长春高新(000661.SZ):GenSci134注射液境内生产药品注册临床试验申请获批准

智通财经
Nov 03

智通财经APP讯,长春高新(000661.SZ)公告,公司子公司长春金赛药业有限责任公司(简称“金赛药业”)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》,金赛药业GenSci134注射液的境内生产药品注册临床试验申请获得批准。

公告显示,GenSci134注射液是金赛药业自主研发的一款治疗用生物制品1类药物,拟用于生长激素缺乏症(GHD)包括成人生长激素缺乏症(AGHD)、儿童生长激素缺乏症(PGHD)和非GHD(包括ISS等)患者的治疗。本次申请针对的是特发性身材矮小(ISS)。

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