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PreS HBsAg
PreS HBsAg is a Biologic drug developed by Vaxine Pty Ltd. It is currently in Phase 1 development. Also known as: preS hepatitis B surface antigen.
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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 | PreS HBsAg |
|---|---|
| Also known as | preS hepatitis B surface antigen |
| Sponsor | Vaxine Pty Ltd |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection (PHASE1, PHASE2)
- Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC (PHASE1)
- Vulvovaginal Atrophy Correction Using Neodymium Laser (NA)
- Clinical Trial of "Magic Gyno" Laser Device (NA)
- Safety and Efficacy Study of Adjuvanted Prophylactic Hepatitis B Vaccine (PHASE1)
- HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy
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:
- PreS HBsAg CI brief — competitive landscape report
- PreS HBsAg updates RSS · CI watch RSS
- Vaxine Pty Ltd portfolio CI
Frequently asked questions about PreS HBsAg
What is PreS HBsAg?
Who makes PreS HBsAg?
Is PreS HBsAg also known as anything else?
What development phase is PreS HBsAg in?
Related
- Manufacturer: Vaxine Pty Ltd — full pipeline
- Also known as: preS hepatitis B surface antigen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing