Last reviewed 2026-05-18 · How we verify

BRAF Inhibito

Suzhou Genhouse Bio Co., Ltd. · Phase 2 active Small molecule Quality 55/100

BRAF Inhibito is a BRAF inhibitor Small molecule drug developed by Suzhou Genhouse Bio Co., Ltd.. It is currently in Phase 2 development.

Inhibits mutated BRAF protein kinase to block aberrant MAPK signaling pathway activation in cancer cells.

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	BRAF Inhibito
Sponsor	Suzhou Genhouse Bio Co., Ltd.
Drug class	BRAF inhibitor
Modality	Small molecule
Phase	Phase 2

Mechanism of action

BRAF inhibitors selectively target mutant BRAF kinase, most commonly the V600E mutation, which drives uncontrolled cell proliferation through constitutive activation of the MAPK/ERK signaling pathway. By blocking this aberrant signaling, the drug induces tumor cell death and inhibits cancer growth.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors (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:

BRAF Inhibito CI brief — competitive landscape report
BRAF Inhibito updates RSS · CI watch RSS
Suzhou Genhouse Bio Co., Ltd. portfolio CI

Frequently asked questions about BRAF Inhibito

What is BRAF Inhibito?

BRAF Inhibito is a BRAF inhibitor drug developed by Suzhou Genhouse Bio Co., Ltd..

How does BRAF Inhibito work?

Inhibits mutated BRAF protein kinase to block aberrant MAPK signaling pathway activation in cancer cells.

Who makes BRAF Inhibito?

BRAF Inhibito is developed by Suzhou Genhouse Bio Co., Ltd. (see full Suzhou Genhouse Bio Co., Ltd. pipeline at /company/suzhou-genhouse-bio-co-ltd).

What drug class is BRAF Inhibito in?

BRAF Inhibito belongs to the BRAF inhibitor class. See all BRAF inhibitor drugs at /class/braf-inhibitor.

What development phase is BRAF Inhibito in?

BRAF Inhibito is in Phase 2.

Drug class: All BRAF inhibitor drugs
Manufacturer: Suzhou Genhouse Bio Co., Ltd. — full pipeline

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