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恆瑞醫藥(600276.SH):子公司藥品鹽酸非索非那定片通過仿製藥一致性評價
格隆匯 12-07 17:21

格隆匯12月7日丨恆瑞醫藥(600276.SH)公佈,近日,公司子公司成都盛迪醫藥有限公司收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,公司鹽酸非索非那定片通過仿製藥質量和療效一致性評價。

該藥品的適應症:

季節性過敏性鼻炎,適用於緩解成人和6歲及6歲以上兒童的季節性過敏性鼻炎相關的症狀,如打噴嚏,流鼻涕,鼻、上顎、咽喉發癢,眼睛發癢、潮濕、發紅。

慢性特發性蕁麻疹,適用於治療成人和6歲及6歲以上兒童的慢性特發性蕁麻疹的皮膚症狀,能夠減輕瘙癢和風團的數量。

鹽酸非索非那定是具有選擇性外周H1-受體拮抗作用的抗組胺藥物。鹽酸非索非那定片由Hoechst Marion Roussel公司(現為Sanofi)研發,1996年3月首次在英國獲批上市,現已在中國獲批上市。同類產品有阿伐斯汀、西替利嗪和氯雷他定等。

經查詢EvaluatePharma數據庫,2020年鹽酸非索非那定相關劑型全球銷售額約為6.36億美元。

截至目前,鹽酸非索非那定片在仿製藥一致性評價項目上累計已投入研發費用約為761萬元。

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