君实生物(01877.HK):特瑞普利单抗一线治疗HER2表达的尿路上皮癌的新适应症上市申请获得受理

智通财经
Aug 08
【君实生物(01877.HK):特瑞普利单抗一线治疗HER2表达的尿路上皮癌的新适应症上市申请获得受理】智通财经APP讯,君实生物(01877.HK)发布公告,公司收到国家药品监督管理局核准签发的《受理通知书》,特瑞普利单抗(商品名:拓益®,产品代号:JS001)联合荣昌生物制药(烟台)股份有限公司自主研发的抗体偶联药物维迪西妥单抗用于 HER2表达的(HER2表达定义为HER2免疫组织化学检查结果为1+、2+或3+)局部晚期或转移性尿路上皮癌患者的新适应症上市申请获得受理。

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