Shengshi Taikang: The Molecular Designer and Their Business Vision

✔   Shengshi Taikang, renowned for its expertise in molecular design, focuses on optimizing DPP4 The inhibitor sitagliptin has been the subject of a head-to-head clinical trial against saxagliptin, and the company has also made several strategic moves in the diabetes space.

✔   Shengshi Taikе is also leveraging its "integrated drug R&D technology platform" to accelerate its strategic expansion into innovative oncology therapies.

✔   Shengshi Taikе pays close attention to business opportunities and possibilities, which is why the areas and directions involved tend to be quite diverse.

　 　In 2006, Merck’s sitagliptin was officially launched for diabetes treatment—making it the world’s first approved DPP4 inhibitor. At the time, Yu Qiang, co-founder and CEO of Shengshi Taikang, was running a U.S.-based company focused on applying fragment-based drug discovery technology to deliver drug precursor compounds. 　　After sitagliptin hit the market, Yu Qiang noticed that the product still had room for improvement in terms of its compatibility with its target, DPP4. Driven by this discovery, Yu Qiang’s company synthesized numerous compounds targeting the same enzyme and compared them with the publicly available data on sitagliptin. Ultimately, these compounds all demonstrated comparable efficacy to sitagliptin, prompting Yu Qiang to realize that this might be the right path—and that there was clear potential for further optimization.
　　A molecule with optimization potential in a promising therapeutic area became the catalyst for the founding of Shengshitaike. In 2010, Yu Qiang returned to China and, together with Ding Juping, established Shengshitaike in Suzhou. Leveraging its strength in molecular design, Shengshitaike has conducted head-to-head clinical trials comparing its optimized DPP4 inhibitor, sengliflozin, directly with sitagliptin—and has since strategically expanded into multiple areas of diabetes research. Behind the company’s extensive product pipeline, which now spans diabetes, cancer, rare-disease generics, and even Type 2 improved-drug candidates, lies a clear vision and well-structured approach that enable Shengshitaike to seize lucrative business opportunities.

　　Advanced Shengglitine

　　Clearly, from its inception, Shengshi Taike has prioritized optimized DPP4 inhibitors as a key strategic direction.
　　After designing, synthesizing, testing, and optimizing nearly 50 compounds in total, Shengshi Taikang identified Shengglitine and has now entered the pre-clinical development phase.
　　Yu Qiang stated that Shengshi Taikang aims to develop a DPP4 inhibitor that is superior to all others in its class. Therefore, throughout the entire development process of shengglitine—spanning both preclinical and clinical studies—it has consistently been compared head-to-head with sitagliptin, the earliest-market and best-selling drug in this therapeutic area.
　　"Chronic conditions require long-term medication, and when it comes to diabetes treatments, safety and efficacy remain the two key factors. In these areas, senglitagliptin is highly comparable to sitagliptin, with senglitagliptin even demonstrating slight advantages in certain indicators," Yu Qiang told Researcher.
　　In terms of safety, both preclinical and clinical study data indicate that senglutide demonstrates a better safety profile compared to sitagliptin. Senglutide was associated with adverse reactions similar to the placebo group—primarily side effects related to its target mechanism—and notably, no cases of joint pain, a known side effect of sitagliptin, were observed. Additionally, when it comes to the incidence of adverse events, neither senglutide nor sitagliptin showed any serious adverse events (SAEs), though senglutide appeared to have a slightly lower overall rate of AEs compared to sitagliptin.
　　In terms of efficacy, a Phase I head-to-head clinical study demonstrated that 50 mg of senglutide achieved the same blood glucose control levels as the approved dose of sitagliptin (100 mg), while also boasting a longer drug half-life compared to sitagliptin. Using 50 mg as the final dose for senglutide means the product offers a wider safety margin, fewer side effects, and lower costs.
　　Shengglitine completed preclinical studies in 2016 and officially entered the clinical phase in early 2018. Currently, Phase III clinical trials are underway. Notably, in November 2019, Shengglitine received approval from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration, allowing it to skip Phase II and proceed directly to Phase III trials. This decision has been a key factor driving the product’s rapid advancement in clinical development.
　　According to Yu Qiang, achieving a Phase II clinical trial exemption requires more detailed planning and robust data from the earlier stages. First, the Phase I clinical trial of senglitazone enrolled 194 participants—a notably large sample size—which will yield comprehensive data, enabling a thorough assessment of the product’s safety profile. Second, the Phase I study already included a head-to-head comparison with sitagliptin, with separate cohorts for healthy individuals and patients, adding significant credibility to the findings. Finally, Shengshi Taikang collaborated with Professor Jiang Ji from Peking Union Medical College Hospital, leveraging his advanced quantitative pharmacology platform. By integrating this cutting-edge technology with the Phase I clinical data of senglitazone, they successfully simulated optimal dosing schedules, drug concentrations, and the resulting glycemic control and safety outcomes for the planned Phase II clinical trial.
　　After completing this series of preparations, Shengshi Taikang submitted both Phase I data and Phase II simulation data to the CDE. Following a comprehensive review by two CDE departments—Pharmacodynamics & Safety, and Pharmacokinetics—the company was granted an exemption from holding an expert meeting. As a result, the product has been approved to skip Phase II clinical trials and proceed directly to Phase III clinical studies.
　　In accordance with the requirements of the National Medical Products Administration—specifically, efficacy studies must be conducted over six months, while safety studies require one year—Shengshi Taikang has developed the Phase III clinical trial plan for its product. Shenggeletin is currently undergoing two separate Phase III clinical trials: one as a monotherapy and the other in combination with metformin. These trials are being actively rolled out across more than 120 hospitals nationwide, with an anticipated enrollment of approximately 1,000 patients in total. Both Phase III studies will share some overlapping patient cohorts to evaluate safety at higher dose levels, ensuring a robust assessment while also exploring innovative and cost-effective clinical approaches. Currently, partial patient enrollment for these Phase III trials has already been completed.
　　It is understood that the Phase III clinical trial for senglitinib is scheduled to wrap up in mid-2022, with an anticipated New Drug Application (NDA) submission by July of the same year.

　　A Diabetes Treatment Cohort Centered on DPP4

　　Type 2 diabetes treatment strategies are closely tied to the progression of the disease itself. Typically, therapy begins with dietary control and increased physical activity. The first-line oral medication of choice is metformin, followed by the possible standalone use of DPP4 inhibitors. As the condition advances, combining DPP4 inhibitors with either metformin or SGLT-2 inhibitors—either as a dual or triple therapy—may be considered. In more advanced stages, injectable GLP-1 receptor agonists or insulin therapy could then be introduced. 　　It is evident that DPP4 inhibitors play a crucial role in diabetes treatment. According to a report released by Evaluate, the global market for diabetes drug therapies reached $46.1 billion in 2017, with DPP-4 inhibitors and their combination products accounting for $13.438 billion in global sales—representing 29.28% of the total market share. Additionally, based on Merck’s annual report, the best-selling drug sitagliptin, along with its combination formulation containing metformin, generated sales of $5.52 billion in 2019 alone.
　　Given the significant importance and market potential of DPP4 inhibitors, Shengshitaike’s strategic focus in the diabetes treatment space is primarily centered around its DPP4 inhibitor, sotagliflozin. According to Yu Qiang, the company currently has a combination product in its pipeline—sotagliflozin paired with metformin—that is already in the pre-clinical research phase. Looking ahead, the company may also explore developing a combination product that includes an SGLT-2 inhibitor, or even a triple-combination therapy featuring sotagliflozin, an SGLT-2 inhibitor, and metformin. Additionally, the company plans to introduce an oral GLP-1 receptor agonist, with pre-clinical studies expected to begin next year. This comprehensive approach effectively covers all key therapeutic targets for oral diabetes medications.
　　Currently, Merck’s sitagliptin, Takeda’s alogliptin, Boehringer Ingelheim’s linagliptin, AstraZeneca’s saxagliptin, and Novartis’s vildagliptin—five single-agent DPP4 inhibitors—are already available in the Chinese market. Additionally, four combination products—including sitagliptin metformin tablets, metformin vildagliptin tablets, linagliptin metformin tablets, and saxagliptin metformin extended-release tablets—have been approved for launch in China. Meanwhile, several generic versions of these drugs have also begun entering the market one after another. In 2017, all five original-brand single-agent DPP4 inhibitors were included in China’s National Medical Insurance Catalogue. Since being added to the insurance list, sales of these products have seen significant growth across the board.
　　When asked about his perspective on the intense competition in the market and how Shenglidi will approach its commercialization strategy amid this rivalry, Yu Qiang noted that, on one hand, the five original research products currently available in China have varying sales performances, with the main competitors concentrated among just two or three of them—among which sitagliptin enjoys the highest sales volume. In contrast, Shenglidi features a smaller dosage and lower production costs compared to sitagliptin, giving it greater flexibility in adjusting prices. On the other hand, Shenglidi’s Phase III clinical trial is being conducted across more than 120 clinical centers nationwide, laying a solid foundation early on to build strong physician awareness—and ultimately establishing a robust platform for effective product promotion.

