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LY01015 is a biosimilar of nivolumab, developed by Boan Biotech, a subsidiary of Luye Pharma Group. It is a recombinant human monoclonal antibody that targets programmed cell death protein 1 (PD-1), functioning as an immune checkpoint inhibitor. By blocking the PD-1 pathway, LY01015 restores T-cell activity against tumor cells and is intended for the treatment of various cancers including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma and advanced gastric or gastroesophageal junction cancer. Clinical studies have demonstrated pharmacokinetic equivalence to Opdivo (nivolumab) with comparable safety and immunogenicity profiles[1][3][6].
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