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普洛藥業(000739.SZ)子公司獲左氧氟沙星片藥品註冊批件
格隆匯 10-22 16:08

格隆匯10月22日丨普洛藥業(000739.SZ)公佈,近日,公司控股子公司浙江普洛康裕製藥有限公司收到國家藥監局核准簽發的《藥品註冊批件》。

左氧氟沙星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兩倍。其抗菌作用強,抗菌譜廣,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。

左氧氟沙星片由賽諾菲-安萬特公司開發,商品名為“Tavanic”,美國市場授權給強生公司,1993年將亞洲、非洲、中東和南美等地區的生產和銷售權授予第一三共。第一三共株式會社在日本上市規格為0.25g和0.5g,商品名為“Cravit”。第一三共製藥(北京)有限公司在中國分別於2001年和2004年上市規格為0.1g和0.5g的左氧氟沙星片,商品名為“可樂必妥”。目前國內擁有生產批件的企業主要有第一三共製藥(北京)有限公司、廣東東陽光藥業有限公司、長春海悦藥業股份有限公司和花園藥業股份有限公司4家公司。

根據米內網數據顯示,原研廠家第一三共株式會社該品種2019年在國內的銷售數據為7.85億元,同比增長13.01%。

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