New Information | Shengshi Taikе’s Hypoglycemic Compound Formulation Approved for Clinical Trials

Recently, Shengshi Taikе’s independently developed combination formulation of sengliptin phosphate and metformin hydrochloride has been approved for clinical trials, intended for type 2 diabetes patients whose glycemic control remains suboptimal despite monotherapy with metformin or who are already receiving dual therapy with the two agents. This represents another significant milestone in the company’s diabetes drug R&D pipeline, following the launch of sengliptin, a Class 1 innovative drug at the national level.

According to the United Kingdom Prospective Diabetes Study (UKPDS), after three years of treatment, 50% of patients with newly diagnosed diabetes require combination therapy to achieve glycemic targets. Moreover, even patients with very high baseline blood glucose levels often necessitate combination therapy to attain adequate glycemic control. In an exclusive interview with International Diabetes, Professor Shi Yongquan of Shanghai Changzheng Hospital stated: “Saxagliptin, owing to its outstanding efficacy, favorable safety profile, and flexible compatibility with other antidiabetic agents, holds broad clinical application prospects and plays a crucial role in diabetes management, providing a reliable foundational medication to meet diverse clinical needs.”

Senglitin, a next-generation, highly selective DPP-4 inhibitor independently developed by Shengshi Tech, was consecutively selected for the National “Major New Drug Development” programs during the 12th and 13th Five-Year Plans. Owing to the outstanding results demonstrated in its head-to-head Phase 1 clinical trial against the market-leading product in this class, it was granted an exemption from Phase 2 and proceeded directly to Phase 3, thereby pioneering the “Phase 2 waiver, direct Phase 3” approach in clinical trials for this therapeutic area.

In the Phase III clinical trial of senglitin, led by Professor Ji Linong, an internationally renowned diabetes expert, patients in the combination therapy group who had inadequate glycemic control on metformin monotherapy achieved a further, statistically significant reduction in HbA1c of 1.23% when senglitin was added. After 24 weeks of treatment, the proportion of patients with HbA1c levels below 7% increased to 51%, which was 3.5 times that of the placebo group, demonstrating superior efficacy in this class when used in combination. Based on these outstanding combination results, and with the aim of providing patients with a higher-quality, more convenient treatment option, the company promptly decided to develop a fixed-dose combination formulation of senglitin and metformin.

This combination formulation integrates two antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes, particularly those with insulin deficiency, insulin resistance, and excessive hepatic glucose output resulting from pancreatic β-cell dysfunction. It offers a more optimized therapeutic option for this patient population. The development of this product is expected to enable robust and sustained glycemic lowering while enhancing treatment adherence.

Shengshi Taikе is a biotechnology company in the commercialization stage, with a core team boasting decades of international experience across the entire lifecycle of pharmaceutical products. The company is committed to the R&D and industrialization of high-quality, differentiated innovative medicines. Leveraging an integrated drug-development technology platform and a diversified commercial vision, Shengshi Taikе has built a robust pipeline of innovative therapies spanning areas such as glucose-lowering, oncology, and autoimmune diseases. In the glucose-lowering segment, the company has established a comprehensive strategic footprint centered on diabetes and its associated comorbidities. Beyond traditional glucose-lowering agents, it is developing cutting-edge therapeutics for diabetic nephropathy, non-alcoholic fatty liver disease, weight loss and muscle gain—conditions for which effective treatments remain lacking worldwide—thereby poised to fill critical unmet clinical needs in these therapeutic areas.