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Hep B + Pentabio (registered)
Hep B + Pentabio (registered) is a Combination vaccine Biologic drug developed by PT Bio Farma. It is currently in Phase 3 development for Hepatitis B prevention, Diphtheria prevention, Tetanus prevention. Also known as: Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma).
Hep B + Pentabio is a combination vaccine that provides immunization against hepatitis B and five other infectious diseases (diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b) by stimulating adaptive immune responses.
The Pentabio vaccine, when primed with recombinant Hepatitis B, was compared in a clinical trial (NCT04071379) to the DTP-HB-Hib vaccine from Bio Farma for immunogenicity and safety. The trial, conducted by PT Bio Farma, studied the reactions to the diphtheria, tetanus, and pertussis vaccines in addition to the Hepatitis B vaccine.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Hep B + Pentabio (registered) |
|---|---|
| Also known as | Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma) |
| Sponsor | PT Bio Farma |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease Prevention |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated or recombinant antigens from hepatitis B virus and other pathogens that trigger B and T cell responses, leading to production of protective antibodies and cellular immunity. This combination formulation allows simultaneous protection against multiple diseases in a single injection, improving vaccination compliance and coverage in pediatric populations.
Approved indications
- Hepatitis B prevention
- Diphtheria prevention
- Tetanus prevention
- Pertussis (whooping cough) prevention
- Poliomyelitis prevention
- Haemophilus influenzae type b infection prevention
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability or fussiness
- Drowsiness
Key clinical trials
- Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) (PHASE3)
- Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B (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:
- Hep B + Pentabio (registered) CI brief — competitive landscape report
- Hep B + Pentabio (registered) updates RSS · CI watch RSS
- PT Bio Farma portfolio CI
Frequently asked questions about Hep B + Pentabio (registered)
What is Hep B + Pentabio (registered)?
How does Hep B + Pentabio (registered) work?
What is Hep B + Pentabio (registered) used for?
Who makes Hep B + Pentabio (registered)?
Is Hep B + Pentabio (registered) also known as anything else?
What drug class is Hep B + Pentabio (registered) in?
What development phase is Hep B + Pentabio (registered) in?
What are the side effects of Hep B + Pentabio (registered)?
Related
- Drug class: All Combination vaccine drugs
- Manufacturer: PT Bio Farma — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease Prevention
- Indication: Drugs for Hepatitis B prevention
- Indication: Drugs for Diphtheria prevention
- Indication: Drugs for Tetanus prevention
- Also known as: Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing