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Pertuzumab biosimilar - Shanghai Henlius Biotech

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Drug Profile

Pertuzumab biosimilar - Shanghai Henlius Biotech

Alternative Names: Anti-HER2 monoclonal antibody - Shanghai Henlius Biotech; HLX 11

Latest Information Update: 14 Jul 2025

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At a glance

  • Originator Shanghai Henlius Biotech
  • Developer Organon; Shanghai Henlius Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Dimerisation 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

  • Preregistration HER2 positive breast cancer

Most Recent Events

  • 02 Jul 2025 Preregistration for HER2-positive-breast-cancer (Adjuvant therapy, Early-stage disease) in Canada (IV) prior to July 2025
  • 02 Jul 2025 Preregistration for HER2-positive-breast-cancer (Neoadjuvant therapy, Combination therapy, Early-stage disease) in Canada (IV) prior to July 2025
  • 02 Jul 2025 Preregistration for HER2-positive-breast-cancer (Neoadjuvant therapy, Combination therapy, Late-stage disease) in Canada (IV) prior to July 2025

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