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IBI307 is a fully human monoclonal antibody developed by Innovent Biologics as a biosimilar candidate for denosumab. It targets the receptor activator of nuclear factor kappa-B ligand (RANKL), a cytokine essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By binding to RANKL and preventing its interaction with the RANK receptor, IBI307 inhibits osteoclast-mediated bone destruction, thereby increasing bone mineral density and reducing the risk of fractures. It is being developed for the treatment of postmenopausal osteoporosis and the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. The drug received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) in July 2018 and subsequently entered Phase 1 clinical trials.
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