Kidney Vessel Alveolar Bone Nerve Heart Eye Cartilage Skin Source: Ministry of Economy Trade and Industry (METI)

3 Introduced world-class expedited approval system for regenerative medicinal products Japan introduced an expedited approval system for regenerative medicinal products in 2014 and created an environment conducive to the development and provision of regenerative medicinal products. PMD Act (formerly PAL) (Implemented November 2014) Regenerative medicinal product approval system Traditional System Clinical research Clinical trials (confirmation of efficiency and safety) Approval On market US/EU Japan (until Nov. 2014) Normally 6 years Can be as short as 3 years Time Required Until Approval Halved Shorter product launch period compared to the US/EU New System Clinical Approval On market Japan (after Nov. 2014) Clinical research trials (likely to predict efficacy, cy confir ming safety) With applied conditions and time limit Confirm efficiency Additional safety confirmation Apply for re-approval within the time limit Approval On market *Source: National Institute of Health Sciences, "International Comparison of Regenerative Medicine and Cell Therapy Regulations, 2013 In addition, the Regenerative Medicine Safety Act, also implemented in November 2014, allows outsourcing from medical institutions to private companies. Source: Ministry of Health, Labour and Welfare (MHLW)

4 Business opportunities created by the expansion of the regenerative medicine market in Japan Regenerative medicine is supported by a range of related industries, and the regenerative medicine market is expected to expand through advances in Japanese manufacturing technology and new technology entering the market from overseas. Consumable Supplies and Materials 1) Mediums 2) Reagents 3) Culture vessels Cell Processing Center (CPC) 1) Design, construction 2) Maintenance ips cells Supporting Industries Drug Evaluation System / Appliances Cardiac cells Transportation Transportation Genetic Manipulation Drug evaluation system w/ cardiac cells Procurement Autologous transplantation (Marketed Terumo Co., 2 products) (Under review in Japan) Japan Tissue Engineering Co. CellSeed Inc. (skin, cartilage) (cardiac cell sheet) (Under review in Europe) Cultured skin Leading companies on regenerative medicine products / services Healios K.K. (retina cell sheet processed by ips cell) (Under development) Culture Innovative Drug Discovery Retina cell sheet Regenerative Medicine Cardiac cell sheet Tissue Formation Cell Culture Devices 1) Incubators Allogenic transplantation 2) Auto-culturing devices Transportation Services 1) Transportation of cultured cells Cell Assessment Devices 1) Flow cytometers 2) Image analysis devices Source: Ministry of Economy Trade and Industry (METI)

5 State of the Clinical Trial Support Environment Japan has more than 70 CRO/SMO companies that provide assistance with clinical trials and approval procedures required to enter the Japanese market. It is expected that the regenerative medicine industry will also be supported by those companies. In addition, the government has already approved 10 Clinical Trial Core Hospitals. Tasks CRO (Contract Research Organization) Agency contracted to implement clinical trials Assisting with clinical trials Preparing clinical trial protocols Enrolling subjects Monitoring, etc. Preparing pharmaceutical materials Preparing applications for Marketing Business License/Manufacturing/Foreign Manufacturer Accreditation for drugs, etc. Preparing applications and other related documentation, etc. SMO (Site Management Organization) Agency contracted for clinical trial site management Assisting with clinical trials Assisting with conducting clinical trials in medical institutions Assisting with establishing and operating an IRB Training and staffing CRCs Tokyo National Cancer Center Clinical Trial Core Hospitals They are able to plan and implement complicated clinical Chiba National Center for Global Health and Medicine National Center for Child Health and Development National Hospital Organization National Center Hospital Keio University School of Medicine Chiba University Hospital Kanagawa Kitasato University School of Medicine Osaka The National Cardiovascular Center (NCVC) Oita Oita University Hospital Source :Ministry of Health, Labour and Welfare (MHLW)

