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Pertuzumab/trastuzumab biosimilar - Shanghai Henlius Biotech

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Drug Profile

Pertuzumab/trastuzumab biosimilar - Shanghai Henlius Biotech

Alternative Names: HLX-319; trastuzumab/pertuzumab - Shanghai Henlius Biotech

Latest Information Update: 29 May 2026

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At a glance

  • Originator Shanghai Henlius Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Dimerisation inhibitors; ERBB 2 receptor antagonists; Hyaluronidase replacements
  • 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 Breast cancer

Most Recent Events

  • 29 May 2026 Shanghai Henlius Biotech plans a phase I trial for HER2-positive-breast-cancer (Late-stage disease, Neoadjuvant Therapy) (SC) (NCT07601620)
  • 10 Apr 2026 Phase-I clinical trials in Breast cancer (In volunteers) in China (SC) (NCT07495930)
  • 01 Apr 2026 Shanghai Henlius Biotech plans a phase I trial in Breast cancer (In volunteers) in China (SC) (NCT07495930)

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