Last reviewed 2026-05-31 · How we verify

Firmonertinib Mesilate Tablets

Allist Pharmaceuticals, Inc. · Phase 3 active Small molecule

Firmonertinib Mesilate Tablets is a Third-generation EGFR tyrosine kinase inhibitor Small molecule drug developed by Allist Pharmaceuticals, Inc.. It is currently in Phase 3 development for Non-small cell lung cancer with EGFR mutations including T790M resistance mutations.

Firmonertinib mesilate is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations.

Firmonertinib mesilate is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations. Used for Non-small cell lung cancer with EGFR mutations including T790M resistance mutations.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Firmonertinib Mesilate Tablets
Sponsor	Allist Pharmaceuticals, Inc.
Drug class	Third-generation EGFR tyrosine kinase inhibitor
Target	EGFR (Epidermal Growth Factor Receptor)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Firmonertinib is designed to target EGFR mutations commonly found in non-small cell lung cancer, particularly those resistant to first and second-generation EGFR inhibitors due to the T790M gatekeeper mutation. By covalently binding to the ATP-binding pocket of mutant EGFR, it prevents downstream signaling through the MAPK and PI3K/AKT pathways, leading to cancer cell growth inhibition and apoptosis.

Approved indications

Non-small cell lung cancer with EGFR mutations including T790M resistance mutations

Common side effects

Diarrhea
Rash
Nausea
Fatigue
Decreased appetite

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:

Firmonertinib Mesilate Tablets CI brief — competitive landscape report
Firmonertinib Mesilate Tablets updates RSS · CI watch RSS
Allist Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about Firmonertinib Mesilate Tablets

What is Firmonertinib Mesilate Tablets?

Firmonertinib Mesilate Tablets is a Third-generation EGFR tyrosine kinase inhibitor drug developed by Allist Pharmaceuticals, Inc., indicated for Non-small cell lung cancer with EGFR mutations including T790M resistance mutations.

How does Firmonertinib Mesilate Tablets work?

Firmonertinib mesilate is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations.

What is Firmonertinib Mesilate Tablets used for?

Firmonertinib Mesilate Tablets is indicated for Non-small cell lung cancer with EGFR mutations including T790M resistance mutations.

Who makes Firmonertinib Mesilate Tablets?

Firmonertinib Mesilate Tablets is developed by Allist Pharmaceuticals, Inc. (see full Allist Pharmaceuticals, Inc. pipeline at /company/allist-pharmaceuticals-inc).

What drug class is Firmonertinib Mesilate Tablets in?

Firmonertinib Mesilate Tablets belongs to the Third-generation EGFR tyrosine kinase inhibitor class. See all Third-generation EGFR tyrosine kinase inhibitor drugs at /class/third-generation-egfr-tyrosine-kinase-inhibitor.

What development phase is Firmonertinib Mesilate Tablets in?

Firmonertinib Mesilate Tablets is in Phase 3.

What are the side effects of Firmonertinib Mesilate Tablets?

Common side effects of Firmonertinib Mesilate Tablets include Diarrhea, Rash, Nausea, Fatigue, Decreased appetite.

What does Firmonertinib Mesilate Tablets target?

Firmonertinib Mesilate Tablets targets EGFR (Epidermal Growth Factor Receptor) and is a Third-generation EGFR tyrosine kinase inhibitor.

Drug class: All Third-generation EGFR tyrosine kinase inhibitor drugs
Target: All drugs targeting EGFR (Epidermal Growth Factor Receptor)
Manufacturer: Allist Pharmaceuticals, Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer with EGFR mutations including T790M resistance mutations

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