潤都股份(002923.SZ):沙庫巴曲纈沙坦鈉獲得中國境內化學原料藥上市申請批准通知書及中國台灣衞生福利部藥品許可證
格隆匯10月10日丨潤都股份(002923.SZ)公佈,公司近日收到國家藥品監督管理局核准簽發的沙庫巴曲纈沙坦鈉原料藥(簡稱:“本品”)《化學原料藥上市申請批准通知書》和中國台灣衞生福利部簽發的本品《衞生福利部藥品許可證》。
沙庫巴曲纈沙坦鈉片(商品名:諾欣妥®)原研為瑞士諾華公司(以下簡稱“Novartis”),於2015年獲得美國食品藥品監督管理局(以下簡稱“FDA”)批准上市,是一種新型心衰治療藥物,也是全球首個血管緊張素受體-腦啡肽酶抑制劑(ARNI)。該藥品用於射血分數降低的慢性心力衰竭(NYHAⅡ-Ⅳ級,LVEF≤40%)成人患者,降低心血管死亡和心力衰竭住院的風險。沙庫巴曲纈沙坦鈉片可代替血管緊張素轉化酶抑制劑(ACEI)或血管緊張素Ⅱ受體拮抗劑(ARB),與其他心力衰竭治療藥物(例如:β受體阻斷劑、利尿劑和鹽皮質激素拮抗劑)合用。2017年7月,國家藥品監督管理局正式批准該藥品在中國上市。
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