Recently, at the 19th Peking University Diabetes Forum, Professor Ji Linong, chairman of the conference and director of the Department of Endocrinology of Peking University People's Hospital, announced the data and results of two Phase III clinical trials of Shengglitin. As a new generation of highly selective DPP-4 inhibitor independently developed by CGeneTech, Shengglitin's clinical results show that compared with similar drugs already on the market, Shengglitin has very good efficacy and safety, and will become a domestic original 1.1 class hypoglycemic new drug for the treatment of type 2 diabetes.

Professor Ji Linong was speaking at the Peking University Diabetes Forum

Shengglietine has been shortlisted in the national 12th Five-Year and 13th five-year "major new drug creation" special. Due to the excellent data demonstrated in the head-to-head Phase I clinical trial with the best product in the market, we were exempted from the phase II clinical trial and entered the phase III clinical trial directly. Prior to the application of NDA, CGeneTech carried out two phase III clinical trials of Shengglitin and Shengglitin combined with metformin in the treatment of Type 2 diabetes in China, led by Professor Linong Ji, director of Endocrinology Department of Peking University People's Hospital, Director of Peking University Diabetes Center, and chairman of the Western Pacific Region of the International Diabetes Alliance.
Two Phase III trials of Shengliptin enrolled nearly 1000 participants. The Shengliptin monotherapy trial enrolled patients with type 2 diabetes who had not been treated with medication, and the Shengliptin plus metformin trial enrolled patients with type 2 diabetes who had been treated with metformin monotherapy. Both were randomized placebo dose-controlled studies. Subjects were randomly assigned to receive placebo, 50mg of Shengliptin, or 100mg of Shengliptin.
The results showed that the reduction of HbA1c in the 50mg and 100mg dose groups at the end of the 24th week was 1.07% and 1.08%, respectively. In Shengglitin combined with metformin, the HBA1c decreased by 1.17% and 1.23% in the 50mg and 100mg dose groups at the end of the 24th week, respectively. At the same time, HBA1c dropped more sharply in patients with higher blood sugar levels in both trials.
In the subsequent 28-week trial of Shengglitin alone and in combination, data showed a sustained and steady reduction of HBA1c in subjects. At the same time, the 100mg dose group (high dose group) compared with placebo group showed good drug safety, and the incidence of adverse reactions was similar to that of placebo group.

Professor Ji Linong was speaking at the Peking University Diabetes Forum

Professor Gillinon said in his clinical summary: "Clinical trial data of Shengglitin 50mg low dose single drug and combination drug showed significant improvement of glycosylated hemoglobin in patients with different years of diabetes history, which has significant clinical significance. The drug also significantly improved beta cell function and reduced systolic blood pressure. In terms of drug safety, no additional safety issues were observed between Shengglitin and placebo. Therefore, Shengagliptin has a very good efficacy and safety, and we hope that it can soon provide more diabetes treatment drugs for our clinicians."
Professor Hong Tianpei, vice Chairman of Endocrinology Branch of Chinese Medical Association, who presided over the forum, also said on the spot: "As a Class 1.1 new drug independently developed by a Chinese company, Shengglitin has shown us very good clinical data, especially the exemption from phase II clinical trials directly into phase III clinical trials, and the impressive comparison between the two dose groups showed lower effective dose and safer advantages, so we look forward to the early launch of this product."
With the increasing popularity of DPP-4 inhibitors in China, the market size of such drugs (all imported) will reach nearly 10 billion yuan in 2022. At present, metformin combined with statins has become the main treatment scheme in the clinical application of type 2 diabetes. According to the research report of Sullivan, the market scale of statins in China will exceed 30 billion yuan by 2030, with a broad market prospect.
Mr. Ding Juping, co-founder and President of CGeneTech, said, "We are very pleased to see the therapeutic effect of Shengglietine developed by our company in clinical phase III, which is half the 'dosage' of 50mg dosage, and is expected to make it the best new hypoglycemic drug of its kind. I hope it can be approved for market as soon as possible, and benefit the vast number of diabetes patients in China as soon as possible."