2025年1月9日,北京,思路迪医药股份有限公司(股票代码:1244.HK)宣布,国家药品监督管理局(NMPA)已正式受理其商业化产品恩维达®(通用名:恩沃利单抗注射液,原研代号:KN035)联合吉西他滨和奥沙利铂(GEMOX)方案,用于一线治疗不可切除或转移性胆道癌(BTC)的新药上市申请(NDA)。此次受理基于Ⅲ期临床试验的临床研究结果。若此次NDA成功获批,将成为恩维达®的另一个适应症,有望...
Source Link2025年1月9日,北京,思路迪医药股份有限公司(股票代码:1244.HK)宣布,国家药品监督管理局(NMPA)已正式受理其商业化产品恩维达®(通用名:恩沃利单抗注射液,原研代号:KN035)联合吉西他滨和奥沙利铂(GEMOX)方案,用于一线治疗不可切除或转移性胆道癌(BTC)的新药上市申请(NDA)。此次受理基于Ⅲ期临床试验的临床研究结果。若此次NDA成功获批,将成为恩维达®的另一个适应症,有望...
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