Liraglutide

The rapid iteration of global GLP-1 receptor agonist drugs has brought breakthrough options for the treatment of type 2 diabetes and obesity. As a glucagon-like peptide-1 analog, liraglutide can activate GLP-1 receptors 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. In addition to being used for blood glucose control in adult patients with type 2 diabetes, it is also approved for weight loss treatment in adults with BMI ≥ 28kg/㎡ or BMI ≥ 24kg/㎡ accompanied by at least one weight-related comorbidity, and has multiple clinical advantages of significant hypoglycemic effect, low risk of hypoglycemia, and clear weight loss benefit.

At present, GLP-1 drugs have become the mainstream category in the global field of hypoglycemia and weight loss. As a long-acting GLP-1 analog that was the first to achieve wide clinical application, liraglutide had a global market size of over 4 billion US dollars in 2023. With the expiration of the patent of domestic original research drugs and the intensive approval of generic drugs, the domestic market size of liraglutide has exceeded 1.5 billion yuan in 2024, with an annual growth rate of more than 120%. At present, the domestic market has formed a competitive pattern where the original research product coexists with 3 domestic generic drugs, and the explosive demand for weight loss indications has further driven the expansion of upstream API production capacity.

The original research enterprise of liraglutide is Novo Nordisk, and the original research trade names are "Victoza (Novolid, hypoglycemic indication)" and "Saxenda (Nuohying, weight loss indication)". Its compound patent in China expired in March 2023, and the core preparation patent will expire in July 2024. The main dosage form of the original research is injection, with the specification of 3ml:18mg for hypoglycemic indication and 3ml:18mg/pre-filled injection pen for weight loss indication. The original research preparation has been included in the Chinese Catalogue of Reference Preparations of Chemical Drugs, and is also a reference preparation recognized by the FDA. Up to now, the liraglutide APIs of 12 domestic enterprises have been approved through CDE registration (A status), and more than 10 domestic liraglutide injections (including hypoglycemic and weight loss indications) have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for liraglutide, covering impurities in the synthesis process, degradation impurities and polypeptide characteristic related impurities, which fully meet the requirements of the Chinese Pharmacopoeia and relevant FDA regulations. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day, which can provide stable and reliable reference substance support for API and preparation R&D and quality research stages.