普利製藥(300630.SZ):500mg注射用更昔洛韋獲得意大利藥品監管局上市許可
格隆匯 3 月 31日丨普利製藥(300630.SZ)公佈,公司近日收到了意大利藥品監管局(AIFA)簽發的注射用更昔洛韋的上市許可,規格500mg。
適應症:(1)用於治療免疫功能低下患者(包括艾滋病患者)發生的鉅細胞病毒性視網膜炎;(2)預防可能發生於有鉅細胞病毒感染風險的器官移植受者的鉅細胞病毒病
更昔洛韋(Ganciclovir)是鳥嘌呤核苷衍生物,與阿昔洛韋類似,是第一個對人類鉅細胞病毒有效的藥物,它不僅能抑制所有皰疹類病毒,而且也能阻斷EB病毒引起的正常帶狀淋巴細胞的病變。最早於1980年由Syntex Research (現在為Roche)的JulienVerheyden和John Martin合成。更昔洛韋抑制病毒DNA合成的機制在於:競爭抑制脱氧鳥苷的三價磷酸鹽與DNA聚合酶的結合;丙氧鳥苷的三價硝酸鹽與病毒DNA的結合最終導致DNA延長的停止。
近日公司收到的意大利藥品監管局批准通知,標誌着普利製藥具備了在意大利銷售注射用更昔洛韋的資格,將對公司拓展意大利市場帶來積極影響。
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