China NMPA Accepts Alphamab Oncology NDA for KN035 in First-Line Biliary Tract Cancer

Reuters01-09

China NMPA Accepts Alphamab Oncology NDA for KN035 in First-Line Biliary Tract Cancer

Alphamab Oncology announced that the National Medical Products Administration (NMPA) of China has formally accepted the new drug application (NDA) for KN035 (Envafolimab Injectable, brand name: ENWEIDA) in combination with the GEMOX regimen for the first-line treatment of unresectable or metastatic biliary tract cancer $(BTC)$. The acceptance is based on results from a Phase III clinical trial (KN035-CN-005) evaluating the efficacy and safety of this combination in Chinese patients with advanced BTC. The company cautioned that there is no guarantee of successful approval for this new indication.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alphamab Oncology published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260109-11986924), on January 09, 2026, and is solely responsible for the information contained therein.

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