What makes the promising new diabetes drug, senglutide—poised to become the best-in-class—so exceptional?

　　Last month, Shengshi Taikang Biopharmaceutical Technology (Suzhou) Co., Ltd. announced the completion of its Pre-A round of financing, noting that its flagship product, Shengeteglin, is poised to become a best-in-class drug in its category.
　　Saxagliptin is a novel antidiabetic drug belonging to the class of DPP-4 inhibitors, which are part of the incretin-based therapies. Since Merck introduced sitagliptin, the world's first DPP-4 inhibitor, to the U.S. market in 2006, DPP-4 has virtually become the hottest target in the development of new diabetes treatments. Over just a few years, several top-10 pharmaceutical companies have successfully developed multiple new DPP-4 inhibitors—each representing incremental advancements over sitagliptin—in terms of efficacy, formulation, and minimizing side effects.
　　In China, despite the availability of five imported DPP-4 inhibitor drugs already on the market and covered by medical insurance, DPP-4 inhibitors remain the most fiercely contested battleground for the country's strongest pharmaceutical companies vying for R&D leadership. According to an incomplete tally by Arterial Network, more than 10 pharmaceutical firms—including Hengrui, Xinlitai, Shengshitaike, and Haishike—have advanced 12 domestically developed DPP-4 inhibitor candidates into clinical trials, making the competition undeniably intense.
　　However, Dr. Yu Qiang, founder of Shengshi Taike, emphasized that the phrase "expected to become Best in Class" was a carefully chosen expression he decided to include in the press release after much deliberation. Recently, Arterial Network conducted an exclusive interview with Dr. Yu, during which he shared his entrepreneurial journey and revealed the source of his confidence in shengliruetin.

　　 A chemist who doesn’t want to work on new drugs isn’t a good boss.

