GenSci134注射液

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长春高新:子公司GenSci134注射液临床试验获批
Xin Lang Cai Jing· 2025-08-26 13:03
长春高新8月26日晚间公告,公司子公司长春金赛药业有限责任公司收到国家药品监督管理局核准签发 的《受理通知书》,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受理。药品适应 症为:用于因内源性生长激素缺乏所引起的儿童生长缓慢/特发性身材矮小(ISS)。 ...
长春高新:子公司GenSci134注射液临床试验申请获受理
Zheng Quan Shi Bao Wang· 2025-08-26 12:17
Group 1 - The core point of the article is that Changchun High-tech (000661) announced that its subsidiary, Gensci Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci134 injection, a biopharmaceutical developed for treating growth hormone deficiency (GHD) [1] - GenSci134 is intended for the treatment of both adult growth hormone deficiency (AGHD) and pediatric growth hormone deficiency (PGHD), as well as non-GHD conditions such as idiopathic short stature (ISS) [1] - The application specifically targets children experiencing growth retardation due to endogenous growth hormone deficiency (PGHD) and idiopathic short stature (ISS) [1]