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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: 21 Apr 2026

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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

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

Most Recent Events

  • 11 Apr 2026 Efficacy and adverse event data from phase I/IIa trial in Solid tumours releasec by BioNTech
  • 09 Apr 2026 Trastuzumab pamirtecan licensed to 3SBio in China Mainland, Hong Kong, and Macau
  • 09 Apr 2026 China's NMPA accepts BLA for Trastuzumab pamirtecan for HER2-positive breast cancer (Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) for review

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