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EMB-01
EMB-01 is a Small molecule drug developed by Shanghai EpimAb Biotherapeutics Co., Ltd.. It is currently in Phase 2 development for Non-small cell lung cancer, PD-L1 positive. Also known as: FIT-013a, metyrapone, oxazepam.
EMB-01 is an investigational monoclonal antibody targeting PD-1.
EMB-01 is an investigational monoclonal antibody targeting PD-1. Used for Non-small cell lung cancer, PD-L1 positive.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | EMB-01 |
|---|---|
| Also known as | FIT-013a, metyrapone, oxazepam |
| Sponsor | Shanghai EpimAb Biotherapeutics Co., Ltd. |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
It works by binding to PD-1 on T cells, preventing its interaction with PD-L1 on tumor cells and thereby enhancing anti-tumor immune response.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pyrexia
Key clinical trials
- Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients (PHASE2)
- EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (PHASE1, PHASE2)
- EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer (PHASE1, PHASE2)
- A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors (PHASE1, PHASE2)
- Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment (PHASE2, 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:
- EMB-01 CI brief — competitive landscape report
- EMB-01 updates RSS · CI watch RSS
- Shanghai EpimAb Biotherapeutics Co., Ltd. portfolio CI
Frequently asked questions about EMB-01
What is EMB-01?
How does EMB-01 work?
What is EMB-01 used for?
Who makes EMB-01?
Is EMB-01 also known as anything else?
What development phase is EMB-01 in?
What are the side effects of EMB-01?
What does EMB-01 target?
Related
- Target: All drugs targeting PD-1
- Manufacturer: Shanghai EpimAb Biotherapeutics Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Also known as: FIT-013a, metyrapone, oxazepam
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing