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A smart diabetes drug—will the DPP-4 inhibitor senglutide eventually surpass its competitors?

A smart diabetes drug—will the DPP-4 inhibitor senglutide eventually surpass its competitors?

Since the National Medical Products Administration (NMPA) accepted Shengkeli’s New Drug Application for Shengglietin, its first-in-class innovative drug independently developed by Shengtaike, the product has garnered significant attention within the industry. Recently, the renowned industry publication *Beike She* seized this opportunity to provide a comprehensive overview of the rapidly growing DPP-4 inhibitor market in China, highlighting its promising prospects and vast potential—content we’d like to share with you today. Facing the high expectations from the industry, Shengtaike remains committed to delivering its product to market with a scientific and rigorous approach, seeing out the final "mile" of the development process. Diabetes mellitus (DM), as a chronic condition, continues to draw widespread attention. Diabetes medications have emerged as the second-largest pharmaceutical market segment, trailing only oncology drugs—and are now fiercely contested territory for pharmaceutical companies. With advancements in medical science, recent years have witnessed the emergence of novel therapies that differ significantly from traditional oral antidiabetic agents. Among these is the Dipeptidyl Peptidase-4 (DPP-4) inhibitor class, which now includes dozens of marketed drugs collectively known as "gliptin" medications. Looking ahead, the gliptin market in China is projected to surpass 30 billion yuan in size. --- ### Shengglietin: A Seven-Year Journey On February 2, Shengtaike submitted its New Drug Application (NDA) for Shengglietin, a DPP-4 inhibitor, to the NMPA. The application has already been accepted, marking the drug’s imminent entry into the Chinese market. Shengglietin is specifically designed for the treatment of type 2 diabetes. This milestone not only introduces a new player to the domestic DPP-4 inhibitor landscape but also solidifies Shengtaike’s position as a leader in this competitive field. Shengtaike’s official website promptly updated its product pipeline to reflect the ongoing progress of Shengglietin, confirming that its launch is now virtually assured. ![Pipeline Progress](https://www.shengtaike.com/images/pipeline-progress.png) *Source: Shengtaike Official Website* --- Shengglietin represents Shengtaike’s pioneering, first-in-class innovation—a flagship asset long anticipated within the company’s pipeline. From its inception to today, the journey has spanned seven transformative years, culminating in this groundbreaking achievement. The story begins in 2006, when sitagliptin, the world’s first targeted glucose-lowering drug, received FDA approval in the U.S., marking a landmark moment in the field. Ten years later, Shengtaike completed preclinical studies comparing Shengglietin head-to-head with sitagliptin, laying the groundwork for its future success. In early 2018, Shengtaike initiated Phase I clinical trials comparing Shengglietin directly with sitagliptin. Results from nearly 200 patients enrolled in this pivotal trial demonstrated that Shengglietin, at a dose of just 50 mg, exhibited DPP-4 inhibitory activity equivalent to 100 mg of sitagliptin. Notably, Shengglietin requires once-daily dosing, reaching peak levels within 1–2 hours after administration. Moreover, it boasts a longer half-life compared to sitagliptin, ensuring sustained blood sugar control over an extended period. For diabetic patients requiring long-term medication, safety remains the top priority for physicians when selecting a treatment. In safety assessments, Shengglietin showed minimal adverse effects on patients, even outperforming both the placebo group and the sitagliptin group. Additionally, despite its prolonged half-life, no evidence of drug accumulation was observed during the Phase I trials, underscoring Shengglietin’s exceptional selectivity and potent inhibitory properties. These compelling Phase I results provided strong confidence for advancing Shengglietin into larger-scale clinical studies. In 2019, Shengglietin earned a landmark regulatory breakthrough: the National Center for Drug Evaluation granted Shengtaike “Phase II Clinical Trial Exemption,” allowing the drug to proceed directly to Phase III validation trials. As a result, Shengglietin became the world’s first DPP-4 inhibitor to bypass Phase II testing entirely, relying instead on quantitative pharmacological modeling. This groundbreaking decision drew intense