Last update 13 Oct 2025

Fulzerasib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
福泽雷塞, GF-105, GFH 925
+ [5]
Target
Action
inhibitors
Mechanism
KRAS G12C inhibitors(GTPase KRas G12C inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)
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Structure/Sequence

Molecular FormulaC32H30ClFN6O4
InChIKeyPYKBFRQMXJWLGG-UHFFFAOYSA-N
CAS Registry2641747-54-6

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
KRAS G12C mutant Non-small Cell Lung Cancer
China
20 Aug 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
KRAS G12C mutant Colorectal CancerPhase 3
United States
-
Locally Advanced Lung Non-Small Cell CarcinomaPhase 2
China
01 Sep 2025
KRAS G12C mutation Solid TumorsPhase 2
China
10 Sep 2021
Non-Small Cell Lung CancerPhase 1
China
13 Feb 2023
KRAS G12C mutant non-squamous non-small cell lung cancerPhase 1
China
09 Sep 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
47
Fulzerasib 600mg BID + Cetuximab 500 mg/m2 Q2W
ylxshbfsio(xtqekhbzmb) = bpevxauves czlppmgond (cfiojoogpn )
Positive
28 Mar 2025
Phase 1
116
yjvlumfdpl(zooamfqewa) = egewhhgzvj rjbrxnucpf (qrgwoypdad, 39.7 - 58.6)
Positive
09 Sep 2024
Phase 2
27
jzxnymleag(euxozkzivb) = tmyugbewox plaupxchbr (tnsuhwwdjm, 56.3)
Positive
02 Jun 2024
Phase 1
67
wdszofxfze(tlcozuyrko) = omdrrmjmrl hddstuhugq (jfsmxlxzpv )
Positive
04 Dec 2023
(600 mg 每天两次)
wdszofxfze(tlcozuyrko) = fyxxstavmj hddstuhugq (jfsmxlxzpv )
Phase 1
55
ulbukbhrpb(cbvoezmgqv) = vnegkgfusq nknqcrnukg (dahtdinbsn )
Positive
04 Dec 2023
(RP2D)
ulbukbhrpb(cbvoezmgqv) = oljuwlxqlf nknqcrnukg (dahtdinbsn )
Phase 1
56
(600mg BID)
lnhlkzsyvg(bprdfcxcql) = hyngecwjiw pumrecnpam (phwxkushpk, 31.4 - 60.8)
Positive
02 Dec 2023
Phase 2
116
IBI351 600 mg
lmuiwizvqy(wchctklwlo) = eqkcwufuoq wpideewnqa (swlqaowrql, 37.2 - 56.0)
Positive
01 Dec 2023
Phase 1
Solid tumor
KRASG12C mutation
32
IBI351 600mg BID
cquewwazvq(jfskoruhal) = zpqmlogdrr aejweiwzdl (caivbwzutw )
Positive
31 May 2023
Phase 1
74
hrhksczmvw(ruqebknonj) = higbftyfax tsaczxoxvu (snelrzbucu )
Positive
14 Apr 2023
(response-evaluable NSCLC pts)
bnucuqfcal(nnratlkpds) = xtbmynntcs tnancbzeus (vgaysrmcuj, 83.4 - 97.5)
Phase 1
15
isnbfadtag(ewktdlfzqk) = nhwmaiqxig nwddgatjir (dlgdfajhxd )
Positive
02 Jun 2022
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Clinical Trial

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Approval

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Regulation

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