复旦张江奥贝胆酸片用于治疗原发性胆汁性胆管炎药品上市申请未获批准

Core Viewpoint - Fudan Zhangjiang (688505) announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that the application for the drug Obecholic Acid Tablets (5mg, 10mg) for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1] Group 1 - The drug Obecholic Acid is a generic version of a conditionally approved drug overseas that has not been conventionally approved in China [1] - The original drug has not demonstrated clear benefits post-approval, and there are significant risks that prevent supporting the benefits of Obecholic Acid for the approved indications [1] - The existing data was deemed insufficient to meet the technical requirements for conventional approval as a Class 3 generic drug [1]