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Trastuzumab pamirtecan - BioNTech

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Drug Profile

Trastuzumab pamirtecan - BioNTech

Alternative Names: BNT-323; DB-1303

Latest Information Update: 02 Aug 2025

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At a glance

  • Originator Duality Biologics
  • Developer BioNTech; Duality Biologics
  • Class Alkaloids; Antibodies; Antineoplastics; Camptothecins; Drug conjugates; Immunoconjugates
  • Mechanism of Action DNA topoisomerase I 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 Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Breast cancer; Endometrial cancer; HER2 positive breast cancer
  • Phase I/II Solid tumours

Most Recent Events

  • 10 Jun 2025 Phase-III clinical trials in Endometrial cancer (Second-line therapy or greater, Recurrent) in Taiwan (IV) (NCT06340568)
  • 23 Apr 2025 Phase-I/II clinical trials in Breast cancer (Late-stage disease, Metastatic disease, Combination therapy) in Moldova, USA (IV) (NCT06827236)
  • 23 Apr 2025 Phase-I/II clinical trials in Breast cancer (Late-stage disease, Metastatic disease, Monotherapy) in Moldova, USA (IV) (NCT06827236)

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