News

Every small group should not be abandoned

  • Categories:Media
  • Author:盛世小科
  • Origin:引力播
  • Time of issue:2022-02-28
  • Views:0

(Summary description)Today is the annual "International Rare Disease Day". Ltd. has entered the countdown to market for the first domestic teriflunomide. The drug is approved for relapsing multiple sclerosis (MS).

Every small group should not be abandoned

(Summary description)Today is the annual "International Rare Disease Day". Ltd. has entered the countdown to market for the first domestic teriflunomide. The drug is approved for relapsing multiple sclerosis (MS).

  • Categories:Media
  • Author:盛世小科
  • Origin:引力播
  • Time of issue:2022-02-28
  • Views:0

Today is the annual "International Rare Disease Day". Ltd. has entered the countdown to market for the first domestic teriflunomide. The drug is approved for relapsing multiple sclerosis (MS).1

Multiple sclerosis (MS) is a lifelong, chronic, progressive disease that affects more than 2.3 million people worldwide, with a prevalence of approximately 0.03% and more than 30,000 patients in China.In May 2018, MS was included in the First Catalogue of Rare Diseases in China.Its cause stems from autoimmune system pathology, which causes the breakdown and denudation of nerve myelin, resulting in damage to the spinal cord, brain, and optic nerve function The cause of the disease is an autoimmune disorder that causes the breakdown and denudation of the myelin sheath, resulting in damage to the spinal cord, brain and optic nerve function. The neurological disability of the patient gradually increases, resulting in loss of self-care, blindness and even loss of life. According to the research of authoritative institutions, MS is incurable and patients have to live with the disease. Therefore, the earlier treatment can better control the patient's disease activity and reduce the occurrence of irreversible neurological damage.

Founded in 2010 in the park, with the philosophy of "every small group should not be abandoned", CGeneTech continues to focus on rare disease drug development and has built an integrated drug development technology platform covering the entire R&D chain of small molecule innovative drugs. Earlier this year, Teriflunomide was approved by the State Drug Administration for the treatment of relapsing forms of multiple sclerosis. "In the consistency evaluation with Sanofi's original drug, CGeneTech's teriflunomide reached a level consistent with the original drug in terms of efficacy, side effects and other dimensions." said Yu Qiang, founder and CEO of Centra Tech.

At present, Suzhou is accelerating to build an innovation cluster with international competitiveness and global influence. With an integrated drug R&D technology platform of the whole R&D chain and continuous layout in various fields such as rare diseases, hypoglycemic drugs and anti-tumor drugs, CGeneTech also has its own ideas for the creation of Suzhou innovation cluster.

In addition to focusing on rare disease drug R&D, CGeneTech is also committed to hypoglycemic and anti-tumor drug R&D. Cetagliptin phosphate tablets, a novel and highly active and safe DPP-4 inhibitor, have been successfully selected for the National 12th Five-Year Plan and 13th Five-Year Plan in 2012 and 2018 respectively. In the second half of 2019, Cetagliptin phosphate was formally approved by the National Drug Review Center, exempting Phase II clinical trials and entering Phase III trials directly, which is expected to be completed in the second half of this year and is expected to fill the gap of domestic DPP-4 inhibitors. In the field of tumor therapy, the company avoided the popular areas of antibody therapy such as PD-1/L1 and focused on the types of mutations that are currently difficult for tumor immunotherapy to be effective.

For a long time, the new target, route of administration, dosage form, strength of action and therapeutic effect often determine whether a domestic innovative drug will "fail" or not. The reason why Cetagliptin Phosphate Tablets of Centene were able to "enter the clinical stage" is the breakthrough in molecular design and formulation process of the company.

"There are various proteins, or enzymes, in the human body that regulate physiological activities. Very often, people get sick because these enzymes are inactive or too hyperactive. Small-molecule drugs enter the body and achieve therapeutic purposes by regulating the relevant enzymes." Yu Qiang said that the efficacy and safety of small molecule drugs are closely related to the molecular design. In layman's terms, the molecule to be designed for small molecule drugs is the earliest form of the drug - the appearance of the lead compound, its fat and thin determines the size of the activity, whether it will "bite" determines whether there is toxicity. When everything is "broken" successfully, this small molecule drug can be registered, that is, registered patent, and then slowly grow into an adult.

It is reported that the core technical team of CGeneTech is composed of four people, all from the chemistry department of Peking University, which is good at molecular design. "We hope that high-quality small-molecule drugs can be combined with large-molecule antibody drugs across borders to bring more choices for patients." Yu Qiang said.
 

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Milestones

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

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