Accro Bioscience secures China regulatory clearance for vitiligo trial
Accro Bioscience partner Fosun Pharma received investigational new drug clearance from China NMPA to begin Phase II III clinical trials of TYK2 JAK1 inhibitor AC 201 for non segmental vitiligo
Accro Bioscience has secured regulatory clearance in China for a vitiligo clinical trial. The Shanghai Fosun Pharmaceutical Industrial Development Company Limited, a subsidiary of Shanghai Fosun Pharmaceutical Group, has received approval from China's National Medical Products Administration to conduct a Phase II/III adaptive seamless design trial of AC-201 tablets.
The trial will focus on the treatment of non-segmental vitiligo. AC-201 is a novel oral small-molecule inhibitor of TYK2/JAK1, targeting the pseudo kinase domain of the protein with minimal impact on the JAK2/JAK2 signaling pathway. The development of AC-201 is aimed at treating immune-mediated inflammatory diseases. Fosun Pharma Industrial plans to initiate the clinical trial in mainland China when the necessary conditions are met.
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