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A股異動丨貝達藥業(300558.SZ)午後直線拉昇 鹽酸恩莎替尼獲批上市
格隆匯 11-19 13:10
格隆匯11月19日丨貝達藥業(300558.SZ)午後開盤直線拉昇至5.85%,報112.9元,暫成交3億元,總市值455億元。貝達藥業午間公告,公司今日從國家藥品監督管理局網站查詢獲悉,公司提交的鹽酸恩沙替尼膠囊藥品註冊申請在國家藥監局網站的辦理狀態已變更為“審批完畢-待制證”階段。“審批完畢-待制證”狀態表示國家藥監局行政受理服務中心正在製作藥品註冊批件。公司曾表示,將積極準備恩沙替尼一線ALK陽性適應症的中美上市申報,一線適應症計劃於明年申報NDA。

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