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普利製藥(300630.SZ):注射用更昔洛韋鈉獲塞浦路斯上市許可
格隆匯 02-04 19:16

格隆匯2月4日丨普利製藥(300630.SZ)公佈,公司近日收到通知,提交塞浦路斯藥監當局的注射用更昔洛韋鈉500mg註冊申請已獲批准。

藥品名稱:注射用更昔洛韋鈉;劑型:注射劑;規格:500mg;適應症:適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。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JohnMartin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。

注射用更昔洛韋鈉由RochePalo於1989年6月申請在美國上市,商品名為CYTOVENE®-IV。根據Pharmaprojects數據庫,注射用更昔洛韋鈉繼在美國上市後,陸續在世界各國上市,如1990年上市於西班牙與日本,1991年在愛爾蘭、葡萄牙等國家上市,1992年在新西蘭、泰國上市,迄今為止,注射用更昔洛韋鈉還在意大利、澳大利亞、加拿大、中國、香港、法國等多國上市。

普利製藥的注射用更昔洛韋鈉500mg是研發後同步國內外註冊申報的品種,已分別於2012年12月通過WHO的資格預確認程序;於2014年2月獲得荷蘭上市許可;於2014年4月獲得德國上市許可;於2015年1月獲得香港上市許可;於2016年12月獲得法國上市許可;於2017年2月獲得英國上市許可;於2018年5月23日獲得國家食品藥品監督管理總局頒發的藥品註冊批件;於2018年11月8日獲得美國FDA的批准上市。

近日公司收到的塞浦路斯批准通知,標誌着普利製藥具備了在塞浦路斯銷售注射更昔洛韋鈉的資格,將對公司拓展塞浦路斯市場帶來積極影響。

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