先聲藥業(02096.HK):創新藥先必新®被納入新版醫保目錄
格隆匯 12 月 28日丨先聲藥業(02096.HK)公吿,於2020年12月28日,國家醫保局、人力資源社會保障部印發《國家基本醫療保險、工傷保險和生育保險藥品目錄(2020年)》,公司用於治療腦卒中的創新藥先必新®(依達拉奉右莰醇注射用濃溶液)被納入新版醫保目錄。
先必新®自2020年7月獲得國家藥監局批准上市,當年即進入醫保談判。作為腦卒中治療領域近5年來唯一獲批的一類新藥,先必新®此次進入醫保目錄將快速更大範圍惠及中國的腦卒中患者,藥品可及性大幅提高。
先必新®(依達拉奉右莰醇注射用濃溶液)是公司自主研發的一類創新藥。該藥以4:1的配比組合科學配伍了兩種活性成分-依達拉奉(抗氧化劑和自由基清除劑,清除羥自由基、一氧化氮自由基和ONOO-離子)和右旋莰醇(雙環單萜類化合物,抑制腦缺血再灌注導致的炎性細胞因子TNF-α、IL-1β的表達和致炎蛋白COX-2、iNOS的產生或表達),應用兩種成分清除自由基、抗炎以及改善血腦屏障通透性等多重作用機制,可顯著降低和改善急性缺血性腦卒中引發腦神經損傷。
在一項約1200名急性缺血性腦卒中患者參與的隨機、雙盲、陽性對照、頭對頭比較的III期研究表明,對比單方依達拉奉注射液,依達拉奉右莰醇注射用濃溶液顯示出明確的療效優勢、臨牀安全性相似,並大幅度將現有治療窗從24小時延長至48小時。
依達拉奉右莰醇注射用濃溶液於2020年7月取得NDA批文,且公司於2020年8月在中國推出先必新®(依達拉奉右莰醇注射用濃溶液)。
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