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。
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。
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