Saxagliptin

In response to the long-term glycemic control needs of type 2 diabetes, dipeptidyl peptidase-4 (DPP-4) inhibitors have become one of the core categories of oral hypoglycemic agents by virtue of their clinical advantages of stable hypoglycemic effect, low risk of hypoglycemia and no impact on body weight. As a representative variety of this class of drugs, saxagliptin reversibly inhibits the activity of DPP-4, prolongs the action time of endogenous glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), promotes insulin secretion and inhibits glucagon release in a glucose-dependent manner. Monotherapy or combination with metformin can effectively reduce the glycosylated hemoglobin level of adult patients with type 2 diabetes, and is especially suitable for elderly patients and patients with combined cardiovascular risk.

The global market size of saxagliptin has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.28 billion, with the Chinese market accounting for 21%, and the compound annual growth rate maintained at around 8%. After the expiration of the patent, generic enterprises entered the market rapidly. At present, more than 15 domestic enterprises have obtained approval for saxagliptin generic preparations, and 3 enterprises have obtained CDE approval for their APIs. In the seventh batch of national centralized drug procurement in 2022, the winning bid price of saxagliptin tablets decreased by up to 92% compared with the original research drug, which greatly reduced the medication burden of patients and also drove the continuous expansion of upstream API demand.

The original saxagliptin was jointly developed by Bristol-Myers Squibb and AstraZeneca, with the original brand name "Onglyza". The core compound patent expired in 2021 in the United States, and the Chinese compound patent expired in March 2021. The dosage form approved for the original research drug is tablet, with conventional specifications of 2.5mg and 5mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a reference preparation published by the FDA. At present, there are 6 domestic registration numbers of saxagliptin APIs, 3 of which are in Class A status and can be used for associated preparation declaration. The saxagliptin preparations approved for marketing in China include two dosage forms: tablets and sustained-release tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for saxagliptin API, covering the full spectrum of requirements such as process impurities and degradation impurities. Most of the products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the various reference standard use needs of pharmaceutical enterprises in the stages of API R&D, quality research and declaration.