Regadenoson

As a commonly used adenosine A2A receptor agonist in cardiac stress testing, regadenoson can selectively dilate coronary arteries and significantly increase coronary blood flow, without causing non-selective vasoconstriction adverse reactions like traditional dipyridamole drugs. It is clinically mainly used for myocardial perfusion imaging examination in patients with coronary heart disease who cannot tolerate exercise stress, and can also be used for the evaluation of coronary flow reserve function, especially suitable for elderly subjects, subjects with joint lesions or cardiopulmonary insufficiency, which greatly reduces the risk of adverse events in stress testing.

At present, the global market size related to regadenoson is about 1.2 billion US dollars, with a compound annual growth rate maintained at around 4.2%, and the growth momentum mainly comes from the release of demand for cardiac examinations in primary medical institutions. The domestic market is currently in a period of rapid expansion, and the generic drug substitution process is accelerating. As of 2024, regadenoson injections from 3 domestic enterprises have been approved for marketing. After the centralized procurement, the terminal price has dropped by more than 70% compared with the original research drug, and the drug burden for a single examination of patients has dropped from nearly 1,000 yuan to less than 200 yuan, and the clinical penetration rate is continuously increasing.

The original research enterprise of regadenoson is Amgen, and the original research trade name is Lexiscan. The expiration date of its core compound patent in the United States is 2026, and the core compound patent in China expired in 2022. The main dosage form approved for the original research drug is injection, with the specification of 5ml:0.4mg, which has been included in the FDA Reference Listed Drug Catalog and the *Catalogue of Reference Preparations for Chemical Drugs (9th Batch)* of China. In terms of domestic API registration, at present, regadenoson APIs from 4 enterprises have completed registration with the status of "A" in CDE, and regadenoson injections from another 6 enterprises 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 regadenoson, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards of pharmaceutical enterprises in the process of API R&D, quality research and production.