　　Continuing to leverage molecular design advantages in the cancer field

　　In addition to the faster-progressing sotagliflozin, Shengshi Taikang is also leveraging its "integrated drug R&D technology platform" to accelerate its efforts in developing innovative oncology therapies.
　　In China's emerging pharmaceutical R&D market, cancer and diabetes together account for approximately 90% of the sector, with cancer alone making up as much as 70%. The substantial size of this market is one of the key reasons why Shengshi Taikang is focusing heavily on cancer research and development.
　　In the cancer treatment field, where innovative pharmaceutical companies are flocking, Shengshi Taikang’s strategies and competitive edge warrant careful examination.
　　In Yu Qiang's view, the primary advantage of small-molecule chemical drugs lies in their molecular design—factors like efficacy and safety are closely tied to how these molecules are engineered. Meanwhile, Shengshi Taikang’s core team consists of four members, all of whom come from Peking University’s Department of Chemistry, a department renowned for its exceptional expertise in molecular design. As a result, the company is leveraging its team’s deep understanding of molecules as it strategically builds its cancer-focused product pipeline—using this advantage to design even better, more effective molecular structures from the ground up.
　　When it comes to selecting specific products for development, Shengshi Taikang adheres to several key principles: It focuses on target areas where either a product is already on the market or another is actively in development—this is because first-in-class products typically carry higher risks, and the company has previously experienced setbacks in early-stage target development. Additionally, given the challenge of small-molecule oncology therapies competing directly with antibodies like PD-1/L1, the company is concentrating on mutation types where tumor-immune antibodies struggle to deliver effective results, while also exploring opportunities for combination therapies that could enhance treatment outcomes when used alongside antibodies. Finally, the company identifies molecules with room for improvement, using sotagliflozin as the benchmark for such advancements.
　　Currently, three products in Shengshi Taikang's oncology pipeline have been identified as clinical candidate compounds (PCCs), with two already in the patent-writing stage and one having completed its patent application. All three are expected to kick off formal preclinical studies as soon as possible. In April of this year, Shengshi Taikang also partnered with Yunxuan Pharma, securing global exclusive rights for the development and commercialization of a preclinical-stage chemokine receptor type 4 (CXCR4) antagonist from Yunxuan Pharma. This promising compound holds potential for treating conditions such as cancer and autoimmune diseases.