6 Regenerative Medical Clusters Regenerative Medical Clusters are located in the three major regions of Kanto, Chubu and Kansai. Osaka (Saito): Osaka has the largest number of top pharmaceutical companies. It is developing a cluster centered on Osaka University. It ranks 3rd in the nation in terms of the monetary value of medicines and pharmaceuticals. Hyogo (Kobe): The Kobe Biomedical Innovation Cluster (KBIC) has nearly 292 companies (as of April 1st, 2015). The world s first clinical research for retina regeneration using ips cells is being done here Fukuoka Kyoto: Kyoto is the location of Kyoto University, famous for its ips cell research Kansai region Shizuoka: Tokyo Nagoya Chubu region Sendai Kanto region Sapporo Shizuoka ranks 2 nd in the nation in terms of the monetary value of medical device shipments ( ). It is currently promoting the Pharma Valley Project centered on the Shizuoka Cancer Center. (Aichi is the location of Japan Tissue Engineering Co., Ltd. (J-TEC), a leader in regenerative medicine.) Kanagawa (Yokohama/ Kawasaki): Kanagawa has a cluster of medical and pharmaceutical research institutions that pursue research based on collaboration by industry, government and academia. It ranks 6th in the nation in terms of the monetary value of medicines and pharmaceuticals (2013). Source: Ministry of Health, Labour and Welfare (MHLW)

7 World-class environment for research and development Kyoto University`s CiRA Research Institute, the world leader in ips cell research, is targeting the initiation of regenerative medicine research in humans, the search for drugs for intractable diseases, and the ips cell stock project. Active research is also being conducted at other universities. In addition, numerous regenerative medicine associations have been newly established, and the research environment is in place. Kyoto University Keio University Prof. Okano Regenerative therapy for spinal cord injuries Osaka University Prof. Sawa Regeneration of heart muscle using cell sheets Prof. Yamanaka Regenerative medicine research in humans The search for drugs for intractable diseases The ips cell stock project The Japanese Society for Regenerative Medicine (JSRM) The Japanese Society of Inflammation and Regeneration (JSIR) World Academy of Anti-Aging & Regenerative Medicine (WAARM) Japanese Society for Repro-Regeneral Medicine (JSRR) Japanese Association of Regenerative Dentistry (JARD) (Source) Kyoto University: Osaka University: Terumo Life Science Foundation Keio University: National Research and Development Agency Riken: RIKEN Dr. Takahashi Implementation of clinical trials for retina implants

8 Key Points for Entering the Japanese Market Regulatory review required prior to marketing regenerative medical products in Japan is performed in three main areas, as shown below. Review of Corporate Responsibility Review of Efficacy and Safety of the Products Review of the Production and Management of the Products (Domestic Manufacturing ) (Foreign Manufacturing) R&D, etc. <In case of Contract Manufacturing> Contract Manufacturing Agreement (Outsourcing Manufacturers make the following applications ) <In case of in-house manufacturing> Company Code Registration Company Code Registration Company Code Registration 1 Application for Marketing Business License 2Application for Marketing Approval 3Application for Manufacturing 4Foreign Manufacturer Accreditation Document Exam or On-site Audit by Relevant Authority Document Review or On-site Audit by Relevant Authority Obtaining of License Review for Approval, etc. (PMDA) Obtaining of License Obtaining of License 5GCTP (Good Gene, Cellular, and Tissuebased Products Manufacturing Practice) Inspection Document Exam or On-site Audit by Relevant Authority Approval <Overall Judgment> Commencement of Marketing <Regenerative Medicine Market specific> Source:PMDA

9 The Attractive Regenerative Market in Japan Market Attractiveness of Japan World-class expedited approval system Eight hundred thousand patients for biopharmaceuticals An estimated market size for regenerative medicine of US$10 billion in 2030 World-leading regenerative medicine related research and development centers Vast accumulation of clinical research JETRO offers a wide range of support services for setting up R&D centers and manufacturing and sales centers in Japan. Please contact us for more information, or to discuss your business development needs.

