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The listing application of CGeneTech's new hypoglycemic drug Shenggliptin was accepted

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  • Time of issue:2023-02-02
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(Summary description)Today, Shengshi Tyco has accepted the marketing application (NDA) of Shenggliptin, a DPP-4 inhibitor, submitted to the National Drug Administration (NMPA) for the treatment of type 2 diabetes.

The listing application of CGeneTech's new hypoglycemic drug Shenggliptin was accepted

(Summary description)Today, Shengshi Tyco has accepted the marketing application (NDA) of Shenggliptin, a DPP-4 inhibitor, submitted to the National Drug Administration (NMPA) for the treatment of type 2 diabetes.

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2023-02-02
  • Views:0

Today, CGeneTech has accepted the marketing application (NDA) of Cetagliptin, a DPP-4 inhibitor, submitted to the National Drug Administration (NMPA) for the treatment of type 2 diabetes.

Public data show that DPP-4 (dipeptidyl peptidase-4) inhibitor can not only inhibit DPP-4, prevent it from inactivating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin-promoting polypeptide (GIP), thus promoting insulin release, but also inhibit pancreatic islets α Cells secrete glucagon, increase insulin level, reduce blood sugar, and are not easy to induce hypoglycemia and weight gain. The mechanism of action of these drugs is consistent with the mechanism of human physiological regulation of blood sugar, and experts call them "the most intelligent hypoglycemic drugs".

Cetagliptin is a class 1 innovative drug independently developed by CGeneTech. As a new oral DPP-4 inhibitor, it has the advantages of high selectivity and strong inhibition. With the increasing popularity of DPP-4 inhibitors in China, the market scale of such drugs (all imported) will be nearly 7 billion yuan in 2021. At present, metformin combined with leptin has become the main treatment scheme in the clinical application of treating type 2 diabetes. According to Sullivan's research report, by 2030, the market size of leptin in China will exceed 30 billion, with broad market prospects.

Cetagliptin has been listed in the "major new drug development" special projects of the 12th and 13th Five-Year Plan of the People's Republic of China, and has been exempted from phase II clinical trials directly entering phase III trials. Before applying for NDA, CGeneTech carried out two key phase III clinical trials of "Cetagliptin for treatment of type 2 diabetes" in China. Professor Ji Linong, director of the Endocrinology Department of Peking University People's Hospital, director of Peking University diabetes Center, and former chairman of the Western Pacific Region of the International diabetes Alliance, served as the leading PI. The unblinding results of the phase III clinical trial of Cetagliptin showed that the reduction of glycosylated hemoglobin (HbA1c) in the 50mg dose group (low dose group) reached the main clinical end point at the end of the 24th week, which was significantly superior to the control group. After 28 weeks, the Cetagliptin 100mg dose group (high dose group) showed good drug safety, and the incidence of adverse reactions was similar to that of the placebo group.

Dr. Yu Qiang, founder and CEO of CGeneTech, said: "At present, the total population of diabetes in China is more than 110 million, and there is still a gap between China and Europe and the United States in the targeted drug treatment of the new mechanism. The therapeutic effect of Cetagliptin developed by the company is expected to make it the best hypoglycemic drug of its kind in clinical practice. It is hoped that Cetagliptin will be approved and listed as soon as possible, and benefit the majority of diabetes patients in China as soon as possible. At the same time, Cetagliptin's current international patent has protected it until 2038, In the past 15 years, there is no worry about being included in the centralized purchase, and it will become the mainstream of hypoglycemic drugs in the long life cycle. "

CGeneTech was founded in Suzhou Industrial Park in 2010. Its core team has decades of experience in the whole life cycle of international drugs, and is committed to the R&D and industrialization of small molecular innovative drugs for breakthrough therapies. Relying on the integrated drug R&D technology platform and a diversified business vision, the company has built a rich pipeline of innovative drugs, covering multiple disease fields such as hypoglycemic, anticancer and autoimmunity. In addition to Cetagliptin, four of the anticancer drugs under research have entered the clinic, and two of them have obtained the clinical license of FDA in the United States, which is a solid step forward in the company's innovative drug market.

Shengshi

Shengshi Taike has been awarded the "Double Yellow Egg" of Jiangsu Province's innovation and entrepreneurship talents

Jiangxiang is near Xiaoman, with warm air and moving grasshoppers. Recently, the selection results of Jiangsu Province's "Double Innovation Plan" for 2024 have been officially announced. Shengshi Taike's talent team has won the "Double Yellow Egg" award: the core team led by Dr. Wang Tong, Chief Scientific Officer, has been successfully selected as the "Double Innovation Team" in Jiangsu Province in 2024, and is the only "Innovation Team" in the field of biomedicine in Suzhou; Dr. Zhao Jiahong, Chief Medical Officer, has been successfully selected as a "Double Innovation Talent" in Jiangsu Province in 2024. The "Double Innovation Plan" in Jiangsu Province mainly focuses on introducing and funding scarce talents in the "high-precision and cutting-edge" and "bottleneck" fields, supporting the development of new technologies in key areas, and is an important brand project for talent work in Jiangsu Province. This plan focuses on the key industries prioritized for development in Jiangsu Province, playing an important role in enhancing independent innovation capabilities, promoting industrial structure optimization and upgrading, and driving rapid economic development. Dr. Wang Tong was just awarded the title of "Double Innovation Talent" in Jiangsu Province last year, and this time he led the company's core team to win the honor of "Double Innovation Team" in Jiangsu Province, fully reflecting the continuous innovation ability of the company's talent team. Dr. Wang Tong, as the Chief Scientific Officer of Shengshi Taike, has over 20 years of experience in the full chain drug research and management of top pharmaceutical companies and research institutes in the United States. He is a strategic scientist who can break through key technologies, drive emerging disciplines, and promote the new drug industry. Since joining Shengshi Taike, I have been awarded the title of leading technology talent at all levels, bringing innovative thinking and advanced technological means to the company. I have integrated and formed a complete new drug development and industrialization platform, leading the company's R&D team to accelerate the development of the new drug product pipeline. One of the core product pipelines, the hypoglycemic drug sengliptin, has been launched for sale. Dr. Zhao Jiahong, a core member of the "Double Creation Team", was also awarded the honor of "Double Creation Talent" in Jiangsu Province this time. Dr. Zhao Jiahong, as the Chief Medical Officer of Shengshi Taike, has over 20 years of experience in drug clinical trials and team management, and is an external expert of CDE; Has rich practical experience in medical affairs and early drug development, clinical development strategies, and international multicenter clinical trials, and has led and participated in over 600 clinical projects; I also have some experience in post market re evaluation of drugs. Since joining Shengshi Taike, I have been fully responsible for the company's new drug clinical development strategy and pathway, as well as post market expansion research and other important tasks. Among the core members of the "Double Creation Team", Dr. Lu Qin graduated from Fudan University with a major in Medical Systems Biology and holds the associate senior professional title. She has achieved fruitful research results in the field of biology, published multiple high-quality papers, obtained nearly 10 authorized invention patents, led the company's biology team to complete multiple project research tasks, and won multiple honors such as leading the park. Dr. Ouyang Zhenwu graduated from the Organic Chemistry Department of the Chinese Academy of Sciences. He has demonstrated outstanding academic and professional achievements in the field of pharmaceutical chemistry. He has published six high-quality papers in internationally renowned chemical journals, demonstrating his profound skills in chemical synthesis and drug design. Since joining the company, Dr. Ouyang has repeatedly used "innovative synthesis methods" to simplify the synthesis route, which not only significantly improves the efficiency of new drug screening, but also saves costs for the company in new drug development. Shengshi Taike, composed of these innovative talent teams, is a biotechnology company in the commercial stage. The core team has decades of experience in the entire lifecycle of international drugs and is committed to the research and industrialization of high-quality and differentiated small molecule innovative drugs. The company has built a rich pipeline of innovative drugs covering hypoglycemic, anticancer, and autoimmune diseases through an integrated drug research and development technology platform and diversified business perspectives.
2025-05-22
Media

Media Attention | Yu Qiang, an "unsmart" entrepreneur, and his new diabetes drug Sengliptin

Qiang Yu, the founder and CEO of CGeneTech, a doctor of chemistry from Peking University, founded a biotechnology company in the United States at the beginning of this century, and later returned to China to found CGeneTech and developed a new type 2 diabetes drug, a new generation of DPP-4 inhibitor senpaglitin, which has now been approved for marketing.
2025-04-16

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