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A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2026

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At a glance

  • Drugs Cyclophosphamide (Primary) ; Docetaxel (Primary) ; Doxorubicin (Primary) ; Pertuzumab (Primary) ; Trastuzumab (Primary)
  • Indications Advanced breast cancer; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 29 May 2026 According to a Shanghai Henlius Biotech media release, the New Drug Application (NDA) for its independently developed pertuzumab biosimilar HANBEIYOU (trade name in US and Europe: POHERDY) has been approved by the National Medical Products Administration (NMPA).
  • 28 Apr 2026 According to a Shanghai Henlius Biotech media release, European Commission (EC) has granted marketing authorization for POHERDY (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.
  • 10 Dec 2025 According to a Shanghai Henlius Biotech media release, data from this study presented at the ESMO Asia 2025

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