11:43 AM EDT, 04/08/2024 (MT Newswires) -- Shanghai Henlius Biotech and Organon (OGN) said Monday that the phase 3 study for the investigational Prolia and Xgeva (denosumab) biosimilar HLX14 met the primary endpoints.

The study aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia(r)) in postmenopausal women with osteoporosis at high risk for fracture.

The primary endpoint of the study measured the percentage change in bone mineral density at the lumbar spine from baseline to week 52 assessed by central imaging.

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