Sacubitril

Chronic heart failure, as the end-stage manifestation of cardiovascular diseases, has long relied on the "golden triangle" regimen for clinical treatment in the past, but the 5-year survival rate of patients is still less than 50%. Sacubitril is the core active ingredient of the first angiotensin receptor neprilysin inhibitor (ARNI). The compound preparation composed of sacubitril and valsartan exerts therapeutic effects through a dual mechanism of action: on the one hand, it inhibits neprilysin activity and increases the level of natriuretic peptides to exert vasodilation, natriuresis and diuresis, and anti-myocardial remodeling effects; on the other hand, it blocks the angiotensin II type 1 receptor to avoid the adverse effects caused by excessive activation of the renin-angiotensin system. This ingredient is mainly used for adult patients with chronic heart failure with reduced ejection fraction, which can reduce the risk of cardiovascular death and heart failure hospitalization. It is also suitable for the treatment of essential hypertension, especially for hypertensive patients with comorbid heart failure.

The global market size of sacubitril-related preparations had exceeded USD 13 billion in 2023, with a compound annual growth rate of 27% in the recent 5 years. The market size in China exceeded RMB 7 billion in 2023, with an annual growth rate remaining above 40%. In terms of the competitive landscape, the original research product still occupies the major global market share at present. With the expiration of core patents one after another, more than 20 domestic enterprises have submitted marketing applications for sacubitril valsartan preparations, and more than 10 enterprises in the API sector have completed CDE registration. Under the background of centralized procurement, cost control and compliance of APIs have become the core competitive elements for downstream preparation enterprises.

The original research enterprise of sacubitril is Novartis, and the trade name of its original research compound preparation is Entresto®. Its core compound patent will expire in China in 2026, and the crystal form patent will expire in 2033. The main dosage form of the original marketed product is tablet, with three specifications of 50mg, 100mg and 200mg calculated by sacubitril/valsartan. This preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, there have been more than 30 CDE registration numbers for domestic sacubitril APIs, most of which are in A status, and nearly 20 domestic sacubitril valsartan preparations have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of sacubitril impurity reference standards, which can cover the requirements of all research scenarios such as process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable material basis support for the quality research and consistency evaluation work of API and preparation enterprises.