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Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) just unveiled an update.
Shanghai Henlius Biotech has received U.S. Food and Drug Administration approval for an investigational new drug application to conduct a phase 1 clinical trial of HLX05-N, a cetuximab biosimilar injection, for metastatic colorectal cancer. The company plans to initiate the trial in the United States once conditions are met, following earlier approval of a similar trial by China’s National Medical Products Administration.
HLX05-N is designed to mirror the reference cetuximab product in treating colorectal cancer and head and neck squamous cell carcinoma by targeting the epidermal growth factor receptor pathway. With global sales of cetuximab biosimilars reaching about USD 1.66 billion in 2025, the FDA green light positions Henlius to tap into a sizable oncology biosimilar market, although the company cautions that successful development and commercialization are not guaranteed.
The most recent analyst rating on (HK:2696) stock is a Buy with a HK$99.78 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 medicines. The company targets major oncology indications, including colorectal and head and neck cancers, aiming to expand its presence in global markets such as the United States.
Average Trading Volume: 1,016,057
Technical Sentiment Signal: Buy
Current Market Cap: HK$39.97B
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