"Get More Done with Half the Effort": Shengshi Taikang's Class 1 New Diabetes Drug, Senglidiptin, Unblinds with Promising Data

Today, Shengshi Taikang’s Class 1 novel antidiabetic drug has completed its pivotal clinical study: the Phase III trial of its DPP-4 inhibitor, senglitin, for the treatment of type 2 diabetes. The 50mg dose successfully met the pre-specified primary endpoint, and this "half-dose" approach not only achieves enhanced efficacy but also improves the drug’s safety profile, positioning it as a strong contender to become the best-in-class antidiabetic therapy available.

DPP-4, short for dipeptidyl peptidase-4, is seeing growing popularity as DPP-4 inhibitors become increasingly popular in China. In 2021, the market size for these drugs (all imported) reached nearly 7 billion RMB, with promising prospects ahead. Publicly available information indicates that these drugs not only inhibit DPP-4, preventing it from inactivating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), but also enhance insulin secretion. Additionally, they suppress glucagon release from pancreatic alpha cells, helping to boost insulin levels, lower blood sugar, and reduce the risk of hypoglycemia or weight gain—both common side effects associated with other diabetes treatments. Due to their mechanism of action aligning closely with the body’s natural processes for regulating blood glucose, experts have dubbed them "the smartest class of antidiabetic medications."

Shenggletin is a Class 1 innovative drug independently developed by Shengshi Taikang. As a novel oral DPP-4 inhibitor, it boasts advantages such as high selectivity and potent inhibitory activity. The compound was successively selected for China's 12th and 13th Five-Year Plans' "Major New Drug Development" initiatives and has been granted an exemption from Phase II clinical trials, allowing it to proceed directly into Phase III studies. Shengshi Taikang is currently conducting two pivotal Phase III clinical trials in China evaluating "Shenggletin for the Treatment of Type 2 Diabetes." Led by Professor Ji Linong, 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, The study components include the Phase III trial of sitagliptin tablets as a monotherapy and the Phase III trial of sitagliptin tablets in combination with metformin, with a total of approximately 1,000 type 2 diabetes patients enrolled.

The results from the Phase III clinical trial of senglitazone, now unblinded, show: The 50mg dose group of Sitagliptin tablets (low-dose group) achieved the primary clinical endpoint, with a significant reduction in HbA1c levels by Week 24, outperforming the control group. Additionally, the 100mg dose group of Sitagliptin (high-dose group) demonstrated excellent drug safety over the following 28 weeks, with an adverse event rate comparable to that of the placebo group. Following this, the company will promptly submit an application for Shengglietin's market approval to the National Medical Products Administration, in accordance with relevant national drug registration regulations, to bring early benefits to the vast number of diabetes patients in China.

Founded in 2010 in Suzhou Industrial Park, Shengshi Taikang boasts a core team with decades of international experience spanning the entire lifecycle of pharmaceutical products. The company is dedicated to the research, development, and commercialization of groundbreaking small-molecule innovative drugs aimed at delivering transformative therapies. Leveraging an integrated drug R&D technology platform and a diversified business perspective, Shengshi Taikang has built a robust pipeline of cutting-edge medicines, covering therapeutic areas such as diabetes management, cancer treatment, and rare diseases. In addition to sengagliptin, three of the company’s investigational anti-cancer drugs have already advanced into clinical trials—two of which have received U.S. FDA approval, marking a significant milestone in Shengshi Taikang’s journey to bring its innovative drugs to global markets.