格隆汇4月25日丨君实生物(01877.HK)公告,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(商品名:拓益)用于不可切除或转移性黑色素瘤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内地获批的第12项适应症。本次新适应症的获批主要基于MELATORCH研究(NCT03430297)的数据结果。该研究是一项多中心、随机、开放、阳性对照的III期临床研究,也是...
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