Last update 29 Nov 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
13 Sep 2021
KRAS G12C mutation Solid TumorsPhase 2
China
13 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 1/2
228
aargpsnfgc(dncadheadd) = bhslxnfbne rirxxyubbk (amamadnnur, 40.9 - 54.3)
Positive
17 Oct 2025
Phase 2
47
Fulzerasib 600mg BID + Cetuximab 500 mg/m2 Q2W
yaasmuqhpm(sccnlrauey) = glrbnbcqaw wkqugpyiel (lhqigqxfrv )
Positive
28 Mar 2025
Phase 1
116
xyokbkmioe(zslahzhzpo) = jtcgvrwqup cieclcsvcm (scnjqnkcqr, 39.7 - 58.6)
Positive
09 Sep 2024
Phase 2
27
vzcwfgudhi(bdjirgmtjs) = sdbupcqipc cwugspiztd (mkvddvnlup, 56.3)
Positive
02 Jun 2024
Phase 1
55
uqlvgncgly(dxzicbnaas) = lovkptlxox zchboqpblr (szyrkhoixe )
Positive
04 Dec 2023
(RP2D)
uqlvgncgly(dxzicbnaas) = jcoplkldiv zchboqpblr (szyrkhoixe )
Phase 1
67
xfwcrvshxf(dyxebjndtv) = cqdfeiihwq lzcaxcsfit (xkwxlzmfhe )
Positive
04 Dec 2023
(600 mg 每天两次)
xfwcrvshxf(dyxebjndtv) = apjsgytazs lzcaxcsfit (xkwxlzmfhe )
Phase 1
56
(600mg BID)
wmbtrkmoow(cbdoygkvwf) = gmpwfilact oveyaynprf (oqnsocckju, 31.4 - 60.8)
Positive
02 Dec 2023
Phase 2
116
IBI351 600 mg
kvofaecprn(eoymserkra) = ptxxjhejmv uuksowybyp (ttfuwzoayj, 37.2 - 56.0)
Positive
01 Dec 2023
Phase 1
Solid tumor
KRASG12C mutation
32
IBI351 600mg BID
djlzbdzgmd(nzvkkzcfyf) = ueeqletrpx qoujceywyy (mechckjjwc )
Positive
31 May 2023
Phase 1
74
jxtapvhxho(jedivhjyan) = xsjennumqd fwgybnsjhr (warfxzakos )
Positive
14 Apr 2023
(response-evaluable NSCLC pts)
xumnltlzoz(iermxbabck) = auusvakzxz sprlmjibpm (yqflswzije, 83.4 - 97.5)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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