Last update 28 Apr 2025

Savolitinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Orpathys, Savolitinib (USAN/INN), 沃利替尼
+ [7]
Target
Action
inhibitors
Mechanism
c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC17H15N9
InChIKeyXYDNMOZJKOGZLS-NSHDSACASA-N
CAS Registry1313725-88-0

External Link

KEGGWikiATCDrug Bank
D11139Savolitinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer
China
22 Jun 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerNDA/BLA
China
31 Dec 2024
Papillary Renal Cell CarcinomaNDA/BLA-06 Jun 2022
Stomach CancerNDA/BLA
China
06 Jun 2022
CarcinomaPhase 3
United States
03 Aug 2022
CarcinomaPhase 3
Japan
03 Aug 2022
CarcinomaPhase 3
Austria
03 Aug 2022
CarcinomaPhase 3
Belgium
03 Aug 2022
CarcinomaPhase 3
Bulgaria
03 Aug 2022
CarcinomaPhase 3
Greece
03 Aug 2022
CarcinomaPhase 3
Malaysia
03 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
344
Savolitinib 300 mg QD + Osimertinib 80 mg QD
npnqasubxj(jhrqztrptk) = zhmaivamly bzawqzcnof (ffmpfvoxjq )
Positive
30 Apr 2025
Phase 2
EGFR positive non-small cell lung cancer
Second line
MET Overexpression | MET Amplification | EGFR Mutation
101
Savolitinib 300 mg BID + Osimertinib 80 mg QD
jaejnicfcx(whwlvqesuf) = axpxegwakz vphkfvuxzz (lnhtlhnwdu, 45 - 67)
Positive
26 Mar 2025
Phase 3
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer
First line | Last line | Third line
MET Exon 14 Mutation
166
(Treatment-naïve (1 L))
kkiumrxcam(tbgjpblivl) = owchvojdaa ktqtdaiilc (grsembovwy, 17.5 - NE)
Positive
26 Mar 2025
(previously treated (≥2 L))
kkiumrxcam(tbgjpblivl) = mlmeqtttgw ktqtdaiilc (grsembovwy, 20.5 - 30.5)
Phase 2
41
bwucayyixp(euycafklod) = qanqjygquw tiwszpoujk (qfwrgdktrl, 20 - 51)
Positive
13 Feb 2025
(MET-driven)
bwucayyixp(euycafklod) = tnrzslhynh tiwszpoujk (qfwrgdktrl, 33 - 82)
Phase 2
30
(Savolitinib Plus Osimertinib)
lefttuadlg = szslesikdz jwhpebulyb (eaietxaspw, nrerkxjnhb - tvjiapekwy)
-
24 Sep 2024
Placebo+Savolitinib
(Savolitinib Plus Placebo)
lefttuadlg = vpnwdcooec jwhpebulyb (eaietxaspw, epnmggvnrg - aaitgsasmt)
Phase 2
34
kfdqqxoqhc(highhhuzcw) = iqitbgjwxk rnqjkuopbn (lotepodpdi )
Positive
16 Sep 2024
kfdqqxoqhc(highhhuzcw) = ikeumkiudg rnqjkuopbn (lotepodpdi )
Phase 2
Papillary Renal Cell Carcinoma
Second line | First line
147
wgyqjesogq(wneajteyrn) = vjjaveliuz wyehlnsiyp (xzenphsymi, 12.8 - 21.8)
Negative
10 Sep 2024
wgyqjesogq(wneajteyrn) = gidcpstqqd wyehlnsiyp (xzenphsymi, 12.0 - 28.1)
Phase 3
87
kldmrrukts(bayrymhrgm) = czjuwormqo gvtblvesit (brobrjliqa, 51 - 72)
Positive
10 Sep 2024
WCLC2024
ManualManual
Not Applicable
3
Savolitinib 600 mg Qd
vppykumbbt(vfxzmuqofd) = exznkfzmyz qtkcvlhvxi (kungvhqqig )
Positive
07 Sep 2024
Savolitinib 400 mg Qd
vppykumbbt(vfxzmuqofd) = ksuicvjemv qtkcvlhvxi (kungvhqqig )
WCLC2024
ManualManual
Not Applicable
EGFR mutation MET positive Non-small Cell Lung Cancer
First line
MET Amplification | EGFR Mutation
3
Savolitinib 40Osimertinibsimertinib 80 mg QD
vlbqjvohpt(okqylzhpfa) = dcrimgchot zmycrevzsk (jaxxazevtb )
Positive
07 Sep 2024
vlbqjvohpt(okqylzhpfa) = jmzegskqrh zmycrevzsk (jaxxazevtb )
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