　　Like most entrepreneurs currently active in the pharmaceutical industry, Dr. Yu Qiang also carries the hallmarks of being a returnee with advanced degrees and extensive hands-on experience. However, unlike others who might first focus on identifying a business opportunity or seeking angel investment, Dr. Yu’s very first step upon returning to China was to file an invention patent application for the molecular formula of the sengliflozin drug precursor he had brought back with him.
　　In 2009, Yu Qiang returned to China with funding and his team. By 2010, he established his new company, Shengshi Taikе, at the BioNano Science and Technology Park (BioBay) in Suzhou Industrial Park. At the time, the young BioBay was just getting off the ground, but its team’s expertise and enthusiasm deeply impressed Yu Qiang. Describing his first impression of joining BioBay, he said, "We visited many parks across China, but BioBay felt like the perfect place to bring our ideas to life."
　　During his 9 years at BioBAY, Dr. Yu experienced both the darkest moments—when there was barely enough funding to invest in new drug development—and the exhilarating joy of advancing sengliflozin from a drug precursor molecule weighing less than 400 daltons all the way to a groundbreaking new diabetes treatment, culminating in a massive Phase 1 clinical trial involving an impressive 194 participants.
　　Today, Shengshi Taikang has become a well-known domestic developer of small-molecule drugs, having established a robust pipeline spanning from the research and development of Class 1 new drugs and the development of Class 2 fast-release formulation platforms to the creation of Class 3 first-generic drugs. This diverse portfolio covers a wide range of therapeutic areas, including cancer, diabetes, mental health disorders, and rare diseases.
　　Yu Qiang earned his bachelor’s degree from the Department of Chemistry at Peking University, holds a PhD in Chemistry from the University of Kansas, and completed his postdoctoral research at the University of Kansas under the mentorship of Professor Ronald Borchardt, who serves as the President of the American Association of Pharmaceutical Scientists (AAPS). This experience has given him a unique perspective on evaluating the bioavailability of pharmaceuticals.
　　Before returning to China, Dr. Yu founded a new drug fragment-molecule company in the U.S., providing early-stage drug molecule R&D services to major U.S. pharmaceutical and biotech firms.
　　At the end of 2006, sitagliptin (generic name: Januvia) received FDA approval for marketing in the United States. For type 2 diabetes, a condition that still lacks a definitive cure, the launch of this targeted therapy was undoubtedly a landmark event. Sitagliptin quickly became one of the fastest-growing new drugs in terms of sales after its introduction, and it also set a record as the fastest-ever new drug to surpass $1 billion in annual sales. Today, it holds over 15% of the U.S. diabetes medication market. Since then, companies like Novartis, Bristol-Myers Squibb, Eli Lilly, and Takeda Pharmaceutical have followed suit, introducing their own DPP-4 inhibitors—such as vildagliptin, saxagliptin, alogliptin, and linagliptin—that operate via the same mechanism.
　　At that time, Yu Qiang, who was already involved in the research and development of drug precursors, also began focusing on DPP-4 (dipeptidyl peptidase IV) inhibitors. After a meal, the small intestine releases incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate beta cells to secrete insulin, thereby helping to lower blood sugar levels. However, DPP-4 enzymes present in the bloodstream quickly break down GLP-1 and GIP, rendering these incretins ineffective—a phenomenon particularly common among patients with type 2 diabetes. DPP-4 inhibitors work by blocking the activity of DPP-4, preserving the beneficial effects of incretins and preventing post-meal spikes in blood glucose levels in people with type 2 diabetes.
　　After conducting research, Yu Qiang discovered that modifying the right-hand molecular structure in the two formula combinations of sitagliptin significantly enhanced its DPP-4 inhibitory activity. Building on this insight, he leveraged the company’s platform to design more than 20 modified DPP-4 inhibitor precursor compounds, which were subsequently marketed for external sale. These precursor compounds quickly became a vital "ammunition" for first-tier U.S. researchers developing DPP-4 inhibitors, leading to strong sales and earning Yu Qiang a substantial income.
　　However, making a profit wasn’t his primary goal in selling these precursor compounds. Instead, Yu Qiang hoped to identify the most promising DPP-4 inhibitor precursor structure by gathering feedback from the specialized market. Two months later, he discovered the structurally optimal DPP-4 inhibitor precursor under the given conditions—what would eventually become the precursor to sotagliflozin.
　　Probably every chemist harbors a medicinal chemist within. Yu Qiang quickly wrapped up his career in the U.S. and devoted all his energy to studying the drug-like properties of this promising precursor compound. But transforming a precursor into a lead compound—and ultimately advancing through preclinical and clinical trials—requires extensive drug-development efforts. That’s why Yu Qiang brought in Mr. Ding Juping, who previously led the successful development and submission of dozens of nationally recognized new drugs. Ding holds a Bachelor’s degree in Chemistry from Peking University and a Master’s degree in Pharmaceutical Chemistry from China Medical University’s Peking Union Medical College. His expertise has accelerated the preclinical research phase of senglitazone, putting the project on a fast track to potential breakthroughs.

