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Henlius Starts Phase 1b/2 Trial of HLX43 Combinations in Advanced Colorectal Cancer

Story Highlights
  • Henlius has begun dosing patients in a phase 1b/2 trial of its PD-L1-targeting ADC HLX43 combined with HLX07 or HANSIZHUANG for advanced colorectal cancer in Chinese Mainland.
  • The multicentre study will assess safety, pharmacokinetics, biomarkers, and efficacy across several HLX43 dose levels, supporting Henlius’s strategy to expand its oncology pipeline and strengthen its position in metastatic solid tumour therapies.
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Henlius Starts Phase 1b/2 Trial of HLX43 Combinations in Advanced Colorectal Cancer

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

Shanghai Henlius Biotech, Inc. has initiated patient dosing in a phase 1b/2 clinical trial in Chinese Mainland evaluating its anti-PD-L1 antibody-drug conjugate HLX43 in combination with either HLX07, an anti-EGFR humanised monoclonal antibody, or HANSIZHUANG (serplulimab), in patients with advanced or metastatic colorectal cancer. The study is designed in two parts to assess safety, tolerability, pharmacokinetics, immunogenicity, and biomarkers, as well as to determine the efficacy of different HLX43 dosing regimens in combination therapies, underscoring Henlius’s push to expand its oncology pipeline and strengthen its position in the competitive market for advanced colorectal cancer treatments.

The phase 1b portion includes a safety run-in with dose escalation followed by dose expansion of HLX43 plus HLX07, while subsequent randomized, multicentre, open-label stages will compare multiple dose levels of HLX43 with fixed doses of HLX07 or HANSIZHUANG. By advancing HLX43 across several tumour types and geographies, including permissions for studies in the United States, Japan, and other regions, Henlius is positioning this PD-L1-targeting ADC as a potentially important component of combination regimens for metastatic solid tumours, which could enhance its clinical footprint and offer new options for colorectal cancer patients if trial outcomes are favourable.

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 biopharmaceutical company focused on developing innovative biologic therapies, including monoclonal antibodies and antibody-drug conjugates, for the treatment of cancers and other serious diseases. The company conducts extensive clinical research in Chinese Mainland and internationally, targeting solid tumours and other oncology indications across multiple stages of development.

Average Trading Volume: 818,729

Technical Sentiment Signal: Buy

Current Market Cap: HK$46.33B

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