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KSHB011 is a biosimilar monoclonal antibody candidate developed by Kashiv BioSciences, referencing the biologic drug denosumab (marketed under brand names such as Prolia and Xgeva). It is designed to bind with high affinity and specificity to the Receptor Activator of Nuclear Factor kappa-B Ligand (RANKL). By neutralizing RANKL, KSHB011 prevents the activation of its receptor, RANK, which is located on the surface of osteoclasts and their precursors. This inhibition leads to a decrease in osteoclast formation, function, and survival, effectively reducing bone resorption and increasing bone mineral density. KSHB011 is currently in clinical development, with Phase 1 trials focused on demonstrating pharmacokinetic and pharmacodynamic bioequivalence to the reference product in healthy subjects.
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