ALPHAMAB-B (09966): NDA for KN035 as First-line BTC Treatment Accepted by NMPA

Stock News01-09

ALPHAMAB-B (09966) announced that China's National Medical Products Administration has formally accepted the New Drug Application for KN035 (Envafolimab Injection, brand name: ENVYDA®) in combination with a Gemcitabine and Oxaliplatin regimen for the first-line treatment of unresectable or metastatic biliary tract cancer. This acceptance is based on clinical research results from the Phase III clinical trial (KN035-CN-005), which is a randomized, parallel-controlled, multi-center Phase III clinical trial designed for Chinese patients with advanced first-line BTC. The trial aims to evaluate the efficacy and safety of the KN035 combination GEMOX regimen compared to the GEMOX regimen alone.

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