Expansion of the iPS Cell and Regenerative Medicine Business

「In May of the same year, we obtained marketing approval in Japan for Saibisukasu injection, a regenerative medicine product.」

「In the life sciences business, the Company’s U.S. subsidiary FUJIFILM Cellular Dynamics, Inc. and Opsis Therapeutics, LLC agreed to grant BlueRock Therapeutics LP, a subsidiary of major pharmaceutical company Bayer AG, a licence for the development and commercialisation of treatments for retinal diseases using iPS cells.」

「In the life sciences business, revenue increased as media sales grew and sales of cells for drug discovery support remained solid. The media market continues to grow as demand for antibody drugs increases. Through its global production structure in the United States, Europe and Japan, the Company will provide strong support for the research, development and manufacturing of biopharmaceuticals.」

「In the life sciences business, the Company’s U.S. subsidiary FUJIFILM Cellular Dynamics, Inc. entered into an agreement with globally operating healthcare company Novo Nordisk granting it the right to use therapeutic iPS cells.」

「In November 2022, the Company announced the establishment of a new media production site in North Carolina, United States. The global media market continues to grow as demand for antibody drugs increases and advanced medicine, including cell and gene therapies, develops. Through its global production structure in Europe, the United States and Japan, the Company will provide strong support for the research, development and manufacturing of biopharmaceuticals.」

「In March 2022, the Company acquired U.S. biotech company Shenandoah Biotechnology, Inc., which develops, manufactures and sells cytokines that promote cell proliferation, differentiation and functional expression. Through the acquisition, the Company will further strengthen research and development of cell culture-related products combining media and cytokines, as well as its ability to make proposals to customers, and expand its research, development and manufacturing support business for cell therapies, a market experiencing rapid growth.」

「In April 2022, the Company completed the acquisition of a cell therapy manufacturing site owned by U.S. biotech company Atara Biotherapeutics, Inc. Going forward, it will fully develop its contract business for the development and manufacture of cell therapies, including genetically modified cell therapies, to further expand its contract development and manufacturing business for biopharmaceuticals.」

「Following completion of the acquisition, Shenandoah was launched as a subsidiary of FUJIFILM Irvine Scientific, Inc., the media-focused U.S. subsidiary of FUJIFILM Corporation. Going forward, the Company will combine FISI’s media technology with Shenandoah’s cytokine development expertise to develop cell therapy media that can efficiently culture cells expressing the desired functions.」

「In December 2021, the Company announced the opening of the Innovation & Collaboration Center, a media customisation service centre in Suzhou New District, to expand its media business in China. In the same month, it commissioned a new plant in the Netherlands to increase media production capacity. Through a global production structure with 3 sites in Japan, the United States and Europe, the Company will provide stronger support for customers’ drug discovery and pharmaceutical manufacturing.」

「In September 2021, the Company announced that it had reached a basic agreement with regenerative medicine venture Cynata Therapeutics Limited for a framework of collaboration that would maximise the strengths and resources of both companies. Under the agreement, the Company plans to provide contract manufacturing services for clinical trial materials and commercial production for Cynata’s pipeline of regenerative medicine products derived from iPS cells.」

「FUJIFILM Cellular Dynamics, Inc. (United States) and its subsidiary Opsis Therapeutics, LLC (United States) agreed with BlueRock Therapeutics LP, a subsidiary of major pharmaceutical company Bayer AG, on a strategic partnership for the research and development of treatments for eye diseases using iPS cells. Under the terms of the agreements signed for the strategic partnership, FCDI and Opsis will receive upfront payments and funding for part of the research and development and clinical trial material manufacturing costs related to the development of 3 retinal disease treatment programmes. They will also be entitled to receive milestones tied to development and sales progress, as well as sales royalties at a rate of approximately 10% for each treatment programme.」

「In March 2021, as part of the optimisation of its business portfolio in the biomedicine field, the Company transferred all of its holdings in Japan Tissue Engineering Co., Ltd. to Teijin Limited. While focusing on cells and media, where it can maximise its strengths, the Company will further strengthen its drug discovery support business and pursue efficient research and development in collaboration with partners and expand its contract development business for cell therapies, which are expected to see substantial growth as the market develops.」

「FUJIFILM Corporation, the Company’s wholly owned subsidiary, entered into a tender offer agreement on 29 January 2021 with Teijin Limited, under which it would tender all of its common shares in Japan Tissue Engineering Co., Ltd., a consolidated subsidiary of the Company’s Group, into the tender offer to be conducted by Teijin for J-TEC’s common shares. Teijin commenced the tender offer on 1 February 2021. The tender offer was expected to be completed during fiscal 2020, after which J-TEC would cease to be a consolidated subsidiary of the Group.」

「In November 2020, FCDI began full-scale provision of therapeutic iPS cells and licensing of patents related to iPS cell production technology. As its first such transaction, it granted Lonza Walkersville, Inc. a non-exclusive, worldwide licence to use patents related to iPS cell production technology for the development of regenerative medicine products.」

「In September 2020, Japan Tissue Engineering Co., Ltd. filed an application for manufacturing and marketing approval for autologous cultured oral mucosal epithelium (development name: COMET01) for the treatment of limbal stem cell deficiency.」

「In addition, from March 2020, FCDI began operations at its new production facility for therapeutic iPS cells, the Innovation Facility for Advanced Cell Therapy (i-FACT).」

