On April 10, 2025, Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that its independently developed antibody-drug conjugate (ADC), SIM0686, which targets FGFR2b (Fibroblast Growth Factor Receptor 2b), has received clinical trial approval from the China National Medical Products Administration. This achievement permits the company to initiate clinical trials involving Chinese patients with FGFR2b-positive, locally advanced, or metastatic solid tumors.
FGFR2b is a transmembrane tyrosine kinase receptor expressed in epithelial tissues. Its overexpression or gene fusion has been associated with various solid tumors. SIM0686 is a clinical-stage ADC 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 will be presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR), Abstract No. 2964.