SanBio’s SB623 Regenerative Cell Therapy for TBI nudges closer to approval in Japan


SanBio Co / SanBio Inc. has successfully received Sakigake Designation from the Ministry of Health, Labour and Welfare in Japan.

Sakigake Designation is similar to programs like the FDA Fast Track Designation, where once a therapy can prove itself effective and capable of filling an unmet need, the approval process for the therapy is given priority, and government also provides resources to the developer to speed commercialization and regulatory approval.

SB623 is a therapy that uses modified and cultured stem cells from adult bone marrow. The cells are implanted into injured nerve tissue in the brain and help trigger the brain’s natural regenerative ability.

SB623 is currently undergoing phase 2 trials in both the United States and Japan. Early clinical trials have demonstrated a statistically significant improvement in motor function compared to the control group in TBI patients. SB623 is also undergoing trials for alzheimer’s, stroke, and other brain disorders.

The original press release is here:


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