一品紅(300723.SZ):纈沙坦氨氯地平片(I)獲批上市
格隆匯1月6日丨一品紅(300723.SZ)公佈,公司全資子公司廣州一品紅製藥有限公司於近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》,藥品通用名稱為纈沙坦氨氯地平片(I)。
根據核准的藥品説明書,公司研發的纈沙坦氨氯地平片(I)用於治療原發性高血壓。本品用於單藥治療不能充分控制血壓的患者。
高血壓是一種常見慢性病,也是心腦血管病的主要危險因素,近年來患病率趨勢總體持續增高,防控形勢嚴峻。高血壓治療主要是控制病情,將血壓控制在正常範圍內,不引發其他併發症。單片複方製劑因減少服藥數量、使用方便、可改善治療依從性及療效,已成為高血壓聯合治療的新趨勢。
纈沙坦氨氯地平片由Novartis研發,最早於2007年在歐盟上市。公司獲批的纈沙坦氨氯地平片(I)是以化學藥品4類申報註冊,視同通過仿製藥一致性評價。纈沙坦氨氯地平片(I)為國家醫保乙類品種,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、浙江華海藥業股份有限公司等。
據統計,2020年纈沙坦氨氯地平製劑產品(包括所有劑型)全球市場銷售額約9.18億美元(數據來源於MIDAS數據庫)。
此次獲得纈沙坦氨氯地平片(I)註冊證書,標誌着公司具備了在國內市場銷售該藥品的資格,將進一步豐富了公司產品管線和品類,增強公司在慢病領域的競爭力。
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