華潤雙鶴(600062.SH):苯磺酸氨氯地平片(2.5mg)獲藥品補充申請批件
格隆匯4月8日丨華潤雙鶴(600062.SH)公佈,近日,華潤雙鶴藥業股份有限公司全資子公司華潤賽科藥業有限責任公司(“華潤賽科”)收到了國家藥監局頒發的苯磺酸氨氯地平片(2.5mg)《藥品補充申請批件》(批件號:2020B02729)。
苯磺酸氨氯地平片主要用於治療高血壓及冠心病。
苯磺酸氨氯地平片原研為2.5mg、5mg、10mg三個規格,華潤賽科已於2011年獲批5mg規格並於2018年7月24日通過一致性評價。為滿足不同患者人羣的用藥需求,華潤賽科自2018年8月啟動增加2.5mg規格的補充研究工作,於2019年8月26日向國家藥監局提交了增加2.5mg規格的補充申請,並於2019年9月5日獲得受理通知書,最終於2020年3月24日獲得國家藥監局審核通過。
截至公告日,華潤賽科就苯磺酸氨氯地平片(2.5mg)累計研發投入約人民幣211.49萬元(未經審計)。
此次《藥品補充申請批件》的獲得是對苯磺酸氨氯地平片規格的進一步補充,將有利於發揮該藥品未來市場銷售和市場競爭的潛力。
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