New Oral Antidiabetic Drug Approved for Market Launch Amid China's Booming $134 Billion Diabetes Therapeutics Sector

 

On December 3, the website of the National Medical Products Administration (NMPA) of China announced that the marketing application for CGeneTech's Category 1 new drug, Sengliptin (formerly known as Shengliptin), has been officially approved.
 

Data shows that Cengliptin, as a new type of oral DPP-4 inhibitor, has the advantages of high selectivity and strong inhibition. The approved indication this time is for the treatment of type 2 diabetes.
 

According to the press release previously issued by CGeneTech, clinical trial data of Seng列汀 (Senglitin) at a 50mg low dose as monotherapy and combination therapy showed significant improvement in glycated hemoglobin levels across patients with varying durations of diabetes history, demonstrating substantial clinical significance. Additionally, the drug notably improved β-cell function and reduced systolic blood pressure. In terms of safety, no additional safety issues were observed with Senglitin compared to placebo. Moreover, the comparison between the two dosage groups highlighted the advantages of a lower effective dose and enhanced safety, indicating that Senglitin achieves clinically remarkable therapeutic effects with "half the dose," offering promising benefits for a vast number of diabetes patients in China.
 

Data show that the full Chinese name of DPP-4 is dipeptidyl peptidase-4, and DPP-4 inhibitors are one of the main types of drugs for treating diabetes. These drugs not only inhibit DPP-4, preventing it from inactivating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby promoting insulin release, but also suppress glucagon secretion by pancreatic α cells, increase insulin levels, reduce blood glucose, and are not prone to inducing hypoglycemia or increasing body weight.
 

It is reported that in the DPP-4 inhibitor field, besides CGeneTech's Senglynetine being approved for marketing, Haisco Pharmaceutical's innovative Class 1 drug Coglynnetine Tablets was also approved for marketing in June this year. It is suitable for improving blood glucose control in adult patients with type 2 diabetes.
 

Data shows that Cogrelitin tablets, a Class 1 new chemical drug independently developed by Haisco for the oral treatment of type 2 diabetes, are an ultra-long-acting DPP-4 inhibitor (DPP-4i) and a biweekly oral hypoglycemic agent. As an ultra-long-acting biweekly DPP-4 inhibitor, clinical results indicate that the efficacy and safety of Cogrelitin tablets are comparable to daily formulations. With a half-life of 131.5 hours at 10mg, persistent DPP-4 inhibition (average inhibition rate exceeding 80% after 14 days of administration), minimal drug interactions, no need for dose adjustment in patients with mild to moderate liver or kidney impairment, no gastrointestinal adverse reactions, and no increase in body weight, it effectively lowers blood glucose without increasing the incidence of hypoglycemia and cardiovascular events. The longer dosing interval of once every two weeks greatly simplifies the hypoglycemic treatment regimen, further enhancing compliance and glycemic control, reducing medication burden, and expanding treatment options for patients with type 2 diabetes (T2DM).
 

Experts in the industry indicate that DPP-4 inhibitors are a new generation of oral hypoglycemic drugs, which have been gradually applied in clinical practice in China. The overall effects are good and they can be used as an important auxiliary medication for lowering blood glucose, showing promising development prospects.
 

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