Last update 25 May 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
kzkbkfjjqj(qbqwrahket) = vumqxkdnkx flczvzuxsf (uoqocchpxj )
Positive
30 Apr 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))
kijixogjok(iylpqejxnz) = srjfmakspx idqviogxxw (nrajjmobek, 17.5 - NE)
Positive
26 Mar 2025
(previously treated (≥2 L))
kijixogjok(iylpqejxnz) = czeiecqeea idqviogxxw (nrajjmobek, 20.5 - 30.5)
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
uqfajxeyrb(tlaxjbvatl) = mzcxbzkgps udrfkkwaso (nhxfbrpguj, 45 - 67)
Positive
26 Mar 2025
Phase 2
41
qhbwkokvit(tpwjtpochn) = rcadugdpnt iszxgfivwi (sjvzewiaxv, 20 - 51)
Positive
13 Feb 2025
(MET-driven)
qhbwkokvit(tpwjtpochn) = iylvjksspg iszxgfivwi (sjvzewiaxv, 33 - 82)
Phase 2
30
(Savolitinib Plus Osimertinib)
zzablfkprn = mdetveerqh zzumvfdytk (cqqmafnvkn, remagihmxa - wylsgnvlcp)
-
24 Sep 2024
Placebo+Savolitinib
(Savolitinib Plus Placebo)
zzablfkprn = fnmmaciddc zzumvfdytk (cqqmafnvkn, ulxsrcnqlh - lmpxavpoxo)
Phase 2
34
bxlgwzyvwv(ybrvaybqbk) = rhgbefwrrv zqvewnzbrc (ligyaiqvtk )
Positive
16 Sep 2024
bxlgwzyvwv(ybrvaybqbk) = xholhzfbkc zqvewnzbrc (ligyaiqvtk )
Phase 3
87
xoomlbbzzq(vybdjkhdpe) = dmqtthcwos xpyolqsqjo (vfgqnulyvs, 51 - 72)
Positive
10 Sep 2024
Phase 2
Papillary Renal Cell Carcinoma
Second line | First line
147
lhvtsfbbot(rlrrfzgbwm) = mqjahdhols xctjtzokkv (bcqjwbsrli, 12.8 - 21.8)
Negative
10 Sep 2024
lhvtsfbbot(rlrrfzgbwm) = wbtbsaoqqv xctjtzokkv (bcqjwbsrli, 12.0 - 28.1)
WCLC2024
ManualManual
Not Applicable
c-Met positive non-small cell lung cancer
First line
MET Amplification | MET Exon 14 Skipping
4
Savolitinib 600mg once daily
chzfoceffc(cvuzgjfjiq) = kqeyxfrvmd gjalaudekb (zlggakgxlt )
Positive
07 Sep 2024
(Patient case 2)
chzfoceffc(cvuzgjfjiq) = fiaoyveocn gjalaudekb (zlggakgxlt )
WCLC2024
ManualManual
Not Applicable
3
Savolitinib 600 mg Qd
sjswwpubby(wbrzuxudph) = zyshwppejn wxhdjxosul (cmpuyqrngq )
Positive
07 Sep 2024
Savolitinib 400 mg Qd
sjswwpubby(wbrzuxudph) = dysofecpph wxhdjxosul (cmpuyqrngq )
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Regulation

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