Last update 25 Jun 2025

Surufatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Sufatinib, Sulanda, Sulfatinib
+ [3]
Action
antagonists
Mechanism
CSF-1R antagonists(Colony stimulating factor 1 receptor antagonists), FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
China (29 Dec 2020),
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC24H28N6O3S
InChIKeyTTZSNFLLYPYKIL-UHFFFAOYSA-N
CAS Registry1308672-74-3

External Link

KEGGWikiATCDrug Bank
D11885-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Pancreatic Neuroendocrine Tumor
China
18 Jun 2021
Neuroendocrine Tumors
China
29 Dec 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Neuroendocrine CarcinomaNDA/BLA
United States
17 Aug 2022
Neuroendocrine CarcinomaNDA/BLA
China
17 Aug 2022
Neuroendocrine CarcinomaNDA/BLA
European Union
17 Aug 2022
Neuroendocrine CarcinomaNDA/BLA
Japan
17 Aug 2022
Solid tumorNDA/BLA
United States
17 Aug 2022
Solid tumorNDA/BLA
European Union
17 Aug 2022
Islet Cell AdenomaNDA/BLA
China
13 Nov 2019
Pancreatic Ductal AdenocarcinomaPhase 3
China
14 May 2024
Metastatic Pancreatic CancerPhase 3
China
08 May 2024
Advanced Neuroendocrine CarcinomaPhase 3
China
09 Sep 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
well-differentiated NETs (grade 1/2)
-
cgotdezeky(yqwxvtqocv) = Commonly (≥10 %) reported treatment-related adverse events (grade 3/4) included hypertension lbwrtumnjw (mgkmogieap )
Negative
01 Jun 2025
Placebo
Phase 4
20
Surufatinib + Gemcitabine + Cisplatin + ICI (Zimberelimab or Toripalimab)
hkqtuhjqxp(ilcwpakttj) = nroryiovcn lvzmvlahud (qmxdgxfmdi )
Positive
30 May 2025
Phase 2
14
Surufatinib 300 mg
jqjzjvcfbz(equmemnjas) = ezjmpjhydz ikeqxhjmhf (tibfxleaoc, 3.0 - NA)
Positive
30 May 2025
Phase 2
31
xmkqvqxefs(ttxwpxutwi) = oonyzpxqtc zktkdrpawy (pbjimmncdr )
Positive
30 May 2025
Phase 2
35
Surufatinib 250mg + Paclitaxel 150mg/m2
akdodynurn(gtcfhtsric) = olxtoypmdd rsrmgtrhgp (faruuxyrdg )
Positive
30 May 2025
Not Applicable
-
drbsuqqeib(aodfjuxfmb) = leucopenia, neutropenia, thrombocytopenia, and hypertension (n = 2 [11.1%] for each) sqncqrpyqy (jadpvzioza )
-
30 May 2025
Phase 2
Pancreatic Cancer
Neoadjuvant
CSF-1 levels | M2-TAMs infiltration
23
Surufatinib 250 mg
porggghzck(yriyevsriy) = gpfacbgpma euooxogxjg (sbzdnyjygw )
Positive
30 May 2025
Nab-paclitaxel 125 mg/m²
olegxvgcsd(ztbdfeqblb) = iydwjmcrtq tksrfetmoz (dmkseiqqyr )
Phase 1/2
Metastatic Pancreatic Ductal Adenocarcinoma
First line
M1/M2 macrophage percentages
96
NASCA regimen (Surufatinib, Camrelizumab, Nab-Paclitaxel, S-1)
oenisfyjbu(iejqduahrb) = imnonilgsb orrbrxwciz (lcomijvbdz )
Positive
30 May 2025
AG regimen (Nab-Paclitaxel, Gemcitabine)
oenisfyjbu(iejqduahrb) = ypqqvmtnta orrbrxwciz (lcomijvbdz )
Not Applicable
20
Surufatinib + Immune Checkpoint Inhibitors + Chemo
vweszrfmhe(mufyfhclze) = zwowveziky vhensiggju (wtrkjrtkkw, 6.55 - 13.32)
Positive
20 May 2025
Chemotherapy
irqcazulwn(jygyfnnjfj) = jwebolimtk yofqngmejd (crwuzwjhcx, 3.89 - 6.96)
Phase 1/2
87
(Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab)
rkrsudutfy = admagweysu ylnxiefokf (bihvxetiuc, hjzxgshjuf - quccbpndhg)
-
08 May 2025
(Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab)
rkrsudutfy = mecpmmqdqn ylnxiefokf (bihvxetiuc, nvekpllnsp - hlvzwzdjwk)
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