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亞寶藥業(600351.SH):子公司塞來昔布膠囊取得藥品註冊證書
格隆匯 01-21 16:17

格隆匯1月21日丨亞寶藥業(600351.SH)公佈,近日,公司全資子公司北京亞寶生物藥業有限公司(“亞寶生物”)收到了國家藥品監督管理局核准簽發的塞來昔布膠囊《藥品註冊證書》。

塞來昔布膠囊主要適用於緩解骨關節炎、成人類風濕關節炎和強直性脊柱炎的症狀和體徵,以及治療成人急性疼痛。原研廠家為輝瑞(Pfizer)公司,於1998年以商品名“Celebrex®”獲美國FDA批准上市;於2000年8月以商品名“西樂葆”在中國批准進口。根據米內數據統計,塞來昔布膠囊2020年中國公立醫療市場銷售金額為18.54億元。

亞寶生物首次提交本品註冊申請的受理時間為2019年7月17日(受理號:CYHS1900503、CYHS1900504)。截止目前,除原研廠商外,國內已取得塞來昔布膠囊藥品註冊證書的廠家共計14家,公司在該產品研發項目上已投入研發費用約為1815.06萬元人民幣。

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