Shandong Xinhua Pharmaceutical Gets Drug Registration Certificate for Sacubitril Valsartan Sodium Tablets

Stock News

3 hours ago

Shandong Xinhua Pharmaceutical (00719) has announced that the company recently received the Drug Registration Certificate for Sacubitril Valsartan Sodium Tablets approved and issued by the National Medical Products Administration.

In April 2025, Xinhua Pharmaceutical submitted the marketing authorization application materials for Sacubitril Valsartan Sodium Tablets to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which were accepted for review. In October 2026, the Drug Registration Certificate was obtained, with the review conclusion being approval of registration.

This product is indicated for adult patients with chronic heart failure with reduced ejection fraction (NYHA Class II-IV, LVEF ≤ 40%) to reduce the risk of cardiovascular death and heart failure hospitalization. It can replace angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) and be used in combination with other heart failure therapeutic drugs.

This product belongs to Category B of the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog (2025). According to relevant statistics, the sales of Sacubitril Valsartan Sodium Tablets in Chinese public medical institutions in 2025 were approximately RMB 7.8 billion.

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