Henlius Wins FDA Clearance to Start US Trial of Nivolumab Biosimilar HLX18

Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) has shared an announcement.

Shanghai Henlius Biotech has received approval from the U.S. Food and Drug Administration for its investigational new drug application to begin a phase 1 clinical trial in the United States of HLX18, a nivolumab biosimilar designed as a recombinant anti-PD-1 humanized monoclonal antibody injection for multiple solid tumors. HLX18, which mirrors the mechanism of the blockbuster immunotherapy nivolumab across a broad range of cancers, positions Henlius to enter a global market where nivolumab generated about US$11.1 billion in 2024 sales, potentially strengthening the company’s presence in the competitive immuno-oncology biosimilar space if clinical development and eventual commercialization prove successful.

The most recent analyst rating on (HK:2696) stock is a Hold with a HK$74.00 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 commercialising biosimilar and biologic therapies, particularly monoclonal antibody drugs, for oncology and other indications in global markets. The company targets high-value therapeutic areas such as immuno-oncology, leveraging independently developed antibody products to compete in large, branded biologics markets.

Average Trading Volume: 1,209,815

Technical Sentiment Signal: Buy

Current Market Cap: HK$32.96B

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