Last reviewed 2026-05-31 · How we verify

GFH312 200 mg

Zhejiang Genfleet Therapeutics Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

GFH312 200 mg is a Small molecule drug developed by Zhejiang Genfleet Therapeutics Co., Ltd.. It is currently in Phase 1 development. Also known as: GFH312.

GFH312 is a small molecule with the synonym MG-S-2525, as per ChEMBL. It is being studied in a Phase I clinical trial (NCT05991362) for its pharmacokinetics and safety in healthy Chinese subjects, with doses including 100 mg, 120 mg, and 200 mg.

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	GFH312 200 mg
Also known as	GFH312
Sponsor	Zhejiang Genfleet Therapeutics Co., Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase I Study of GFH312 in Healthy Chinese Subjects (PHASE1)

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:

GFH312 200 mg CI brief — competitive landscape report
GFH312 200 mg updates RSS · CI watch RSS
Zhejiang Genfleet Therapeutics Co., Ltd. portfolio CI

Frequently asked questions about GFH312 200 mg

What is GFH312 200 mg?

GFH312 200 mg is a Small molecule drug developed by Zhejiang Genfleet Therapeutics Co., Ltd..

Who makes GFH312 200 mg?

GFH312 200 mg is developed by Zhejiang Genfleet Therapeutics Co., Ltd. (see full Zhejiang Genfleet Therapeutics Co., Ltd. pipeline at /company/zhejiang-genfleet-therapeutics-co-ltd).

Is GFH312 200 mg also known as anything else?

GFH312 200 mg is also known as GFH312.

What development phase is GFH312 200 mg in?

GFH312 200 mg is in Phase 1.

Manufacturer: Zhejiang Genfleet Therapeutics Co., Ltd. — full pipeline
Also known as: GFH312

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