恒瑞医药:重新提交注射用卡瑞利珠单抗的生物制品许可申请获FDA受理
Xin Lang Cai Jing·2026-02-02 08:59

Core Viewpoint - The company has resubmitted its Biologics License Application (BLA) for injection of Carrelizumab in combination with Apatinib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, which has been accepted by the FDA [1] Group 1 - The target review date set by the FDA for the injection of Carrelizumab is July 23, 2026, according to the Prescription Drug User Fee Act (PDUFA) [1]

Hengrui Pharma-恒瑞医药:重新提交注射用卡瑞利珠单抗的生物制品许可申请获FDA受理 - Reportify