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樂普醫療(300003.SZ):替格瑞洛片獲得藥品註冊批件及單硝酸異山梨酯緩釋片通過藥品一致性評價
格隆匯 02-26 20:13

格隆匯 2 月 26日丨樂普醫療(300003.SZ)公佈,公司全資子公司樂普藥業股份有限公司(樂普藥業)於近日收到國家藥品監督管理局核准簽發的《藥品註冊批件》,替格瑞洛片獲得產品註冊批件,“單硝酸異山梨酯緩釋片”通過了仿製藥質量和療效一致性評價。

替格瑞洛(Ticagrelor)是一種環戊基三唑嘧啶類新型口服抗血小板藥物,由AstraZenecaAB公司研製,2010年12月3日在歐盟上市,2011年7月20日在美國上市,2012年11月在中國上市。用於急性冠脈綜合徵患者,包括接受藥物治療和經皮冠狀動脈介入(PCI)治療的患者,降低血栓性心血管事件的發生率。

公司該品是以生產線商業規模大生產樣品與原研參比製劑進行BE等效性評價,與原研完全等效,商業規模生產的處方工藝可以保證持續穩定地生產出與原研質量和療效一致的產品。

單硝酸異山梨酯片由德國廠商Boehringer Mannheim,GmbH首先研製並於1981年上市,樂普藥業是該藥品國內第二家通過一致性評價的企業。單硝酸異山梨酯為硝酸異山梨酯的主要活性代謝產物,主要用於治療冠心病的長期治療,心絞痛(包括心肌梗塞後)的長期治療和預防;與洋地黃及(或)利尿劑合用治療慢性充血性心力衰竭。

上述替格瑞洛和單硝酸異山梨酯片的獲批上市,進一步豐富了公司心血管藥品組合,公司將藉助在心血管領域的品牌優勢,發揮樂普的醫療機構、零售藥店和互聯網醫療等營銷網絡的協同效應,實現產品的放量。

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