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]

本品作为血管紧张素II拮抗剂的复方药物，属于《国家基本医疗保险、工伤保险和生育保险药品目录 (2025年)》乙类品种。根据相关统计数据，2024年中国公立医疗机构沙库巴曲缬沙坦钠片销售额约为人 民币49亿元。 新华制药的沙库巴曲缬沙坦钠片于2025年8月取得药品注册证书，有利于丰富本公司心血管疾病治疗药 物，提升公司综合竞争优势。 智通财经APP讯，山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"新 华制药"或"本公司")收到国家药品监督管理局核准签发的沙库巴曲缬沙坦钠片(以下简称"该产品")《药 品注册证书》。 沙库巴曲缬沙坦钠片用于射血分数降低的慢性心力衰竭(NYHA Ⅱ-Ⅳ级，LVEF≤40%)成人患者，降低心 血管死亡和心力衰竭住院的风险。沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂(ACEI)或血管紧 张素Ⅱ受体拮抗剂(ARB)，与其他心力衰竭治疗药物合用。沙库巴曲缬沙坦钠片也可用于治疗原发性高 血压。 ...