Anhui Huaren Health Pharmaceutical (301408.SZ): The application for the registration and market approval of Sacubitril Valsartan Sodium Tablets has been accepted.
10/01/2025
GMT Eight
Anhui Huaren Health Pharmaceutical (301408.SZ) announced that its wholly-owned subsidiary Jiangsu Shenhuayao Industry Co., Ltd. has received the "Acceptance Notice" of the drug registration and market authorization application for Sacubitril Valsartan Sodium Tablets (100mg) issued by the National Medical Product Administration.
The announcement states that Sacubitril Valsartan Sodium is a type of angiotensin receptor neprilysin inhibitor, mainly composed of valsartan and sacubitril in a 1:1 ratio. Sacubitril valsartan sodium inhibits neprilysin with LBQ657 (the active metabolite of sacubitril) and blocks type 1 angiotensin II receptors with valsartan. The product for which the market authorization application is being filed is a tablet form of sacubitril valsartan sodium, suitable for adult patients with chronic heart failure with reduced ejection fraction (NYHA II-IV, LVEF 40%), to reduce the risk of cardiovascular death and hospitalization for heart failure. Sacubitril valsartan sodium tablets can be used as a substitute for angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) and can be used in combination with other treatments for heart failure. It is also suitable for the treatment of primary hypertension.