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CMAB807 is a biosimilar of denosumab, developed as a recombinant human monoclonal antibody targeting RANKL (receptor activator of nuclear factor kappa-B ligand). It binds with high affinity and specificity to human RANKL, preventing its interaction with the RANK receptor on osteoclasts and their precursors. This inhibition suppresses osteoclast formation, function, and survival—reducing bone resorption and increasing bone mass in both cortical and trabecular bone. The drug is primarily being developed for the treatment of osteoporosis, particularly postmenopausal osteoporosis. Clinical studies have demonstrated pharmacokinetic bioequivalence to reference denosumab (Prolia), with similar safety and immunogenicity profiles[1][5][6][7].
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