Core Points - The application for the generic drug developed by Fudan Zhangjiang, which cost 125 million yuan, was rejected due to safety concerns related to its reference drug, which has been withdrawn from the European and American markets [1][2] - The original drug, Ocaliva, has faced multiple safety warnings since 2017, leading to its withdrawal from the market and suspension of all related clinical trials [3][4] - The domestic market for the generic version of Ocaliva is now highly uncertain due to the original drug's safety issues and market withdrawal [4][5] Company Summary - Fudan Zhangjiang's subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., received a notice from the National Medical Products Administration stating that the application for Obechol acid tablets was not approved due to non-compliance with drug registration requirements [1][5] - The company has invested approximately 125 million yuan in the development of Obechol acid tablets, but the rejection of the application is not expected to have a significant impact on its current financial status [1][5] - Other domestic companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obechol acid generics, with several applications still pending approval [5] Industry Summary - Obechol acid, originally developed by Intercept Pharmaceuticals, was first approved in 2016 for treating primary biliary cholangitis (PBC) but has since faced serious safety concerns leading to its market withdrawal [2][3] - The prevalence of PBC in China has been increasing, reaching 21.05 per 100,000 in 2022, indicating a potential market for treatments despite the current setbacks [2] - The domestic market for Obechol acid generics is now fraught with uncertainty, as the original drug's safety risks have raised doubts about the viability of its generic counterparts [4][5]