Last reviewed · How we verify
BNT323/DB-1303
BNT323/DB-1303 is a Bispecific antibody Small molecule drug developed by BioNTech SE. It is currently in Phase 3 development for Solid tumors (specific indication under clinical evaluation in Phase 3). Also known as: trastuzumab pamirtecan.
BNT323/DB-1303 is a bispecific antibody that simultaneously engages tumor-associated antigens and immune effector cells to redirect immune responses against cancer cells.
BNT323/DB-1303 is a bispecific antibody that simultaneously engages tumor-associated antigens and immune effector cells to redirect immune responses against cancer cells. Used for Solid tumors (specific indication under clinical evaluation in Phase 3).
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BNT323/DB-1303 |
|---|---|
| Also known as | trastuzumab pamirtecan |
| Sponsor | BioNTech SE |
| Drug class | Bispecific antibody |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This bispecific antibody platform is designed to bridge tumor cells and immune cells, enhancing T-cell activation and cytotoxic killing. By targeting both a tumor-associated antigen and an immune checkpoint or activating receptor, the drug aims to overcome immune evasion and drive anti-tumor immunity. The exact targets and mechanism are proprietary to BioNTech's development program.
Approved indications
- Solid tumors (specific indication under clinical evaluation in Phase 3)
Common side effects
Key clinical trials
- A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (PHASE3)
- A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (PHASE3)
- A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors (PHASE1, PHASE2)
- A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BNT323/DB-1303 CI brief — competitive landscape report
- BNT323/DB-1303 updates RSS · CI watch RSS
- BioNTech SE portfolio CI
Frequently asked questions about BNT323/DB-1303
What is BNT323/DB-1303?
How does BNT323/DB-1303 work?
What is BNT323/DB-1303 used for?
Who makes BNT323/DB-1303?
Is BNT323/DB-1303 also known as anything else?
What drug class is BNT323/DB-1303 in?
What development phase is BNT323/DB-1303 in?
Related
- Drug class: All Bispecific antibody drugs
- Manufacturer: BioNTech SE — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Solid tumors (specific indication under clinical evaluation in Phase 3)
- Also known as: trastuzumab pamirtecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing