"Quantity" Half Achieves Double Prosperity: CGeneTech's Class 1 New Hypoglycemic Drug Cetagliptin Uncovers Blindness Data

Today, CGeneTech has completed a key clinical study on a class 1 new hypoglycemic drug under development: phase III clinical trial of DPP-4 inhibitor Cetagliptin in the treatment of type 2 diabetes. A dose of 50mg can reach the preset end point of the trial. A therapeutic dose of "half the dose" will further improve the safety of this drug and is expected to become the best hypoglycemic drug in the same class.

The full name of DPP-4 is dipeptidyl peptidase-4. DPP-4 inhibitors are becoming increasingly popular in China. In 2021, the market size of such drugs (all imported) will be nearly 7 billion yuan, and the future is promising. Public data show that such drugs can not only inhibit DPP-4, prevent it from inactivating glucagon like peptide-1 (GLP-1) and glucose dependent insulin secreting polypeptide (GIP), but also promote insulin release and inhibit islets α The cells secrete glucagon, increase insulin level, reduce blood sugar, and are not easy to induce hypoglycemia and weight gain. The mechanism of action of such drugs is consistent with the mechanism of human physiological regulation of blood sugar, which is called "the most intelligent hypoglycemic drug" by experts.

Cetagliptin is a Class 1 innovative drug independently developed by CGeneTech. As a new type of oral DPP-4 inhibitor, it has the advantages of high selectivity and strong inhibition. It has been selected for the National Twelfth Five Year Plan and the 13th Five Year Plan "Major New Drug Creation" project, and exempted from Phase II clinical trials and directly entered Phase III trials. CGeneTech has carried out two key phase III clinical trials of "Cetagliptin in the treatment of type 2 diabetes" in China. Professor Ji Linong, director of Endocrinology Department of Peking University People's Hospital, director of diabetes center of Peking University, and former president of Western Pacific region of International Diabetes alliance, is the leading pi. The research contents are the phase III trial of Cetagliptin tablets alone and the phase III trial of Cetagliptin tablets combined with metformin, About 1000 subjects with type 2 diabetes were enrolled.

The unblinding results of the phase III clinical trial of Cetagliptin showed that the decrease of HbA1c in the 50mg dose group (low-dose group) of Cetagliptin tablets reached the main clinical end point at the end of the 24th week, which was significantly better than that in the control group. After 28 weeks, the 100mg dose group (high-dose group) of Cetagliptin also showed good drug safety, and the incidence of adverse reactions was similar to that of the placebo group. Subsequently, the company will submit the listing application of Cetagliptin to the State Drug Administration as soon as possible in accordance with the relevant provisions of the national drug registration, so as to benefit the majority of diabetes patients in China as soon as possible.

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 research, development and industrialization of small molecule innovative drugs for breakthrough therapies. Relying on the integrated drug R&D technology platform and diversified business vision, the company has built a rich pipeline of innovative drugs, covering many disease fields such as hypoglycemic, anti-cancer and rare diseases. In addition to Cetagliptin, three anti-cancer drugs developed by the company have entered the clinic, two of which have been approved by the FDA of the United States, making a solid step forward for the company's innovative drugs to go abroad.