Allisartan Isoproxil

As the first domestically independently developed angiotensin Ⅱ receptor antagonist (ARB) class antihypertensive drug, allisartan isoproxil has a mechanism of action different from that of traditional precursor ARB drugs. It can be directly hydrolyzed into the active metabolite EXP-3174 without metabolism by hepatic CYP450 enzymes, exerts an antihypertensive effect by selectively blocking the type 1 receptor of angiotensin Ⅱ, and simultaneously reduces the serum uric acid level. It is mainly clinically used for the treatment of mild to moderate essential hypertension, especially suitable for hypertension patients complicated with hyperuricemia and abnormal liver function. It has better long-term medication safety and good patient tolerance.

At present, the number of hypertension patients in China has exceeded 270 million. ARB drugs account for approximately 30% of the antihypertensive drug market and are the first-line antihypertensive category preferred in clinical practice. As a domestically produced Class 1 innovative drug, allisartan isoproxil had a domestic market size exceeding RMB 1.5 billion in 2023, with a compound annual growth rate of over 35% in the recent three years. Relying on the unique advantage of its metabolic pathway, its share in the market segment continues to increase. It has been included in the National Medical Insurance Catalog, and the original research product occupies the entire market share, with no generic drug launched yet, showing great market growth potential.

The original research enterprise of allisartan isoproxil is Shenzhen Salubris Pharmaceuticals Co., Ltd., with the trade name Xinlitan, and the core compound patent will expire in 2026. Currently, the domestically approved dosage form is tablet, with specifications of 80mg and 240mg. It has been included in the *Catalog of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration, and is also an original research drug marketed in China. As of the search time point, only Salubris' allisartan isoproxil active pharmaceutical ingredient (API) has been approved for marketing in the API registration database (registration number Y20190001148), with the status of A, which can be marketed and sold domestically. At present, more than 10 domestic enterprises have submitted clinical applications for generic allisartan isoproxil, and no generic preparation has been approved for marketing yet. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for allisartan isoproxil. Relevant products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in sufficient stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard requirements in the processes of drug research and development, quality research and consistency evaluation.