Drug intelligence / Profile preview

SIM0686

Development stage
Phase 1
Lead developer
Simcere Pharmaceutical Group
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

SIM0686 is a clinical-stage **antibody-drug conjugate (ADC)** developed by Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group. It targets **FGFR2b (Fibroblast Growth Factor Receptor 2b)**, a transmembrane tyrosine kinase receptor overexpressed or gene-fused in several solid tumors. The ADC uses a proprietary platform to combine an FGFR2b-specific monoclonal antibody with a topoisomerase I inhibitor payload. SIM0686 is designed to deliver the cytotoxic agent directly to tumor cells expressing FGFR2b, thereby enhancing anti-tumor efficacy and reducing systemic toxicity. Its bystander effect allows it to impact FGFR2b-negative tumor cells in the vicinity as well. As of mid-2025, SIM0686 is undergoing Phase 1 clinical trials in patients with **locally advanced or metastatic solid tumors** positive for FGFR2b[1][3][9].

02

Targets

TOP1 (DNA Topoisomerase I)FGFR2b (Fibroblast growth factor receptor 2 IIIb isoform)

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