微芯生物(688321.SH):西格列他钠片获药品注册受理通知书
格隆汇9月19日丨微芯生物(688321.SH)公布,公司及全资子公司成都微芯药业有限公司2019年9月19日收到国家药监局下发的抗II型糖尿病国家1类新药西格列他钠片新药上市申请(NDA)的《受理通知书》。
国家1类新药西格列他钠是公司自主设计、合成、筛选和开发的新一代胰岛素增敏剂类新分子实体,针对2型糖尿病现已完成III期临床试验,也是全球最早完成III期临床试验的PPAR全激动剂。可以持续控制血糖及伴随脂代谢紊乱的严重胰岛素抵抗和糖尿病。
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