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受理的公告

Core Viewpoint - The announcement highlights that Changchun High-tech Industry (Group) Co., Ltd.'s subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of GenSci141 ointment from the National Medical Products Administration, indicating progress in the company's drug development efforts [1][3]. Group 1: Drug Information - Product Name: GenSci141 Ointment [1] - Application Type: Domestic production drug registration clinical trial [1] - Acceptance Numbers: CXHL2501394, CXHL2501395, CXHL2501396, CXHL2501397 [1] - Indications: Used to improve conditions related to hypergonadotropic hypogonadism, 5α-reductase type 2 deficiency, congenital adrenal hyperplasia due to reduced androgen synthesis, and idiopathic causes leading to micropenis in children [1]. Group 2: Drug Characteristics - GenSci141 ointment is a dihydrotestosterone ointment developed by Jinsai Pharmaceutical, primarily functioning through paracrine action in target tissues, classified as chemical drugs of categories 2.2 and 2.4 [2]. Group 3: Company Impact - If the clinical trial application progresses smoothly, it will help the company broaden its business structure, optimize its product structure, enrich its strategic product line, and enhance its core competitiveness [3]. - The company will actively promote the research and development of the project and fulfill its information disclosure obligations regarding subsequent progress [4].

CCHT-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受理的公告 - Reportify