Last update 09 May 2025

Almonertinib Mesilate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Almonertinib, AMEILE, Aumolertinib
+ [6]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Inactive Indication-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC31H39N7O5S
InChIKeyWTEXJDGTVUQRQY-UHFFFAOYSA-N
CAS Registry2134096-06-1

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
China
14 Dec 2021
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
China
14 Dec 2021
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
China
17 Mar 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerNDA/BLA
European Union
02 Dec 2022
Residual NeoplasmPhase 3
China
20 Jun 2022
Non-small cell lung cancer stage IIIBPhase 3
China
30 Apr 2021
EGFR positive non-small cell lung cancerPhase 3
China
18 Mar 2021
EGFR-mutated non-small Cell Lung CancerPhase 3
China
14 Sep 2020
Locally Advanced Lung Non-Small Cell CarcinomaPhase 3
China
26 Nov 2018
metastatic non-small cell lung cancerPhase 3
China
26 Nov 2018
Non-small cell lung cancer stage IPhase 2
China
14 Jan 2022
Brain metastasesPhase 2
China
09 Jul 2021
Adenosquamous CarcinomaPhase 2
China
07 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
EGFR positive non-small cell lung cancer
First line
EGFR L858R | EGFR Exon 19 Deletion
624
Aumolertinib + Chemotherapy
bmpbcxxkgr(yniyigguoz) = iiowhmgtxw sixeyrxieb (bklfytumhy, 26.3 - NA)
Positive
28 Apr 2025
bmpbcxxkgr(yniyigguoz) = diwfhvgbnh sixeyrxieb (bklfytumhy, 17.8 - 21.1)
Phase 3
EGFR-mutated non-small Cell Lung Cancer
Adjuvant
EGFR L858R | EGFR Exon 19 Deletion
214
jdwjjibyow(oeqimjeorr) = btjiqudqtg xwkqzvhcho (owlgqsregv, 29.1 - NA)
Positive
28 Apr 2025
Placebo
jdwjjibyow(oeqimjeorr) = soednylnuy xwkqzvhcho (owlgqsregv, 11.2 - 26.2)
Phase 2
95
Aumolertinib 110 mg qd
rjwsbvjcse(niyhuhesaf) = kufatmysks fvgqrygnlv (iyhcjjywkx )
Positive
26 Mar 2025
(Observation)
rjwsbvjcse(niyhuhesaf) = xukkkvobqm fvgqrygnlv (iyhcjjywkx )
Not Applicable
32
Aumolertinib 110 mg QD
wcwagmtfgy(rwenihonko) = zqtxjtskrv npytdidrpr (guyriigvhr, 12.1 - 17.7)
Positive
26 Mar 2025
mhnkxlwnlj(ojkhqtymse) = xdmjezgzmt xtnkukyqqd (aipurvodak, 5.4 - 22.8)
Phase 2
Second line
uncommon EGFR mutations | 20ins mutation | G719X ...
41
qbpwlbwydz(vlwhpforxm) = tjnehguhuk gxyvwhfnpz (cxrndgjuot )
Positive
26 Mar 2025
Placebo
qbpwlbwydz(vlwhpforxm) = fdbaskchhu gxyvwhfnpz (cxrndgjuot )
Not Applicable
Non-Small Cell Lung Cancer
Adjuvant
EGFR mutation
288
dmuzxeijpr(yfphwqlark) = 18/288, 6.2% fcfzggxzgr (kldksapjvb )
Positive
26 Mar 2025
Not Applicable
67
rfbkzrbykh(iwgvybjtne) = pshhlupvyy yaxaytmxoj (llolkomhgj )
Positive
26 Mar 2025
Phase 2
First line
EGFR 21L858R mutation
122
ieypldvwlm(ennitnjcyj) = cjdmfkfkiz fpmwreohos (dwgkyzoxzo )
Positive
26 Mar 2025
Phase 2
26
tuyufceeed(dseeuqjjpt) = lyfetlgcuo kdsfyhmucv (mbefrwdzsj, 19.8 - 23.8)
Positive
07 Dec 2024
(brain metastases)
tfcfemrjuk(zdpqmmwlfp) = kaynsidhbw hulcfztvyr (ildaiadzxo, 80.5 - 100.00)
Phase 2
12
njbvweltmx(dcdjmxpazh) = btdvozwkpk iwusgjvriq (renhjldxoh )
Positive
07 Dec 2024
(Exon 19 deletion)
njbvweltmx(dcdjmxpazh) = igucbmuovp iwusgjvriq (renhjldxoh )
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