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Henlius Wins NMPA Nod to Start Trials of Cetuximab Biosimilar HLX05-N

Story Highlights
  • Henlius gained NMPA approval to begin phase 1 trials of HLX05-N. HLX05-N is a cetuximab biosimilar for metastatic colorectal and head and neck cancers.
  • Henlius plans an international multicenter study of HLX05-N to enter the USD1.66 billion cetuximab biosimilar market, bolstering its oncology-focused biosimilar portfolio despite development uncertainties.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Henlius Wins NMPA Nod to Start Trials of Cetuximab Biosimilar HLX05-N

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

Shanghai Henlius Biotech has secured approval from China’s National Medical Products Administration for a phase 1 clinical trial application of HLX05-N, its independently developed cetuximab biosimilar, for metastatic colorectal cancer. HLX05-N is designed for colorectal cancer and head and neck squamous cell carcinoma, and comparative pharmaceutical and non-clinical studies indicate similarity to the reference cetuximab product.

The company plans to launch an international multicenter phase 1 study once conditions are met, positioning HLX05-N to tap into the sizeable global cetuximab biosimilar market, which generated about USD1.66 billion in sales in 2025. The move underscores Henlius’s strategy to deepen its oncology portfolio and compete in the expanding global biosimilar segment, though the company cautions there is no guarantee of successful development or commercialization.

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 the research, development and commercialization of biosimilar and innovative monoclonal antibody therapies. The company targets major oncology indications, including colorectal and head and neck cancers, aiming to expand its presence in global biologics markets.

Average Trading Volume: 1,168,717

Technical Sentiment Signal: Buy

Current Market Cap: HK$45.3B

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