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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; POHERDY

Latest Information Update: 19 Mar 2026

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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

  • Marketed HER2 positive breast cancer

Most Recent Events

  • 27 Feb 2026 CHMP of EMA issues positive opinion for HER2-positive-breast-cancer (Combination therapy, Late-stage disease, Neoadjuvant therapy) and HER2-positive-breast-cancer (Combination therapy, Early-stage disease, Neoadjuvant therapy) in the European Union
  • 30 Jan 2026 Launched for HER2-positive-breast-cancer (Adjuvant therapy, Early-stage disease, Combination therapy) in USA (IV), prior to January 2026 (Shanghai Henlius Biotech pipeline, January 2026)
  • 30 Jan 2026 Launched for HER2-positive-breast-cancer (Combination therapy, First-line therapy, Metastatic disease) in USA (IV), prior to January 2026 (Shanghai Henlius Biotech pipeline, January 2026)

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