Accro Bioscience Secures China Regulatory Clearance for Vitiligo Trial
Key Insights
China's NMPA has approved a Phase II/III adaptive seamless design trial of AC-201 tablets for non-segmental vitiligo (search), Accro Bioscience (search) announced.
The filing was made by Shanghai Fosun Pharmaceutical Industrial Development, a subsidiary of Accro's partner Fosun Pharma, which holds development code FXS5626 (search).
AC-201 is an oral small-molecule TYK2 (search)/JAK1 (search) inhibitor binding the JH2 pseudo kinase domain, with minimal effect on JAK2 (search)/JAK2 signaling.
Accro Bioscience (search) (Suzhou) Limited said that Shanghai Fosun Pharmaceutical Industrial Development Company Limited (search), a subsidiary of its partner Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (search), has received approval from China's National Medical Products Administration (search) to run a Phase II/III adaptive seamless design clinical trial of AC-201 tablets for non-segmental vitiligo (search). Fosun Pharma Industrial plans to initiate the trial in mainland China once the necessary conditions are met.
AC-201, known in Fosun's pipeline as FXS5626 (search), is a novel, highly selective and potent oral small-molecule inhibitor of TYK2 (search)/JAK1 (search). It binds to the pseudo kinase domain (JH2) of TYK2/JAK1 and has minimal effect on the JAK2 (search)/JAK2 signaling pathway. The compound is in development for immune mediated inflammatory diseases.