累计研发投入约1.25亿元 复旦张江奥贝胆酸片仿制药上市申请遭否

Core Viewpoint - Fudan Zhangjiang's application for the drug Ocaliva (Obeticholic Acid) has been rejected by the National Medical Products Administration due to safety concerns and lack of sufficient evidence to support its approval as a generic drug [1][4]. Group 1: Company Updates - Fudan Zhangjiang's subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., received a notification of non-approval for its drug application for Obeticholic Acid, which is intended for treating primary biliary cholangitis (PBC) [1]. - The company has invested approximately 125 million yuan in the development of Obeticholic Acid [1]. - The rejection of the drug application is not expected to have a significant impact on the company's current financial status [1]. Group 2: Industry Context - Obeticholic Acid, originally developed by Intercept Pharmaceuticals, was first approved by the FDA in May 2016 and subsequently received conditional approval in Europe [2]. - The global sales of Obeticholic Acid showed steady growth from 2016 to 2021, reaching approximately $363 million in 2021 before stabilizing around $300 million in subsequent years [2]. - Safety concerns regarding Obeticholic Acid have led to multiple warnings and restrictions, including its classification under a "black box warning" by the FDA due to reports of severe liver damage and increased risk of liver transplant and death [3]. - The European Medicines Agency recommended the withdrawal of Obeticholic Acid's marketing authorization in 2023, and Intercept Pharmaceuticals voluntarily withdrew the drug from the U.S. market in September 2023 [3]. - There are currently no approved Obeticholic Acid products in China, and the safety risks associated with the original drug have created uncertainty for domestic generic drug prospects [4]. - Other domestic companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics, with some projects being halted after significant investments [5].