康恩貝(600572.SH):注射用帕瑞昔布鈉獲藥品註冊批件
格隆匯4月7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”)收到國家食品藥品監督管理總局核准簽發的注射用帕瑞昔布鈉《藥品註冊批件》。
注射用帕瑞昔布鈉適應症為用於手術後疼痛的短期治療,是由美國法瑪西亞公司研發的第一個可靜脈注射或肌肉注射用的選擇性COX-2抑制劑,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。2002年在歐洲獲准上市,商品名為Dynastat。2008年獲得SFDA批准進口,商品名:特耐。
帕瑞昔布鈉原料藥及注射用帕瑞昔布鈉是由金華康恩貝與南京華威醫藥科技開發有限公司合作開發的產品,由金華康恩貝2014年1月遞交帕瑞昔布鈉原料藥及注射用帕瑞昔布鈉的註冊申請,並於近日獲得國家食品藥品監督管理總局核准簽發的注射用帕瑞昔布鈉《藥品註冊批件》,同時帕瑞昔布鈉原料藥也已通過了國家藥品審評中心的審評審批,完成了在原料藥登記系統的備案並激活,產權屬金華康恩貝所有。截至目前,金華康恩貝對該產品已投入研發費用人民幣約1100萬元。
根據國家藥品審評中心(CDE)網站顯示,截至公告日,國內共有41家企業申報生產注射用帕瑞昔布鈉,其中已有18家企業獲得藥品註冊批件,16家企業正在審評中。
藥學會677家樣本醫院臨牀採購數據顯示,國內2019年注射用帕瑞昔布鈉臨牀採購金額為5.92億元,同比增長64.86%。
注射用帕瑞昔布鈉為凍乾粉針劑,其生產上市所需的帕瑞昔布鈉原料藥由金華康恩貝配套生產。該產品的獲批生產上市,增加了公司產品種類,提高了公司核心競爭力,對公司業績將產生積極影響。
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