康宁杰瑞制药-B(09966)：KN035一线治疗BTC的NDA已获国家药监局受理

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced that the National Medical Products Administration of China has officially accepted the new drug application for KN035 (Envafolimab injection) in combination with gemcitabine and oxaliplatin for first-line treatment of unresectable or metastatic biliary tract cancer [1] Group 1 - The acceptance of the application is based on the results of the Phase III clinical trial (KN035-CN-005) [1] - This trial is a randomized, parallel-controlled, multi-center Phase III clinical study designed for advanced first-line BTC patients in China [1] - The study aims to evaluate the efficacy and safety of KN035 in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]