Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., received approval for the clinical trial application of GenSci134 injection for domestic production, aimed at treating pediatric growth hormone deficiency (PGHD) [1][2] Group 1: GenSci134 Injection - GenSci134 injection is a self-developed biological product intended for the treatment of growth hormone deficiency, specifically for children experiencing growth retardation due to endogenous growth hormone deficiency [1][2] - The clinical trial approval for GenSci134 is expected to facilitate further clinical development and address unmet clinical needs for PGHD patients, who require long-term growth hormone replacement therapy [2] Group 2: GenSci143 Injection - The company also announced that its subsidiary received approval for the clinical trial application of GenSci143 injection, which targets advanced solid tumors, including prostate and lung cancers [6][7] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) that targets B7-H3 and PSMA, potentially offering dual therapeutic effects and addressing the heterogeneity of tumors [7][8] - The clinical trial application for GenSci143 has been accepted both domestically and internationally, indicating a broad scope for its development [8][9] Group 3: Impact on the Company - Successful progress in clinical trials for both GenSci134 and GenSci143 is expected to enhance the company's business structure, optimize product offerings, and strengthen its core competitiveness in the pharmaceutical industry [3][9]
长春高新技术产业(集团)股份有限公司关于子公司GenSci134注射液境内生产药品注册临床试验申请获得批准的公告