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儿童生长发育药物研发
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长春高新技术产业(集团)股份有限公司关于子公司GS3-007a 干混悬剂境内生产药品注册临床试验申请获得受理的公告
Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received the acceptance notice from the National Medical Products Administration for the clinical trial application of GS3-007a dry mixed suspension, aimed at treating idiopathic short stature (ISS) [1][3]. Group 1: Drug Information - The product GS3-007a is an orally administered small molecule growth hormone secretagogue developed by JinSai Pharmaceutical, classified as a Class 1 chemical drug [1][2]. - The drug is intended for the treatment of idiopathic short stature (ISS), which accounts for approximately 40% of short stature cases in children in China [2]. Group 2: Clinical Trial and Development - GS3-007a has previously been approved for clinical trials related to growth retardation due to endogenous growth hormone deficiency (PGHD), with trials currently ongoing [2]. - The acceptance of the clinical trial application for GS3-007a is expected to facilitate further clinical development and address unmet clinical needs in pediatric growth [3]. Group 3: Company Strategy and Market Position - The development of GS3-007a aligns with the company's strategic focus on pediatric health and growth development products, with no similar products currently available in the domestic market [3]. - The company is committed to advancing the research and development of this project and will fulfill its information disclosure obligations regarding subsequent progress [4].