深圳高速公路股份(00548.HK):抗炎鎮痛藥物注射用帕瑞昔布鈉獲批上市
格隆匯 2 月 25日丨深圳高速公路股份(00548.HK)公佈,於公吿刊發之日,公司之附屬公司泰州復旦張江藥業有限公司("泰州復旦張江")的抗炎鎮痛藥物注射用帕瑞昔布鈉(規格:20mg、40mg)已獲國家藥品監督管理局頒發的《藥品註冊證書》,批准文號為國藥準字H20213127及國藥準字H20213128。該藥物按與原研藥品質和療效一致的審評標準獲批上市,泰州復旦張江將盡快開展該藥品的生產及銷售。
作為集團首個與治療鮮紅斑痣的海姆泊芬(商品名:復美達®)共線的仿製類藥物,該藥物獲批上市,使集團藥品產品線進一步豐富,同時將提升泰州復旦張江生產線的產能利用,對集團未來經營發展起到積極的作用。
該藥物為選擇性環氧化酶-2(Cyclooxygenase-2,COX-2)抑制劑,主要用於手術後疼痛的短期治療,根據國外文獻報導,已經廣泛於口腔科、骨科、婦科以及冠狀動脈搭橋術中使用。該藥物具有起效迅速,作用持久、胃腸安全性高,不增加心血管風險的特點,且可顯著減少術後阿片類藥物用量,為臨牀多模式鎮痛的基礎用藥之一。2008年注射用帕瑞昔布鈉獲准在中國上市,目前屬於《國家基本醫療保險、工傷保險和生育保險藥品目錄》乙類品種藥物。
截至公吿日,該藥物累計投入研發費用約為人民幣2,000萬元。
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