雙鷺藥業(002038.SZ):注射用丁二磺酸腺苷蛋氨酸獲得藥品註冊批件
格隆匯 6 月 19日丨雙鷺藥業(002038.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的丁二磺酸腺苷蛋氨酸原料藥備案及注射用丁二磺酸腺苷蛋氨酸“藥品註冊批件”。
丁二磺酸腺苷蛋氨酸系醫保乙類產品,臨牀主要用於治療肝硬化前和肝硬化所致肝內膽汁淤積及妊娠期肝內膽汁淤積。
腺苷蛋氨酸是人體中的一種生理活性分子,在多種重要的生化反應中作為甲基供體和生理性硫基化合物(如半胱氨酸,牛磺酸,谷胱甘肽和輔酶A等)的前體,是我公司產品複合輔酶中的重要成份之一。近年來,隨着人們生活水平的不斷提高,脂肪、蛋白質等攝入量不斷增加,使得膽道疾病發病率逐步上升。有研究表明,肝內膽汁淤積在慢性肝病中普遍存在。在一項納入2520例患者的研究中顯示,初次診斷的慢性肝病患者中有35%出現肝內膽汁淤積。肝硬化、膽管炎、藥物性肝病、酒精性肝炎、脂肪肝等慢性肝病患者膽汁淤積的發生率隨年齡的增加有上升趨勢。妊娠期肝內膽汁淤積症是妊娠中晚期的常見併發症,是導致圍產兒死亡的主要原因之一。中國重慶、上海等地區該病的發生率較高,分別為2.3%和3.4%。再次妊娠ICP複發率為40%~70%。有數據顯示,2008年注射用丁二磺酸腺苷蛋氨酸銷售額3.9億元,腸溶片銷售額6200萬元。2019年注射用丁二磺酸腺苷蛋氨酸在我國的銷售額約為10億元。目前該產品在國內市場上市銷售的企業有浙江震元、浙江海正等國內企業和雅培製藥。
注射用丁二磺酸腺苷蛋氨酸的獲批上市,將部分彌補公司複合輔酶受政策變化所致的影響,豐富公司在肝病領域的產品儲備,對公司未來幾年業績提升產生積極的影響。
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