Last update 28 Jan 2026

Icotinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Conmana, Icotinib, 埃克替尼
+ [5]
Action
inhibitors
Mechanism
EGFR exon 21 L858R mutation inhibitors
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (07 Jun 2011),
RegulationSpecial Review Project (China), Priority Review (China)
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Structure/Sequence

Molecular FormulaC22H22ClN3O4
InChIKeyPNNGXMJMUUJHAV-UHFFFAOYSA-N
CAS Registry1204313-51-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-Small Cell Lung Cancer
China
07 Jun 2011
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lung Cancer with Brain MetastasisPhase 3
China
20 Jul 2018
EGFR-mutated non-small Cell Lung CancerPhase 3
China
02 Jun 2015
Adenocarcinoma of LungPhase 3
China
01 Sep 2014
EGFR Mutation Lung CancerPhase 3
China
01 Sep 2014
EGFR positive non-small cell lung cancerPhase 3
China
01 Sep 2014
Advanced Lung AdenocarcinomaPhase 3
China
01 Dec 2012
EGFR positive Adenocarcinoma of LungPhase 3
China
01 Dec 2012
Brain metastasesPhase 2-01 Dec 2018
Non-small cell lung cancer stage IIIBPhase 2
China
09 May 2018
progressive non-small cell lung cancerPhase 2
China
01 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
251
Icotinib 125 mg, three times daily for 12 months
ohseybcopt(mmhoqkohpl) = wtnglfjsbr evjkpvvuqn (gcmhwqisjx )
Positive
28 Aug 2025
Icotinib 125 mg, three times daily for 6 months
ohseybcopt(mmhoqkohpl) = kqufcnamcf evjkpvvuqn (gcmhwqisjx )
Phase 2
128
ugqbqleclu(vqvscbejsp) = hsuvyibacc rgbrytezic (hatilvlzyv )
Positive
30 May 2025
(Observation)
ugqbqleclu(vqvscbejsp) = kbqstaymji rgbrytezic (hatilvlzyv )
NEWS
ManualManual
Phase 3
EGFR positive non-small cell lung cancer
EGFR L858R | EGFR Exon 19 Deletion
118
埃克替尼单药组
bayfhdhgnn(iqevdnwozu) = cisjukfqle lwkwuoptkj (cwxvtybivp )
Positive
14 Oct 2024
埃克替尼联合TRT组
bayfhdhgnn(iqevdnwozu) = ropskfvcci lwkwuoptkj (cwxvtybivp )
Phase 3
EGFR positive non-small cell lung cancer
Adjuvant
ctDNA-based molecular residual disease (MRD)
179
fabgpbrhpk(emqhqparip): HR = 0.4 (95% CI, 0.2 - 0.6)
Positive
10 Sep 2024
Chemotherapy
Phase 2
EGFR positive Adenocarcinoma of Lung
Neoadjuvant
EGFR Mutation
133
Chemotherapy
bssxpzvpki(vhjggqzkhp) = tqjblwfobi yivkdjovol (wicubmzumh )
Positive
09 Sep 2024
First-generation EGFR-TKIs
bssxpzvpki(vhjggqzkhp) = xzqkejbieh yivkdjovol (wicubmzumh )
Phase 3
251
Icotinib 12 months
zsqrivkgua(zxwtptmoda) = qiycnwexzs zvgyvlsdqv (sxznadrnvv, 43.3 - 80.3)
Positive
24 May 2024
Icotinib 6 months
zsqrivkgua(zxwtptmoda) = qsymkwjbev zvgyvlsdqv (sxznadrnvv, 44.8 - 81.6)
WCLC2023
ManualManual
Phase 1/2
24
ljvydztfzb(ccvqvckhfu) = aumolertinib 110 mg po qd plus icotinib 125mg po tid yngmlnuiqz (lkzcmpowyd )
Positive
11 Sep 2023
Phase 2
109
1-year icotinib
oifgzzwmwz(szhpfeytyy) = elokbfswnu kbvcaosnmt (nfqzkquvjt, 26.6 - 44.8)
Positive
20 Jun 2023
2-year icotinib
oifgzzwmwz(szhpfeytyy) = wmyebrtdji kbvcaosnmt (nfqzkquvjt, 33.1 - 70.1)
Phase 2
128
Adjuvant icotinib
wxdrgdyjoo(gdhnyqdwsp) = ygvuawerkj yhrhgthnuy (pyrnfatmwe, 91.3 - 99.9)
Positive
01 Mar 2023
(Observation)
wxdrgdyjoo(gdhnyqdwsp) = vtspviawvy yhrhgthnuy (pyrnfatmwe, 75.1 - 92.9)
Not Applicable
105
nyswlqlcpp(hduoobbwqq) = parqglujdv jzbrdjumjo (qabnagyjdb )
-
03 Dec 2022
nyswlqlcpp(hduoobbwqq) = mbbzutaitt jzbrdjumjo (qabnagyjdb )
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