Recently, CGeneTech's Class 1 innovative drug, the SGLT-2/DPP-4 dual-target inhibitor CGT-2201, has received tacit approval for clinical trials from the National Medical Products Administration.CGT-2201, targeting the two major glucose metabolism-related key points SGLT-2 and DPP-4, can be better utilized for the treatment of diabetes and its derivative diseases, including diabetic nephropathy and non-alcoholic fatty liver, etc.
By 2021, the number of diabetes patients in China had reached 141 million, ranking first globally. Among the large population of diabetes patients in China, 20-40% may develop diabetic nephropathy complications. Among existing hypoglycemic drugs, only sodium-glucose cotransporter-2 (SGLT-2) inhibitors have been clinically proven to provide significant renal protection, but their inherent risk of infections in the reproductive and urinary systems limits their use. Based on SGLT-2 inhibitors and incorporating the characteristics of dipeptidyl peptidase-4 (DPP-4) inhibitors, the design and development of a drug that improves blood glucose, reduces side effects like infections in the urinary and reproductive systems, is not restricted by kidney function, and provides renal benefits would fill a market gap and meet patient needs.
Based on this market background and target characteristics, CGeneTech has utilized its self-developed small molecule chimera drug technology platform to develop multi-headed, multi-functional new drug products with synergistic mechanisms. CGT-2201 is one of its representative works. It integrates the respective mechanism characteristics of SGLT-2 and DPP-4. On the basis of inhibiting SGLT-2 activity to reduce glucose reabsorption in the kidneys, it simultaneously slows down the inactivation of GLP-1 by DPP-4, achieving the purpose of a dual mechanism for an enhanced effect. While achieving comparable blood sugar reduction, it alleviates the urinary tract infection side effects associated with existing SGLT-2 drugs. Moreover, as it is not excreted through the kidneys, it reduces the burden on the kidneys and mitigates usage contraindications for diabetic patients with renal insufficiency. Therefore, this drug will offer superior blood sugar control while protecting patients' kidney function.
CGeneTech was founded in 2010 in Suzhou Industrial Park. The core team has decades of international experience in the entire lifecycle of pharmaceuticals and is committed to the research, development, and commercialization of high-quality and differentiated small-molecule innovative drugs. With an integrated drug R&D technology platform and diverse business perspectives, the company has established a product pipeline covering multiple disease areas such as hypoglycemic, anti-cancer, and autoimmune diseases. In the field of hypoglycemic drugs, the company's independently developed core product, CGeneTech’s Zhenlitin, has submitted an NDA (New Drug Application) to the National Medical Products Administration (NMPA) and has been accepted. Phase 3 clinical trial results show that a low dose can achieve the pre-set trial endpoint, while the high-dose group demonstrates excellent drug safety. This "half the dose for double the effect" therapeutic outcome positions it as a potential best-in-class hypoglycemic drug. Additionally, the company has comprehensively laid out plans around oral medications targeting various points related to diabetes and its derivative conditions. CGT-2201, recently approved to enter clinical trials, is one of the members of its pipeline portfolio.
