Fujifilm agrees on core terms with Australian regenerative medicine venture Cynata  to manufacture Cynata’s iPS cell-derived regenerative medicine products

Tokyo, September 30, 2021 — FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) has reached agreement on core terms with Australian regenerative medicine venture Cynata Therapeutics Limited (Cynata) to manufacture regenerative medicine products using induced pluripotent stem (iPS) cells. Based on the core terms, Fujifilm will conduct clinical and commercial manufacturing for Cynata’s pipeline of iPS cell-derived regenerative medicine products.

Cynata is a venture that aims to commercialize regenerative medicine products using iPS cell-derived mesenchymal stem cells^*1. Cynata has used iPS cells supplied by FUJIFILM Cellular Dynamics, Inc., a leading company in the development, manufacture and sale of iPS cells, to develop regenerative medicine products including CYP-001 targeting graft-versus-host disease (GvHD^*2) that develops after a bone marrow transplant, and CYP-004 targeting osteoarthritis. Fujifilm made a minority investment in Cynata in 2017 focusing on its growth potential as a leader in the field of iPS cell-derived cell therapies, and acquired the rights for development, manufacturing and sales of CYP-001 in 2019.

Fujifilm will build a new partnership with Cynata that can maximize the strengths and resources of both companies and further promote industrial application of iPS cell-derived regenerative medicine.
Under this new partnership, Fujifilm has returned the rights to Cynata for the development, manufacturing and sales of CYP-001, and will conduct clinical and commercial manufacturing for Cynata’s pipeline of iPS cell-derived regenerative medicine products, including CYP-001.

Under the medium-term management plan VISION2023, Fujifilm is pursuing a growth strategy for healthcare, which is one of its four priority business areas. In the field of regenerative medicine, its U.S. subsidiary, FUJIFILM Cellular Dynamics, Inc., has developed the technology to consistently and efficiently produce iPS cells. The company also has a cGMP^*3 production facility which manufactures high-quality therapeutic iPS cells. Leveraging these capabilities, Fujifilm is forging strategic partnerships to conduct efficient R&D and promote contract development and manufacturing business for cell therapies.

Fujifilm will expand Life Sciences business and contribute to the industrialization of the regenerative medicine field, including cell therapies, by bringing together the resources of its group companies.

• *1 Stem cells that exist in the body and have a certain level of differentiation and proliferation ability.
• *2 Abbreviation for Graft versus Host Disease. It is a general term for symptoms caused by the organs of a donor (organ donor) attacking the organs of a recipient (organ recipient) by an immune response.
• *3 Abbreviation for current Good Manufacturing Practice. The latest manufacturing and quality control regulations for pharmaceuticals and quasi-drugs established by the US FDA (Food and Drug Administration).

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