　　 Creating the best Me-Too new drug

　　“It’s very easy to be different, but very difficult to be better (Differentiation is simple, yet optimization is tough).” Becoming Best in Class has always been Dr. Yu Qiang’s unwavering expectation for Shengglitagliptin from the very beginning.
　　In 2016, Shengshi Taikang completed preclinical studies comparing senglitin with sitagliptin head-to-head, evaluating parameters such as efficacy, safety, half-life, toxicology, and pathology. The results demonstrated significantly superior performance compared to sitagliptin, leading to the initiation of Phase I clinical trials in early 2018.
　　In July 2019, the Phase I clinical trial comparing senglitagliptin head-to-head with sitagliptin was completed. Dr. Yu Qiang told Arterial Network that choosing to directly pit senglitagliptin against a star DPP-4 inhibitor like sitagliptin in a head-to-head study during Phase I was, in fact, a highly risky move. After all, failing to demonstrate superior glucose-lowering efficacy and safety compared to sitagliptin would essentially mean senglitagliptin’s immediate exit from the new drug development arena.
　　However, Dr. Yu has full confidence in senglitagliptin: "Our goal is to be the best in our class—so we have no choice but to outperform the top-tier drugs in head-to-head comparisons." In 2016, sitagliptin already accounted for nearly half of the sales of DPP-4 inhibitors in key domestic hospitals, and direct comparative data against sitagliptin would carry significant market credibility. Thanks to his persistence, the Phase I clinical trial of senglitagliptin enrolled 194 patients, successfully completing a comprehensive study that evaluated safety, efficacy, and drug-related factors.
　　Phase I clinical trial data show that when the dose of senglutide reaches 50 mg, it already achieves DPP-4 inhibitory activity equivalent to that of 100 mg sitagliptin. Senglutide is administered once daily, reaching peak levels within 1 to 2 hours after dosing, and boasts a longer half-life compared to sitagliptin, enabling more sustained maintenance of stable blood glucose control over time.
　　In safety studies, data indicate that sitagliptin intake resulted in virtually undetectable adverse effects on patients' bodies, falling below both the placebo group and the sitagliptin group. Since diabetes often requires long-term medication, safety is the primary factor doctors consider when selecting a drug for prescription. Additionally, despite sitagliptin's long half-life, Phase I clinical trials revealed no evidence of drug residues accumulating in the body over time.
　　In the verification of drug interactions between sotagliflozin and metformin, the most widely used non-insulin antidiabetic medication in China, sotagliflozin showed no significant interaction with the latter.
　　Dr. Yu Qiang pointed out that although domestic pharmaceutical companies have been conducting research on new domestically produced DPP-4 inhibitors for quite some time, breakthroughs have been scarce—making drug safety control the biggest bottleneck hindering the advancement of clinical studies. "Notably, rash remains a widespread and unresolved side effect associated with these domestically developed DPP-4 inhibitors." However, in nearly 200 patients who completed the Phase I clinical trial for sengliflozin, not a single participant experienced a rash. It is precisely this promising Phase I data that has enabled Shengshi Taikang to move forward with initiating the late-stage clinical trials for sengliflozin. As a result, Shengshi Taikang is poised to become the fastest-moving developer of a new DPP-4 inhibitor among its domestic peers.
　　Diabetes is one of the most widespread chronic diseases globally, and China has the largest number of diabetes patients in the world. According to statistics, by 2017, the country’s diabetic population had already reached 114 million, marking a shift from an explosive growth phase into a more stable period—yet this transition has also resulted in a significant accumulation of long-term, untreated cases. However, the domestic diabetes drug market remains highly unique: fewer than one-quarter of patients with diabetes adhere to their prescribed medication regimens, while high-risk drugs like insulin and biguanide-based medications continue to dominate the treatment landscape despite their pronounced side effects. Data reveals that in major urban hospitals across China, the usage rate of newer-generation antidiabetic drugs—such as DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT-2 inhibitors—remains below 10% of all diabetes prescriptions.
　　As new drugs like DPP-4 inhibitors continue to be included in basic medical insurance and various treatment guidelines, market demand for them will gradually unlock.

　　 The "self-hematopoiesis" model combining innovation with imitation

　　Unlike new pharmaceutical companies founded by biologists and pharmacologists, which typically focus on vertical research in specific therapeutic areas, Dr. Yu Qiang’s Shengshi Taikang boasts a more extensive pipeline for drug development.
　　"Survival is the most critical issue for innovative pharmaceutical companies." Developing new drugs requires massive financial investments and often spans an extremely long timeline. Relying solely on external funding could easily lead to drug development being stalled under immense cash-flow pressure. In Dr. Yu's view, abandoning ongoing research pipelines would not only deal a fatal blow to the company itself but also betray the trust of investors.
　　Looking back after many years, choosing to focus on the research and development and sales of generic drugs with higher technological barriers not only brought cash flow to the company, helping it weather the most challenging period from 2014 to 2016—when R&D investments were at their peak—but also played a key role in enhancing the team's overall R&D capabilities.
　　After building up its generic drug development capabilities, Shengshi Taikang’s technical team now possesses a solid foundation in pharmaceutical R&D. "Rather than equipping our team with the most cutting-edge technologies, we’ve chosen to leverage our relatively mature drugs and expertise." Currently, several of Shengshi Taikang’s first-to-market generic drugs for rare diseases have already been licensed out to other companies or have advanced into clinical trials.
　　Dr. Yu Qiang noted that the company will further intensify its efforts in developing innovative anti-cancer drugs, aiming to build R&D capabilities comparable to those for diabetes treatments.