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Daratumumab biosimilar - Henlix Biotech

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Drug Profile

Daratumumab biosimilar - Henlix Biotech

Alternative Names: HLX-15; Recombinant anti-CD38 fully humanised monoclonal antibody injection

Latest Information Update: 01 Apr 2025

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At a glance

  • Originator Henlix Biotech
  • Developer Henlix Biotech; Shanghai Henlius Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Apoptosis stimulants; Phagocyte stimulants; T lymphocyte stimulants
  • 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

  • Phase I Multiple myeloma

Most Recent Events

  • 01 Apr 2025 Shanghai Henlius Biotech plans a phase III trial for Multiple myeloma (Newly diagnosed) in China in April 2025 (IV) (NCT06895512)
  • 06 Feb 2025 Daratumumab biosimilar licensed to Dr. Reddy's Laboratories in USA, Europe
  • 06 Feb 2025 Clinical trials in Multiple myeloma (IV) before February 2025

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