SHANGHAI, CHINA & JERSEY CITY, N.J. -- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia and Xgeva (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.

The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia) every six months. The primary efficacy endpoint of this study was the percentage change in bone mineral density (BMD) at the lumbar spine from baseline to Week 52 (D365) assessed by central imaging. The primary pharmacodynamic endpoint was the area under the effect-time curve for percentage change of serum type I collagen C-telopeptide (s-CTX) from baseline to Week 26 (D183) (AUEC0-26W). The primary endpoints of this study were met.

Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others.