SanBio gains partial MHLW approval for AKUUGO® brain therapy

SanBio Co., Ltd. announced on December 9, 2025, that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved a partial change to the marketing authorization for AKUUGO® suspension for intracranial implantation. This approval lifts Condition ①, which previously restricted product shipment. AKUUGO®, the world's first regenerative therapy for the brain, remains approved under a conditional and time-limited framework, with the company aiming for full approval within seven years of the initial July 2024 authorization.

Following National Health Insurance (NHI) price listing, SanBio plans to launch AKUUGO®, which treats chronic motor paralysis associated with traumatic brain injury. The company will continue post-marketing evaluations for all cases where the product is used, collecting information on quality and biological characteristics to improve its quality control strategy.

Looking ahead, SanBio plans to advance its traumatic brain injury program in the U.S. with Phase 3 clinical trials scheduled to begin next fiscal year. Discussions with regulatory authorities regarding clinical trials for its stroke program in Japan are also planned for the next fiscal year. The company expects a minimal impact on current fiscal year business results from this development.