Alphamab Oncology’s KN035 NDA for First-Line Biliary Tract Cancer Accepted by China’s NMPA

Alphamab Oncology ( (HK:9966) ) has provided an announcement.

Alphamab Oncology announced that China’s National Medical Products Administration has accepted its new drug application for KN035 (Envafolimab, ENWEIDA) in combination with GEMOX chemotherapy as a first-line treatment for unresectable or metastatic biliary tract cancer, based on data from a phase III trial in Chinese patients comparing the combo against GEMOX alone. KN035, a subcutaneously injected PD-L1 inhibitor invented by Alphamab and co-developed with 3D Medicines, is already approved in China for certain MSI-H/dMMR advanced solid tumors and is licensed to partners including Jiangsu Simcere for marketing in mainland China and Glenmark for development and commercialization across multiple emerging markets, underscoring the company’s strategy to expand the drug’s global oncology footprint while it seeks to broaden its label into earlier-line BTC treatment.

The most recent analyst rating on (HK:9966) stock is a Hold with a HK$11.00 price target. To see the full list of analyst forecasts on Alphamab Oncology stock, see the HK:9966 Stock Forecast page.

More about Alphamab Oncology

Alphamab Oncology is a leading China-based biopharmaceutical company focused on oncology, built around proprietary platforms in antibody-drug conjugates, bispecific antibodies and multi-functional protein engineering. Its pipeline includes ADCs, monoclonal and bispecific antibodies at various stages of development, with one product already approved by China’s National Medical Products Administration and multiple candidates in phase III or pivotal trials aimed at patients globally.

Average Trading Volume: 2,564,050

Technical Sentiment Signal: Buy

Current Market Cap: HK$9.94B

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