思路迪医药股份(01244)：恩维达®一线胆道癌新药上市申请获国家药监局受理

智通财经

01/09

智通财经APP讯，思路迪医药股份(01244)发布公告，国家药品监督管理局(NMPA)已正式受理公司商业化产品恩维达^® (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(KN035-CN-005)的临床研究结果，这是一项针对中国晚期一线胆道癌患者设计的随机、平行对照、多中心III期临床试验，旨在评估恩维达^®(KN035)联合GEMOX方案对比单纯GEMOX方案的疗效与安全性。

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