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HS629 is a recombinant human anti-RANKL monoclonal antibody developed by Zhejiang Hisun Pharmaceutical as a biosimilar to Xgeva (denosumab). It is specifically formulated for oncology indications, including the prevention of skeletal-related events in patients with bone metastases from solid tumors and the treatment of giant cell tumor of bone. HS629 works by binding with high affinity to the receptor activator of nuclear factor kappa-B ligand (RANKL), thereby blocking its interaction with the RANK receptor on the surface of osteoclasts. This inhibition prevents osteoclast formation, function, and survival, leading to a reduction in bone resorption and the preservation of bone integrity in the presence of metastatic disease. The drug was approved by the China National Medical Products Administration (NMPA) in May 2023.
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