荣昌生物：维迪西妥单抗新适应症获批准

每日经济新闻04-10

每经AI快讯，4月10日，荣昌生物(688331.SH)公告称，公司近日收到国家药监局核准签发的《药品注册证书》，维迪西妥单抗联合特瑞普利单抗用于治疗HER2表达的局部晚期或转移性尿路上皮癌的新适应症上市申请获得批准。这是维迪西妥单抗在国内获批的第五项适应症。该适应症获批基于一项Ⅲ期临床试验结果，研究显示相比传统含铂化疗，该联合方案在无进展生存期和总生存期上均具有显著改善，且安全性更优。此次获批将...

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