10 JETRO IBSC Services JETRO is a governmental organization with more than 70 overseas offices in over 50 countries across the world. For foreign companies planning to start a business in Japan, we provide information, consultation and other services free of charge, as well as a few fee-based services. When you come to Japan, JETRO IBSC will support you depending on your business needs by providing consultation and facilities for establishing a business base and starting your business in Japan. JETRO IBSC JETRO IBSC is a one-stop center for establishing a business base and starting your business in Japan. Consulting Facilities Information Free individual consultation for your company Temporary office space offered free of charge Gather a wide range of information needed for your business Legal system 50 working days free Market reports Cost estimation Located in 6 major cities Business advisor Taxation Fully equipped Online database Market regulation Shared reception Platform of professional Business practice PC room with printer/scanner etc. service provider Human resource Conference rooms available Connection to ministries and Location Event hall available regulatory authority Subsidy application Deregulation Request Hyogo (Kobe): IBSC Kobe 福 岡 Osaka: Kyoto: IBSC Kyoto 関 西 地 域 中 部 地 域 関 東 地 域 東 京 仙 台 札 幌 Shizuoka Kanagawa (Yokohama) IBSC Yokoha ma We provide a wide range of services for your needs. Please contact your nearest JETRO office. Overseas Offices: verseas Domestic Offices: pan/ invest-japan@jetro.go.jp IBSC Osaka

11 FIRM Services FIRM (The Forum for Innovative Regenerative Medicine) is an industrial organization of approximately 150 regenerative medicine related companies. FIRM has organized a Regenerative Medicine Industrialization Task Force (RMIT) and has newly established a consultation service to answer questions from overseas. FIRM (RMIT) Consultation Service for Overseas Companies Overview Major Services Established on April 1, 2015 Consultation service for partnering with Japanese firms Inquiry service for specialized topics related to Japan`s regenerative medicine system The service is basically provided free of charge. Please see the website below for more details. 1 Consultations and inquiries on regulatory affairs 2 Consultations on procurement of ingredients and materials 3 Consultations on procurement, provision, and trial use of machines, equipment and facilities 4 Consultations and requests on manufacturing and quality assurance 5 Consultations on clinical studies 6 Consultations on clinical trials 7 Consultations on clinical applications and marketing plans including alliances with medical institutions 8 Consultations, requests and inquiries on industrialization of regenerative medical products and others Contact For consultations, requests, and inquiries, please contact us at the address below. For phone consultations, please contact us at one of the phone numbers during the times indicated below (Japan time). Phone: info-tf@firm.or.jp (Japanese) (English) Business hours:9:00~12:00, 13:00~16:00 (Monday ~ Friday) Source: RMIT

12 Regenerative Medicine Related Events and Industry Organizations Regenerative medicine-related businesses are brought together at events held throughout the year; presenting opportunities to seek potential business partners and identify trends in the Japanese market. Regenerative medicine related events Event overview Location/Timing BIO JAPAN Event aimed primarily at business partnering with a focus on bio-clusters and ventures Over 600 exhibiting companies Yokohama/annual (Next meeting 2015/10/14-16) BioPh Japan Regenerative Medicine Expo & Conference Biotechnology industry showcase for medical-related products and services, including bio-pharmaceuticals and regenerative medicine products, contract services, licensing, etc. Over 420 exhibiting companies Showcase for products and services related to the commercialization of regenerative medicine, including media, reagents, culture/cell products, contract services, licensing, etc. First meeting was held in February 2015 Tokyo /annual (Next meeting 2016/4/20-22) Osaka/annual (Next meeting 2016/2/24-26 Related industry organizations FIRM (Regenerative Medicine Innovation Forum) An industry body with a membership of approximately 150 main players, focused on supporting regenerative medicine businesses all the way from discovery of seeds up to development of advanced technology in the industrial manufacturing base Activities include recommendations on regenerative medicine commercialization strategies and issues, exchanges and partnerships among stakeholders in regenerative medicine in Japan and abroad, and implementation and publication of research and statistics on regenerative medicine Participating companies A wide variety of regeneration medicine related companies covering products, reagents, mediums, culture vessels, devices, chemicals, insurance, etc. JBA(Japan Bioindustry Association ) Pharmaceuticals, food, cosmetics, chemical, information, Natural Resources and Energy, such as biotechnology companies about 190 companies of business and universities, public research institutions, including about 90 organizations to affiliation Through the advancement of science and technology relating to biotechnology industry, comprehensively promote to have the organization to the development of biotechnology industry in the industry, academia and government cooperation