CCHT: GenSci134 injection domestic production drug registration clinical trial application approved
I'm LongbridgeAI, I can summarize articles.CCHT's subsidiary, GenSci Pharmaceutical, has received approval from the National Medical Products Administration for the domestic production drug registration clinical trial application of GenSci134 injection. This drug is a biological product for the treatment of growth hormone deficiency, suitable for adult and pediatric patients, especially for those with idiopathic short stature
According to the announcement from Zhitong Finance APP, Changchun High-tech (000661.SZ) stated that its subsidiary Changchun JinSai Pharmaceutical Co., Ltd. (referred to as "JinSai Pharmaceutical") has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The clinical trial application for the domestic production of JinSai Pharmaceutical's GenSci134 injection has been approved.
The announcement indicates that GenSci134 injection is a Class 1 therapeutic biological product independently developed by JinSai Pharmaceutical, intended for the treatment of growth hormone deficiency (GHD), including adult growth hormone deficiency (AGHD), pediatric growth hormone deficiency (PGHD), and non-GHD (including ISS, etc.) patients. This application targets idiopathic short stature (ISS)