On July 21, 2025, Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that the U.S. Food and Drug Administration (FDA) has recently cleared the company's Investigational New Drug (IND) application for its independently developed antibody-drug conjugate (ADC), SIM0686, which targets FGFR2b (Fibroblast Growth Factor Receptor 2b).
FGFR2b is a transmembrane tyrosine kinase receptor expressed in epithelial tissues. Dysregulation of its signaling pathway is associated with the occurrence and progression of various cancers. Overexpression of FGFR2b protein or FGFR2 gene amplification can be observed in gastric cancer and many other types of solid tumors.
SIM0686 is developed using Simcere Zaiming’s proprietary technology platform. The molecule combines the tumor-specific targeting capabilities of antibodies with the anti-cancer properties of topoisomerase inhibitors. Preclinical studies indicate that it demonstrates significant anti-tumor activity, not only in FGFR2b-positive tumor cells but also in FGFR2b-negative tumor cells via a bystander effect. The preclinical findings have been presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR), Abstract No. 2964.
SIM0686 is currently being investigated in a Phase 1 clinical trial in China. The approval of the IND allows the study to be conducted in the US for patients with FGFR2b-positive, locally advanced, or metastatic solid tumors.