Zhong Guo Jing Ji Wang·2025-10-16 08:59Core Insights - Fudan Zhangjiang Biopharmaceutical Co., Ltd. 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 Obeticholic Acid Tablets for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1][2] Group 1: Company Developments - The drug Obeticholic Acid, developed by Intercept Pharmaceuticals, was initially approved by the FDA in May 2016 for PBC patients who are intolerant to or do not respond to Ursodeoxycholic Acid (UDCA) [2] - Fudan Zhangjiang completed the bioequivalence study for Obeticholic Acid in July 2020 and finished the on-site inspection for the registration application in June 2025 [1] - The total R&D investment for the Obeticholic Acid project reached approximately RMB 125 million (unaudited) as of the announcement date [1] Group 2: Regulatory Challenges - The application for Obeticholic Acid was rejected because the reference drug did not receive regular approval in foreign markets, and there was insufficient evidence to support the drug's benefits outweighing risks [1] - Intercept Pharmaceuticals voluntarily withdrew Obeticholic Acid from the U.S. market in September 2023 at the request of the FDA, which also suspended all clinical trials involving the drug [2]