Last update 04 Nov 2025

SIM-0686

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
SIM 0686, SIM0686
Target
FGFR2b x Top I
Action
inhibitors
Mechanism
FGFR2b inhibitors(fibroblast growth factor receptor 2 IIIb inhibitors), TOP1 inhibitors(DNA topoisomerase I inhibitors)
Therapeutic Areas
Neoplasms
Active Indication
FGFR2 Mutation Solid TumorsSolid tumor by SiteFGFR2 Mutant Neoplasms
Inactive Indication-
Originator Organization
Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.
Active Organization
Shanghai Xianxiang Medical Technology Co., Ltd.Simcere Pharmaceutical Group Ltd.Simcere Pharmaceutical Group Ltd.Jiangsu Simcere Pharmaceutical Co., Ltd.Jiangsu Simcere Pharmaceutical Co., Ltd.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-
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Structure/Sequence

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Related

1
Clinical Trials associated with SIM-0686
NCT07050459
/ RecruitingPhase 1
A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors
100 Clinical Results associated with SIM-0686
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100 Translational Medicine associated with SIM-0686
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100 Patents (Medical) associated with SIM-0686
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100 Deals associated with SIM-0686
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R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
FGFR2 Mutation Solid TumorsPhase 1
China
Shanghai Xianxiang Medical Technology Co., Ltd.
06 May 2025
Solid tumor by SitePhase 1
China
Shanghai Xianxiang Medical Technology Co., Ltd.
06 May 2025
FGFR2 Mutant NeoplasmsIND Approval
United States
Simcere Pharmaceutical Group Ltd.Simcere Pharmaceutical Group Ltd.
21 Jul 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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