Novo Nordisk Submits China NDA for Semaglutide Oral Tablets, the First GLP-1R Agonist in Oral Form for Type 2 Diabetes

On May 27, the CDE website showed that Novo Nordisk's oral semaglutide tablet marketing application was officially accepted by the National Medical Products Administration. This is the first GLP-1R oral formulation to be submitted for marketing in China. It is speculated that the indication for this submission may be for the treatment of type 2 diabetes.

Semaglutide (formerly known as Somaglutide) was originally developed by Novo Nordisk. It is a new type of long-acting glucagon-like peptide-1 (GLP-1 receptor agonist) analog that achieves blood sugar reduction with just one dose per week. GLP-1R agonists activate GLP-1 receptors by mimicking natural GLP-1, enhancing insulin secretion and inhibiting glucagon secretion in a glucose concentration-dependent manner. Additionally, it can delay gastric emptying and reduce food intake through central appetite suppression, thereby lowering blood sugar levels. GLP-1RA not only has significant blood sugar-lowering effects with a low risk of hypoglycemia when used alone, but also offers weight loss, blood pressure reduction, and lipid profile improvement benefits.

Currently, the drug has been approved for marketing in multiple countries and regions, including the United States and Europe. After its market launch, the antidiabetic drug has maintained rapid growth and has gradually become the highest sales revenue product of Novo Nordisk.

According to the PharmaCloud database, the global sales of semaglutide reached $5.5 billion (approximately 36.9 billion yuan) in 2021, increasing by 76% year-on-year, making it a blockbuster hypoglycemic drug.

Source: CDE, PharmaCube Info, PharmSnap Database