HL05

HL05 is a recombinant human monoclonal antibody developed by Hualan Genetic Engineering Co., Ltd. as a biosimilar to denosumab (reference products Xgeva and Prolia). It specifically targets and binds to the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), a cytokine essential for the formation, function, and survival of osteoclasts. By inhibiting the interaction between RANKL and its receptor RANK on the surface of osteoclasts and their precursors, HL05 prevents osteoclast-mediated bone resorption and destruction. The drug is primarily being developed for the treatment of bone metastases from solid tumors and giant cell tumor of bone, as well as for postmenopausal osteoporosis. HL05 is currently in late-stage clinical development, with Phase 3 trials ongoing in China.

Other names

denosumab biosimilar