Last reviewed 2026-05-25 · How we verify

SCTV01E on D28

Sinocelltech Ltd. · Phase 2 active Biologic ✓ Verified May 2026

SCTV01E on D28 is a Biologic drug developed by Sinocelltech Ltd.. It is currently in Phase 2 development.

SCTV01E is a small molecule vaccine candidate being studied for its immunogenicity and safety in treating COVID-19 and SARS-CoV-2 infection. It was administered to participants on day 0 and day 28 as part of a randomized, double-blind Phase II clinical trial.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 D28
Sponsor	Sinocelltech Ltd.
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years (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 D28 CI brief — competitive landscape report
SCTV01E on D28 updates RSS · CI watch RSS
Sinocelltech Ltd. portfolio CI

Frequently asked questions about SCTV01E on D28

What is SCTV01E on D28?

SCTV01E on D28 is a Biologic drug developed by Sinocelltech Ltd..

Who makes SCTV01E on D28?

SCTV01E on D28 is developed by Sinocelltech Ltd. (see full Sinocelltech Ltd. pipeline at /company/sinocelltech-ltd).

What development phase is SCTV01E on D28 in?

SCTV01E on D28 is in Phase 2.

Manufacturer: Sinocelltech Ltd. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing