Today, CGeneTech has accepted the marketing application (NDA) of Cetagliptin, a DPP-4 inhibitor, submitted to the National Drug Administration (NMPA) for the treatment of type 2 diabetes.

Public data show that DPP-4 (dipeptidyl peptidase-4) inhibitor can not only inhibit DPP-4, prevent it from inactivating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin-promoting polypeptide (GIP), thus promoting insulin release, but also inhibit pancreatic islets α Cells secrete glucagon, increase insulin level, reduce blood sugar, and are not easy to induce hypoglycemia and weight gain. The mechanism of action of these drugs is consistent with the mechanism of human physiological regulation of blood sugar, and experts call them "the most intelligent hypoglycemic drugs".

Cetagliptin is a class 1 innovative drug independently developed by CGeneTech. As a new oral DPP-4 inhibitor, it has the advantages of high selectivity and strong inhibition. With the increasing popularity of DPP-4 inhibitors in China, the market scale of such drugs (all imported) will be nearly 7 billion yuan in 2021. At present, metformin combined with leptin has become the main treatment scheme in the clinical application of treating type 2 diabetes. According to Sullivan's research report, by 2030, the market size of leptin in China will exceed 30 billion, with broad market prospects.

Cetagliptin has been listed in the "major new drug development" special projects of the 12th and 13th Five-Year Plan of the People's Republic of China, and has been exempted from phase II clinical trials directly entering phase III trials. Before applying for NDA, CGeneTech carried out two key phase III clinical trials of "Cetagliptin for treatment of type 2 diabetes" in China. Professor Ji Linong, director of the Endocrinology Department of Peking University People's Hospital, director of Peking University diabetes Center, and former chairman of the Western Pacific Region of the International diabetes Alliance, served as the leading PI. The unblinding results of the phase III clinical trial of Cetagliptin showed that the reduction of glycosylated hemoglobin (HbA1c) in the 50mg dose group (low dose group) reached the main clinical end point at the end of the 24th week, which was significantly superior to the control group. After 28 weeks, the Cetagliptin 100mg dose group (high dose group) showed good drug safety, and the incidence of adverse reactions was similar to that of the placebo group.

Dr. Yu Qiang, founder and CEO of CGeneTech, said: "At present, the total population of diabetes in China is more than 110 million, and there is still a gap between China and Europe and the United States in the targeted drug treatment of the new mechanism. The therapeutic effect of Cetagliptin developed by the company is expected to make it the best hypoglycemic drug of its kind in clinical practice. It is hoped that Cetagliptin will be approved and listed as soon as possible, and benefit the majority of diabetes patients in China as soon as possible. At the same time, Cetagliptin's current international patent has protected it until 2038, In the past 15 years, there is no worry about being included in the centralized purchase, and it will become the mainstream of hypoglycemic drugs in the long life cycle. "

CGeneTech was founded in Suzhou Industrial Park in 2010. Its core team has decades of experience in the whole life cycle of international drugs, and is committed to the R&D and industrialization of small molecular innovative drugs for breakthrough therapies. Relying on the integrated drug R&D technology platform and a diversified business vision, the company has built a rich pipeline of innovative drugs, covering multiple disease fields such as hypoglycemic, anticancer and autoimmunity. In addition to Cetagliptin, four of the anticancer drugs under research have entered the clinic, and two of them have obtained the clinical license of FDA in the United States, which is a solid step forward in the company's innovative drug market.