证券代码：000661 证券简称：长春高新 公告编号：2025-118 长春高新技术产业（集团）股份有限公司 关于子公司 GS3-007a 干混悬剂境内生产药品注册临床试验申请 获得受理的公告 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"）控股 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《受理通知书》，金赛药业 GS3-007a 干混悬剂境内生产 药品注册临床试验申请获得受理，现将有关情况公告如下： 一、药品的基本情况 产品名称：GS3-007a 干混悬剂 申请事项：境内生产药品注册临床试验 受理号：CXHL2500968 申请人：长春金赛药业有限责任公司 二、药品的其它情况 GS3-007a 干混悬剂是金赛药业自主研发的口服小分子生长激素促分泌药物， 注册分类为化药 1 类，拟用于因内源性生长激素缺乏所引起的儿童生长缓慢 （PGHD）的治疗。 PGHD 是儿科临床常见的内分泌疾病之一，会导致儿童身材矮小，发育迟缓， 骨龄落后于实际年龄。国内 PG ...

每经AI快讯，9月8日，长春高新(000661.SZ)公告称，公司控股子公司金赛药业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GS3-007a干混悬剂境内生产药品注册临床试验申请获得受 理。截至目前，国内尚无同类产品上市。该产品为口服小分子生长激素促分泌药物，拟用于因内源性生 长激素缺乏所引起的儿童生长缓慢的治疗。 ...

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GS3-007a, an orally administered small molecule growth hormone secretagogue, aimed at treating pediatric growth hormone deficiency (PGHD) [1] Group 1 - The clinical trial application for GS3-007a has been accepted, which is a significant step in the product's clinical development [1] - GS3-007a is classified as a Class 1 chemical drug and is intended for the treatment of children with growth retardation due to endogenous growth hormone deficiency [1] - Currently, there are no similar products available in the domestic market, indicating a potential unmet clinical need [1]

Market Overview - In the first week of September (September 1 to September 5), the A-share market experienced wide fluctuations, with the solid-state battery concept driving the rise of the new energy sector, leading to over 10% gains in related indices such as CS Battery and Innovative Energy [1][2] - The A-share innovation and entrepreneurship sector saw increased volatility, with the leading products in related ETFs actively traded, and the ChiNext ETF (159915) recording a trading volume exceeding 40 billion yuan [1][4] Sector Performance - The solid-state battery sector saw significant gains, with companies like Xian Dao Intelligent rising over 50%, and other firms such as Sunshine Power, Jinlang Technology, and Yiwei Lithium Energy increasing by over 30% [2] - More than 20 related thematic ETFs in the battery, new energy, and photovoltaic sectors collectively rose over 10%, with the Easy Fund New Energy ETF (516090) and the Energy Storage Battery ETF (159566) tracking indices that also saw gains exceeding 10% [2] ETF Trading Activity - The trading activity of thematic ETFs related to innovation and entrepreneurship was notably high, with the ChiNext ETF (159915) and the Sci-Tech 50 ETF (588080) recording trading volumes of over 40 billion yuan and 10 billion yuan, respectively [4] - In the Hong Kong market, the innovation drug sector remained active, attracting significant trading volumes, with some leading ETFs surpassing 60 billion yuan in trading volume [4] Fund Flows - Recent inflows into ETFs tracking sectors such as securities, chemicals, batteries, and gold stocks were substantial, with ETFs tracking securities companies seeing net inflows exceeding 8 billion yuan [5][6] - Conversely, the innovation and entrepreneurship thematic ETFs experienced net outflows, with the ChiNext ETF (159915) and the Sci-Tech 50 ETF (588080) seeing combined net outflows exceeding 6 billion yuan [5][6] New ETF Launches - Fund managers have accelerated the launch of new related ETF products, including the Easy Fund Shanghai Stock Exchange Sci-Tech Board New Energy ETF and various other thematic ETFs focused on artificial intelligence and software [8] - The Easy Fund Shanghai Stock Exchange Sci-Tech Board New Energy ETF completed its fundraising on September 5, tracking an index composed of 50 large-cap stocks in the photovoltaic, wind power, and new energy vehicle sectors [8]

