Zheng Quan Ri Bao·2025-10-13 13:35Core Points - Fudan Zhangjiang announced that its wholly-owned subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that the application for the marketing authorization of Obecholic Acid Tablets (5mg, 10mg) for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [2] Company Summary - Taizhou Fudan Zhangjiang's application for Obecholic Acid Tablets was rejected by the regulatory authority [2] - The drug was intended for the treatment of Primary Biliary Cholangitis (PBC) [2] - The rejection indicates potential challenges in meeting regulatory standards for drug registration [2] Industry Summary - The news highlights the regulatory scrutiny faced by pharmaceutical companies in the drug approval process [2] - The incident may reflect broader trends in the industry regarding compliance with drug registration requirements [2] - The rejection could impact the company's future product pipeline and market strategy [2]