智飛生物(300122.SZ):子公司變更藥品生產許可證 生產範圍增加重組新型冠狀病毒疫苗(CHO細胞)
格隆匯 9 月 29日丨智飛生物(300122.SZ)公佈,公司今日收到全資子公司安徽智飛龍科馬生物製藥有限公司(“智飛龍科馬”或“子公司”)上報信息,獲悉智飛龍科馬收到安徽省藥品監督管理局換髮的《藥品生產許可證》,在原許可證(詳情可參考公司公告2018-07號)的基礎上,對藥品生產範圍等予以變更。
經監管部門同意,智飛龍科馬新《藥品生產許可證》變更事項為:
1、同意在合肥市高新區浮山路100號原有生產範圍基礎上增加重組新型冠狀病毒疫苗(CHO細胞);
2、分類碼由“Sb”變更為“As”;
3、發證日期變更至2020-09-29;
其他內容不變。
公司子公司藥品生產許可證原生產範圍基礎上增加重組新型冠狀病毒疫苗(CHO細胞),標誌着智飛龍科馬已具備重組新型冠狀病毒疫苗(CHO細胞)的生產條件和資格,有利於實施公司的疫苗產業戰略規劃;分類碼由“Sb”變更為“As”,系按照2020年7月1日生效的《藥品生產監督管理辦法》中分類碼編號進行的調整。原分類碼中S代表生物製品,b代表製劑,現分類碼中A代表自行生產的藥品上市許可持有人,s代表生物製品;重組新型冠狀病毒疫苗(CHO細胞)的研發進展請以公司發佈於創業板信息披露網站巨潮資訊網的公告為準,敬請廣大投資者謹慎決策,注意投資風險。
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