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High-Dose IFN-a2b
High-Dose IFN-a2b is a Interferon Small molecule drug developed by Peking University Cancer Hospital & Institute. It is currently in Phase 3 development for Melanoma (adjuvant or metastatic disease), Other solid tumors under investigation. Also known as: Intron.
High-dose interferon-alpha-2b activates the innate and adaptive immune system to enhance anti-tumor immunity and inhibit tumor cell proliferation.
High-dose interferon-alpha-2b activates the innate and adaptive immune system to enhance anti-tumor immunity and inhibit tumor cell proliferation. Used for Melanoma (adjuvant or metastatic disease), Other solid tumors under investigation.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | High-Dose IFN-a2b |
|---|---|
| Also known as | Intron |
| Sponsor | Peking University Cancer Hospital & Institute |
| Drug class | Interferon |
| Target | Interferon-alpha receptor (IFNAR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
IFN-α2b is a cytokine that binds to interferon-alpha receptors on immune cells and tumor cells, triggering JAK-STAT signaling pathways. This leads to upregulation of MHC molecules, enhanced natural killer cell and T-cell activation, increased production of pro-inflammatory cytokines, and direct anti-proliferative effects on malignant cells. High-dose regimens are designed to maximize systemic immune activation for cancer treatment.
Approved indications
- Melanoma (adjuvant or metastatic disease)
- Other solid tumors under investigation
Common side effects
- Flu-like symptoms (fever, chills, fatigue)
- Hepatotoxicity
- Myelosuppression
- Depression/neuropsychiatric effects
- Autoimmune phenomena
Key clinical trials
- Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery (PHASE3)
- Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma (PHASE3)
- The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery (PHASE3)
- The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by Surgery (PHASE2)
- HDI Versus Chemotherapy as Systemic Adjuvant Therapy for Resected Mucosal Melanoma (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:
- High-Dose IFN-a2b CI brief — competitive landscape report
- High-Dose IFN-a2b updates RSS · CI watch RSS
- Peking University Cancer Hospital & Institute portfolio CI
Frequently asked questions about High-Dose IFN-a2b
What is High-Dose IFN-a2b?
How does High-Dose IFN-a2b work?
What is High-Dose IFN-a2b used for?
Who makes High-Dose IFN-a2b?
Is High-Dose IFN-a2b also known as anything else?
What drug class is High-Dose IFN-a2b in?
What development phase is High-Dose IFN-a2b in?
What are the side effects of High-Dose IFN-a2b?
What does High-Dose IFN-a2b target?
Related
- Drug class: All Interferon drugs
- Target: All drugs targeting Interferon-alpha receptor (IFNAR)
- Manufacturer: Peking University Cancer Hospital & Institute — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Melanoma (adjuvant or metastatic disease)
- Indication: Drugs for Other solid tumors under investigation
- Also known as: Intron
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing