Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the marketing of Sacubitril/Valsartan tablets, which are indicated for the treatment of chronic heart failure and hypertension, enhancing the company's competitive edge in cardiovascular disease treatment [1] Group 1: Product Approval and Indications - The product, Sacubitril/Valsartan tablets, is approved for adult patients with reduced ejection fraction chronic heart failure (NYHA II-IV, LVEF ≤ 40%), aimed at reducing cardiovascular mortality and hospitalizations due to heart failure [1] - The tablets can replace ACE inhibitors or ARBs and can be used in combination with other heart failure medications [1] - Additionally, the product is indicated for the treatment of primary hypertension [1] Group 2: Market Potential and Financial Impact - Sacubitril/Valsartan tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The estimated sales revenue for Sacubitril/Valsartan tablets in Chinese public medical institutions is approximately RMB 4.9 billion in 2024 [1] - The approval of this product is expected to enrich the company's portfolio in cardiovascular treatments and enhance its overall competitive advantage [1]
山东新华制药股份获得沙库巴曲缬沙坦钠片《药品注册证书》