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pneumococcal disease prevention
pneumococcal disease prevention is a Pneumococcal vaccine Biologic drug developed by Beijing Minhai Biotechnology Co., Ltd. It is currently in Phase 3 development.
Stimulates the immune system to produce antibodies against Streptococcus pneumoniae capsular polysaccharides.
Pneumococcal disease can be prevented through vaccination, as indicated by ClinicalTrials.gov, which has studied the effects of pneumococcal vaccination in preventing conditions such as pneumonia and pneumococcal infections. According to ChEMBL, pneumococcal vaccination works by inducing an immune response, a biological mechanism that is consistent with the use of vaccines as a preventive measure.
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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).
| 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 | pneumococcal disease prevention |
|---|---|
| Sponsor | Beijing Minhai Biotechnology Co., Ltd |
| Drug class | Pneumococcal vaccine |
| Modality | Biologic |
| Phase | Phase 3 |
Mechanism of action
Pneumococcal vaccines contain purified capsular polysaccharides or polysaccharide-protein conjugates from multiple serotypes of Streptococcus pneumoniae. Upon administration, the vaccine triggers an immune response that generates protective antibodies, providing immunity against pneumococcal infections caused by the included serotypes.
Approved indications
Common side effects
Key clinical trials
- Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire (PHASE4)
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
- Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk. (NA)
- A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine (PHASE3)
- Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital (PneumoVIH)
- Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders (PHASE4)
- Predictive Value of Heart Rate Variability on Cardiorespiratory Events
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:
- pneumococcal disease prevention CI brief — competitive landscape report
- pneumococcal disease prevention updates RSS · CI watch RSS
- Beijing Minhai Biotechnology Co., Ltd portfolio CI
Frequently asked questions about pneumococcal disease prevention
What is pneumococcal disease prevention?
How does pneumococcal disease prevention work?
Who makes pneumococcal disease prevention?
What drug class is pneumococcal disease prevention in?
What development phase is pneumococcal disease prevention in?
Related
- Drug class: All Pneumococcal vaccine drugs
- Manufacturer: Beijing Minhai Biotechnology Co., Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing