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LY01011 is a recombinant fully human monoclonal antibody that targets the receptor activator of nuclear factor kappa-B ligand (RANKL). It is developed as a biosimilar to denosumab (reference product Xgeva) and is intended for the prevention of skeletal-related events in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with unresectable giant cell tumor of bone or where surgical resection would result in severe morbidity, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Clinical studies have demonstrated pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity profiles equivalent to those of denosumab. The drug was developed by Shandong Boan Biotechnology Co., Ltd., a subsidiary of Luye Pharma Group[2][3][5][7].
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