China’s National Medical Products Administration has accepted an application for the approval of denosumab copy biological HLX 14.- Shanghai Henlius Biotech

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of denosumab copy biological HLX 14.

China-based Shanghai Henlius Biotech (Henlius) announced that its proposed denosumab copy biological HLX14 had been accepted for review by the NMPA. The product is a copy biological of Amgen’s Prolia/Xgeva (denosumab), which is indicated for the treatment of bone resorption and postmenopausal osteoporosis.