Last reviewed 2026-05-22 · How we verify

Single administration Bmg dose Group

J2H Biotech · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Single administration Bmg dose Group is a Small molecule drug developed by J2H Biotech. It is currently in Phase 1 development.

J2H-1702 is a vaccine component that induces an immune response, and it is being investigated in a clinical trial (NCT06308874) for its safety, tolerability, and pharmacokinetics/pharmacodynamics in healthy females. The trial involves a single administration of different doses, including a Bmg dose, to study its effects in the context of Non-alcoholic Steatohepatitis.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Single administration Bmg dose Group
Sponsor	J2H Biotech
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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:

Single administration Bmg dose Group CI brief — competitive landscape report
Single administration Bmg dose Group updates RSS · CI watch RSS
J2H Biotech portfolio CI

Frequently asked questions about Single administration Bmg dose Group

What is Single administration Bmg dose Group?

Single administration Bmg dose Group is a Small molecule drug developed by J2H Biotech.

Who makes Single administration Bmg dose Group?

Single administration Bmg dose Group is developed by J2H Biotech (see full J2H Biotech pipeline at /company/j2h-biotech).

What development phase is Single administration Bmg dose Group in?

Single administration Bmg dose Group is in Phase 1.

Manufacturer: J2H Biotech — full pipeline

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