思路迪醫藥股份(01244)：恩維達®一線膽道癌新藥上市申請獲國家藥監局受理

智通財經

01/09

智通財經APP訊，思路迪醫藥股份(01244)發布公告，國家藥品監督管理局(NMPA)已正式受理公司商業化產品恩維達^® (通用名：恩沃利單抗注射液，原研代號：KN035)聯合吉西他濱和奧沙利鉑(GEMOX)方案，用於一線治療不可切除或轉移性膽道癌 (BTC)的新藥上市申請(NDA)。此次受理基於III期臨床試驗(KN035-CN-005)的臨床研究結果，這是一項針對中國晚期一線膽道癌患者設計的隨機、平行對照、多中心III期臨床試驗，旨在評估恩維達^®(KN035)聯合GEMOX方案對比單純GEMOX方案的療效與安全性。

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