China's first weekly hypoglycemic drug Baidayang obtained CFDA approval

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Recently, Sansheng Pharmaceutical announced that China's first glucagon-like peptide-1 (GLP-1) receptor agonist weekly preparation of Bydureon (common name: exenatide microsphere for injection) was officially acquired. CFDA approval.

It is understood that exenatide microspheres are suitable for patients with metformin, sulfonylurea and metformin combined with sulfonylureas with poor glycemic control. It is the first and currently the only GLP-1 drug administered once a week in China. Through the microsphere technology, the glucagon-like peptide-1 (GLP-1) receptor agonist exenatide is slowly released in the body to exert a long-acting hypoglycemic effect, subcutaneous injection once a week, 2mg each time, Patients can be administered at any time of the day, regardless of meal or not.

Its clinical trials have shown that exenatide microspheres can reduce glycated hemoglobin (HbA1c) by 1.3%-1.9% once a week, and can reduce body weight from 2.0kg to 3.7kg, while reducing blood sugar, taking into account weight loss. Significantly reduce the risk of all-cause death and safety.

Jessin, a principal investigator of phase III Asian clinical research and cardiovascular safety research (EXSCEL study), and a professor of Peking University People's Hospital, said that: Exenatide microspheres are clinically staged in Asia III. Evidence from the study shows that for Chinese patients, the addition of exenatide microspheres to oral hypoglycemic agents can improve blood glucose better than exenatide administered twice daily in China. Control, the risk of hypoglycemia is smaller, and the weight loss is comparable to exenatide. In addition, in the weekly GLP-1 receptor agonist preparations, exenatide microspheres are also the only GLP-1 receptor agonists in China that have demonstrated cardiovascular safety through large clinical trials (EXSCEL study). Weekly preparations. The results of this study provide a guarantee for long-term patient safety using exenatide microspheres to control blood glucose. "

With the development of social economy and changes in people's lifestyles, the prevalence of diabetes in China is rapidly rising in the world, and it is increasingly becoming a global chronic disease that seriously threatens human health. The incidence of diabetes in China has risen sharply, the number of patients has reached 114 million, and the trend of youthfulness has developed. China has become a veritable "global diabetes major country".

According to the epidemiological survey data of Chinese diabetes patients published in JAMA magazine in 2017, the latest prevalence rates of adult diabetes and pre-diabetes in China are 10.9% and 35.7%, respectively. Among patients receiving hypoglycemic therapy, only 49.2% of patients met the standard for blood glucose. How to effectively control blood sugar and improve the quality of life of patients has become an important challenge for contemporary clinical medicine.

Ji Linong pointed out: "There are many reasons for poor blood sugar control. The multiple doses, the pain of injection, etc. will greatly reduce the patient's long-term medication compliance, and at the same time reduce the efficacy of the drug. GLP-1 receptor agonist week The introduction of the formulation in China will provide a weekly long-acting hypoglycemic treatment model for diabetic patients, which is expected to further improve the control rate of type 2 diabetes in China."

At present, GLP-1 receptor agonist weekly preparations have been listed in the United States, Europe, Japan, South Korea, Hong Kong, Taiwan and the like.

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