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Cetuximab biosimilar - Shanghai Henlius Biotech

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Drug Profile

Cetuximab biosimilar - Shanghai Henlius Biotech

Alternative Names: Anti-EGFR monoclonal antibody 225 biosimilar - Shanghai Henlius Biotech; Erbitux biosimilar - Shanghai Henlius Biotech; HLX-05; HLX05-N

Latest Information Update: 19 Aug 2026

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At a glance

  • Originator Shanghai Henlius Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Angiogenesis inhibitors; Antibody-dependent cell cytotoxicity; ErbB receptor antagonists
  • 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 Colorectal cancer; Squamous cell cancer

Most Recent Events

  • 17 Aug 2026 Sandoz and Shanghai Henlius Biotech agree to co-develop HLX05-N in Colorectal cancer and Squamous cell carcinoma
  • 08 Jul 2026 Phase-I clinical trials in Colorectal cancer (Combination therapy, Metastatic disease, Late-stage disease, Inoperable/Unresectable, Recurrent, First line therapy) in China (IV) (NCT07543471)
  • 10 May 2026 US FDA approves IND application for phase I trial of Cetuximab biosimilar in Colorectal cancer (Metastatic disease)

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