恆瑞醫藥(600276.SH):子公司ω-3脂肪酸乙酯90軟膠囊獲得藥品註冊證書
格隆匯5月10日丨恆瑞醫藥(600276.SH)公佈,近日,公司子公司成都盛迪醫藥有限公司收到國家藥監局核准簽發的《藥品註冊證書》。藥品名稱:ω-3脂肪酸乙酯90軟膠囊;審批結論:經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。
ω-3脂肪酸乙酯90軟膠囊的主要成分為二十碳五烯酸乙酯(EPA)與二十二碳六烯酸乙酯(DHA),由於EPA和DHA是負責合成甘油三酯的酶的弱底物,並且EPA和DHA對其他脂肪酸的酯化具有抑制作用,因此本品可減少甘油三酯在肝臟中的合成。ω-3脂肪酸乙酯90軟膠囊適用於在控制飲食的基礎上,降低重度高甘油三酯血癥(≥500mg/dL)成年患者的甘油三酯(TG)水平。
ω-3脂肪酸乙酯90軟膠囊最早由挪威Pronova公司開發,1994年在意大利獲批上市,2004年在美國獲批上市,商品名為Lovaza。國外有APOTEX、TEVAPHARMSUSA等多家公司仿製藥在美國、歐洲上市。原研製劑於2022年4月29日在國內獲批上市,國內另有四川國為製藥有限公司的仿製藥獲批。
經查詢,2020年ω-3脂肪酸乙酯90軟膠囊原研製劑全球銷售額約為1109萬美元。截至目前,ω-3脂肪酸乙酯90軟膠囊相關項目累計已投入研發費用約3035萬元。
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