Valsartan

Cardiovascular diseases are the category of chronic diseases with the highest mortality rate globally. The abnormal activation of the renin-angiotensin-aldosterone system (RAAS) is one of the core pathological mechanisms of diseases such as hypertension and heart failure. ARB drugs, by virtue of their effect of targeted blocking of the angiotensin Ⅱ type 1 receptor, have become first-line clinical antihypertensive drugs at present. Valsartan is a classic variety of this category of drugs. It can not only be used alone or in combination with other antihypertensive drugs to treat adult primary hypertension, but also reduce the risk of cardiovascular death in high-risk patients after acute myocardial infarction. Meanwhile, it is suitable for patients with heart failure with reduced ejection fraction to improve prognosis, covering multiple patient groups such as middle-aged and elderly patients with hypertension, post-myocardial infarction rehabilitation patients, and patients receiving long-term management of heart failure.

At present, the global market size of valsartan has exceeded 6 billion US dollars, and the market size in China is close to 4 billion yuan. Driven by the rising prevalence of chronic diseases and the popularization of medication at the primary level in recent years, the compound annual growth rate has remained at around 5%. In terms of the competitive landscape, the original research product still accounts for about 30% of the high-end hospital market. Domestic generic preparations have passed the consistency evaluation and been included in the national centralized drug procurement. The bid price has dropped by more than 90% at the maximum compared with the original research product, which has greatly improved the overall accessibility of medication. The domestic API production capacity is mainly concentrated in leading pharmaceutical enterprises in Zhejiang, Guangdong and other regions. At present, a stratified competitive landscape of "original research products dominating the high-end market and generic drugs meeting the primary-level demand" has been formed.

The original research enterprise of valsartan is Novartis, with the trade name "Diovan". The expiration date of its core compound patent in the United States and Europe is 2012, and the expiration date of the compound patent in China is 2013. The original research dosage forms approved in China mainly include 80mg and 160mg tablets, as well as 40mg and 80mg capsules. Among them, the 80mg tablet has been included in the *Reference Preparation Catalogue of Chemical Drugs* issued by the NMPA, and is also listed in the FDA reference preparation catalogue. Up to now, there are more than 40 valsartan API registration records on the CDE API registration platform of China, among which more than 30 are in status A (already used in marketed preparations), and more than 50 domestic enterprises have obtained approval for the marketing of valsartan oral preparations. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for valsartan API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference substance support for pharmaceutical enterprises' API quality research and generic drug consistency evaluation work.