Insulin Degludec

As a new generation of ultra-long-acting basal insulin analog, insulin degludec achieves a smooth, peak-free drug release for more than 24 hours through the reversible binding of insulin molecules to human albumin, which significantly reduces the risk of hypoglycemia. Its indications cover type 1 and type 2 diabetes in adults. For patients who require long-term basal blood glucose control, especially elderly patients with poor tolerance to blood glucose fluctuations caused by traditional insulins or people with diabetes complicated by comorbidities, it can greatly improve medication safety and treatment compliance, and is currently one of the first-line basal insulin options recommended by international guidelines.

The continuous rise in the global prevalence of diabetes has driven the expansion of the ultra-long-acting insulin market. In 2023, the global market size of insulin degludec was approximately USD 2.8 billion, with a compound annual growth rate of 11% in the past three years. In terms of the domestic market, with the expansion of medical insurance coverage, the sales of insulin degludec exceeded RMB 2.5 billion in 2023, with a growth rate higher than the global average. The current market is still dominated by the original research product, and a number of local pharmaceutical companies have submitted marketing applications for biosimilars. As related patents expire one after another, market competition will gradually intensify.

The original research enterprise of insulin degludec is Novo Nordisk, and the original research brand name is "Tresiba" (Nuohoda). Its compound patent in China expired in 2024, and the formulation patent will expire in 2027. The formulation of the original research product approved in China is injection, with two specifications: 3ml:300 units (cartridge) and 3ml:300 units (prefilled injection pen), which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the NMPA. Up to now, there is no valid registration information of insulin degludec API on the CDE API Registration Platform. All marketed preparations in China are imported original research products, and no domestic preparation has been approved yet. (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 insulin degludec API. Most products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet the reference standard needs throughout the whole process of API R&D, quality research and registration.