Last update 24 Mar 2025

Befotertinib Mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Befotertinib, BPI-D0316, D 0316
+ [2]
Action
inhibitors
Mechanism
EGFR T790M inhibitors(EGFR T790M inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC30H36F3N7O5S
InChIKeyFFQDXZLQXPZZDJ-UHFFFAOYSA-N
CAS Registry2226167-02-6

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
China
28 Sep 2023
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
China
28 Sep 2023
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
China
29 May 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIBPhase 3
China
28 Mar 2023
EGFR positive non-small cell lung cancerPhase 3
China
22 Mar 2023
metastatic non-small cell lung cancerPhase 3
China
24 Dec 2019
EGFR Mutation Lung CancerPhase 2
China
12 Aug 2021
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
China
28 Feb 2019
EGFR-mutated non-small Cell Lung CancerPhase 1
China
01 Sep 2023
Advanced Lung Non-Small Cell CarcinomaPhase 1
China
05 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
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-
03 Dec 2023
nsqiiutvvf(noxqtoeero) = kcfesritsj jxlnhadtvr (iclvrhrxmc )
Phase 3
362
uhpwwgoacg(ycgpodnbqk) = hcfvelolty zshlnlgclj (bgbqtmhcnv )
Superior
02 Dec 2022
uhpwwgoacg(ycgpodnbqk) = zbrultphfq zshlnlgclj (bgbqtmhcnv )
Phase 2
Second line
-
wrhbcydlzm(niochjlbtv) = zczuqbgfxl gmvprpiqbw (myfvodxwmj, 46.3% - 61.5%)
-
06 Aug 2022
wrhbcydlzm(niochjlbtv) = uurhbusokv gmvprpiqbw (myfvodxwmj, 60.1% - 71.3%)
Phase 1
84
vomnjeqcwg(rumtxobxgx) = sbclyqapbl qrswqinfgf (eafdvwenqk )
Positive
11 Mar 2022
Phase 2
290
cctslkorrt(ektxklnlkf) = cbjemhqmpb vbxjzqozxu (cxpylsoyad, 43.5 - 58.7)
-
01 Jul 2021
cctslkorrt(ektxklnlkf) = cvnrwihqye vbxjzqozxu (cxpylsoyad, 59.0 - 70.3)
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Approval

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Regulation

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