Investment Rating - The report maintains an "Overweight" rating for the industry [6]. Core Insights - The report emphasizes the significant potential of innovative drugs in extending overall survival (OS) for cancer patients, with a growing focus on improving quality of life (QoL) through palliative care solutions [10][14]. - The pharmaceutical sector has shown resilience amid market fluctuations, with innovative drugs and their supply chains leading the performance [12][38]. - The report highlights the increasing competitiveness of domestic innovative drugs and the positive outlook for the innovation-driven industry chain [12][38]. Summary by Sections Industry Overview - The pharmaceutical industry consists of 494 listed companies with a total market capitalization of approximately 78,182.34 billion [3]. - The industry has demonstrated a 27.26% return since the beginning of 2025, outperforming the Shanghai Composite Index by 13.91 percentage points [38]. Market Dynamics - Recent market trends indicate a 1.40% increase in the pharmaceutical sector, while the broader market (CSI 300) decreased by 0.81% [12][38]. - The report notes a divergence in sub-sector performance, with chemical pharmaceuticals and biological products showing gains of 3.92% and 1.93%, respectively [12][38]. Innovative Drug Development - The report discusses the advancements in innovative therapies such as dual antibodies, antibody-drug conjugates (ADC), and small molecule targeted therapies, which are crucial for improving OS and QoL for cancer patients [10][14]. - Specific companies like Changchun High-tech and Lee's Pharmaceutical are highlighted for their innovative treatments targeting cancer cachexia and breakthrough cancer pain [10][29]. Investment Recommendations - The report recommends focusing on companies with strong innovative drug pipelines and those that are likely to benefit from upcoming data catalysts, particularly in the context of the WCLC conference [12][38]. - Key companies to watch include WuXi AppTec, Innovent Biologics, and others involved in the innovative drug supply chain [12][38]. Valuation Metrics - The current valuation of the pharmaceutical sector is approximately 28.1 times PE based on 2025 earnings forecasts, indicating a premium over the broader A-share market [41][42]. - The report notes that the sector's valuation is below its historical average, suggesting potential for growth [41][42].

Group 1 - The core announcement is that Changchun High-tech Industry (Group) Co., Ltd.'s subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., has received acceptance for the clinical trial application of the injectable GenSci140 from the National Medical Products Administration [1][2] - GenSci140 is a novel dual-target antibody-drug conjugate specifically designed to target the folate receptor alpha (FRα), which is expressed in various tumors, including ovarian cancer [2][3] - The drug utilizes a unique linker technology and is expected to enhance tumor cell killing while maintaining a favorable safety profile, making it a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium expression levels [3] Group 2 - If the clinical trial progresses smoothly, it will help the company expand its business scope, optimize its product structure, and enhance its core competitiveness [4] - The pharmaceutical product development process is characterized by high technology, high risk, and long timelines, which may be influenced by various uncertainties [4][5] - The company will actively promote the research and development of this project and fulfill its information disclosure obligations regarding subsequent progress [5]

人民财讯9月5日电，长春高新（000661）9月5日晚间公告，近日，公司子公司金赛药业收到国家药监局 核准签发的《受理通知书》，金赛药业注射用GenSci140注册临床试验申请获得受理。 GenSci140是金赛药业自主研发的一款新型靶向叶酸受体α亚型双表位抗体药物偶联物。 ...

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice for the clinical trial application of GenSci140 from the National Medical Products Administration, indicating progress in the development of a new targeted therapy for cancer [1][2]. Group 1 - GenSci140 is a novel dual-target antibody-drug conjugate that targets the folate receptor alpha (FRα), designed to enhance binding and internalization in tumor cells [1]. - The drug combines Fab fragments targeting different epitopes of FRα with a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and a topoisomerase I (TOPOI) inhibitor payload [1]. - GenSci140 has shown significant anti-tumor effects in various models, including ovarian cancer, regardless of FRα expression levels [2]. Group 2 - Preclinical studies indicate that GenSci140 possesses strong tumor cell binding and internalization activity, along with high plasma stability of the linker technology developed in-house [2]. - The innovative dual-epitope design and effective cytotoxic mechanism suggest that GenSci140 could become a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium FRα expression [2].

长春高新(000661.SZ)公告，公司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《受理通知书》，金赛药业注射用GenSci140注册临床试验申请获得受理。GenSci140 是金赛药业自主研发的一款新型靶向叶酸受体α亚型双表位抗体药物偶联物，由结合FRα不同表位的Fab 和单域重链抗体(VHH)构成双表位抗体，采用可裂解的连接子并搭载拓扑异构酶I(TOPOI)抑制剂载荷。 GenSci140可同时结合肿瘤细胞上表达的FRα抗原的两个不同表位，增加抗体的结合和内化，促进 TOPOI抑制剂细胞毒性载荷进入细胞，从而直接杀伤肿瘤细胞，同时可通过旁观者杀伤效应进一步增强 抑瘤效果。 ...

综上，GenSci140凭借其创新的双表位设计、稳定的链接子技术和高效的细胞杀伤机制，有望成为FRα 阳性的肿瘤患者的潜在最佳治疗选择，尤其在FRα中低表达人群。 格隆汇9月5日丨长春高新(000661.SZ)公布，近日，长春高新技术产业(集团)股份有限公司子公司——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《受理通知书》，金赛 药业注射用GenSci140注册临床试验申请获得受理。 临床前体外和体内研究表明，GenSci140具有良好的肿瘤细胞结合和内化活性，在卵巢癌等多种CDX(细 胞系来源的异体移植肿瘤)和PDX(患者来源肿瘤异种移植)模型中，无论FRα表达水平，均展现了显著的 抗肿瘤效果。另外，GenSci140采用自主研发的接头技术，具备有效载荷活性强和连接子血浆稳定性高 等特性，在产生更强肿瘤杀伤作用的同时，还具备更优的潜在安全性。 GenSci140是金赛药业自主研发的一款新型靶向叶酸受体α亚型(Folate Receptor Alpha,FR α/FOLR1)双表 位抗体药物偶联物，由结合FRα不同表位的Fab和单域重链抗体(VHH)构成双表位抗体，采用可裂 ...