智通财经APP讯,君圣泰医药-B(02511)发布公告,中国国家药品监督管理局(NMPA)已受理 HTD1801用于治疗2型糖尿病(T2DM)的新药上市申请(NDA)。这是君圣泰医药提交的首个新药上市申请,也是公司迈向产品商业化的重要里程碑。
HTD1801已完成3项针对T2DM适应症的多中心、随机、双盲、对照的III期临床研究,均达主要终点和多项次要终点,在血糖、血脂、炎症、肾功能等多个心肾代谢关键维度呈现出一致的改善趋势,充分展现了其一药多效、综合获益的临床价值。
智通财经APP讯,君圣泰医药-B(02511)发布公告,中国国家药品监督管理局(NMPA)已受理 HTD1801用于治疗2型糖尿病(T2DM)的新药上市申请(NDA)。这是君圣泰医药提交的首个新药上市申请,也是公司迈向产品商业化的重要里程碑。
HTD1801已完成3项针对T2DM适应症的多中心、随机、双盲、对照的III期临床研究,均达主要终点和多项次要终点,在血糖、血脂、炎症、肾功能等多个心肾代谢关键维度呈现出一致的改善趋势,充分展现了其一药多效、综合获益的临床价值。
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