億帆醫藥(002019.SZ):鹽酸替羅非班注射液獲得藥品註冊受理通知書
格隆匯1月25日丨億帆醫藥(002019.SZ)公佈,公司全資子公司遼寧億帆藥業有限公司於2022年1月24日收到國家藥品監督管理局(以下簡稱“藥監局”)簽發的鹽酸替羅非班注射液境內註冊上市許可申請《受理通知書》。
鹽酸替羅非班注射液適用於末次胸痛發作12小時之內且伴有ECG改變和/或心肌酶升高的非ST段抬高型急性冠脈綜合徵(NSTE-ACS)成年患者,預防早期心肌梗死。最可能受益的患者是在急性心絞痛症狀發作後頭3-4天內具有較高心肌梗死風險的患者,包括可能進行早期經皮冠狀動脈介入術(PCI)的患者。用於計劃進行直接PCI的急性心肌梗死患者(STEMI),以減少重大心血管事件的發生。本品應與普通肝素和阿司匹林一起使用。
鹽酸替羅非班注射液最早由MSDSharp&DohmeGmbH開發,1998年首次在美國上市。公司於2021年6月完成鹽酸替羅非班注射液藥學研究工作,於2022年1月向藥監局遞交上市申請,並於2022年1月24日獲得受理。
截止本報吿披露日,中國境內鹽酸替羅非班注射劑的主要廠家有魯南貝特製藥有限公司、遠大醫藥(中國)有限公司、貴州景峯注射劑有限公司等,多家企業按照一致性評價標準申報,其中7家企業通過或視同通過一致性評價,1家企業獲得臨牀試驗默示許可。
根據米內網數據顯示,2020年鹽酸替羅非班注射劑國內市場銷售額約4.34億元。截止本報吿披露日,公司在本項目上研發投入390.79萬元。
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