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Anbenitamab plus docetaxel (specifically evaluated as the albumin-bound formulation HB1801) is an investigational combination regimen being developed for the treatment of HER2-positive breast cancer and other HER2-expressing solid tumors. Anbenitamab (KN026) is a recombinant humanized bispecific monoclonal antibody that simultaneously targets two non-overlapping extracellular domains of the HER2 receptor (domains II and IV), which are the respective binding sites of pertuzumab and trastuzumab. This dual-epitope targeting leads to a more complete blockade of HER2 signaling, enhanced receptor internalization and downregulation, and potent antibody-dependent cellular cytotoxicity (ADCC). Docetaxel is a taxane-based cytotoxic chemotherapy agent that binds to beta-tubulin, promoting microtubule assembly and inhibiting disassembly, which arrests the cell cycle in the G2/M phase and induces apoptosis. The albumin-bound nanoparticle formulation of docetaxel (HB1801) is solvent-free, avoiding the hypersensitivity reactions associated with conventional docetaxel vehicles (polysorbate 80 and ethanol) and eliminating the need for steroid premedication. Developed co-operatively by Alphamab Oncology and CSPC Pharmaceutical Group, the combination has demonstrated significant clinical efficacy in Phase III trials, including the HEALER trial for first-line advanced breast cancer and the Neo-Healer trial for neoadjuvant treatment of early or locally advanced breast cancer.
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