Core Viewpoint - Changchun Gaoxin announced that its subsidiary has received acceptance for the clinical trial application of GS3-007a dry mixed suspension, a drug aimed at treating pediatric growth hormone deficiency (PGHD) [1] Group 1: Product Development - GS3-007a is an orally administered small molecule growth hormone secretagogue developed by Jinsai Pharmaceutical, classified as a Class 1 chemical drug [1] - The drug is intended for the treatment of PGHD, a common endocrine disorder in pediatrics that leads to short stature and delayed development in children [1] - The incidence of PGHD in China is approximately 1 in 8,600, with the majority of cases (about 70%) attributed to isolated growth hormone deficiency (GHD) due to insufficient secretion of growth hormone-releasing hormone (GHRH) [1] Group 2: Strategic Alignment - The development of GS3-007a aligns with the company's strategic focus on products for children's growth and development [1] - Currently, there are no similar products available in the domestic market, and the acceptance of this clinical trial application will facilitate the clinical development of the product and address unmet clinical needs for patients [1]
长春高新:GS3-007a干混悬剂境内生产药品注册临床试验申请获受理