FDA再次推迟恒瑞医药PD-1组合上市批准

Core Viewpoint - Heng Rui Medicine has received a Complete Response Letter (CRL) from the FDA regarding its application for the combination of Carrelizumab and Apatinib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, indicating further responses are needed regarding production site inspections [1][2] Group 1: FDA Response and Approval Process - The FDA's CRL indicates that there are deficiencies and risks that need to be addressed, but it does not specify the exact reasons for the delay [1] - Heng Rui Medicine received its first CRL in May 2024, citing production site inspection deficiencies and travel restrictions affecting necessary biological research monitoring [1] - The company has actively responded to the FDA's new improvement requests and is in close communication with the agency [2] Group 2: Clinical Research and Market Context - The application is based on positive results from an international multicenter Phase III clinical study (CARES-310), which has already led to approval in China for the same treatment indication in 2023 [2] - The combination of Carrelizumab and Apatinib has shown the longest median overall survival (mOS) data among approved treatment options for unresectable or metastatic hepatocellular carcinoma [2]