2015 - 2016

Categories:History
Author:
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Time of issue:2016-03-09
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(Summary description)
◆ Winning support from the national major special fund duringthe12th Five-Year period for the project initialization of a Class 1 new drug, and the project was completed without any defects.
◆ Submittingapplications for clinical trials of severalClass3.1 new drugs.

2015 - 2016

(Summary description)
◆ Winning support from the national major special fund duringthe12th Five-Year period for the project initialization of a Class 1 new drug, and the project was completed without any defects.
◆ Submittingapplications for clinical trials of severalClass3.1 new drugs.

Categories:History
Author:
Origin:
Time of issue:2016-03-09
Views:0

Early Achievements

Previous: 2016 - 2018

Next: 2013 - 2015

Previous: 2016 - 2018

Next: 2013 - 2015

Milestones | Shengshi Taike's new generation DPP-4 inhibitor approved for market launch

Today, the official website of the National Medical Products Administration (NMPA) of China announced that Shengshi Taike's independently developed Class 1 innovative drug, saxagliptin phosphate tablets (formerly known as saxagliptin phosphate tablets), has been approved for market in China. This is a new generation of highly selective DPP-4 inhibitor, which is suitable for improving the blood sugar control of adult type 2 diabetes patients. According to the Guidelines for the Prevention and Treatment of Type 2 diabetes in China, the prevalence of diabetes among adults in China has risen to 11.2%, of which more than 90% are type 2 diabetes. In order to meet the huge clinical demand, some new drugs with different mechanisms of action from traditional oral hypoglycemic drugs have emerged in recent years. Dipeptidyl peptidase-4 (DPP-4) inhibitors are one of them. They not only improve hyperglycemia, but also are not easy to induce hypoglycemia and weight gain. They have the characteristics of rapid oral absorption, long half-life, and long-lasting effect, and are known as "smart" hypoglycemic drugs. Currently, they have been recommended by many domestic and foreign guidelines. As a new generation of highly selective DPP-4 inhibitor independently developed by Shengshi Taike, sengliptin has been continuously selected for the national "Major New Drug Development" special projects in the 12th and 13th Five Year Plans. Due to the excellent data demonstrated in the first phase clinical trial of the best product in the market, it was exempted from phase 2 clinical trials and directly entered phase 3 clinical trials, pioneering the "exemption from two to three" clinical trials in the field of this drug. The results of the phase III clinical trial of Sengliptin led by Professor Ji Linong, director of the Endocrinology Department of Peking University People's Hospital and director of Peking University diabetes Center, showed that in the single drug treatment trial of Sengliptin, the reduction values of HbA1c in the 50mg and 100mg dose groups at the end of the 24th week were 1.08% and 1.07% respectively; In the treatment trial of sengliptin combined with metformin, the glycated hemoglobin decreased by 1.23% and 1.17% in the 50mg and 100mg dose groups at the end of the 24th week, respectively. Meanwhile, both sets of experimental data showed that patients with higher blood sugar levels experienced a greater decrease in glycated hemoglobin levels. In addition to its excellent hypoglycemic effect, what is even more commendable is that in the comparison between the 100mg dose group (high-dose group) and the placebo group in the last 28 weeks, the incidence of adverse reactions of sengliptin is similar to that of the placebo group, and its safety further solves the common adverse reactions in marketed products. 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. Ding Juping, the co-founder and president of Shengshi Tyco, said: "I am very glad to see the company's self-developed product, Sengliptin Phosphate Tablets, has been approved for listing. This drug will be the best new hypoglycemic drug of its kind with half the effort and twice the treatment effect. I hope it will benefit the majority of diabetes patients in China as soon as possible after it is approved for listing." Dr. Yu Qiang, the founder and CEO of Shengshi Tyco, said: "Sengliptin's successful approval for listing benefits from Suzhou and the park as a fertile land for entrepreneurship and the strong support of many departments. It is also a" promise of gold "to use our innovative drugs to repay the business friendly services in Suzhou Park. At this moment, I would like to use an original poem to bless this new drug for its successful launch." Morimu's sounds of nature are listed in the palace. The morning light shines on the clouds, and the prosperous world welcomes the sunrise.

2024-12-05