NMPA Approves World's First ARNI for Hypertension Indication: Sacubitril/Valsartan (Entresto)

Hypertensionis the primary risk factor for cardiovascular events, with approximately 245 million adults currently in ChinaHypertensionPatients, but the blood pressure control rate was only 15.3%,HypertensionThe resulting damage to organs such as the heart, kidneys, and vasculature significantly increases the risk of cardiovascular mortality, therebyHypertensionThe associated disability and mortality rates remain high. On June 1, the National Medical Products Administration approved sacubitril/valsartan (Entresto), the world's first angiotensin receptor-neprilysin inhibitor (ARNI), for the treatment of primary hypertension.

ARNI is an innovative drug that simultaneously acts on the renin-angiotensin-aldosterone system (RAAS) and the natriuretic peptide system. By enhancing the blood pressure-regulating effects of the natriuretic peptide system while concurrently inhibiting RAAS, it achieves multi-pathway blood pressure reduction. Specifically, it augments the body's blood pressure-lowering mechanisms while suppressing pressor pathways, thereby delivering substantial blood pressure reduction, rapid onset of action, and 24-hour blood pressure control.

Results from a Phase III clinical trial led by Professor Huo Yong, Vice Chairman of the Chinese Alliance for Cardiovascular Health and affiliated with Peking University First Hospital, demonstrated that after 8 weeks of treatment, the antihypertensive efficacy of sacubitril/valsartan was significantly superior to that of the control medication with the best blood pressure-lowering effect among ARBs, and it significantly improved the rate of blood pressure target attainment in patients. The study enrolled a total of 1,438 Asian patients aged 18 years and above with mild-to-moderate essential hypertension. Enrolled patients had a seated systolic blood pressure of ≥140 to <180 mmHg, with Chinese patients accounting for 85% of the cohort.

Furthermore, multiple domestic and international studies have demonstrated that regardless of baseline blood pressure levels or the presence of concomitant risk factors or cardiorenal impairment, sacubitril/valsartan exhibits consistent antihypertensive efficacy. Hypertensive target organs refer to the various organs affected by hypertension, typically including the heart, kidneys, brain, and blood vessels. Multiple studies and meta-analyses have indicated that sacubitril/valsartan not only exerts potent antihypertensive effects in patients with essential hypertension but also provides significant protective benefits to target organs such as the heart, kidneys, and blood vessels.

Professor Huo Yong stated: “Hypertension management in China faces multiple challenges, including a low blood pressure control rate, a high prevalence of comorbidities, and worsening target organ damage. In recent years, hypertension treatment has increasingly emphasized a strategy centered on blood pressure reduction as the cornerstone, while simultaneously reducing the risk of cardiovascular events and improving patient prognosis. Sacubitril/valsartan demonstrates substantial blood pressure reduction, rapid onset of action, and 24-hour blood pressure control. It also exhibits superior protective effects on the heart, kidneys, and blood vessels, and can interrupt the cardiovascular event chain through multiple pathways, thereby lowering the risk of cardiovascular events. The application of sacubitril/valsartan in hypertension will further optimize existing treatment regimens and holds milestone significance for hypertension management.”(BioonBioon.com）