　　A Business Perspective Under Diverse Pipeline Strategies

　　In fact, Shengshi Taikang’s product pipeline includes not only innovative drugs in the diabetes and oncology fields, but also first-to-market generic versions of rare-disease treatments and Class 2 improved products—seemingly a bit "diverse" in focus.
　　When Shengshi Taikang was first established, domestic investment in the pharmaceutical sector was still relatively tepid, leaving the company facing its most immediate challenge: survival. To navigate this critical period, before 2015, Shengshi Taikang had no choice but to pursue a diversified growth strategy—expanding into areas like developing pharmaceutical intermediates and Class 3 drugs. In 2015, the company even managed to overcome a financial crunch by selling the marketing approval for its Class 3 drug, asenapine.
　　In addition to the survival challenges left over from its history, considerations of R&D strategy also drive the company’s diversification of product lines.
　　Yu Qiang noted that many biotech companies abroad are founded by doctors or researchers, and these companies typically focus on highly specialized areas of research. In contrast, Shengshi Taikang pays close attention to commercial opportunities and possibilities, which is why its areas of focus and research directions tend to be broader and more diverse.
　　The development of the first generic version of teriflunomide is a prime example of how business opportunities can drive innovation.
　　In 2014, just as the Ice Bucket Challenge sparked global attention on the rare disease amyotrophic lateral sclerosis (ALS), Shengshi Taikang officially initiated a project to develop the first generic version of teriflunomide, a treatment for multiple sclerosis. Given the small patient population and limited market size—factors that typically make rare-disease generics less prioritized in China—Shengshi Taikang keenly recognized the opportunity lying within this niche area.
　　In 2016, the company received clinical approval for its product; however, due to policy requirements at the time mandating confirmatory clinical trials—which would have cost tens of millions—Shengshi Taikang temporarily put product development on hold after completing all necessary technical preparations. It wasn’t until May 2018 that five ministries jointly released the first-ever Rare Disease Catalogue, which included multiple sclerosis. As a result, teriflunomide was subsequently added to the priority review list, creating favorable regulatory conditions that allowed the company to streamline the development process by leveraging existing overseas clinical data—essentially requiring only a consistency evaluation. Just days after the release of the new catalog, Shengshi Taikang immediately reactivated its teriflunomide project, swiftly advancing through process validation and manufacturing of both the active pharmaceutical ingredient and the final dosage form, before initiating the consistency evaluation. According to Yu Qiang, the NMPA mandates that the human pharmacokinetic (PK) profile of these products must align with the originator drug within an 80%–120% range. Notably, Shengshi Taikang’s first-to-market generic version achieved consistency levels of 98%–102%, closely matching the reference standard. In February 2020, the NMPA officially accepted the product’s marketing application.
　　Currently, there are only two drugs available in China for treating multiple sclerosis. Among them, the original drug teriflunomide was approved for marketing in 2018 and became the first oral medication of its kind. In 2019, teriflunomide was included in China's national medical insurance program. As rare diseases and their treatments increasingly gain attention across the country, the market potential is clearly promising.
　　There are also similar opportunities in the area of Class 2 improved products. When Shengshi Taikang was founded, it introduced a lyophilized rapid-release formulation platform—technology that enables products to be absorbed directly under the tongue. Leveraging this platform, the company developed Asenapine, a Class 3 drug, which became the only product among the seven companies that submitted applications at the time to achieve complete consistency with the original research formulation. This discovery prompted Yu Qiang to recognize the platform’s distinct competitive advantage, leading him to decide to build a new platform for Class 2 improved new drugs based on this cutting-edge technology.
　　However, due to production challenges, Shengshi Taikang's Class 2 improved new drug platform was temporarily put on hold. It is understood that the company is now planning to build a formulation facility to handle in-house manufacturing. Once these production issues are resolved, the company expects to resume submitting applications for its Class 2 improved new drugs as early as late this year or at the latest by early next year.

　　Source: R&D Guest, Author: Cheng Haohong