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Fortrastuzumab is a monoclonal antibody biosimilar developed by Harvest Moon Pharmaceuticals, targeting the human epidermal growth factor receptor 2 (HER2). It is intended for the treatment of HER2-overexpressing cancers, including breast cancer and gastric cancer. The drug's mechanism of action involves binding to the extracellular domain of the HER2 protein, which inhibits ligand-independent HER2 signaling and recruits immune effector cells to mediate antibody-dependent cellular cytotoxicity (ADCC) against the tumor cells. As a biosimilar, it is designed to be highly similar to the reference product, trastuzumab, in terms of safety, purity, and potency.
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