2023年4月6日，基石药业宣布，舒格利单抗联合化疗一线治疗无法手术切除的局部晚期、复发或转移性食管鳞癌的新适应症上市申请获中国国家药品监督管理局（NMPA）受理。
此次舒格利单抗新适应症上市申请获受理是基于GEMSTONE-304研究，该研究是一项随机、双盲、多中心、安慰剂对照的III期注册性临床试验，旨在评估舒格利单抗联合氟尿嘧啶及顺铂作为无法手术切除的局部晚期、复发或转移性食管鳞癌一线治疗的疗效和安全性。该试验的主要研究终点为盲态独立中心审阅委员会（BICR）评估的PFS和OS，次要研究终点包括研究者评估的PFS、BICR和研究者评估的客观缓解率（ORR）及缓解持续时间（DoR）等。
来源：基石药业
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