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位于江宁高新园的“千人计划”企业、前沿生物药业(南京)股份有限公司上周宣布,其自主研发的国家一类新药艾博卫泰的验证性临床三期试验已提前达到所有预设的临床终点指标,将在近期向国家食品药品监督管理总局申报新药上市许可。这是我国本土开发的第一个抗艾新药,也是全球首个治疗艾滋病的长效药。据介绍,艾博卫泰三期临床试验按国际标准设计,主要终点指标为治疗48周血液中HIV病毒载量小于50拷贝/毫升的患者百分比。中期数据显示,艾博卫泰组有80.4%的患者达到主要终点指标。
Located at Jiangning High-tech Park, Qianman Bio-Pharmaceutical (Nanjing) Co., Ltd. announced last week that its self-developed first-class national drug, All preset clinical end points will be announced to the State Food and Drug Administration in the near future. This is the first AIDS drug developed in our country and the first long-acting drug to treat AIDS in the world. According to reports, Tribulus Phase III clinical trials designed according to international standards, the main endpoint index for the treatment of 48 weeks the blood HIV viral load of less than 50 copies / ml of patients. In the interim data, 80.4% of patients in the Arvivax group achieved the primary endpoint.