Recently, the oral glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide tablets (Novoxin ®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult type 2 diabetes. In this regard, Professor Wang Weiqing, Director of the Department of Endocrinology and Metabolism of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Professor Ji Linong, Director of the Department of Endocrinology of Peking University People's Hospital, the leading experts in the registration clinical study of semaglutide tablets in China, expressed their messages on the approval of semaglutide tablets and their expectations for future clinical applications.
As a high-profile new hypoglycemic drug in the field of diabetes, GLP-1RA has provided a simplified solution for the comprehensive treatment of patients with type 2 diabetes in recent years, and has been recognized by major guidelines at home and abroad. However, peptide drugs are absorbed through the gastrointestinal tract and can be taken orally, which has always been a difficult problem in the drug development process. With the innovative technology of "SNAC absorption promoter", semaglutide tablets broke through technical barriers and achieved a historic leap in the oral route of GLP-1RA drug administration, becoming the world's first and currently only* oral GLP-1RA. The pro-absorption effect of SNAC increases the bioavailability of semaglutide molecules by approximately 100-fold in the oral route of administration[1]. Semaglutide tablets can be administered orally every day, which can effectively lower blood sugar and obtain a stable blood concentration curve.
Professor Wang Weiqing, the leading expert in the clinical study of semaglutide tablets in China and director of the Department of Endocrinology and Metabolism of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, said: "As an oral hypoglycemic drug, semaglutide tablets can help more patients with type 2 diabetes overcome the injection barrier and obtain the hypoglycemic effect of GLP-1RA drugs earlier. The study showed that the drug showed a strong hypoglycemic effect in the Chinese cohort and had a good safety profile. This provides strong evidence support for the application of semaglutide tablets in Chinese patients with early-stage type 2 diabetes, and also greatly increases the confidence of Chinese clinicians. ”
The PIONEER study, a global series of phase 3 clinical studies of semaglutide tablets, covered a wide range of people with type 2 diabetes at different stages of the disease, and verified the efficacy and safety of semaglutide tablets in 11 505 patients with type 2 diabetes with multiple treatment background characteristics, and confirmed its significant hypoglycemic effect and multiple metabolic regulatory capabilities such as weight loss, blood pressure reduction, and lipid regulation [2-13]. Among them, the PIONEER 11 study showed that the glycosylated hemoglobin (HbA1c) compliance rate of Chinese patients with newly diagnosed type 2 diabetes mellitus after monotherapy with semaglutide tablets was as high as 92.3% [14].
The number of diabetic patients in China is as high as 140 million, ranking first in the world [15]. However, the combined compliance rate of blood pressure, lipids, and glycemic management in patients with type 2 diabetes in mainland China is only about 5.6 percent [16], while the proportion of patients with type 2 diabetes who are overweight or obese has exceeded 60 percent [17]. Therefore, comprehensive management of patients with type 2 diabetes mellitus with multiple metabolic abnormalities is urgent.
Professor Ji Linong, the leading expert of the clinical study of semaglutide tablets in China and director of the Department of Endocrinology of Peking University People's Hospital, said: "The research of semaglutide tablets in China and the clinical studies related to semaglutide tablets in other countries in the world have observed a high degree of efficacy, which also shows the strong hypoglycemic effect of the drug in the Chinese population, and can better comprehensively manage a variety of metabolic indicators including weight, blood pressure and blood lipids, regulate metabolism from the overall level, and comprehensively improve multiple metabolic disorders." After nearly 20 years of accumulation of clinical evidence, GLP-1RA drugs have become one of the most important drugs for the treatment of type 2 diabetes. The approval of semaglutide tablets in China is expected to promote a wider early clinical application of GLP-1RA drugs to better improve the health of patients with type 2 diabetes. ”
In addition, the results of the PIONEER 6 study confirmed the cardiovascular safety of semaglutide tablets in patients with type 2 diabetes who have cardiovascular disease or cardiovascular risk factors [8]. The large cardiovascular outcome study, the SOUL study, will further explore the cardiovascular benefits of semaglutide tablets.
As the world's first and only* innovative oral GLP-1RA, semaglutide tablets can effectively lower blood sugar and have multiple metabolic benefits with its unique oral convenience, helping patients improve treatment compliance. It is believed that with the approval of semaglutide tablets in China, it is expected to lead a new standard for the treatment of oral hypoglycemic drugs in China, promote the early application of GLP-1RA drugs in a wider range of people with type 2 diabetes with efficient and simple treatment options, help achieve high-quality blood glucose standards** and comprehensive disease management, and help empower the early realization of the goals of the "Healthy China 2030" plan.
*As of January 2024
**Quality attainment: HbA1c <7%, no severe or confirmed hypoglycemia, and no weight gain
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