Zhong Guo Jing Ji Wang·2025-10-16 08:46Group 1 - 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 Ocaliva (Obeticholic Acid) for the treatment of primary biliary cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1] - The drug is a generic version of a conditionally approved overseas drug, and the original reference formulation has not received regular approval abroad, leading to concerns about the risk-benefit profile of the drug [1] - The company has invested approximately RMB 125 million in the research and development of this drug as of the announcement date [1] Group 2 - Ocaliva, developed by Intercept Pharmaceuticals, is a Farnesoid X receptor (FXR) agonist that received accelerated approval from the FDA in May 2016 for PBC patients who are intolerant to or unresponsive to Ursodeoxycholic acid (UDCA) [2] - On September 11, 2023, Intercept Pharmaceuticals voluntarily withdrew Ocaliva from the U.S. market at the request of the FDA, which also suspended all clinical trials involving the drug [2]