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Shengshi Taikang's FGFR/VEGFR dual-target inhibitor approved for clinical trials to treat advanced solid tumors.

Release date:

2021-10-22

　　Recently, Shengshi Taikang announced that it has received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration (NMPA), granting permission to initiate a single-agent clinical trial of its investigational FGFR/VEGFR dual-target inhibitor CGT-6321 in patients with advanced solid tumors. This drug is poised to become China's potential first-in-class new therapy.

　　Founded in 2010, Shengshi Taikang is a biotechnology company dedicated to the research and development of small-molecule drugs in the areas of blood sugar control, anti-cancer therapies, and rare diseases. Since its establishment, the company has built an extensive pipeline of Class 1 innovative drug candidates. Among them, its independently developed drug, phosphate sengliflozin—a novel DPP-4 inhibitor—is currently in Phase 3 clinical trials. All trial participants are expected to complete the Phase 3 study by mid-2022. Early results from these completed trials indicate that phosphate sengliflozin demonstrates excellent safety profiles and effectively reduces glycated hemoglobin levels. If the drug successfully meets its primary clinical efficacy endpoints, its approval will fill a significant gap in China’s domestic production of DPP-4 inhibitors—currently, all approved DPP-4 inhibitors are imported products—thus opening up vast market opportunities ahead.

　　CGT-6321, recently approved for clinical trials, is another blockbuster candidate following phosphate senglitin. This innovative FGFR/VEGFR inhibitor is specifically designed to treat advanced solid tumors. Preclinical studies have demonstrated that CGT-6321 exhibits excellent safety profiles, robust tolerability, and favorable pharmacokinetic properties in animal models, while also showcasing potent anti-tumor activity across multiple cancer cell lines and in various animal tumor models. Built on a novel molecular structure, CGT-6321 has shown enhanced selectivity and superior therapeutic efficacy in preclinical research. Notably, it proves effective not only for patients with FGFR-positive tumors but also for those with FGFR-negative cancers, significantly broadening its potential clinical applications. Compared to conventional multi-kinase inhibitors, CGT-6321 holds promise for delivering even better treatment outcomes—and it also opens up ample opportunities for future single-agent and combination therapy studies.

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