Shang Hai Zheng Quan Bao·2026-02-02 19:14Core Viewpoint - 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 patients, with a target review date set for July 23, 2026 [1][2]. Group 1: Drug Information - Drug Name: Injection of Carrelizumab [1] - Dosage Form: Injection [1] - Applicant: Jiangsu Hengrui Medicine Co., Ltd. [1] - Indication: First-line treatment for unresectable or metastatic hepatocellular carcinoma in combination with Apatinib [1]. Group 2: Clinical Trial Information - The international multicenter Phase III clinical trial (Study No. SHR-1210-III-310) for Carrelizumab combined with Apatinib was approved in December 2018 [2]. - The trial demonstrated that Carrelizumab combined with Apatinib significantly extended progression-free survival (PFS) and overall survival (OS) compared to Sorafenib [2][3]. - The study enrolled 543 participants and showed a median PFS of 5.6 months and a median OS of 22.1 months, with the final analysis indicating an OS extension to 23.8 months [3]. Group 3: Market Context - Carrelizumab is a humanized anti-PD-1 monoclonal antibody that restores the body's anti-tumor immunity [5]. - The global sales of anti-PD-1 antibodies are projected to reach approximately $41.546 billion in 2024 [5]. - Cumulative R&D investment for Carrelizumab has reached approximately 319.74 million yuan (unaudited) [5].