Drugs / TRASTUZUMAB PAMIRTECAN
TRASTUZUMAB PAMIRTECAN
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | Her2-receptor negative breast cancer | 2026-04-09 | “today announced that the Biologics License Application (BLA) for the investigational antibody-drug conjugate (“ADC”) trastuzumab pamirtecan (“T-Pam”, also known as DB-1303 or...” dualitybiologics.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06827236 | Apr 2025 → Aug 2029 expected | breast carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05150691 | Jan 2022 → Apr 2026 overdue | — | DualityBio Inc. | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT06340568 | Jun 2025 → Mar 2028 expected | endometrial cancer | BioNTech SE | Recruiting | No outcome recorded |
| Phase 3 | NCT06265428 | Jan 2024 → Feb 2026 overdue | HER2 positive breast carcinoma | DualityBio Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT06018337 | Jan 2024 → Aug 2026 overdue | breast cancer | DualityBio Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-04-11 | BioNTech SE | Results BioNTech and DualityBio’s Antibody-Drug Conjugate Trastuzumab Pamirtecan Demonstrated Clinically Meaningful Efficacy in Patients with HER2-Expressing, Recurrent Endometrial Cancer biontech.com ↗
The data demonstrated clinically meaningful efficacy and a manageable safety profile for trastuzumab pamirtecan monotherapy across all HER2 immunohistochemistry (“IHC”) expression levels (IHC1+, IHC2+, IHC3+) ii . |
| 2026-04-09 | DualityBio Inc. | Regulatory DualityBio Announces China NMPA Acceptance of Biologics License Application Seeking Approval for Trastuzumab Pamirtecan for the Treatment of Unresectable or Metastatic HER2-Positive Adult Breast Cancer dualitybiologics.com ↗
the Biologics License Application (BLA) for the investigational antibody-drug conjugate (“ADC”) trastuzumab pamirtecan (“T-Pam”, also known as DB-1303 or BNT323), has been accepted for review by the China National Medical Products Administration (NMPA). |
| 2025-09-05 | BioNTech SE | Results BioNTech and DualityBio Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer biontech.com ↗
met its primary endpoint of progression free survival at a pre-specified interim analysis. |
| 2025-09-05 | DualityBio Inc. | Results DualityBio and BioNTech Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer dualitybiologics.com ↗
DualityBio and BioNTech Announce Phase 3 Trial of ADC Candidate BNT323/DB-1303 Met Primary Endpoint of Progression Free Survival in HER2-Positive Metastatic or Unresectable Breast Cancer |
| 2025-04-29 | DualityBio Inc. | Results DualityBio Presented Early Clinical and Preclinical Data for Novel ADC Therapy Candidates at AACR 2025 dualitybiologics.com ↗
The preclinical data indicate anti-tumor activity compared to each candidate alone in tumor models. |
| 2023-12-21 | BioNTech SE | Regulatory BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer biontech.com ↗
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TRASTUZUMAB PAMIRTECAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068309 ↗ |
| Known as | BNT323 | “This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated...” NCT06265428 ↗3“receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W” NCT06018337 ↗ |
| Known as | DB-1303 | “BNT323 (also known as DB-1303) or chemotherapy” NCT06340568 ↗ |
| Known as | DB-1303/BNT323 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05150691 ↗ |
| Route | Intravenous | “Administered IV” NCT05150691 ↗ |