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SCTV01E on D0
SCTV01E on D0 is a Biologic drug developed by Sinocelltech Ltd.. It is currently in Phase 2 development.
SCTV01E is a small molecule vaccine being studied as a booster vaccine for COVID-19, with a focus on its immunogenicity and safety. It is being evaluated in a Phase II clinical trial, alongside Comirnaty, for its ability to protect against SARS-CoV-2 infection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | SCTV01E on D0 |
|---|---|
| Sponsor | Sinocelltech Ltd. |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of SCTV01E (a COVID-19 Vaccine) in Population Aged ≥18 Years (PHASE3)
- A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines (PHASE2)
- A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines (PHASE3)
- A Phase III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E in Healthy People (PHASE3)
- A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years (PHASE2)
- A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine as a Booster Dose in Population Aged 12-17 Years (PHASE2)
- A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine (PHASE2)
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:
- SCTV01E on D0 CI brief — competitive landscape report
- SCTV01E on D0 updates RSS · CI watch RSS
- Sinocelltech Ltd. portfolio CI
Frequently asked questions about SCTV01E on D0
What is SCTV01E on D0?
Who makes SCTV01E on D0?
What development phase is SCTV01E on D0 in?
Related
- Manufacturer: Sinocelltech Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing