Azelnidipine

As a high-incidence chronic cardiovascular disease, there is an urgent long-term clinical need for treatment options with both stable antihypertensive effect and high tolerance for hypertension. Azelnidipine is a third-generation dihydropyridine calcium channel blocker. It selectively blocks L-type calcium channels on the membrane of vascular smooth muscle cells, reduces calcium ion influx, and dilates peripheral blood vessels to lower blood pressure. Meanwhile, it has the characteristics of little effect on heart rate and renal protective effect, and can be used for the long-term treatment of essential hypertension, especially suitable for patients with combined renal function injury and elderly hypertension人群, and can effectively reduce the risk of cardiovascular and cerebrovascular events.

In recent years, the global market size of antihypertensive APIs has grown steadily. As a segmented variety of long-acting antihypertensive drugs, the global market size of azelnidipine was approximately USD 120 million in 2023, with a compound annual growth rate of around 5.8%. In terms of the domestic market, with the continuous increase of the hypertension patient base and the release of primary-level medication demand, the growth rate of the azelnidipine preparation market has maintained above 8% in recent years. At present, multiple domestic pharmaceutical companies have laid out generic drugs, the overall supply of APIs is dominated by local enterprises, and the market share of original research products is less than 20%. After the implementation of centralized procurement, the substitution rate of generic drugs has further increased.

The original research enterprise of azelnidipine is Daiichi Sankyo Co., Ltd. of Japan, with the original research trade name "Calblock". The core compound patent expired in 2011 in Japan and in 2010 in China. The dosage form approved by the original research is tablet, with mainstream specifications including 8mg and 16mg. Its tablets have been included in the China Listed Drug Catalogue as reference preparations, and are also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, at present, the azelnidipine APIs of multiple local enterprises have obtained Class A status through CDE registration, and the azelnidipine tablets of multiple domestic pharmaceutical companies have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for azelnidipine API. Most products are available in 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 can fully meet the reference standard use needs of pharmaceutical companies in the whole process of API R&D, quality research and production.