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Anruize (安瑞泽) is a trastuzumab biosimilar developed by Betta Pharmaceuticals. It is a recombinant humanized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2), a tyrosine kinase receptor overexpressed in approximately 20-30% of breast cancers and some gastric cancers. Anruize binds to the extracellular domain IV of the HER2 receptor, inhibiting ligand-independent HER2-mediated signaling and preventing the proteolytic cleavage of the extracellular domain, which would otherwise result in a constitutively active kinase. Additionally, it induces antibody-dependent cellular cytotoxicity (ADCC) against HER2-overexpressing tumor cells. Anruize is approved in China for the treatment of HER2-positive metastatic breast cancer, early breast cancer, and metastatic gastric cancer, offering a biosimilar alternative to the reference product, Herceptin.
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