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興齊眼藥(300573.SZ)收到藥品註冊受理通知書 涉貝美前列素滴眼液
格隆匯 04-30 16:40

格隆匯4月30日丨興齊眼藥(300573.SZ)公佈,公司於近日收到國家藥品監督管理局下發的藥品註冊受理通知書,產品名稱為貝美前列素滴眼液。

貝美前列素滴眼液公司研發代碼為SQ-758S。申報的臨牀適應症為:本品用於降低開角型青光眼及高眼壓症患者的眼壓。

原研藥貝美前列素滴眼液於2001年3月首次獲FDA批准上市,2005年4月進口中國,在眼科方面被用於降低開角型青光眼及高眼壓症患者的眼壓。目前國外已有數家企業(LUPIN LTD、SANDOZ INC、APOTEX INC等)進行了本品的仿製,並上市銷售。其中兆科(廣州)眼科藥物有限公司(CYHS1900632)、天津金耀藥業有限公司(CYHS1400195)、上海恆瑞醫藥有限公司(CYHS1201620)、湖北遠大天天明製藥有限公司(CYHS1201399)的仿製申報均在審評審批中。

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