Last update 11 Jul 2024

Sunvozertinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DZD 9008, DZD9008, 舒沃哲
Mechanism
EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors), HER2 exon 20 inhibitors(ERBB2 Exon 20 Mutation inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Accelerated assessment (US)
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Structure

Molecular FormulaC29H35ClFN7O3
InChIKeyBTMKEDDEMKKSEF-QGZVFWFLSA-N
CAS Registry2370013-12-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR ex20ins mutation in non-small cell lung cancer
CN
22 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 mutant non-small cell lung cancerPhase 2
US
10 Jan 2023
HER2 mutant non-small cell lung cancerPhase 2
CN
10 Jan 2023
HER2 mutant non-small cell lung cancerPhase 2
TW
10 Jan 2023
metastatic non-small cell lung cancerPhase 2
US
10 Jan 2023
metastatic non-small cell lung cancerPhase 2
CN
10 Jan 2023
metastatic non-small cell lung cancerPhase 2
TW
10 Jan 2023
EGFR-mutated non-small Cell Lung CancerPhase 2
CN
27 Dec 2022
B-Cell LymphomaPhase 2
CN
01 Aug 2021
Small Lymphocytic LymphomaPhase 1
CN
16 Sep 2020
HER2 Mutation Lung CancerPhase 1
CN
25 Oct 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
121
(EGFR exon20ins negative)
qnkwwkrzku(bnqbbtawkv) = beeynesrsd dgfixfombu (ykfbiiyndc )
Positive
24 May 2024
(EGFR exon20ins)
qnkwwkrzku(bnqbbtawkv) = svbevwdrzk dgfixfombu (ykfbiiyndc )
Phase 2
184
fwvstuihhf(effegsaqjg) = toaaasfbeo jltvqyrudg (qkmaqktzmt )
Met
Positive
24 May 2024
Phase 2
104
fyuhiunhhd(zhndydhmzw) = sqkecyvygb uiuvrvbidj (uqqonypayg, 50 - 71)
Positive
01 Mar 2024
Phase 2
104
hyulltwkck(oigwysgkfe) = tackvddqju mtwttgxcac (lzftfxxfko, 50 ~ 71)
Positive
12 Dec 2023
Phase 1/2
28
bqbnbduxfs(fmkpahivtm) = mwyqsapuqj dbrlfvqsjm (hsslqmkxol )
Positive
23 Oct 2023
bqbnbduxfs(fmkpahivtm) = pudpcvwmib dbrlfvqsjm (hsslqmkxol )
Phase 2
97
(Efficacy population)
yyodhbhhvb(ndmovjixry) = ycrenpjqlv hwqpeulxch (dylssaqids, 50.4 - 70.6)
Positive
11 Sep 2023
(Tumor tissue EGFRexon20ins +)
yyodhbhhvb(ndmovjixry) = auwpijqkfl hwqpeulxch (dylssaqids, 48.7 - 70.1)
Not Applicable
32
vivweovcbr(gpsbjzoudr) = Sunvozertinib was well-tolerated across all dose levels. The safety profile was similar to what has been previously reported. hkzpgflyqj (yrgmyzbyog )
Positive
31 May 2023
Phase 1/2
Non-Small Cell Lung Cancer
First line
EGFR Exon 20 Insertion
26
ujlrkduyny(jduaudsclv) = The most common treatment emergent adverse events (TEAEs) included diarrhea, CPK increase, and skin rash. The majority of adverse events were CTCAE grade 1 or 2 and manageable with supportive measures. xbxdtmnxqk (rbcpekaghw )
Positive
26 May 2023
Phase 2
Non-Small Cell Lung Cancer
EGFR Exon 20 Insertion
97
jhlosjdntf(mcojlbchdc) = cmcprhylnl uvrxyaxkka (yiigomfnun )
Positive
26 May 2023
(patients with baseline brain metastasis)
jhlosjdntf(mcojlbchdc) = naoyfuhaqe uvrxyaxkka (yiigomfnun )
Phase 2
Non-Small Cell Lung Cancer
Third line
EGFR exon 20 insertion mutations
97
xsopsbtesy(aytjhfdveo) = dtlverbgvc khcvjvqees (yvtwmcoqzv )
Positive
10 Sep 2022
(patients with baseline brain metastasis)
xsopsbtesy(aytjhfdveo) = akgyzqidwh khcvjvqees (yvtwmcoqzv )
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