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JHL1188 is a biosimilar candidate of trastuzumab, a humanized monoclonal antibody targeting the Human Epidermal Growth Factor Receptor 2 (HER2). Developed by JHL Biotech, JHL1188 is intended for the treatment of HER2-positive cancers, primarily breast cancer. The drug works by binding to the extracellular domain of the HER2 protein, inhibiting its signaling pathways and inducing antibody-dependent cellular cytotoxicity (ADCC) against overexpressing tumor cells. Clinical development has included pharmacokinetic (PK) equivalence studies in healthy volunteers comparing JHL1188 to both EU- and US-sourced Herceptin (the reference product), and the program has received scientific advice from the EMA for global Phase III trials in metastatic breast cancer.
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