Jiudian Hongyang's API dapagliflozin (Y20230000318) officially obtained the marketing approval from the CDE, and its registration status was successfully transferred to "A".

Dapagliflozin is a new type of oral hypoglycemic drug that can simultaneously reduce blood sugar, blood pressure, and body weight, and has a protective effect on cardiovascular and kidneys. It is increasingly widely used in clinical practice. As a sodium-glucose symporter-2 (SGLT-2) inhibitor hypoglycemic drug, dapagliflozin reduces the glucose level in the blood by inhibiting the reabsorption of glucose by the renal tubules, thereby achieving the effect of treating type 2 diabetes. In addition, because it is not dependent on the secretion and action level of insulin, dapagliflozin has a therapeutic effect on type 2 diabetes at all stages.

The diabetes drug market is the second largest pharmaceutical market after tumor drugs, and the industry has broad development prospects. According to data from the Lancet, the number of diabetes patients in China currently exceeds 118 million, accounting for about a quarter of the world's diabetes patients, of which type 2 diabetes patients account for more than 90%. And because of the widespread obesity causing insulin resistance, the occurrence of type 2 diabetes is becoming younger and younger. According to IDF (International Diabetes Federation) data, the United States will have the highest global diabetes-related expenditure in 2021, with a total expenditure of US$379.5 billion, followed by China, with US$165.3 billion. Dapagliflozin preparations were approved by the State Food and Drug Administration (CFDA) for listing in China in 2017, and were included in the National Medical Insurance Class B Catalog in 2019. Its sales and market size have expanded year by year, and its domestic sales in 2023 will exceed 5 billion yuan. At present, many companies are planning the dapagliflozin tablets generic drug market, and the domestic market will present a fierce competition in the future.

The successful approval of dapagliflozin for listing has further enhanced the company's competitiveness in the metabolic drug market, which is conducive to building a dominant position for the company and will continue to help our company improve its performance in the future. The company will continue to increase investment in technology and product research and development, strengthen the construction of the research and development team, and continue to launch more high-quality APIs and pharmaceutical excipients to meet the ever-evolving market demand.