Accro's AC-101 Enters NMPA Rare Disease Pilot for Blau Syndrome
Suzhou – – September 16, 2026 -- Accro Bioscience said AC-101 tablets have been included in the National Medical Products Administration's Center for Drug Evaluation (CDE) "Caring Plan-Extension" pilot program, targeting Blau syndrome as the proposed indication, with the public notice period closing September 11, 2026.
NMPA pilot program aims to accelerate rare disease drug development in China
The Caring Plan-Extension pilot, run by China's CDE, is designed to encourage innovative drug development for rare diseases. Accro Bioscience confirmed the inclusion took effect September 14, 2026, China Standard Time (UTC+8).
FDA granted AC-101 Rare Pediatric Disease designation three months earlier
The U.S. Food and Drug Administration awarded AC-101 Rare Pediatric Disease (RPD) designation for Blau syndrome in June 2026, ahead of the Chinese regulatory step.