Trastuzumab pamirtecan - BioNTech
Alternative Names: BNT-323; DB-1303Latest Information Update: 17 Nov 2025
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
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 03 Nov 2025 BioNTech announces intention to submit the Biologics License Application to US FDA in 2026
- 10 Jun 2025 Phase-III clinical trials in Endometrial cancer (Recurrent, Second-line therapy or greater) in United Kingdom, South Korea, China, Canada, Australia (IV) (NCT06340568)
- 10 Jun 2025 Phase-III clinical trials in Endometrial cancer (Second-line therapy or greater, Recurrent) in Taiwan (IV) (NCT06340568)