Sacubitril

The number of patients with heart failure worldwide has exceeded 60 million. Traditional ACEI and ARB drugs still have limitations in improving prognosis. Sacubitril, as the core component of the first angiotensin receptor neprilysin inhibitor (ARNI), forms a compound preparation with valsartan, which can simultaneously inhibit neprilysin from degrading natriuretic peptides and block the angiotensin Ⅱ receptor pathway. Compared with traditional ACEI drugs, it reduces the risk of cardiovascular death and heart failure hospitalization by 20%. At present, it has been listed as a first-line recommended drug by heart failure guidelines of many countries, and is suitable for adult patients with chronic heart failure with reduced ejection fraction, and can also be used as an alternative treatment for some heart failure populations intolerant to ACEI/ARB.

Sacubitril valsartan was approved for marketing by the FDA in 2015 and entered the Chinese market in 2017. In 2023, its terminal sales in domestic public medical institutions exceeded 8 billion yuan, with a compound growth rate of 45% in the past three years. At present, the domestic sacubitril API market is still dominated by supply from the original research manufacturer. With the expiration of the core patent in 2021, more than 20 domestic pharmaceutical companies have been approved for sacubitril valsartan generic drugs, and the downstream demand for corresponding APIs continues to be released. At this stage, the localization rate is less than 30%, and local enterprises still have large market penetration space.

CATO can provide a full set of impurity reference standards for sacubitril API. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and the FDA, are fully traceable, and all conventional products are available in stock. It can provide stable material basis support for pharmaceutical enterprises in the links of API R&D, quality research and declaration, effectively shortening the R&D cycle and reducing compliance risks.