Henlius Wins NMPA Nod for Phase 1 Trial of Nivolumab Biosimilar HLX18

An announcement from Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) is now available.

Shanghai Henlius Biotech has received approval from China’s National Medical Products Administration for the investigational new drug application of HLX18, its independently developed nivolumab biosimilar, to begin a phase 1 clinical trial in multiple solid tumors. HLX18 targets the PD-1 pathway to restore antitumor immune responses and is being positioned to mirror the broad range of indications of the reference nivolumab, including melanoma, non-small cell lung cancer, and several other malignancies.

The company’s progress with HLX18 underscores its push into the competitive global immuno-oncology biosimilars market, where nivolumab generated about USD 11.8 billion in worldwide sales in 2025. While the approval marks a meaningful milestone in Henlius’s pipeline development in both China and the U.S., the company cautions that successful development and commercialization of HLX18 remain uncertain, and investors should be mindful of the clinical and regulatory risks ahead.

The most recent analyst rating on (HK:2696) stock is a Hold with a HK$64.00 price target. To see the full list of analyst forecasts on Shanghai Henlius Biotech, Inc. Class H stock, see the HK:2696 Stock Forecast page.

More about Shanghai Henlius Biotech, Inc. Class H

Shanghai Henlius Biotech, Inc. is a China-based biopharmaceutical company focused on developing and commercializing biosimilar and biologic therapies. The company concentrates on innovative antibody drugs for oncology and other serious diseases, targeting both the domestic Chinese market and international markets through independently developed products.

Average Trading Volume: 962,682

Technical Sentiment Signal: Strong Buy

Current Market Cap: HK$23.64B

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