君实生物:特瑞普利单抗联合贝伐珠单抗一线治疗晚期肝细胞癌的新适应症上市申请获得批准

美港电讯
21 Mar

【君实生物:特瑞普利单抗联合贝伐珠单抗一线治疗晚期肝细胞癌的新适应症上市申请获得批准】金十数据3月21日讯,君实生物公告称,公司收到国家药品监督管理局核准签发的《药品注册证书》,特瑞普利单抗联合贝伐珠单抗用于不可切除或转移性肝细胞癌患者的一线治疗的新适应症上市申请获得批准。这是特瑞普利单抗在中国获批的第11项适应症。新适应症的获批主要基于HEPATORCH研究(NCT04723004)的数据结果,该研究是一项国际多中心、随机、开放、阳性药对照的III期临床研究。

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