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A Randomized, Double-Blind, International Multicentre, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab Injection (Prolia) in Postmenopausal Women With Osteoporosis at High Risk of Fracture

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Trial Profile

A Randomized, Double-Blind, International Multicentre, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab Injection (Prolia) in Postmenopausal Women With Osteoporosis at High Risk of Fracture

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2025

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 19 Sep 2025 According to a Shanghai Henlius Biotech media release, based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data and this comparative clinical study, the European Commission has granted marketing authorization for BILDYOS (denosumab) injection 60 mg/mL and BILPREVDA (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA (denosumab), respectively, for all indications of the reference products.
  • 18 Feb 2025 According to a Shanghai Henlius Biotech media release, based on series of head-to-head comparison studies, the marketing applications of HLX14 have been accepted by the European Medicines Agency (EMA), and Health Canada in 2024.
  • 12 Feb 2025 According to a Shanghai Henlius Biotech media release, company announced results of this study were released at the 2025 Orthopaedic Research Society (ORS) Annual Meeting.

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