Core Viewpoint - The National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for Envidat® (generic name: Envafolimab injection) from Sidodi Pharmaceutical Co., Ltd. for use 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 study targeting advanced first-line biliary tract cancer patients in China [1] - The trial aims to evaluate the efficacy and safety of Envidat® (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for the commercial product Envita® (generic name: Envolimab injection) from the company, which is intended for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) in combination with the GEMOX regimen [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 is a randomized, parallel-controlled, multi-center study designed for advanced first-line biliary tract cancer patients in China [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].

此次获批基于本公司开展的恩维达®晚期胃/食管胃结合部腺癌的II期临床研究展现出明确的抗肿瘤疗 效，其联合FOLFOX方案的客观缓解率达60%，疾病控制率高达100%，且安全性与耐受性良好，无导 致治疗终止或死亡的不良事件发生。 智通财经APP讯，思路迪医药股份(01244)发布公告，旗下商业化产品恩维达® (通用名：恩沃利单抗注 射液，原研代号：KN035)针对胃癌和胃食管结合部癌适应症正式获得孤儿药资格认定，这是恩维达® 继胆管癌和软组织肉瘤适应症后成功获批的第叁个孤儿药适应症。 ...