Semaglutide

Against the background of the continuously rising global prevalence of metabolic diseases, GLP-1 receptor agonist drugs have become the focus of clinical attention due to their multiple benefits. As a representative variety of long-acting GLP-1 receptor agonists, semaglutide activates the GLP-1 receptor to promote insulin secretion and inhibit glucagon secretion in a glucose concentration-dependent manner, while delaying gastric emptying and reducing food intake through central appetite suppression. Clinically, it is used not only for glycemic control in adult patients with type 2 diabetes mellitus, but also for long-term weight management in people who are overweight or obese and have at least one weight-related complication. It has multiple clinical values of lowering blood glucose, reducing weight and reducing cardiometabolic risk.

In recent years, the global market size of semaglutide has continued to expand. In 2023, its global sales exceeded 21 billion US dollars, and the revenue contribution ratio of the hypoglycemic indication and the weight loss indication was close to 1:1. In the Chinese market, since the hypoglycemic indication was approved in 2021, the compound annual growth rate of sales in sample hospitals has exceeded 300%. The approval of the weight loss indication in 2023 has further expanded the market space. In terms of the competitive landscape, the original research product currently occupies a dominant position. More than 20 domestic pharmaceutical companies have deployed generic drug R&D. After the core patent expires in 2026, it is expected to usher in a window period for the concentrated launch of generic products.

The original research enterprise of semaglutide is Novo Nordisk, and the original research trade names are "Novotex" (hypoglycemic dosage form) and "Wegovy" (weight loss dosage form). Its core compound patent in China expires in 2026, and peripheral patents such as polypeptide structure patents and preparation patents will expire successively until around 2032. At present, the original research dosage forms approved in China include the pre-filled injection pen with the specification of 1.34mg/ml (for hypoglycemic use) and the pre-filled injection pen with the specification of 2.4mg/0.75ml (for weight loss use), both of which have been included in the China Listed Medicines Catalogue as reference preparations. As of now, no enterprise has submitted the A-status registration number of semaglutide API on the CDE API registration platform, and a number of domestic generic preparations of the same target are in the clinical application stage. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of semaglutide impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the various reference substance needs of pharmaceutical enterprises in the process of generic drug R&D, quality research and consistency evaluation.