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TAB004
TAB004 is a Small molecule drug developed by TopAlliance Biosciences. It is currently in Phase 1 development. Also known as: JS004.
TAB004 is a recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection, administered via intravenous infusion. It is being studied as a treatment for various types of cancer, including advanced unresectable solid tumors, metastatic solid tumors, and limited-stage small cell lung cancer.
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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 | TAB004 |
|---|---|
| Also known as | JS004 |
| Sponsor | TopAlliance Biosciences |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety, Tolerability and Pharmacokinetics of a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA) for Injection in Subjects With Advanced Malignancies (PHASE1)
- Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) (PHASE3)
- A Phase I Clinical Study of JS004 in Subjects With Recurrent/Refractory Malignant Lymphoma of China (PHASE1)
- Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies (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:
- TAB004 CI brief — competitive landscape report
- TAB004 updates RSS · CI watch RSS
- TopAlliance Biosciences portfolio CI
Frequently asked questions about TAB004
What is TAB004?
Who makes TAB004?
Is TAB004 also known as anything else?
What development phase is TAB004 in?
Related
- Manufacturer: TopAlliance Biosciences — full pipeline
- Also known as: JS004
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing