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

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

(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.

Previous: Dr. Yu Qiang: The industry will work together to wait for the flowers to bloom

Next: "Quantity" Half Achieves Double Prosperity: CGeneTech's Class 1 New Hypoglycemic Drug Shenggliptin Uncovers Blindness Data

Previous: Dr. Yu Qiang: The industry will work together to wait for the flowers to bloom

Next: "Quantity" Half Achieves Double Prosperity: CGeneTech's Class 1 New Hypoglycemic Drug Shenggliptin Uncovers Blindness Data

CGeneTech: Exchange 'One Promise, One Thousand Gold' for 'Dreams Come True'

Introduction: Adhere to our original aspiration, forge ahead, and let our dreams shine into reality. The rapid development of Suzhou Industrial Park is the result of generations of park residents' continuous efforts, and also embodies the strength of each enterprise's rooting and growth. Enterprises are witnesses, but also participants. In the park, one group after another of enterprises have run the "upward trend" with their own "hard skills", using abundant vitality as ink and strong resilience as pen, writing a wonderful chapter of "striving for thirty years and building dreams towards the future". On the occasion of 15 years of rooting in Suzhou Industrial Park, Shengshi Taike Biopharmaceutical Technology (Suzhou) Co., Ltd. has reached a major development milestone - the company's first independently developed Class 1 innovative drug, sitagliptin phosphate tablets, has been approved for listing in China. The founder and CEO of Shengshi Taike, Yu Qiang, wrote a poem with deep emotion: "The trees and trees are all singing in heaven, and the colors are shining in the hall. The morning sun shines on the clouds, and the prosperous era welcomes the sunrise The original intention of entrepreneurship and the passion for innovation are intertwined at this moment into a beautiful story of the "two-way rush" between the park and talents. The successful approval of sengliptin for listing is due to the entrepreneurial fertile ground of Suzhou and the park, as well as the strong support of many departments. It is also a way to repay the park's pro business services with our innovative drugs, "said Yu Qiang. Since settling in the park in 2010, Shengshi Taike has been based in Suzhou and has a global perspective, focusing on the research and production of small molecule innovative drugs. With an integrated drug research and development technology platform and diversified business vision, it has built a rich pipeline of innovative drugs covering areas such as blood sugar reduction, anti-cancer, and autoimmune。 Funds - the 'first pot of gold' that leverages innovation leverage In 2010, with rich scientific research and practical experience in the field of pharmaceutical research and development, Yu Qiang and partner Ding Juping established Shengshi Taike in Suzhou Biomedical Industry Park (BioBAY), committed to the research and industrialization of breakthrough small molecule innovative drugs for therapeutic purposes. "China is a big country with diabetes in the world, and the number of patients with diabetes is the first in the world. In 2008, I heard the news that China began to attach importance to the biomedical industry. Around 2010, I decided to bring my initial research and development achievements, raise funds, form a team, and return to China to make a new class of hypoglycemic drugs." Recalling more than a decade ago, Yu Qiang still remembers. The decision to return to China and start a business in the park was impressed by the numerous emails exchanged. At that time, I was still in the United States and consulted the park government about entrepreneurship issues through email. The response I received was not only fluent in English, but also highly professional. The fact has proven that my initial choice was the right one The beginning of everything is difficult. Even if the conditions for starting a business in China are relatively mature, for a new drug research and development company in the start-up stage, the challenges it faces can be imagined. Shortage of funds is the first problem. Fortunately, the park provides very strong financial support to leading talents, "said Yu Qiang. When he settled in 2010, the park could offer a" big gift package "of up to 10 million yuan to leading talents in the biopharmaceutical field, including housing subsidies, rent reductions, subsidized loans, start-up capital, etc. More importantly, the predecessor of Yuanhe Holdings, Zhongxin Venture Capital, gave us 6.5 million yuan in angel investment, which can be said to be a" timely help "for start-up companies. Later, the company's new drugs were successively shortlisted for the national "Twelfth Five Year Plan", "Thirteenth Five Year Plan" and "Major New Drug Creation" special projects, and were included in the national key support track, further obtaining financial support. The guidance fund and leading venture capital of the park's enterprise development service center have provided financing support at different stages of Shengshi Taike's development. With the guidance of government industry funds, they have also attracted more social capital to invest and jointly support enterprise innovation. I have always believed that it is the '1' given by the park that leads to the '0' increase in social capital in the future, "Yu Qiang said with a smile. Funds support the growth of enterprises and drive industrial development. At present, Shengshi Taike has built a rich drug pipeline, with product distribution fr

