人福醫藥(600079.SH):鹽酸納布啡注射液和咪達唑侖注射液通過一致性評價
格隆匯 4 月 6日丨人福醫藥(600079.SH)公佈,近日,公司控股子公司宜昌人福藥業有限責任公司(“宜昌人福”,公司持有其80%的股權)收到國家藥品監督管理局(“國家藥監局”)關於鹽酸納布啡注射液和咪達唑侖注射液的《藥品補充申請批准通知書》(通知書編號:2021B00737,2021B00738,2021B00739),該藥品通過仿製藥質量和療效一致性評價。
鹽酸納布啡注射液廣泛應用於緩解中至重度疼痛,也可作為複合麻醉時麻醉誘導。宜昌人福於2019年向國家藥監局遞交一致性評價申請並獲受理,累計研發投入約為人民幣250萬元。
根據國家藥品監督管理局網站顯示,國內僅宜昌人福獲得鹽酸納布啡注射液的生產批文。根據米內網數據統計,2019年度鹽酸納布啡注射液在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為4億元人民幣。
咪達唑侖注射液主要用於術前鎮靜/抗焦慮/遺忘;診斷、治療、內窺鏡手術;全麻誘導和維持;氣管插管、機械通氣患者和病危護理治療中的鎮靜。宜昌人福於2019年向國家藥監局遞交一致性評價申請並獲受理,累計研發投入約為人民幣380萬元。
根據國家藥品監督管理局網站顯示,國內共有4家企業持有咪達唑侖注射液的生產批文。根據米內網數據統計,2019年度咪達唑侖所有劑型(含片劑、注射劑)在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為6億元人民幣,主要生產廠商為江蘇恩華藥業股份有限公司、宜昌人福、江蘇九旭藥業有限公司。
根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。此次鹽酸納布啡注射液和咪達唑侖注射液通過一致性評價將有利於提高該藥品的市場競爭力。
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