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recombinant human interferon Alpha-1b
recombinant human interferon Alpha-1b is a Interferon alpha Small molecule drug developed by Shanghai Jiao Tong University School of Medicine. It is currently in Phase 3 development. Also known as: interferon α.
Binds to interferon receptors on cell surfaces, triggering signaling cascades that induce antiviral, antiproliferative, and immunomodulatory effects.
Recombinant human interferon Alpha-1b is being studied in clinical trials for the treatment of melanoma and 2019 Novel Coronavirus Infection. It is being used in combination with other interventions, including ex-vivo expanded allogeneic γδ T cells and pembrolizumab, in a study to evaluate its efficacy and safety.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | recombinant human interferon Alpha-1b |
|---|---|
| Also known as | interferon α |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Drug class | Interferon alpha |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Interferon alpha-1b binds to the type I interferon receptor complex (IFNAR1/IFNAR2) on cell membranes, activating the JAK-STAT signaling pathway. This leads to transcription of interferon-stimulated genes that enhance immune responses, inhibit viral replication, and regulate cell proliferation.
Approved indications
Common side effects
Key clinical trials
- Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma (EARLY_PHASE1)
- Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma (PHASE1, PHASE2)
- Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff (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:
- recombinant human interferon Alpha-1b CI brief — competitive landscape report
- recombinant human interferon Alpha-1b updates RSS · CI watch RSS
- Shanghai Jiao Tong University School of Medicine portfolio CI
Frequently asked questions about recombinant human interferon Alpha-1b
What is recombinant human interferon Alpha-1b?
How does recombinant human interferon Alpha-1b work?
Who makes recombinant human interferon Alpha-1b?
Is recombinant human interferon Alpha-1b also known as anything else?
What drug class is recombinant human interferon Alpha-1b in?
What development phase is recombinant human interferon Alpha-1b in?
Related
- Drug class: All Interferon alpha drugs
- Manufacturer: Shanghai Jiao Tong University School of Medicine — full pipeline
- Also known as: interferon α
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing