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LIBP-Rec-Vaccine
LIBP-Rec-Vaccine is a Recombinant protein vaccine Biologic drug developed by National Vaccine and Serum Institute, China. It is currently in Phase 3 development.
LIBP-Rec-Vaccine is a recombinant protein-based vaccine designed to stimulate immune responses against specific disease targets through antigen presentation.
The LIBP-Rec-Vaccine is a vaccine being studied in a Phase III clinical trial for the prevention of COVID-19 and Coronavirus Infections. The vaccine is being compared to a placebo in a randomized, double-blind, placebo-controlled trial.
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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 | LIBP-Rec-Vaccine |
|---|---|
| Sponsor | National Vaccine and Serum Institute, China |
| Drug class | Recombinant protein vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
As a recombinant vaccine, LIBP-Rec-Vaccine likely contains engineered protein antigens that are presented to the immune system to generate both cellular and humoral immune responses. The vaccine is intended to prime T-cell and B-cell mediated immunity against the target pathogen or disease, potentially providing prophylactic or therapeutic benefit depending on the indication.
Approved indications
Common side effects
- Injection site reactions
- Fever
- Myalgia
Key clinical trials
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:
- LIBP-Rec-Vaccine CI brief — competitive landscape report
- LIBP-Rec-Vaccine updates RSS · CI watch RSS
- National Vaccine and Serum Institute, China portfolio CI
Frequently asked questions about LIBP-Rec-Vaccine
What is LIBP-Rec-Vaccine?
How does LIBP-Rec-Vaccine work?
Who makes LIBP-Rec-Vaccine?
What drug class is LIBP-Rec-Vaccine in?
What development phase is LIBP-Rec-Vaccine in?
What are the side effects of LIBP-Rec-Vaccine?
Related
- Drug class: All Recombinant protein vaccine drugs
- Manufacturer: National Vaccine and Serum Institute, China — full pipeline
- Therapeutic area: All drugs in Immunology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing