3D MEDICINES (01244): New Drug Application for ENVAFOLIMAB as First-Line Treatment for Biliary Tract Cancer Accepted by NMPA

Stock News

01/09

3D MEDICINES (01244) announced that the National Medical Products Administration (NMPA) has formally accepted the company's New Drug Application (NDA) for its commercial product ENVAFOLIMAB® (generic name: Envafolimab Injection, original R&D code: KN035) in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC). This acceptance is based on the clinical study results from the Phase III clinical trial (KN035-CN-005), which was a randomized, parallel-controlled, multi-center Phase III trial designed for Chinese patients with advanced first-line biliary tract cancer, aiming to evaluate the efficacy and safety of ENVAFOLIMAB® (KN035) combined with the GEMOX regimen compared to the GEMOX regimen alone.

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