interest from diabetes experts both domestically and internationally. In October 2022, the Phase III clinical trial of Shengglietin reached its primary endpoint: at week 24, the 50-mg dose of Shengglietin significantly reduced HbA1c levels compared to the control group. Furthermore, the 100-mg dose maintained excellent safety profiles throughout the study, with adverse event rates comparable to those of the placebo group. Importantly, the trial demonstrated that halving the dosage still delivered efficacy equivalent to standard gliptin therapies—a key advantage that could enhance patient compliance and affordability. --- ### Shengglietin Approved: A Game-Changer for the Industry With the NMPA’s acceptance of Shengglietin’s NDA, Shengtaike is set to enter the highly competitive DPP-4 inhibitor market in China. This approval not only positions the company as a major contender in the $10-billion gliptin drug segment but also underscores Shengtaike’s commitment to addressing unmet medical needs in diabetes care. --- ### The Booming DPP-4 Inhibitor Market DPP-4 inhibitors work by blocking the DPP-4 enzyme, thereby preserving glucagon-like peptide-1 (GLP-1) and enhancing insulin secretion in a glucose-dependent manner while suppressing glucagon release. This mechanism helps improve beta-cell function without increasing the risk of hypoglycemia or weight gain—a critical advantage for diabetic patients. As the global demand for effective, safe, and convenient diabetes treatments continues to rise, DPP-4 inhibitors have become a cornerstone of modern therapeutic strategies. With their unique benefits and proven efficacy, these drugs are poised to play an increasingly vital role in managing type 2 diabetes worldwide.Moreover, DPP-4 inhibitors are a "gentle all-rounder"—they effectively lower blood sugar levels in a mild and versatile manner, while maintaining a strong safety profile. This makes them an ideal oral medication that can be safely combined with a wide range of other drugs throughout the entire course of diabetes management. As one of the leading classes of antidiabetic drugs today, DPP-4 inhibitors have become highly sought after by major pharmaceutical companies. Currently, there are five daily-administered DPP-4 inhibitors available in China: sitagliptin, vildagliptin, saxagliptin, alogliptin, and linagliptin—and all five of these "golden flowers" have been included in the National Medical Insurance Catalogue. Since being added to the national insurance program, sales of these products have seen significant growth. According to available data, from 2016 to 2022, the annual sales of DPP-4 inhibitors consistently increased, with the highest year-on-year growth rate recorded in 2018. In 2021 alone, domestic sales of DPP-4 inhibitors reached nearly 7 billion yuan. Sitagliptin Sitagliptin was the world's first approved oral DPP-4 inhibitor, developed by Merck & Co. It received FDA approval for marketing in October 2006 and was subsequently approved for use in China in September 2009. A combination formulation of sitagliptin was also approved for registration in China in July 2012. According to Merck’s annual report, sitagliptin has maintained a global market share of over $3 billion for the past four years, firmly securing its position as the top-selling DPP-4 inhibitor worldwide. Domestically, 14 pharmaceutical companies—including Zhengda Tianqing, Qilu Pharmaceutical, Kelun Pharmaceutical, and Zhejiang Medicine—have successfully replicated and obtained production approvals for this drug. Vildagliptin Vildagliptin, developed by Novartis, became the second DPP-4 inhibitor globally to receive regulatory approval. It was first approved by the European Commission in September 2007 and officially launched in China in August 2011. Novartis reports indicate that vildagliptin’s global sales have remained relatively stable in recent years, hovering around $1.1 billion. In China, generic versions of vildagliptin are also gaining immense popularity, with 18 pharmaceutical companies—including Qilu Pharmaceutical, Yangtze River Pharmaceutical Group, Jiangsu Hausen Pharmaceutical, Shandong Langno Pharmaceutical, and Nanjing Sunway Pharmaceutical—already approved for production. Vildagliptin has rightfully earned the title of the "domestic generic blockbuster" among DPP-4 inhibitors. Saxagliptin Saxagliptin was jointly developed by Bristol-Myers Squibb and AstraZeneca. It gained FDA approval in July 2009 and was approved for marketing in China in May 2011. Today, saxagliptin holds a global market share exceeding 20%. Domestically, five Chinese pharmaceutical companies—Zhengda