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Denosumab biosimilar - Luye Pharma

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Drug Profile

Denosumab biosimilar - Luye Pharma

Alternative Names: Anti-RANKL monoclonal antibody; BA-1102; BA-6101; Boluojia; Boyoubei; LY-01011; LY-06006

Latest Information Update: 29 Jun 2026

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At a glance

  • Originator Shandong Boan Biotechnology
  • Developer Luye Pharma Group; Parexel International; Shandong Boan Biotechnology
  • 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

Highest Development Phases

  • Marketed Giant cell tumour of bone; Osteoporosis
  • Preregistration Bone metastases; Malignant hypercalcaemia; Multiple myeloma; Postmenopausal osteoporosis
  • No development reported Unspecified

Most Recent Events

  • 29 Jun 2026 Preregistration for Multiple myeloma in USA (SC) (Shandong Boan Biotechnology pipeline, June 2026)
  • 19 Jun 2026 US FDA accepts BLA for denosumab for Osteoporosis, Postmenopausal osteoporosis, Malignant hypercalcemia, Giant cell tumour of bone, Bone metastases, Multiple myeloma for review (Shandong Boan Biotechnology pipeline, June 2026)
  • 29 May 2026 Preregistration for Bone metastases in USA (SC) (Shandong Boan Biotechnology pipeline, June 2026)

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