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普利製藥(300630.SZ):左氧氟沙星片獲得藥品註冊批件
格隆匯 02-03 19:29

格隆匯 2 月 3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(“浙江普利”)於近日收到國家藥品監督管理局簽發的左氧氟沙星片《藥品註冊證書》(4類仿製藥)。

左氧氟沙星口服制劑可用於治療成年人(≥18歲)由下列細菌的敏感菌株所引起的下列輕、中、重度感染:醫院獲得性肺炎;醫院獲得性肺炎;急性細菌性鼻竇炎;慢性支氣管炎的急性細菌性發作;複雜性皮膚及皮膚結構感染;非複雜性皮膚及皮膚軟組織感染;慢性細菌性前列腺炎;複雜性尿路感染;急性腎盂腎炎;非複雜性尿路感染;吸入性炭疽(暴露後)。

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於2018年啟動研發,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。本品分別於2020年6月和8月獲得荷蘭藥物評價委員和德國BfArM所簽發的上市許可。

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《藥品註冊證書》,對普利製藥意義非凡,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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