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昆藥集團(600422.SH):纈沙坦氨氯地平片(I)獲批上市
格隆匯 09-15 15:52

格隆匯9月15日丨昆藥集團(600422.SH)公佈,近日,公司收到國家藥監局簽發的關於纈沙坦氨氯地平片(I)的《藥品註冊證書》(證書編號為:2021S00974)。

纈沙坦氨氯地平片(I)適應症為治療原發性高血壓,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(I)是由纈沙坦(血管緊張素II受體AT1亞型受體拮抗劑)與氨氯地平(鈣離子拮抗劑)組成的固定劑量複方降壓藥,原諾華製藥(Novartis) ,於2007 年在歐盟和美國批准上市,商品名為EXFORGE2009年底進入中國市場,商品名倍博特。公司纈沙坦氨氯地平片(I)化學藥品4類獲得國家藥監局批准上市,視同通過一致性評價。

除原研諾華外,該藥品全球主要生產廠商有MYLANTEVA等,國內生產廠商主要有江蘇恆瑞醫藥股份有限公司、花園藥業股份有限公司等5家企業,另13家企業在申報生產。經查詢中康數據庫2020年纈沙坦氨氯地平片國內銷售額約人民幣28億元。

截至公吿日,公司針對該藥品的研發已投入研發費用約人民幣2310元。

公司此次纈沙坦氨氯地平片(I)獲批,有助於補充和豐富公司心腦血管病治療領域的產品管線,併為公司後續開展高端仿製藥研發工作積累寶貴的經驗。目前,該藥品獲批不會對公司現階段業績產生重大影響。

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