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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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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: 06 Mar 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

    • 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.
    • 12 Feb 2025 Results presented in the Shanghai Henlius Biotech Media Release.

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