Feng Huang Wang·2025-10-14 14:29Core Viewpoint - The failure of the generic drug application for Obeticholic Acid by Fudan Zhangjiang highlights the high-risk nature of the pharmaceutical industry, particularly in the context of drug approvals and market entry [2][3]. Company Summary - Fudan Zhangjiang Biopharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan Zhangjiang, received a notice of disapproval from the National Medical Products Administration for its application of Obeticholic Acid tablets, which were intended for the treatment of Primary Biliary Cholangitis (PBC) [2]. - The company had invested approximately 125 million yuan in the development of Obeticholic Acid tablets as of the announcement date [4]. - The disapproval was attributed to the lack of sufficient evidence supporting the drug's benefits over risks, particularly due to the original drug's performance in the market, which has raised concerns about severe liver damage [4][6]. - Despite the setback, the company plans to continue increasing its R&D investments and accelerate the progress of other projects to maintain revenue contributions and enhance its core competitiveness [6]. Industry Summary - The pharmaceutical industry is characterized by high risks, with many companies facing challenges in drug development and approval processes [4]. - The original drug, Obeticholic Acid, has faced scrutiny and regulatory actions, including a recommendation for withdrawal of its market authorization by the European Medicines Agency and a voluntary market withdrawal in the U.S. [3]. - Other companies, such as Zai Lab, have also encountered difficulties with FXR agonists, indicating broader challenges within this segment of the pharmaceutical market [5].