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普利製藥(300630.SZ)500mg左氧氟沙星片獲得藥品註冊批件
格隆匯 04-18 17:02

格隆匯4月18日丨普利製藥(300630.SZ)公佈,公司的全資子公司浙江普利藥業有限公司於近日收到國家藥品監督管理局簽發的500mg左氧氟沙星片《藥品註冊證書》(4類仿製藥)。

左氧氟沙星(1evofloxacin,LVLX)是氟喹諾酮類藥物氧氟沙星的左旋光學異構體,體外抗菌活性為氧氟沙星的2倍。由於其抗菌作用強,抗菌譜廣,具有肯定的抗菌後效應,目前是臨牀抗感染的一線藥物。可用於治療成年人(≥18歲)由指定易感細菌引起的感染。左氧氟沙星由第一製藥(第一三共株式會社)研發,先後在全球40多個國家上市。在國內,第一三共製藥(北京)有限公司的左氧氟沙星片獲得批准,商品名:可樂必妥,規格:0.1g和0.5g。

浙江普利的左氧氟沙星片啟動研發後分別遞交了歐盟(荷蘭和德國)和中國註冊申請,屬共線生產產品,並且被納入了優先審評品種。其中同時期研發的另一規格250mg也已於2021年2月獲得國家藥品監督管理局簽發的《藥品註冊證書》,並順利進入國家藥品集採目錄。

近日,公司獲得由國家藥品監督管理局簽發的左氧氟沙星片(規格:500mg)《藥品註冊證書》,不僅有利於提升該藥品的市場競爭力,同時也為公司後續產品的研發申報工作積累了非常寶貴的經驗。

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