先声药业(02096.HK):创新药先必新®被纳入新版医保目录
格隆汇 12 月 28日丨先声药业(02096.HK)公告,于2020年12月28日,国家医保局、人力资源社会保障部印发《国家基本医疗保险、工伤保险和生育保险药品目录(2020年)》,公司用于治疗脑卒中的创新药先必新®(依达拉奉右莰醇注射用浓溶液)被纳入新版医保目录。
先必新®自2020年7月获得国家药监局批准上市,当年即进入医保谈判。作为脑卒中治疗领域近5年来唯一获批的一类新药,先必新®此次进入医保目录将快速更大范围惠及中国的脑卒中患者,药品可及性大幅提高。
先必新®(依达拉奉右莰醇注射用浓溶液)是公司自主研发的一类创新药。该药以4:1的配比组合科学配伍了两种活性成分-依达拉奉(抗氧化剂和自由基清除剂,清除羟自由基、一氧化氮自由基和ONOO-离子)和右旋莰醇(双环单萜类化合物,抑制脑缺血再灌注导致的炎性细胞因子TNF-α、IL-1β的表达和致炎蛋白COX-2、iNOS的产生或表达),应用两种成分清除自由基、抗炎以及改善血脑屏障通透性等多重作用机制,可显著降低和改善急性缺血性脑卒中引发脑神经损伤。
在一项约1200名急性缺血性脑卒中患者参与的随机、双盲、阳性对照、头对头比较的III期研究表明,对比单方依达拉奉注射液,依达拉奉右莰醇注射用浓溶液显示出明确的疗效优势、临床安全性相似,并大幅度将现有治疗窗从24小时延长至48小时。
依达拉奉右莰醇注射用浓溶液于2020年7月取得NDA批文,且公司于2020年8月在中国推出先必新®(依达拉奉右莰醇注射用浓溶液)。
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