Accro Bioscience Announces Inclusion of AC-101 tablets in the NMPA CDE's "Caring Plan-Extension" Pilot Program for Rare Disease Drug Development

NEW YORK and SUZHOU, China, Sept. 13, 2026 /PRNewswire/ -- On September 14, 2026 (China Standard Time, UTC+8), Accro Bioscience announced that AC-101 tablets have been included in the Rare Diseases Innovative Drug Development Encouragement Pilot Program (the "Caring Plan-Extension", known in Chinese as "关爱计划-延伸" of the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), with Blau syndrome as the proposed indication. The relevant public notice period ended on September 11, 2026. Previously, in June 2026, the U.S. Food and Drug Administration (FDA) granted AC-101 Rare Pediatric Disease (RPD) designation for the treatment of Blau syndrome (BS).

About AC-101

AC-101 is a novel, selective RIPK2 inhibitor derived from Accro Bioscience's proprietary drug discovery platform targeting regulatory cell death and inflammation. It is being developed for the treatment of moderate-to-severe ulcerative colitis (UC). Receptor interacting protein kinase 2 (RIPK2) is a key mediator in the NOD signaling pathway, and dysregulation of NOD/RIPK2 signaling is associated with multiple inflammatory and autoimmune diseases, including inflammatory bowel disease (IBD). AC-101 has completed Phase I studies in healthy volunteers in Australia and China, demonstrating favorable safety and PK/PD profile. A Phase Ib/IIa proof-of-concept study in Chinese patients with moderate-to-severe UC has been completed. The efficacy and safety results from this study will be presented at UEG Week 2026. For details, please see the related press release.

About Blau Syndrome

Blau syndrome is a rare hereditary autoinflammatory disease caused by pathogenic variants in the NOD2 gene. It usually begins in early childhood and can involve multiple systems, including the skin, joints and eyes. Its classic clinical presentation is the triad of granulomatous dermatitis, arthritis and uveitis. Joint involvement may lead to joint deformity and functional impairment over time. Ocular involvement can cause uveitis; if not controlled promptly, it may lead to severe visual impairment or even blindness.^[1,2]

About Accro Bioscience

Accro Bioscience Inc. is a clinical-stage biotechnology company pioneering the discovery, development and commercialization of novel therapeutics for inflammatory and autoimmune diseases, by targeting molecular mechanisms of regulatory cell death. The company's robust pipeline of first- and best-in-class compounds offers the potential to bring innovative, paradigm-shifting therapies to patients.

For more information, please visit www.accropeutics.com.

[1]. NIH/NLM MedlinePlus Genetics — Blau syndrome

[2]. NIH/NLM MeSH — Blau syndrome

SOURCE Accro Bioscience (Suzhou) Limited