长春高新技术产业（集团）股份有限公司 关于子公司GenSci141软膏境内生产药品注册临床试验申请 获得批准的公告

Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of GenSci141 ointment, which is aimed at treating conditions related to hypogonadism and congenital adrenal hyperplasia in children [1][2]. Group 1: Drug Information - The product name is GenSci141 ointment, which is a dihydrotestosterone ointment classified as a chemical drug of categories 2.2 and 2.4 [2]. - The clinical trial application for GenSci141 ointment has been approved, allowing the company to proceed with the necessary clinical studies [1]. - The indications for GenSci141 ointment include improving conditions caused by hypergonadotropic hypogonadism, 5α-reductase deficiency, and congenital adrenal hyperplasia, as well as idiopathic causes leading to small penis in children [1][2]. Group 2: Market Context - Current treatment methods for small penis in children include medication, surgery, and psychological counseling, with medication being the primary approach [2]. - There has been no approved medication specifically for the treatment of small penis in children until now, highlighting the potential market opportunity for GenSci141 ointment [2]. Group 3: Company Strategy - The company will actively promote the development of the aforementioned research project and will comply with relevant regulations to disclose subsequent progress in a timely manner [4].