Last update 01 Nov 2024

Simmitinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
希美替尼
+ [1]
Target
FGFRs x M-CSF x VEGFR2
Mechanism
FGFRs antagonists(Fibroblast growth factor receptors antagonists), M-CSF inhibitors(Macrophage Colony Stimulating Factor 1 inhibitors), VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)
Therapeutic Areas
NeoplasmsDigestive System DisordersRespiratory Diseases+ [3]
Active Indication
Metastatic Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaBile Duct Neoplasms+ [12]
Inactive Indication
Transitional Cell Carcinoma
Originator Organization
Shanghai Institute of Materia Medica Chinese Academy of SciShanghai Institute of Materia Medica Chinese Academy of Sci
Active Organization
Shanghai Runshi Pharmaceutical Technology Co., Ltd.Shanghai Institute of Materia Medica Chinese Academy of SciShanghai Institute of Materia Medica Chinese Academy of SciCSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Related

12
Clinical Trials associated with Simmitinib
NCT06656091 / Not yet recruitingPhase 3
Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study
ChiCTR2400089300 / SuspendedPhase 1IIT
An open-label and multicenter Phase ? Clinical Study to Evaluate the Safety and Efficacy of SYS6010 in combination with Enlonstobart and Simmitinib in patients with advanced esophageal cancer
NCT06577376 / Not yet recruitingPhase 1/2
A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Simmitinib or Irinotecan Liposomes Combined With DP303c Injection in the Treatment of HER2 Expressing Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
100 Clinical Results associated with Simmitinib
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100 Translational Medicine associated with Simmitinib
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100 Patents (Medical) associated with Simmitinib
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1
Literatures (Medical) associated with Simmitinib
01 May 2022Bioanalysis
Development and Validation of a High Performance Liquid Chromatography–MS/MS Method for Determination of SOMCL-15-290 in a First-in-Human Study
100 Deals associated with Simmitinib
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Esophageal Squamous Cell CarcinomaPhase 3-
Shanghai Runshi Pharmaceutical Technology Co., Ltd.
31 Oct 2024
Esophageal Squamous Cell CarcinomaPhase 3
CN
Shanghai Institute of Materia Medica Chinese Academy of SciShanghai Institute of Materia Medica Chinese Academy of Sci
13 Sep 2024
HER2-Low Breast CarcinomaPhase 2
CN
Shanghai Institute of Materia Medica Chinese Academy of SciShanghai Institute of Materia Medica Chinese Academy of Sci
22 Aug 2024
HR-positive/HER2-low Solid TumorsPhase 2
CN
Shanghai Runshi Pharmaceutical Technology Co., Ltd.
30 Jan 2024
Advanced Malignant Solid NeoplasmPhase 2
CN
Shanghai Institute of Materia Medica Chinese Academy of SciShanghai Institute of Materia Medica Chinese Academy of Sci
07 Dec 2023
Advanced Malignant Solid NeoplasmPhase 2
CN
Shanghai Runshi Pharmaceutical Technology Co., Ltd.
07 Dec 2023
Bile Duct NeoplasmsPhase 2
CN
CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
-
Endometrial CarcinomaPhase 2
CN
CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
-
squamous cell lung carcinomaPhase 2
CN
CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
-
Stomach CancerPhase 2
CN
CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT04058587 (ASCO2024)
ManualManual
Phase 1
Advanced Malignant Solid Neoplasm
FGF3 | FGF4 | FGF19
98
Simmitinib 4 mg QD
(ybzoqbnhxj) = MTD was not achieved uexkqdfxzd (yvpusuglwq )
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Positive
24 May 2024
Simmitinib 6 mg QD
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Clinical Trial

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Approval

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Regulation

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