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CART-meso cells
CART-meso cells is a Biologic drug developed by Shenzhen BinDeBio Ltd.. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | CART-meso cells |
|---|---|
| Sponsor | Shenzhen BinDeBio Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- CART-meso in Mesothelin Expressing Cancers (PHASE1)
- The Fourth Generation CART-cell Therapy for Refractory-Relapsed Ovarian Cancer (EARLY_PHASE1)
- Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer (NA)
- Pilot Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer (PHASE1)
- Autologous Redirected RNA Meso-CIR T Cells (PHASE1)
- A Study of Mesothelin Redirected Autologous T Cells for Advanced Pancreatic Carcinoma (PHASE1)
- Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso (PHASE1)
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:
- CART-meso cells CI brief — competitive landscape report
- CART-meso cells updates RSS · CI watch RSS
- Shenzhen BinDeBio Ltd. portfolio CI
Frequently asked questions about CART-meso cells
What is CART-meso cells?
Who makes CART-meso cells?
What development phase is CART-meso cells in?
Related
- Manufacturer: Shenzhen BinDeBio Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing