登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：000661 证券简称：长春高新 公告编号：2025-141 长春高新技术产业（集团）股份有限公司 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）子公司一一长春金赛药业有限责任 公司（以下简称"金赛药业"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，金赛 药业GenSci134注射液的境内生产药品注册临床试验申请获得批准，现将相关情况公告如下： 一、药品的基本情况 产品名称：GenSci134注射液 申请事项：境内生产药品注册临床试验 受理号：CXSL2500730、CXSL2500731 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 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 申请人：长春金赛药业有限责任公司 审批结论：经审查，同意本品开展临床试验 特此公告 适应症：用于因内源性生长激素缺乏所引起的儿童生长缓慢 二、药品的其它情况 GenSci134注射液是金赛药业自主研发的一款治疗用生物制品1类药物，拟用于生长激素缺乏症 （GH ...

公告显示，GenSci134注射液是金赛药业自主研发的一款治疗用生物制品1类药物，拟用于生长激素缺乏 症（GHD）包括成人生长激素缺乏症（AGHD）、儿童生长激素缺乏症（PGHD）和非GHD（包括ISS 等）患者的治疗。本次申请针对的是因内源性生长激素缺乏所引起的儿童生长缓慢（PGHD）。 北京商报讯（记者 丁宁）10月31日晚间，长春高新（000661）发布公告称，公司子公司长春金赛药业 有限责任公司（以下简称"金赛药业"）收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》，金赛药业GenSci134注射液的境内生产药品注册临床试验申请获得批准。 ...

【长春高新：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】智通财经10月31日 电，长春高新(000661.SZ)公告称，子公司金赛药业GenSci134注射液的境内生产药品注册临床试验申请 获国家药品监督管理局批准。该药物拟用于因内源性生长激素缺乏所引起的儿童生长缓慢，属于治疗用 生物制品1类药物。此前，该药物已获批用于成人生长激素缺乏症的临床试验。如试验进展顺利，将有 助于公司拓宽业务结构，提升核心竞争力。但医药产品研发具有不确定性，临床试验进程存在风险。 转自：智通财经 ...

格隆汇10月31日丨长春高新(000661.SZ)公布，子公司——长春金赛药业有限责任公司（简称"金赛药 业"）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，金赛药业GenSci134注射液的 境内生产药品注册临床试验申请获得批准。GenSci134注射液是金赛药业自主研发的一款治疗用生物制 品1类药物，拟用于生长激素缺乏症（GHD）包括成人生长激素缺乏症（AGHD）、儿童生长激素缺乏 症（PGHD）和非GHD（包括ISS等）患者的治疗。本次申请针对的是因内源性生长激素缺乏所引起的 儿童生长缓慢（PGHD）。 ...

Core Viewpoint - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical, has received written notification from the FDA regarding the acceptance of the clinical trial application for GenSci143, a dual-target antibody-drug conjugate aimed at treating tumors expressing B7-H3 and PSMA [1][2] Group 1: Product Development - GenSci143 is a self-developed drug that targets B7-H3 and PSMA, combining chemotherapy and tumor immunotherapy potential [1] - The drug utilizes a proprietary linker technology, providing strong cytotoxic activity and high plasma stability, which enhances its safety profile while effectively killing tumor cells [1] - The dual-target design of GenSci143 aims to overcome tumor heterogeneity and resistance, potentially benefiting a broader patient population [1] Group 2: Regulatory Progress - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China, indicating progress in both U.S. and Chinese markets [2] - The company has received multiple approvals for other clinical trial applications, including GS3-007a and GenSci140, showcasing a robust pipeline of innovative drug candidates [2] Group 3: Strategic Focus - The company has undertaken strategic adjustments and increased investment in innovation, establishing core technology platforms with independent intellectual property rights and international competitiveness [3] - There is a focus on high-demand therapeutic areas, particularly in endocrine metabolism and pediatric fields, aligning with the company's sustainable development and internationalization goals [3]

长春高新8月26日晚间公告，公司子公司长春金赛药业有限责任公司收到国家药品监督管理局核准签发 的《受理通知书》，金赛药业GenSci134注射液的境内生产药品注册临床试验申请获得受理。药品适应 症为：用于因内源性生长激素缺乏所引起的儿童生长缓慢/特发性身材矮小（ISS）。 ...

Group 1 - The core point of the article is that Changchun High-tech (000661) announced that its subsidiary, Gensci Pharmaceutical, has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci134 injection, a biopharmaceutical developed for treating growth hormone deficiency (GHD) [1] - GenSci134 is intended for the treatment of both adult growth hormone deficiency (AGHD) and pediatric growth hormone deficiency (PGHD), as well as non-GHD conditions such as idiopathic short stature (ISS) [1] - The application specifically targets children experiencing growth retardation due to endogenous growth hormone deficiency (PGHD) and idiopathic short stature (ISS) [1]