苑東生物(688513.SH):鹽酸納洛酮注射液國內首家通過一致性評
格隆匯8月17日丨苑東生物(688513.SH)公佈,公司於近日收到國家藥監局核准簽發的化學藥品“鹽酸納洛酮注射液”的《藥品補充申請批准通知書》。經審查,該藥品通過仿製藥質量和療效一致性評價。該品種為阿片類受體拮抗藥,用於阿片類藥物複合麻醉術後,拮抗該類藥物所致的呼吸抑制,促使病人甦醒;用於阿片類藥物過量,完全或部分逆轉阿片類藥物引起的呼吸抑制;解救急性乙醇中毒;用於急性阿片類藥物過量的診斷。
鹽酸納洛酮注射液由美國ADAPT製藥公司研發,1971年4月獲美國食品藥品監督管理局批准,商品名為NARCAN,尚未進口國內。公司的鹽酸納洛酮注射液於2005年1月獲批上市,為國內首家通過一致性評價企業。截止該公吿披露日,國內有北京華素、北京四環等多家企業的鹽酸納洛酮注射液獲批生產,舒美奇成都生物科技(受託生產:四川美大康佳樂藥業)按新註冊分類向國家藥監局提交鹽酸納洛酮注射液的上市許可申請,暫無企業申報一致性評價補充申請。
米內網重點省市公立醫院數據庫顯示,2020年納洛酮注射劑(鹽酸納洛酮注射液和注射液用鹽酸納洛酮)在中國重點省市公立醫院的終端銷售額約為1.04億元,市場份額前三的公司分別為北京華素製藥(27.74%)、苑東生物(16.00%)和重慶藥友製藥(12.20%)。
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