Complementary advantages: World's first SGLT-2/DPP-4 dual-target inhibitor approved for clinical trials

Recently, Shengshi Taikang's Class 1 innovative drug, CGT-2201, a dual SGLT-2/DPP-4 inhibitor, has received implicit approval from the National Medical Products Administration for clinical trials. CGT-2201, targeting two key metabolic targets—SGLT-2 and DPP-4—offers enhanced potential for treating diabetes and its related conditions, such as diabetic nephropathy and non-alcoholic fatty liver disease.

In 2021, China had already reached 141 million diabetes patients, ranking first in the world. Among China's large diabetic population, 20% to 40% may develop diabetic kidney disease as a complication. Currently, among available glucose-lowering medications, only sodium-glucose cotransporter 2 (SGLT-2) inhibitors have been clinically proven to offer significant renal protective benefits—but their inherent risks of reproductive and urinary system infections have limited their broader use. By leveraging the unique advantages of SGLT-2 inhibitors while integrating the favorable properties of dipeptidyl peptidase-4 (DPP-4) inhibitors, designing and developing a new drug that not only effectively controls blood sugar levels but also minimizes urinary and reproductive system-related infection side effects—while remaining safe for patients with varying degrees of kidney function—could potentially fill a critical market gap and better meet patients' unmet needs.

Based on this market context and target characteristics, Shengshi Taikе leverages its proprietary small-molecule chimera drug technology platform to develop innovative multi-target, multi-functional new drugs with synergistic mechanisms—CGT-2201 being one of its flagship products. It combines the unique mechanisms of both SGLT-2 and DPP-4 inhibitors: by inhibiting SGLT-2 activity to reduce glucose reabsorption in the kidneys, while simultaneously slowing down DPP-4’s degradation of GLP-1. This dual-action approach amplifies the therapeutic effect. Not only does it achieve comparable blood sugar-lowering efficacy, but it also significantly reduces the urinary system infection side effects commonly associated with existing SGLT-2 inhibitors. Moreover, since the drug is not excreted through the kidneys, it alleviates renal strain and minimizes contraindications for diabetic patients with impaired kidney function. As a result, this medication offers superior glycemic control while safeguarding and preserving patients’ kidney health.

Founded in 2010 in Suzhou Industrial Park, Shengshi Taikang boasts a core team with decades of international experience spanning the entire lifecycle of pharmaceutical products. The company is dedicated to the research, development, and industrialization of high-quality, differentiated small-molecule innovative drugs. Leveraging an integrated drug R&D technology platform and a diversified business perspective, Shengshi Taikang has built a robust product pipeline covering multiple therapeutic areas, including diabetes management, cancer treatment, and autoimmune diseases. In the diabetes segment, the company’s independently developed lead candidate, senglitinib, has already been submitted to the National Medical Products Administration (NMPA) as an NDA (New Drug Application) and has been officially accepted for review. Phase 3 clinical trial results demonstrate that even low doses effectively achieve the pre-specified primary endpoints, while the higher-dose group further highlights the drug’s excellent safety profile. With its remarkable "dose-for-dose" efficacy, senglitinib is poised to become a leading glucose-lowering therapy in its class. Meanwhile, the company has also established a comprehensive pipeline focused on oral medications targeting various diabetes-related pathways, as well as drugs addressing associated complications. CGT-2201, recently approved to enter clinical trials, is one of the key members in this strategic pipeline matrix.