【三生国健：GJ-613新药上市申请获受理】金十数据6月5日讯，三生国健公告，公司重组抗IL-1β人源化单克隆抗体注射液(项目代号“GJ-613”)用于急性痛风性关节炎适应症的III期临床试验达到了主要疗效双终点，并向国家药品监督管理局提交了新药上市申请。该药品为公司创新研发，拥有自主知识产权的抗IL-1β抗体，与已上市的同靶点产品Canakinumab和Gevokizumab具有完全不同的结合表位。已完成的III期临床研究显示，GJ-613在急性痛风性关节炎疼痛缓解和预防复发方面达到双主要疗效终点，与阳性对照药物复方倍他米松注射液的作用相当，并显著优于阳性对照药物。
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