SanBio's AKUUGO® suspension to undergo committee review for expanded approval

SanBio Co., Ltd. announced on October 2, 2025, that its partial change application for marketing approval of AKUUGO® Suspension for Intracranial Implantation (INN: vandefitemcel) will be deliberated by the Ministry of Health, Labour and Welfare's Pharmaceutical Affairs and Subcommittee on October 16. The company anticipates approval in the second half of the fiscal year ending January 2026 (August 2025-January 2026).

AKUUGO® is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell product. It is expected to promote natural regenerative abilities and induce nerve cell proliferation and differentiation when transplanted into damaged brain tissues. SanBio obtained conditional and time-limited approval for AKUUGO® on July 31, 2024, for improving chronic motor paralysis associated with traumatic brain injury.

The company stated that this development would have only a minimal impact on its financial performance for the current fiscal year. SanBio, founded in 2001, specializes in researching, developing, manufacturing, and selling regenerative cell medicines for central nervous system disorders.