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恆瑞醫藥(600276.SH):尼莫地平口服溶液獲得藥品註冊證書
格隆匯 01-24 17:10

格隆匯1月24日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥品註冊證書》。現將相關情況公吿如下:

藥品名稱:尼莫地平口服溶液;規格:20ml:60mg。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。

尼莫地平為二氫吡啶鈣通道阻斷劑,通過抑制鈣離子進入細胞而抑制血管平滑肌細胞的收縮,因具有較高的親脂性而易通過血腦屏障,從而對腦動脈有較強的作用。尼莫地平口服溶液適用於顱內囊性動脈瘤破裂的蛛網膜下腔出血(SAH)成人患者,通過降低缺血性神經損傷的發生率和嚴重程度來改善患者神經系統預後,無論患者發作後的神經情況如何(即Hunt和Hess1-5級)。

尼莫地平口服溶液最早由ArborPharms公司開發,2013年通過FDA批准上市,商品名為Nymalize。國內目前有尼莫地平注射劑、膠囊劑、片劑等多種劑型獲批上市,公司尼莫地平口服溶液為首仿上市。除公司外,另有浙江國鏡藥業、廣東金城金素的尼莫地平口服溶液已申報生產,目前暫無獲批信息。經查詢,2020年尼莫地平相關劑型全球銷售額約1.1億美元。截止目前,尼莫地平口服溶液相關項目累計已投入研發費用約582萬元。

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