2025-01-07

Milestones | Shengshi Taike's new generation DPP-4 inhibitor approved for market launch

Today, the official website of the National Medical Products Administration (NMPA) of China announced that Shengshi Taike's independently developed Class 1 innovative drug, saxagliptin phosphate tablets (formerly known as saxagliptin phosphate tablets), has been approved for market in China. This is a new generation of highly selective DPP-4 inhibitor, which is suitable for improving the blood sugar control of adult type 2 diabetes patients. According to the Guidelines for the Prevention and Treatment of Type 2 diabetes in China, the prevalence of diabetes among adults in China has risen to 11.2%, of which more than 90% are type 2 diabetes. In order to meet the huge clinical demand, some new drugs with different mechanisms of action from traditional oral hypoglycemic drugs have emerged in recent years. Dipeptidyl peptidase-4 (DPP-4) inhibitors are one of them. They not only improve hyperglycemia, but also are not easy to induce hypoglycemia and weight gain. They have the characteristics of rapid oral absorption, long half-life, and long-lasting effect, and are known as "smart" hypoglycemic drugs. Currently, they have been recommended by many domestic and foreign guidelines. As a new generation of highly selective DPP-4 inhibitor independently developed by Shengshi Taike, sengliptin has been continuously selected for the national "Major New Drug Development" special projects in the 12th and 13th Five Year Plans. Due to the excellent data demonstrated in the first phase clinical trial of the best product in the market, it was exempted from phase 2 clinical trials and directly entered phase 3 clinical trials, pioneering the "exemption from two to three" clinical trials in the field of this drug. The results of the phase III clinical trial of Sengliptin led by Professor Ji Linong, director of the Endocrinology Department of Peking University People's Hospital and director of Peking University diabetes Center, showed that in the single drug treatment trial of Sengliptin, the reduction values of HbA1c in the 50mg and 100mg dose groups at the end of the 24th week were 1.08% and 1.07% respectively; In the treatment trial of sengliptin combined with metformin, the glycated hemoglobin decreased by 1.23% and 1.17% in the 50mg and 100mg dose groups at the end of the 24th week, respectively. Meanwhile, both sets of experimental data showed that patients with higher blood sugar levels experienced a greater decrease in glycated hemoglobin levels. In addition to its excellent hypoglycemic effect, what is even more commendable is that in the comparison between the 100mg dose group (high-dose group) and the placebo group in the last 28 weeks, the incidence of adverse reactions of sengliptin is similar to that of the placebo group, and its safety further solves the common adverse reactions in marketed products. 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. Ding Juping, the co-founder and president of Shengshi Tyco, said: "I am very glad to see the company's self-developed product, Sengliptin Phosphate Tablets, has been approved for listing. This drug will be the best new hypoglycemic drug of its kind with half the effort and twice the treatment effect. I hope it will benefit the majority of diabetes patients in China as soon as possible after it is approved for listing." Dr. Yu Qiang, the founder and CEO of Shengshi Tyco, said: "Sengliptin's successful approval for listing benefits from Suzhou and the park as a fertile land for entrepreneurship and the strong support of many departments. It is also a" promise of gold "to use our innovative drugs to repay the business friendly services in Suzhou Park. At this moment, I would like to use an original poem to bless this new drug for its successful launch." Morimu's sounds of nature are listed in the palace. The morning light shines on the clouds, and the prosperous world welcomes the sunrise.

2024-12-05