Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of GenSci143 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is an innovative biopharmaceutical developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which offers dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and producing more durable anti-tumor efficacy [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of GenSci143 in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is an innovative biopharmaceutical developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which offers dual potential therapeutic effects of targeted chemotherapy and tumor immunotherapy [1] - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and providing more durable anti-tumor efficacy [1]

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial application of GenSci134 injection, a self-developed biological product aimed at treating growth hormone deficiency (GHD) [1] Company Summary - Changchun Jinsai Pharmaceutical's GenSci134 injection is classified as a Class 1 therapeutic biological product [1] - The drug is intended for the treatment of GHD, including adult growth hormone deficiency (AGHD), pediatric growth hormone deficiency (PGHD), and non-GHD conditions such as idiopathic short stature (ISS) [1] - The current application specifically targets children experiencing growth retardation due to endogenous growth hormone deficiency (PGHD) [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for clinical trials of its product, GenSci143, in patients with advanced solid tumors [1] Group 1: Product Development - GenSci143 is a first-class therapeutic biological product independently developed by Jinsai Pharmaceutical, intended for the treatment of various advanced solid tumors, including prostate cancer and lung cancer [1] - GenSci143 is a bispecific antibody-drug conjugate (BsADC) targeting B7-H3 and PSMA, which has the potential for both targeted chemotherapy and tumor immunotherapy [1] Group 2: Market Potential - The drug aims to overcome tumor heterogeneity and resistance caused by reduced expression of single targets, thereby covering a broader patient population and producing more durable anti-tumor efficacy [1]

证券代码：000661 证券简称：长春高新 公告编号：2025-142 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci143 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。 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——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》，同意本品在晚期实体瘤患者中 开展临床试验。现将相关情况公告如下： 一、药品的基本情况 产品名称：注射用 GenSci143 申请事项：境内生产药品注册临床试验 受理号：CXSL2500728 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 适应症：晚期实体瘤 二、药品的其它情况 GenSci143 是金赛药业自主研发的一款治疗用生物制品 1 类药物，拟用于前 列腺癌和肺癌等多种晚期实体肿瘤治疗。作为一款靶向 B7-H3 与 PSMA 的双特 异性抗体偶联药物（BsADC），GenSci143 具有靶向化疗和肿瘤免疫双 ...

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 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。 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——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 PGHD 是由于垂体前叶分泌的生长激素不足所导致的一种内分泌代谢性疾 病。PGHD 是导致儿童身材矮小的原因之一，持续存在且未治疗的 GHD 还可以 引起患儿成年期代谢紊乱、心血管疾病等症状，影响生活质量和寿命。基于治疗 现状，PGHD 患者需要长期接受 GH 替代治疗，存在未被满足的临床需求。 综上所述，GenSci134 注射液具有潜在治疗 PGHD 的成药性，本次临床试验 1 申请的获批可推动该产品后续临床开发，也符 ...

Core Viewpoint - Changchun High-tech's subsidiary, GenSci, has received approval for the clinical trial application of GenSci134 injection for domestic production, which is aimed at treating children with growth retardation due to endogenous growth hormone deficiency [1] Group 1: Company Developments - The clinical trial application for GenSci134 injection has been approved by the National Medical Products Administration [1] - The drug is classified as a Class 1 therapeutic biological product and is intended for children with growth issues [1] - GenSci134 has previously been approved for clinical trials in adults with growth hormone deficiency, indicating a potential expansion of its application [1] Group 2: Industry Implications - Successful progress in the clinical trials could help the company diversify its business structure and enhance its core competitiveness [1] - The development of pharmaceutical products is inherently uncertain, and there are risks associated with the clinical trial process [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd. (referred to as "JinSai Pharmaceutical"), has received the Clinical Trial Approval Notification from the National Medical Products Administration for its GenSci134 injection, marking a significant step in the development of a treatment for growth hormone deficiency (GHD) [1] Company Summary - JinSai Pharmaceutical's GenSci134 injection is an independently developed Class 1 biological product intended for the treatment of GHD, including adult growth hormone deficiency (AGHD), pediatric growth hormone deficiency (PGHD), and non-GHD patients [1] - The current application specifically targets the treatment of pediatric growth retardation (PGHD) caused by endogenous growth hormone deficiency [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has received approval from the National Medical Products Administration for the clinical trial of GenSci143 in patients with advanced solid tumors [1] Group 1: Company Developments - Jinsai Pharmaceutical has been granted a Clinical Trial Approval Notice for GenSci143, a first-class therapeutic biological product developed independently by the company [1] - The clinical trial will focus on advanced solid tumors, specifically targeting prostate cancer and lung cancer among other indications [1]

Core Viewpoint - Changchun High-tech reported a decline in both revenue and net profit for the first three quarters of the year, indicating significant challenges in its financial performance [1] Financial Performance - For the first three quarters, the company achieved operating revenue of 9.807 billion, a year-on-year decrease of 5.60% [1] - The net profit attributable to shareholders was 1.165 billion, down 58.23% year-on-year [1] - In Q3 alone, operating revenue was 3.204 billion, reflecting a 14.55% year-on-year decline [1] - The net profit for Q3 was 182 million, a substantial decrease of 82.98% year-on-year [1] Subsidiary Performance - The net profit of subsidiary Jinsai Pharmaceutical decreased by 49.96% year-on-year [1] - The net profit of subsidiary Baike Biological plummeted by 164.76% year-on-year [1] Investment Activities - The company's long-term equity investments increased by 435 million compared to the beginning of the year, marking a growth of 149.56% [1] - This increase was primarily due to Baike Biological's second-phase capital increase in Chuanxin Biological, with an additional investment of 200 million, raising the company's ownership stake to 33.3241% [1]