Henlius doses first patient in phase 2/3 trial of anti-HER2 mAb HLX22 in combination with anti-HER2 ADC HLX87 for first-line treatment of HER2-positive breast cancer

CAR-T Digest - August 2020

Weekly Digest - March 2026

28 February 2026: Henlius doses first patient in phase 2/3 trial of anti-HER2 mAb HLX22 in combination with anti-HER2 ADC HLX87 for first-line treatment of HER2-positive breast cancer

Shanghai Henlius Biotech announced that the first patient has been dosed in China in the Phase 2/3 clinical trial (HLX87-BC001) evaluating its novel anti-HER2 monoclonal antibody HLX22 in combination with the HER2 antibody-drug conjugate HLX87 for the first-line treatment of HER2-positive breast cancer, marking a key milestone in the company’s clinical development program
The trial launch comes amid an ongoing clinical need in HER2-positive metastatic breast cancer, where despite major advances from HER2-targeted therapies over the past two decades, many patients eventually develop resistance and experience disease progression, highlighting the need for safer and more effective treatment strategies beyond current chemotherapy-based regimens
HLX22 has been designed to address this gap through a novel mechanism, binding to a distinct epitope on the HER2 receptor different from trastuzumab, enabling dual-antibody engagement that enhances HER2 internalization and degradation, while preclinical studies suggest that combining HER2 antibodies with HER2-targeting ADCs may produce stronger antitumor activity with manageable toxicity
Building on this rationale, the HLX87-BC001 study will evaluate the HLX22-HLX87 combination in a two-stage Phase 2/3 trial, initially comparing multiple HER2-targeted regimens in a randomized Phase 2 stage to assess objective response rate and progression-free survival, followed by a Phase 3 stage comparing the combination against the current standard regimen of pertuzumab, trastuzumab, and docetaxel
The trial also reflects Henlius’ broader strategy to build an integrated breast cancer treatment ecosystem, with a growing pipeline of HER2-targeted and innovative therapies, including trastuzumab biosimilar HANQUYOU, pertuzumab biosimilar POHERDY®, CDK4/6 inhibitor FUTUONING, and multiple novel assets such as HLX22, HLX87, and other ADCs, aimed at expanding treatment options across the full continuum of breast cancer care