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GB221 is a biosimilar monoclonal antibody referencing Herceptin (trastuzumab), targeting the human epidermal growth factor receptor 2 (HER2). It is primarily developed for the treatment of HER2-positive malignancies, including breast cancer and gastric cancer. The drug functions by binding to the extracellular domain of the HER2 receptor, thereby inhibiting ligand-independent HER2 signaling and mediating antibody-dependent cellular cytotoxicity (ADCC) against tumor cells. Originally developed by Genor Biopharma (which was later acquired by Walvax Biotech), GB221 has been the subject of clinical trials conducted by Jacobio Pharmaceuticals and has been licensed to Biocnd for international development. Clinical studies have demonstrated that GB221 possesses pharmacokinetic and immunogenicity profiles similar to the reference product. Note: The code name GB221 is also used by Gemma Biotherapeutics for an unrelated AAV-based gene therapy for spinal muscular atrophy (SMA).
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