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TB01 is a recombinant chimeric monoclonal antibody developed by Zhuhai Tengbai Pharmaceutical as a biosimilar to cetuximab. It targets the epidermal growth factor receptor (EGFR), a transmembrane glycoprotein that is overexpressed in various solid tumors, including colorectal cancer. By binding to the extracellular domain of EGFR, TB01 competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, thereby blocking the MAPK, PI3K/Akt, and JAK/STAT signaling pathways. This inhibition leads to reduced cell proliferation, induction of apoptosis, and decreased production of angiogenic factors. Additionally, as a chimeric IgG1 antibody, it may mediate antibody-dependent cellular cytotoxicity (ADCC) against tumor cells. TB01 is currently in Phase 3 clinical development for the treatment of metastatic colorectal cancer in patients with RAS wild-type tumors.
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