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IM19 CAR-T
IM19 CAR-T is a Biologic drug developed by Beijing Immunochina Medical Science & Technology Co., Ltd.. It is currently in Phase 1 development. Also known as: fludarabine，cyclophosphamide, IM19.
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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 | IM19 CAR-T |
|---|---|
| Also known as | fludarabine，cyclophosphamide, IM19 |
| Sponsor | Beijing Immunochina Medical Science & Technology Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE) (NA)
- IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients (EARLY_PHASE1)
- Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (EARLY_PHASE1)
- Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (PHASE1, PHASE2)
- Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma (PHASE1, PHASE2)
- Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation (NA)
- Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients (PHASE1, PHASE2)
- Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T) (PHASE1, PHASE2)
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:
- IM19 CAR-T CI brief — competitive landscape report
- IM19 CAR-T updates RSS · CI watch RSS
- Beijing Immunochina Medical Science & Technology Co., Ltd. portfolio CI
Frequently asked questions about IM19 CAR-T
What is IM19 CAR-T?
Who makes IM19 CAR-T?
Is IM19 CAR-T also known as anything else?
What development phase is IM19 CAR-T in?
Related
- Manufacturer: Beijing Immunochina Medical Science & Technology Co., Ltd. — full pipeline
- Also known as: fludarabine，cyclophosphamide, IM19
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing