- CEO
- Keita Mori
- Full Time Employees
- 29
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- St. Luke Tower Tokyo Japan 104-0044
- IPO Date
- Oct 12, 2015
- Business
- SanBio Company Limited (TSE:4592; OTC:SNBIF), a biopharmaceutical company founded in 2001 and headquartered in Tokyo, Japan, with additional facilities in Oakland, California, USA, researches, develops, manufactures, and commercializes regenerative cell therapies using allogeneic mesenchymal stem cells to restore neurological function damaged by disease or injury; its lead product, AKUUGO (vandefitemcel, previously SB623), is a suspension for intracranial implantation targeting chronic traumatic brain injury, ischemic stroke, and Parkinson's disease, while its pipeline also encompasses therapies for eye diseases and other central nervous system disorders through partnerships such as joint development with OcuMension (Hong Kong) Limited and collaboration with D&P Bioinnovations, Inc. for regenerative esophageal implants. The company operates primarily in Japan and the United States, advancing clinical programs with regulatory milestones including conditional approval of AKUUGO by Japan's Ministry of Health, Labour and Welfare in 2024, subsequent partial change applications for manufacturing and marketing in 2025, and an agreement with the U.S. FDA on Phase 3 trial design for traumatic brain injury. Recent developments feature secured commitment lines totaling ¥3 billion from Resona Bank, Mizuho Bank, and Mitsubishi UFJ Financial Group in 2025 for financial stability; a planned international offering to raise up to ¥14.9 billion to fund product launches and clinical trials; revision of expected approval timelines for AKUUGO partial changes; and strategic expansions including interactions for stroke indications in Japan and U.S. market entry, alongside CEO Keita Mori's appointment as Chairman of the Samurai Biotech Association in May 2025.