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Hepavax-Gene
Hepavax-Gene is a Therapeutic vaccine Biologic drug developed by Chiang Mai University. It is currently in Phase 3 development for Chronic hepatitis B infection. Also known as: Berna.
Hepavax-Gene is a therapeutic hepatitis B vaccine designed to generate immune responses against hepatitis B virus through genetic engineering approaches.
Hepavax-Gene is a therapeutic hepatitis B vaccine designed to generate immune responses against hepatitis B virus through genetic engineering approaches. Used for Chronic hepatitis B infection.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | Hepavax-Gene |
|---|---|
| Also known as | Berna |
| Sponsor | Chiang Mai University |
| Drug class | Therapeutic vaccine |
| Target | Hepatitis B virus antigens |
| Modality | Biologic |
| Therapeutic area | Virology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine candidate uses recombinant DNA or gene-based technology to express hepatitis B antigens and stimulate both cellular and humoral immune responses. It is intended to provide therapeutic benefit in patients with chronic hepatitis B infection by enhancing immune control of the virus, rather than serving as a preventive vaccine for naive populations.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Injection site reactions
- Fever
- Fatigue
Key clinical trials
- Hepatitis B Vaccination in HIV-infected Adults (PHASE4)
- Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns (PHASE3)
- Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects (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:
- Hepavax-Gene CI brief — competitive landscape report
- Hepavax-Gene updates RSS · CI watch RSS
- Chiang Mai University portfolio CI
Frequently asked questions about Hepavax-Gene
What is Hepavax-Gene?
How does Hepavax-Gene work?
What is Hepavax-Gene used for?
Who makes Hepavax-Gene?
Is Hepavax-Gene also known as anything else?
What drug class is Hepavax-Gene in?
What development phase is Hepavax-Gene in?
What are the side effects of Hepavax-Gene?
What does Hepavax-Gene target?
Related
- Drug class: All Therapeutic vaccine drugs
- Target: All drugs targeting Hepatitis B virus antigens
- Manufacturer: Chiang Mai University — full pipeline
- Therapeutic area: All drugs in Virology / Infectious Disease
- Indication: Drugs for Chronic hepatitis B infection
- Also known as: Berna
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing