SanBio gains crucial approval for Akugo®, lifting shipment restrictions

SanBio Co., Ltd. announced on December 9, 2025, that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) for a partial change to the manufacturing and marketing authorization of Akugo® (INN: vandefitemcel) for intracerebral transplant injection. This approval includes a crucial revision to the associated conditions, specifically lifting the restriction on product shipment previously imposed. Akugo® is set to launch following its NHI price listing, positioning it as the world's first regenerative therapy for the brain. It was initially granted conditional and time-limited approval in Japan in July 2024 for chronic motor paralysis associated with traumatic brain injury.

The company's medium- to long-term growth strategy includes advancing its traumatic brain injury program in the U.S. market, with Phase 3 clinical trial preparations starting next fiscal year, following agreement with the U.S. FDA on the trial design. In Japan, discussions with regulatory authorities for its stroke program's clinical trials are also slated for the next fiscal year. SanBio aims to become a global leader in regenerative medicine, headquartered in Tokyo and Oakland, California.

Akugo®, designated under Japan's Sakigake Designation System and granted Regenerative Medicine Advanced Therapy (RMAT) by the U.S. FDA, is an allogeneic, human bone marrow-derived mesenchymal stem cell product. It promotes neural cell proliferation and differentiation by releasing FGF-2 when transplanted into damaged brain tissue, enhancing the brain's inherent regenerative capacity. SanBio expects the impact of this approval on the current fiscal year's business results to be minimal.