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Henlius wins Australian nod for global phase 2/3 trial of HLX07 combo in advanced lung cancer

Story Highlights
  • Henlius secured Australian approval for a phase 2/3 trial of HLX07 plus HANSIZHUANG and chemotherapy as first-line therapy for advanced squamous non-small cell lung cancer.
  • The trial extends development of HLX07 and leverages widely approved PD-1 drug HANSIZHUANG, strengthening Henlius’s global oncology position despite ongoing development risk.
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Henlius wins Australian nod for global phase 2/3 trial of HLX07 combo in advanced lung cancer

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

Shanghai Henlius Biotech has received approval in Australia to begin a phase 2/3 clinical trial of its innovative anti-EGFR antibody pimurutamab HLX07 combined with HANSIZHUANG and chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer, versus placebo plus HANSIZHUANG or pembrolizumab and chemotherapy. The move expands clinical development of HLX07 beyond China, leverages HANSIZHUANG’s growing oncology franchise, and positions Henlius at the forefront of a novel combination approach for sqNSCLC at a time when no similar therapy has yet been approved globally, though the company cautions there is no guarantee of successful development or commercialisation.

HLX07 has already shown a favourable safety and tolerability profile in an earlier phase 1b/2 solid tumour study, and is being tested in multiple phase 2 trials in mainland China, including as monotherapy for cutaneous squamous cell carcinoma and in combination with HANSIZHUANG for sqNSCLC and other solid tumours. HANSIZHUANG, already marketed for several lung and esophageal cancer indications in China and approved in regions including the EU, UK and parts of Asia, continues to anchor Henlius’s global strategy as the company pushes forward with additional clinical programs and regulatory filings across major oncology indications.

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 innovative biologic drugs, particularly monoclonal antibodies for oncology. Its core products include HANSIZHUANG, an anti-PD-1 therapy approved in China and multiple overseas markets for various lung and gastrointestinal cancers, with a growing portfolio of global clinical programs and indications.

Average Trading Volume: 1,201,679

Technical Sentiment Signal: Buy

Current Market Cap: HK$43.07B

See more data about 2696 stock on TipRanks’ Stock Analysis page.

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