AC-101

New York and Suzhou, China – September 20, 2026 -- Accro Bioscience Inc. has dosed its first patient in a Phase IIb trial testing AC-101, a selective RIPK2 inhibitor, in patients with moderate-to-severe ulcerative colitis (UC).

Trial spans roughly 50 clinical sites with three treatment arms

The multicenter, double-blind, placebo-controlled study is designed across approximately 50 clinical sites and includes two AC-101 dose cohorts plus a placebo control arm. The primary endpoint is clinical remission rate at Week 12, with exploratory endpoints covering histologic remission and long-term maintenance of clinical and histologic remission.

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.