「In July 2019, the Company announced that Century Therapeutics, Inc., established by its U.S. subsidiary FUJIFILM Cellular Dynamics, Inc., a leader in the development and manufacture of iPS cells, and leading U.S. venture capital firm Versant Venture Management, LLC, had begun developing next-generation cancer immunotherapies using allogeneic iPS cells. Bayer AG, a major pharmaceutical company, is also participating in the development.」

「In June 2019, the Company also announced investments in regenerative medicine ventures JUNTEN BIO Co., Ltd. and PuREC Co., Ltd. By combining the technologies and expertise of FUJIFILM Group companies with the ventures’ advanced technologies, the Company will contribute to the early industrialisation of regenerative medicine.」

「In addition, from January 2019, the U.S. subsidiary FUJIFILM Cellular Dynamics, Inc. began sales of “iCell® Microglia,” differentiated cells derived from iPS cells for drug discovery support that enable the evaluation of new drugs in an environment resembling the human body, in the field of neurological diseases including Alzheimer’s disease.」

「In addition, the Company decided to invest approximately ¥2.5 billion to establish a new production facility for therapeutic iPS cells at its U.S. subsidiary FUJIFILM Cellular Dynamics, Inc., compliant with cGMP*. It will establish production capabilities for regenerative medicine products used in treatment at facilities in Japan and the United States, contributing to the early industrialisation of regenerative medicine.」

「In addition, through joint research with Nagoya City University, the Company successfully developed human intestinal epithelial cells derived from iPS cells, which are optimal for evaluating drug absorption. This will contribute to the wider use of iPS cells in drug discovery support in the future.」

「In the regenerative medicine business, the Company made Irvine Scientific Sales Company, Inc. and IS Japan Co., Ltd., leading companies in the media field, consolidated subsidiaries in June 2018, increasing revenue. Japan Tissue Engineering Co., Ltd. also entered into a patent licence agreement with Nagoya University and Shinshu University for low-cost CAR-T cell manufacturing technology and acquired an exclusive licence to develop, manufacture and sell in Japan an autologous cell-derived therapy for CD19-positive ALL using this technology. The Company is expanding its regenerative medicine product pipeline.」

「In the regenerative medicine business, the Company entered into an agreement with Takeda Pharmaceutical Company Limited granting Takeda preferential negotiating rights for the global joint commercialisation of a regenerative medicine product using cardiomyocytes derived from iPS cells.」

「In the regenerative medicine business, orders for the autologous cultured epidermis “JACE” of Japan Tissue Engineering Co., Ltd. (hereinafter, “J-TEC”) remained strong, partly due to its expanded indication for congenital giant congenital melanocytic nevus from December 2016, contributing to revenue.」

「In addition, by making Wako Pure Chemical Industries, Ltd., which has advanced technology in the media and cytokines that play important roles in regenerative medicine, a consolidated subsidiary, the Group established a structure to develop as an integrated group the three key elements of regenerative medicine, namely cells, media and cytokines, and scaffolds. This structure combines Cellular Dynamics International, Inc. of the United States, a global leader in the development and manufacture of iPS cells, J-TEC and FUJIFILM, which has strengths in scaffolds made from recombinant peptides.」

「FUJIFILM Corporation invested in Cynata Therapeutics Limited of Australia, a regenerative medicine venture that has established technology for the efficient mass production of mesenchymal stem cells derived from allogeneic iPS cells. In May 2017, Cynata began a clinical trial of a regenerative medicine product using mesenchymal stem cells derived from allogeneic iPS cells supplied by CDI.」

「In the regenerative medicine business, Cellular Dynamics International, Inc. of the United States, a global leader in the development and manufacture of iPS cells (hereinafter, “CDI”), entered into a joint research and development agreement with the National Eye Institute concerning the treatment of age-related macular degeneration using allogeneic iPS cells. It also established a new company in the United States with Dr. David Gamm, a global authority on retinal disease treatment, to develop treatments for retinal diseases using allogeneic iPS cells. In September 2016, CDI also obtained in Japan a patent for technology to produce iPS cells safely and efficiently, following the United States and Australia. Taking this patent acquisition as an opportunity, the Company will leverage synergies across the Group, including its engineering expertise and the quality management system of its group company Japan Tissue Engineering Co., Ltd., to expand its contract manufacturing business for iPS cells.」

「In the regenerative medicine business, Cellular Dynamics International, Inc. of the United States, a global leader in the development and manufacture of iPS cells, entered into a joint research and development agreement with the National Eye Institute concerning the treatment of age-related macular degeneration using allogeneic iPS cells. It also established a new company in the United States with Dr. David Gamm, a global authority on retinal disease treatment, to develop treatments for retinal diseases using allogeneic iPS cells. The Company will continue research and development in collaboration with academia, research institutions and others to further expand the business.」

「Cellular Dynamics International, Inc. of the United States, a global leader in the development and manufacture of iPS cells that became a consolidated subsidiary in the previous fiscal year, entered into a joint research and development agreement with the National Eye Institute concerning the treatment of age-related macular degeneration using allogeneic iPS cells. The Company will continue research and development in collaboration with academia, research institutions and others to further expand the business.」

「In the regenerative medicine business, the Company made Cellular Dynamics International, Inc. of the United States, a global leader in the development and manufacture of iPS cells, a consolidated subsidiary in May 2015, and established Cellular Dynamics International Japan Co., Ltd. in Japan in October 2015 to develop the iPS cell business domestically. Together with the Company’s consolidated subsidiary Japan Tissue Engineering Co., Ltd., it will create synergies, accelerate product development and expand its business scope.」