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JS001 and JS004
JS001 and JS004 is a Biologic drug developed by Shanghai Junshi Bioscience Co., Ltd.. It is currently in Phase 1 development.
JS001 and JS004 are interventions in clinical trials for various cancer types, including Advanced Lung Cancer, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal Carcinoma, Recurrent/Refractory Malignant Lymphoma, and Pancreatic Cancer. JS001 and JS004 are recombinant humanized IgG4k monoclonal antibodies specific to BTLA for injection, administered via intravenous infusion.
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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 | JS001 and JS004 |
|---|---|
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer (PHASE1, PHASE2)
- Study of JS004 Combined With Toripalimab for Advanced Lung Cancer (PHASE1, PHASE2)
- A Phase I Clinical Study of JS004 in Subjects With Recurrent/Refractory Malignant Lymphoma of China (PHASE1)
- Newly Emerging Immunotherapy for Pancreatic Cancer Treatment (PHASE1, PHASE2)
- 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)
- The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC (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:
- JS001 and JS004 CI brief — competitive landscape report
- JS001 and JS004 updates RSS · CI watch RSS
- Shanghai Junshi Bioscience Co., Ltd. portfolio CI
Frequently asked questions about JS001 and JS004
What is JS001 and JS004?
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What development phase is JS001 and JS004 in?
Related
- Manufacturer: Shanghai Junshi Bioscience Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing