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.