Tianqing, Qilu Pharmaceutical, Jiangsu Ousikang Pharmaceutical, and others—have already secured approval for producing generic versions of this drug. Linagliptin Linagliptin was developed by Boehringer Ingelheim. It received U.S. FDA approval in May 2011 and is co-marketed by Boehringer Ingelheim and Eli Lilly. Linagliptin was approved for import registration in China in March 2013. The drug currently enjoys a global market share surpassing 15%. In China, six pharmaceutical companies—Guangdong Dongyangguang Pharmaceutical, Yangtze River Pharmaceutical Group, Kelun Pharmaceutical, and others—have been granted production licenses for their generic versions of linagliptin. Alogliptin Alogliptin was developed by Takeda Pharmaceutical Company of Japan. It was approved for marketing in Japan in April 2010 and received U.S. FDA approval in January 2013. In July of the same year, alogliptin was granted import registration in China. According to IQVIA data, alogliptin generated sales of 52.36 million yuan in the Chinese market in 2022. Currently, 11 pharmaceutical companies—including Yabao Pharmaceutical, Ruiyang Pharmaceutical, and Sinopharm Guorui Pharmaceutical—have been approved to produce this drug domestically. Looking at the domestic DPP-4 inhibitor market, it is dominated by both the original research drugs and their generic counterparts—the "five golden flowers." To break through this competitive landscape, pharmaceutical companies are increasingly investing in innovative, internally developed DPP-4 inhibitors. Currently, research and development of novel DPP-4 inhibitors are actively underway. Data shows that, aside from Shenggeletin from Shengshi Taikang—which recently received approval—several other innovative DPP-4 inhibitors (excluding combination formulations) have entered clinical trial stages in China. For instance, TQ-F3083 from Nanjing Shunxin of Zhengda Tianqing, Xingletin from Chenxin Pharmaceutical, and Bogletin from Shandong Baijidi Changzheng Pharmaceutical are all in Phase II clinical trials. Meanwhile, Fugletin from Xinlita, DBPR108 from Shiyao Group, HSK7653 from Hansoh Pharma, and Yougletin from Yuandong Bio are already in Phase III clinical trials. Notably, Regletin from Hengrui Medicine has already submitted its marketing application. Although the number of domestically developed DPP-4 inhibitors that have received official approval remains limited, the approval of Shenggeletin marks a significant milestone, positioning China’s innovative DPP-4 inhibitors to enter a period of rapid growth. This breakthrough not only challenges the dominance of non-domestic DPP-4 inhibitors but also bolsters the confidence of pharmaceutical companies dedicated to advancing DPP-4 inhibitor research and development. In conclusion, the vast potential of the diabetes market acts like a magnet, drawing pharmaceutical companies into the fiercely competitive yet promising arena of DPP-4 inhibitors in China. As the world’s and China’s first approved oral DPP-4 inhibitor, sitagliptin has reigned supreme in the Chinese market for over a decade. However, early-stage clinical trial results suggest that Shenggeletin outperforms sitagliptin significantly in terms of efficacy, safety, half-life, toxicity profiles, and pharmacological characteristics. With such compelling advantages, Shenggeletin is poised to become a best-in-class product in its class, potentially disrupting the current competitive landscape and reshaping the future of DPP-4 inhibitor innovation in China.Sheng Glietin is just one step away from market launch, and not only does Shengshi Taikang have high expectations for it, but the industry as a whole is also pinning great hopes on its success. The future looks bright for Sheng Glietin, and we eagerly anticipate the emergence of more domestically developed, innovative "Glietin" drugs in the years to come. References: 1. Shengshi Taikang Official Website & WeChat Account 2. "A New Weapon for Treating Diabetes (Part 1) — DPP-4 Inhibitors," Department of General Medicine, Shenzhen Hospital, The University of Hong Kong, December 9, 2020 3. "Unique Mechanism, Multidimensional Benefits — How DPP-4 Inhibitors Work and Their Clinical Applications," China Medical Forum Today, Endocrinology Edition, April 9, 2020 4. "New Player Expected to Join the DPP-4 Inhibitor Market: Can Shengshi Taikang Break the Dominance of the 'Big Five'?" Yidu Medicine, February 3, 2023 5. "Market Watch | Examining the Landscape of the DPP-4 Inhibitor Market After Dongyangguang's First Generic Anti-Diabetic Drug Withdraws from Online Platforms," CPHI Pharmaceutical Online, November 17, 2022

