CGeneTech: The first domestic original DPP-4 inhibitor, Shengliptin, is "exempted from two into three"

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Time of issue:2019-11-14
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(Summary description)Today is the 13th "United Nations Diabetes Day", and we have good news from B Village Guest: CGeneTech, which focuses on the research and development of new glucose-lowering drugs, announced that its new glucose-lowering drug, DPP-4 inhibitor Shengliptin phosphate, has been officially approved by the National Center for Drug Review, exempting it from Phase II clinical trials and entering Phase III trials directly, which will promote the first domestic This will facilitate the early launch of the first domestic original DPP-4 inhibitor drug for the benefit of Chinese diabetic patients as soon as possible.

CGeneTech: The first domestic original DPP-4 inhibitor, Shengliptin, is "exempted from two into three"

(Summary description)Today is the 13th "United Nations Diabetes Day", and we have good news from B Village Guest: CGeneTech, which focuses on the research and development of new glucose-lowering drugs, announced that its new glucose-lowering drug, DPP-4 inhibitor Shengliptin phosphate, has been officially approved by the National Center for Drug Review, exempting it from Phase II clinical trials and entering Phase III trials directly, which will promote the first domestic This will facilitate the early launch of the first domestic original DPP-4 inhibitor drug for the benefit of Chinese diabetic patients as soon as possible.

Categories:Company News
Author:admin
Origin:
Time of issue:2019-11-14
Views:0

Today is the 13th "United Nations Diabetes Day", and we have good news from B Village Guest: CGeneTech, which focuses on the research and development of new glucose-lowering drugs, announced that its new glucose-lowering drug, DPP-4 inhibitor Shengliptin phosphate, has been officially approved by the National Center for Drug Review, exempting it from Phase II clinical trials and entering Phase III trials directly, which will promote the first domestic This will facilitate the early launch of the first domestic original DPP-4 inhibitor drug for the benefit of Chinese diabetic patients as soon as possible.

The theme of the 2019 United Nations Diabetes Day is "Prevent and Control Diabetes, Protect Your Family", advocating healthy lifestyles and regular testing, and the whole society to take action together to pay attention to diabetes. At present, the situation of diabetes prevention and control worldwide is still serious. According to the World Health Organization's statistical forecast, the number of people with diabetes worldwide reached 422 million in 2017. Among them, 114 million people have the disease in China, which is already more than a quarter of the global total. In the foreseeable future (2020-2030), with the aging of the population, the number of people with the disease will increase to different degrees in all regions of the world. The resulting medical costs are also increasing year by year, imposing a heavy financial burden on patients' families and society.

Opening speech and concluding remarks by Prof. Ji Linong

CGeneTech (Suzhou, China) Co., Ltd. is an innovative technology company dedicated to the research and development of hypoglycemic drugs. "In 2012 and 2018, Shengliptin was selected as one of the major new drug creation projects in the 12th and 13th Five-Year Plans. The data from a large sample size clinical phase I trial completed this year showed that the efficacy of Centigliptin phosphate in type 2 diabetes is promising, safe and reliable compared with the positive control drug selegiline. At present, Shenggliptin phosphate has received formal approval from the National Center for Drug Review to be exempted from the Phase II clinical trial and enter the Phase III trial directly.

Recently, in Beijing, where autumn is enchanting in the midst of all the beauty, CGeneTech successfully held a phase III clinical trial investigator meeting on the combination of Shengliptin phosphate tablets and metformin for the treatment of type 2 diabetes, with a total of 116 investigators from 50 large clinical research centers and endocrinology departments across China attending the meeting. The meeting was chaired by Prof. Ji Linong from Peking University People's Hospital, and experts at the meeting conducted in-depth communication and discussion on the details of phase III trial design and clinical implementation. Prof. Zhao Weigang from Peking Union Medical College Hospital and other participating investigators not only highly affirmed the results of the phase I clinical study of Shengliptin phosphate, but also made valuable suggestions for the phase III clinical trial. As the lead PI of this trial, Prof. Lignon Ji not only communicated with the participants at the academic level, but also concluded that the core R&D team of CGeneTech comes from the best chemistry department in China - the chemistry department of Peking University, and Shenggliptin phosphate has been continuously supported by the key innovative drugs at the national level. As the first home-made original DPP-4 inhibitor, Shengliptin will certainly have a great impact on the domestic diabetes drug market, benefiting the general public. Meanwhile, Prof. Ji also took this opportunity to invite more experts in the field of diabetes to attend another Investigator Conference on the Phase III trial of Shengliptin phosphate monotherapy for type 2 diabetes to be held in Beijing on the morning of December 19, 2019.

Group photo of all participating researchers

Ding Torping, the chairman of CGeneTech, said he expects that new and good drugs such as Shengliptin phosphate will come into the lives of diabetic patients as soon as possible to better help them. The road to drug creation is difficult, technology is the first. Under the prosperous times, the country will be safe and secure.

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Shengshi Taike: 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