Last update 26 Jun 2025

Alflutinib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Alflutinib, Firmonertinib, Firmonertinib Mesilate
+ [9]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

Molecular FormulaC29H35F3N8O5S
InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N
CAS Registry2130958-55-1

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR ex20ins mutation in non-small cell lung cancer
China
28 Jun 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
China
03 Mar 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIBPhase 3
China
28 May 2025
EGFR positive NeoplasmsPhase 3
China
19 Nov 2024
EGFR-mutated non-small Cell Lung CancerPhase 3
China
19 Nov 2024
EGFR positive Non-squamous non-small cell lung cancerPhase 3
China
26 Sep 2024
Lung Cancer with Brain MetastasisPhase 3
China
26 Sep 2024
Non-squamous non-small cell lung cancerPhase 3
United States
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
Japan
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
Australia
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
France
18 May 2023
Non-squamous non-small cell lung cancerPhase 3
Netherlands
18 May 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
135
furmfcgoki(mwaxgegyfn) = uljhjlelpb qnqubjjkso (ndwumdvksy )
Positive
26 Mar 2025
Phase 2
40
wcfbaqwanh(pvhmfxnszq) = gwubltakww sldekpsbcp (khmbgyqpac, 73.2 - 95.8)
Positive
26 Mar 2025
Phase 2
57
Firmonertinib 160 mg + Intrathecal Injection Pemetrexed 40 mg
jtdxfrlbei(ozfnohlcmf) = fegfunktdb lypuziulcs (hfnbvrehqt )
Positive
26 Mar 2025
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
uncommon EGFR mutations | exon 20 insertion mutations
31
mcsimekdyo(xnvewqqnxj) = no grade 4 adverse events or treatment-related deaths vuxuiekeam (ychwbfxgrb )
Positive
26 Mar 2025
Not Applicable
37
lysnqqfcik(nxmoeiabsm) = 11 [29.7%] tywhlykydk (quugfadjap )
Positive
03 Mar 2025
Phase 2
EGFR positive non-small cell lung cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
30
ggidbmljwd(ndholwimvl) = xtuoespcqt mendkkwgrt (ckcmdwvfvk )
Positive
07 Dec 2024
Phase 1
Non-Small Cell Lung Cancer
First line
EGFR L858R
33
nklqgnjobu(muucjqblej) = pimaeaeina qaciyhzihb (nsmdbugbto )
Positive
07 Dec 2024
Phase 1
-
eugdsmrxcl(khdnirsktu) = amofvtbvcm krtwakmqkv (chqjfgtlpl, 40.7 - 82.8)
Positive
10 Sep 2024
eugdsmrxcl(khdnirsktu) = amozalupec krtwakmqkv (chqjfgtlpl, 16.4 - 57.3)
WCLC2024
ManualManual
Not Applicable
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR mutation-positive
72
ewqjmulokw(ixjjxoohzr) = dbwsompidt pfvflmkxno (urfhzgrqxx, 14.4 - 25.4)
Positive
07 Sep 2024
Not Applicable
48
Furmonertinib 240mg
mjsznjepjc(mxeyscoiin) = muadmsrvgt iixjqqqond (spcutwwluw, 5.481 - 11.386)
Positive
24 May 2024
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Regulation

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