汇宇制药(688553.SH)子公司HY-1016缓释注射液获批开展临床试验

智通财经
Jun 30

智通财经APP讯,汇宇制药(688553.SH)发布公告,近日,公司全资子公司四川汇宇海玥医药科技有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,HY-1016缓释注射液(项目研发代号为“HY-1016”)用于治疗子宫内膜异位症的临床试验获得批准。

据悉,地诺孕素是一种高选择性孕激素受体激动剂,通过抑制下丘脑-垂体-卵巢轴减少雌二醇内源性生成,从而抑制雌二醇对正常位置及异位的子宫内膜的刺激作用,在子宫内膜异位症发挥作用。当连续给药时,地诺孕素导致低雌激素、高孕激素的内分泌环境,引起子宫内膜组织蜕膜化,进而使子宫内膜异位病灶缩小。HY-1016缓释注射液为含有地诺孕素的新剂型、新给药途径,以期在不降低临床疗效、不增加新的重要安全性风险前提下,减少子宫内膜异位症患者长期治疗的用药频率,提升用药依从性。

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