Acarbose

Diabetes is a chronic metabolic disease with a high incidence globally, among which type 2 diabetes accounts for more than 90%. Elevated postprandial blood glucose is a typical onset feature of most Chinese patients. Poor long-term control can easily induce multi-system complications involving the cardiovascular system, kidneys and other systems. Acarbose is a hypoglycemic drug belonging to the α-glucosidase inhibitor class. It competitively inhibits α-glucosidase at the brush border of the small intestinal mucosa, delays the decomposition and absorption of carbohydrates, and specifically reduces postprandial blood glucose fluctuations, with low risk of inducing hypoglycemia. It is a first-line oral hypoglycemic drug suitable for populations whose diet structure is mainly based on carbohydrates. It can be used alone or in combination with other hypoglycemic drugs and insulin, and is also applicable for intervention in populations at the impaired glucose tolerance stage.

China is the largest consumer market of acarbose in the world, with a domestic market size of approximately 4.2 billion yuan in 2023. With the continuous rise in the prevalence of diabetes and the promotion of tiered diagnosis and treatment, the demand in the primary market still maintains a stable growth rate of around 3%. In terms of the competitive landscape, the original research product once occupied more than 70% of the market share. In the second batch of national centralized drug procurement in 2020, acarbose was included in the procurement list, and the winning bid price of generic drugs saw a maximum drop of more than 90% compared with that of the original research product. Since then, the market share of domestic generic drugs has rapidly increased to over 65%. At present, acarbose preparations from more than 20 domestic enterprises have been approved for marketing, and the API supply chain has basically achieved localization.

The original research enterprise of acarbose is Bayer HealthCare Co., Ltd., with the original research brand name "Glucobay". Its core compound patent expired in China in 2010. The main dosage forms of the original research product on the market include tablets and capsules. The tablets have two specifications of 50mg and 100mg, and the capsules have the specification of 50mg. The original research product has been included in the China Listed Drug Catalogue, and is also listed as an FDA reference listed drug. As of now, there are more than 30 acarbose registration numbers on the API registration platform of China CDE, most of which are in the A status and can be used in association with domestic preparation declarations. The domestically approved acarbose preparations cover three dosage forms: tablets, capsules and chewable tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of acarbose impurity reference standards, most of which 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 including the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in API R&D, quality research and registration declaration.