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Nivolumab biosimilar - Shanghai Henlius Biotech

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Drug Profile

Nivolumab biosimilar - Shanghai Henlius Biotech

Alternative Names: HLX-18; Nivolumab biosimilar-Shanghai Henlius Biotech

Latest Information Update: 21 Jan 2026

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At a glance

  • Originator Shanghai Henlius Biotech
  • Class Antineoplastics; Antivirals; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; 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

  • Preclinical Solid tumours

Most Recent Events

  • 19 Dec 2025 US FDA approves IND application of Nivolumab biosimilar in Solid tumors
  • 19 Dec 2025 Shanghai Henlius Biotech plans a clinical trial for Solid tumors in USA
  • 02 Sep 2025 Preclinical trials in Solid tumours in China (unspecified route) prior to September 2025 (Shanghai Henlius Biotech pipeline, September 2025)

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