Fimasartan

As a new generation of angiotensin II receptor antagonist (ARB) antihypertensive drugs, fimasartan blocks AT1 receptors with high selectivity, inhibits vasoconstriction and aldosterone release, exerts a potent blood pressure lowering effect while delivering good target organ protection, and brings particularly significant benefits to hypertensive patients with concomitant diabetes mellitus and chronic kidney disease. Compared with traditional ARB drugs, it has higher receptor affinity, faster onset of action and more stable antihypertensive effect, and its incidence of adverse reactions is comparable to that of placebo. Currently, it is mainly used clinically for monotherapy or combination therapy of essential hypertension, and has become an important option for individualized treatment of hypertension.

The global market size of antihypertensive drugs continues to grow steadily, among which ARB drugs account for nearly 30%. As an upgraded variety of ARBs, the global market size of fimasartan had exceeded USD 420 million in 2023, with a compound annual growth rate remaining above 12%. At present, the market supply of this variety is mainly concentrated in East Asia. The original research product occupies more than 70% of the market share in South Korea and Japan, and the domestic market is still in the generic drug layout stage. Up to now, 3 enterprises have submitted marketing applications for generic drugs. With the subsequent approval of generic drugs and the expansion of medical insurance coverage, the domestic market size is expected to exceed RMB 1.5 billion in 2027.

The original research enterprise of fimasartan is Boryung Pharmaceutical of South Korea, with the original brand name of 메카르탄 (Mecartan). In terms of core patents, the core compound patent in South Korea expires in 2024, and the compound patent in China has expired. The original dosage form is tablet, with conventional specifications including 20mg, 40mg and 80mg. The original tablet has been included in the reference preparation catalogues of South Korea and Japan, but has not yet been included in the China Listed Medicines Catalogue. In China, at present, the fimasartan APIs of 5 enterprises have completed registration and been publicized and activated at the Center for Drug Evaluation (CDE), and no fimasartan preparations of domestic enterprises have 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 fimasartan impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, all products comply with the regulations of multiple countries and regions such as the Chinese Pharmacopoeia and FDA, which can fully meet the needs of the whole process of impurity research, quality control and registration declaration, and provide reliable technical support for pharmaceutical enterprises in generic drug research and development and quality consistency evaluation.