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恆瑞醫藥(600276.SH):“纈沙坦氨氯地平片(I)”獲得藥品註冊證書
格隆匯 09-22 15:36

格隆匯9月22日丨恆瑞醫藥(600276.SH)公佈,近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》。現將相關情況公告如下:

1、藥品名稱:纈沙坦氨氯地平片(I)

劑型:片劑

規格:每片含纈沙坦80mg,氨氯地平5mg

註冊分類:化學藥品4類

受理號:CYHS1800064國

證書編號:2020S00618

藥品批准文號:國藥準字H20203486

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。

2、藥品的其他相關情況

2018年3月12日,恆瑞醫藥向江蘇省食品藥品監督管理局遞交的藥品註冊申請獲得受理。纈沙坦氨氯地平片(I)包括纈沙坦和氨氯地平兩種降壓活性成份,兩種成份合用的降壓效果優於其中任一成份單藥治療。本品擬用於治療原發性高血壓,用於單藥治療不能充分控制血壓的患者。

纈沙坦氨氯地平片(AmlodipineandValsartanTablets,商品名Exforge)是瑞士諾華公司研製的降血壓複方片,2007年1月在歐盟獲得EMEA的批准,同年2月在瑞士獲批上市;2007年6月又經過美國FDA批准上市,並在2008年7月被美國FDA批准用於高血壓的一線治療。本品於2009年9月批准進口,規格為氨氯地平/纈沙坦(5/80mg),商品名為倍博特。目前,除公司外,國內已有百奧藥業、花園藥業同產品獲批上市;另有華海藥業、成都倍特等在內的6家企業申報生產。經查詢EvaluatePharma數據庫,瑞士諾華公司的纈沙坦氨氯地平片2019年全球銷售額約為10.25億美元。

截至目前,該產品累計已投入研發費用約為1535萬元人民幣。

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