Shengshi Taikang's new diabetes drug, senglitinib, has received acceptance for its marketing application.
Release date:
2023-02-02
Today, Shengshi Taikang submitted its application to the National Medical Products Administration (NMPA). Submitted to the NMPA DPP-4 inhibitor The marketing authorization application for senglatagliptin NDA has been accepted for the treatment of Type 2 Diabetes 。
Publicly available information indicates that, DPP-4 ( Dipeptidyl peptidase -4 ) Inhibitors can not only suppress DPP-4 , preventing it from affecting Glucagon-like peptide -1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) Conduct Inactivated, Thus Promote insulin Release , Moreover It can also suppress the islets. Alpha cells secrete glucagon, which helps raise insulin levels, lower blood glucose, and is less likely to trigger hypoglycemia or cause weight gain. These drugs' mechanism of action aligns with the body's natural process of regulating blood sugar, earning them the title of "expert-approved." "The smartest diabetes medication."
Shenggledipin is independently developed by Shengshitaike. Category 1 Create New drug, As A new type of oral DPP-4 inhibitors exhibit high selectivity and potent inhibitory activity. Such advantages. As DPP-4 inhibitor Growing increasingly popular domestically, In 2021, the market size for these drugs (all imported) reached nearly 7 billion RMB. 。 Currently, metformin combined with GLP-1 receptor agonists has become the primary treatment regimen in clinical practice for type 2 diabetes. According to a report by Sullivan Research, by 2 In 2030, gliptin drugs will be available in China. Breakthrough 300 An industry-scale market worth billions , It has vast market potential.
Sheng Gliflozin successively Selected as a candidate for China's 12th and 13th Five-Year Plans "Major New Drug Development" Special Project And Exemption Phase II clinical trials directly advance to Phase III trials. . Filing N DA Previously, Shengshi Taikе Two initiatives have been launched in China. "Sheng Glitidine" Treatment Type 2 Diabetes ” The key III Phase III clinical trial, Prof. Li-Nong Ji, Director of the Department of Endocrinology at Peking University People's Hospital, Director of the Peking University Diabetes Center, and former President of the International Diabetes Federation's Western Pacific Region, will serve as Leading PI Sheng Glitiglin I II Phase clinical Experiment Unblinding The results show :50 mg dose group (low-dose group) Chapter 24 Weekend glycated hemoglobin HbA1c ) Lower the value Achieve Main clinical End point , Significantly better than Comparison Group. Afterward 28 Zhou's Sitagliptin 100 The mg dose group (high-dose group) demonstrated excellent drug safety, with a low incidence of adverse reactions. Similar to the placebo group.
Founder and CEO of Shengshi Taike C EO Dr. Yu Qiang stated: “Currently in China The total population with diabetes exceeds 110 million—there’s still a gap compared to European and American countries in terms of targeted drug therapies under the new mechanism. Company-developed Shengge Lieting Clinically The treatment's "efficiency multiplier" effect holds promise, potentially making it the best-in-class drug for blood sugar control. , hoping it will soon receive approval for market release, bringing timely benefits to the vast number of diabetes patients in China. 。 Meanwhile, Currently, the internationally licensed patents for sotagliflozin extend its protection until In 2038, nearly 15 years Internally not included Centralized Procurement The worry , Longer Will become blood sugar-lowering throughout the lifecycle Medication The mainstream in the field. ”
Shengshi Taikе on Founded in 2010 in Suzhou Industrial Park, the core team boasts decades of international experience across the entire lifecycle of pharmaceutical products. The company is dedicated to the research, development, and commercialization of innovative small-molecule drugs aimed at delivering breakthrough therapies. Leveraging an integrated drug R&D technology platform and a diversified business perspective, the company has built a robust pipeline of cutting-edge drug candidates spanning multiple therapeutic areas, including diabetes management, cancer treatment, and autoimmune diseases. In addition to sengliptin, four of the company’s oncology drugs in development have already advanced into clinical trials—two of which have even received U.S. FDA approval, marking a significant milestone in the global expansion of the company’s innovative medicines.