Core Viewpoint - The company, Sihuan Pharmaceutical Holdings Group Ltd. (01244), has announced that the National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for its commercial product Envita® (generic name: Envolimab injection, original research code: KN035) in combination with Gemcitabine and Oxaliplatin (GEMOX) for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) [1] Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005) [1] - The clinical trial was designed as a randomized, parallel-controlled, multi-center Phase III study targeting Chinese patients with advanced first-line biliary tract cancer [1] - The trial aims to evaluate the efficacy and safety of Envita® (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]
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