Time：2023-03-09 12:42

Shengshi Taikang's new diabetes drug, senglitinib, has received acceptance for its marketing application.

Shengshi Taikang's new diabetes drug, senglitinib, has received acceptance for its marketing application.

Today, Shengshi Taikang’s New Drug Application (NDA) for the DPP-4 inhibitor senglitin, submitted to the National Medical Products Administration (NMPA), has been accepted for review, marking its potential approval to treat type 2 diabetes.

Time：2023-02-02 17:19

Annual Inspection Report for the Experimental Animal License of the Suzhou Area, China (Jiangsu) Pilot Free Trade Zone

Annual Inspection Report for the Experimental Animal License of the Suzhou Area, China (Jiangsu) Pilot Free Trade Zone

Units holding experimental animal licenses must publicly display their annual inspection report for at least 5 working days within their own organization, and submit a screenshot of the public notice along with the inspection report to the Suzhou Area Administration of the Free Trade Zone.

Time：2022-12-28 16:18

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

"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 clinical trial of its DPP-4 inhibitor, senglitin, for the treatment of type 2 diabetes. The 50mg dose successfully met the pre-specified trial 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 in its class.

Time：2022-10-17 11:45

China-U.S. Dual Filing Scores Another Victory: Shengshi Taikang's Next-Generation ALK Inhibitor Approved for Clinical Trials in the U.S.

China-U.S. Dual Filing Scores Another Victory: Shengshi Taikang's Next-Generation ALK Inhibitor Approved for Clinical Trials in the U.S.

Today, Shengshi Taikang’s independently developed next-generation ALK inhibitor, CGT-9475, has received approval from the U.S. Food and Drug Administration (FDA) to enter clinical trials. This breakthrough drug is expected to address several critical clinical challenges in lung cancer treatment, such as drug resistance and brain metastasis. This marks another milestone for Shengshi Taikang, following the recent dual U.S.-China approval of its CXCR4 antagonist CGT-1881 for clinical trials—highlighting the company’s growing presence and innovation in global drug development.

Time：2022-08-09 15:50

Dr. Yu Qiang: Striking a balance between stability and innovation to develop high-quality, differentiated products.

Dr. Yu Qiang: Striking a balance between stability and innovation to develop high-quality, differentiated products.

Recently, Shengshi Taikang announced back-to-back approvals for two innovative drug candidates currently in development, marking the start of their global clinical development journey—both applications were submitted simultaneously in China and the U.S. Earlier this January, Shengshi Taikang’s first product, teriflunomide—a treatment for multiple sclerosis—received regulatory approval, officially propelling the company into its commercialization phase. Meanwhile, the company’s new diabetes drug, a DPP-4 inhibitor called fosdegrelin phosphate, has already entered the final stages of its Phase 3 clinical trials.

Time：2022-08-09 15:47

China's first domestically produced teriflunomide tablet hits the market, bringing new hope for ensuring access to treatments for rare diseases.

China's first domestically produced teriflunomide tablet hits the market, bringing new hope for ensuring access to treatments for rare diseases.

Today, the first domestically produced teriflunomide tablet developed by Shengshi Tai has been launched for sale. The initial batch of patients will benefit in key cities such as Beijing, Shanghai, Guangzhou, Chengdu, and Suzhou, with nationwide coverage expected to follow soon, providing a new treatment option and ensuring reliable drug supply for multiple sclerosis patients across China.

Time：2022-08-09 15:27

Shengshi Taikang Completes First China-U.S. Dual-Reporting New Drug Project, Embarking on Its Overseas Journey

Shengshi Taikang Completes First China-U.S. Dual-Reporting New Drug Project, Embarking on Its Overseas Journey

Today, CGT-1881, a CXCR4 antagonist independently developed by Shengshi Taikang, has received approval from the U.S. Food and Drug Administration (FDA) to enter clinical trials. The drug is intended for mobilizing hematopoietic stem cells in patients with blood cancers. This milestone follows the product’s clinical trial approval from China’s National Medical Products Administration (NMPA) back in June of this year, marking Shengshi Taikang’s first-ever dual-regulatory submission—both in China and the U.S.—for a new drug project.

Time：2022-07-12 15:31

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