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康恩貝(600572.SH):子公司藥品注射用帕瑞昔布鈉通過仿製藥一致性評價
格隆匯 01-17 16:53

格隆匯1月17日丨康恩貝(600572.SH)公佈,近日,公司控股子公司浙江金華康恩貝生物製藥有限公司(金華康恩貝)收到國家藥品監督管理局頒發的注射用帕瑞昔布鈉的《藥品補充申請批准通知書》,該藥品通過仿製藥一致性評價。

注射用帕瑞昔布鈉適應症為用於手術後疼痛的短期治療,通過特異性抑制COX-2阻斷花生四烯酸合成前列腺素而發揮抗炎鎮痛作用,並可減少麻醉性鎮痛藥的用量。該藥品是《國家基本醫療保險、工傷保險和生育保險藥品目錄》2021年版乙類品種。

截至公吿披露日,通過國家藥監局一致性評價的注射用帕瑞昔布鈉廠家有金華康恩貝等27家公司(含以新註冊分類仿製藥4類申報批准的視同通過一致性評價品種)。

米內網數據顯示:相應國內藥品終端市場2020年注射用帕瑞昔布鈉銷售額約22億元。金華康恩貝該藥品取得藥品註冊批件後至今未進行生產銷售。

截至目前,金華康恩貝針對注射用帕瑞昔布鈉的一致性評價已投入研發費用約人民幣125萬元。

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