Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-02-02 23:05Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. has received a confirmation letter from the FDA regarding the acceptance of its Biologics License Application (BLA) for injection of Carrelizumab combined with Apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma [1] - The target review date set by the FDA for the BLA is July 23, 2026, under the Prescription Drug User Fee Act (PDUFA) [1] - The drug Carrelizumab is a humanized anti-PD-1 monoclonal antibody that restores the body's anti-tumor immunity by blocking the PD-1/PD-L1 pathway [5] Group 2 - The clinical trial for Carrelizumab combined with Apatinib was approved in December 2018 and achieved orphan drug designation from the FDA in April 2021 [2] - The Phase III clinical trial (SHR-1210-III-310) demonstrated significant survival benefits, with a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 22.1 months, which was later updated to 23.8 months [3] - The study involved 543 participants and compared the efficacy and safety of Carrelizumab combined with Apatinib against Sorafenib, marking it as the first successful Phase III trial of immunotherapy combined with a small molecule tyrosine kinase inhibitor for advanced hepatocellular carcinoma [3] Group 3 - The total research and development investment for Carrelizumab has reached approximately 319.74 million yuan (unaudited) [5] - The global sales of anti-PD-1 antibodies are projected to be around 41.546 billion USD in 2024 [5] - The company plans to continue advancing the project and will fulfill its information disclosure obligations regarding subsequent developments [1]