The board of directors of Shanghai Henlius Biotech, Inc. announced that, recently, an international multi-centre phase 3 clinical study of a biosimilar of denosumab HLX14 (recombinant anti-RANKL human monoclonal antibody injection) independently developed by the Company for the treatment of osteoporosis in postmenopausal women at high risk for fracture has met the primary study endpoints. Design, purpose and conclusion of the clinical trial: This randomised, double-blind, international multicentre, parallel-controlled phase 3 clinical study aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with reference denosumab (Prolia®) in postmenopausal women subjects with osteoporosis at high risk of fracture. Eligible subjects were randomised into two groups at a ratio of 1:1 to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months.

The primary endpoints of this study were the percentage change in bone mineral density (BMD) at the lumbar spine from baseline to Week 52 (D365) assessed by central imaging, and the area under the effect-time curve for percentage change of serum collagen C-telopeptide (s-CTX) from baseline to Week 26 (D183) (AUEC0-26W). The secondary endpoints included other efficacy measures and pharmacodynamic characteristics, as well as the incidence of intercurrent events, safety, pharmacokinetic characteristics, and immunogenicity. The primary endpoints of this study were met.