China’s Bio-Thera Solutions Ltd (SHA: 688177) has received clinical trial approval from the National Medical Products Administration (NMPA) for BAT1006, its recombinant humanized monoclonal antibody, in combination with trastuzumab and chemotherapy for HER2-positive unresectable or metastatic breast cancer patients previously treated with antibody-drug conjugates (ADCs).
Drug Profile
BAT1006 targets the extracellular dimerization domain (Subdomain II) of the HER2 receptor, blocking interactions with EGFR, HER3, and HER4. This inhibition disrupts downstream signaling via the MAP kinase and PI3K pathways, inducing cell growth arrest and apoptosis.
Clinical Trial Design
The trial will evaluate BAT1006’s efficacy and safety in patients who progressed after prior ADC therapy. The combination regimen aims to enhance treatment options for advanced HER2+ breast cancer.
Strategic Outlook
Bio-Thera plans to leverage the trial results to advance BAT1006’s development, addressing unmet needs in HER2+ metastatic breast cancer. The drug’s mechanism offers a novel approach to overcoming resistance to existing therapies.-Fineline Info & Tech
