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Pimurutamab - Shanghai Henlius Biotech

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Drug Profile

Pimurutamab - Shanghai Henlius Biotech

Alternative Names: Cetuximab biobetter - Henlix Biotech; HLX 07; Recombinant humanized anti-EGFR monoclonal antibody - Shanghai Henlius Biotech

Latest Information Update: 12 Jan 2026

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At a glance

  • Originator Shanghai Henlius Biotech
  • Developer Shanghai Henlius Biotech; Wuhan Union Hospital
  • Class Antineoplastics; Biobetters; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Epidermal growth factor 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 Yes

Highest Development Phases

  • Phase II Gastric cancer; Nasopharyngeal cancer; Non-small cell lung cancer; Oesophageal cancer; Rectal cancer; Squamous cell cancer
  • Phase I/II Solid tumours

Most Recent Events

  • 06 Jan 2026 Shanghai Henlius Biotech plans to initiate a phase II/III trial for Squamous non-small cell lungs cancer (Combination therapy, Late-stage disease, First-line treatment, Recurrent, Metastatic disease) in China (IV) (NCT07318883)
  • 02 Nov 2025 Efficacy and adverse events data from a phase II trial in Non-small cell lung cancer released by Shanghai Henlius Biotech
  • 30 May 2025 Efficacy and adverse events data from a phase-II clinical trials in Squamous cell cancer presented at the 61st Annual Meeting of the American Society of Clinical Oncology

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