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Denosumab biosimilar - Shanghai Henlius Biotech

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Drug Profile

Denosumab biosimilar - Shanghai Henlius Biotech

Alternative Names: BILDYOS; Bildyos; BILPREVDA; Bilprevda; HLX 14

Latest Information Update: 13 Oct 2025

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At a glance

  • Originator Shanghai Henlius Biotech
  • Developer Organon; Shanghai Henlius Biotech
  • Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; RANK ligand inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Registered Bone metastases; Giant cell tumour of bone; Hypercalcaemia; Male osteoporosis; Osteoporosis; Postmenopausal osteoporosis
  • No development reported Solid tumours

Most Recent Events

  • 13 Oct 2025 Registered for Hypercalcaemia in USA (SC)
  • 13 Oct 2025 Registered for Male osteoporosis in USA (SC)
  • 19 Sep 2025 Registered for Bone metastases (Metastatic disease) in Norway (SC), Liechtenstein (SC), Iceland (SC), European Union (SC)

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