长春高新9月5日公告，公司子公司长春金赛药业有限责任公司注射用GenSci140注册上市许可申请获得 国家药品监督管理局出具的《受理通知书》。注射用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, FRα/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，采用可裂解的连接子并搭载拓扑异构酶I（TOPO I）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TOPO I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。适应症：晚期实体瘤。 ...

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 ...

长春高新（000661）(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。 ...

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"）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》，金赛药业注射用 GenSci140 注册临床试验申 请获得受理，现将相关情况公告如下： 一、药品的基本情况 证券代码：000661 证券简称：长春高新 公告编号：2025-117 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci140 境内生产药品注册临床试验申请 产品名称：注射用 GenSci140 申请事项：境内生产药品注册临床试验 受理号：CXSL2500763 适应症：晚期实体瘤 二、药品的其它情况 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, FRα/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，采用可裂解的连接子并搭载拓扑 异构酶 I（TOPO I）抑制剂载荷。GenS ...

Core Viewpoint - The approval of the clinical trial application for GenSci140 by the National Medical Products Administration is a significant milestone for the company, enhancing its business scope and product structure [1] Company Summary - The subsidiary, Jinsai Pharmaceutical, has received the acceptance notice for the clinical trial application of GenSci140, a novel targeted antibody-drug conjugate for the treatment of advanced solid tumors [1] - GenSci140 is independently developed by Jinsai Pharmaceutical and targets the folate receptor alpha subtype [1] - The successful acceptance of this application is expected to enrich and improve the strategic product line layout, thereby enhancing the company's core competitiveness [1] Industry Summary - The development and commercialization of new drugs involve lengthy and complex processes, which are subject to various uncertainties [1] - The clinical trial process for GenSci140 may face uncertainties that could impact its timeline and outcomes [1]

Group 1 - The A-share innovative drug sector experienced a strong rebound, with the Biopharmaceutical ETF (159839) rising by 4.17% and a trading volume exceeding 44 million yuan [1] - The Biopharmaceutical ETF (159839) has seen a net inflow of over 15 million yuan for two consecutive days [1] - Several innovative drug companies reported significant stock price increases, with notable gains including 9.99% for Zhaoyan New Drug and 7.53% for Changchun High-tech [2] Group 2 - The pharmaceutical industry is experiencing structural differentiation, with a 0.7% decline in revenue and a 1.5% increase in net profit for listed companies in the first half of 2025 [3] - Leading innovative drug companies are achieving profitability, driven by strong sales of key products such as Zebutinib and Furmetinib [3] - The innovative drug sector is expected to benefit from improved policies and a downward trend in global central bank interest rates, which may enhance long-term valuations [4] Group 3 - The CXO industry is entering a recovery phase, with a resurgence in overseas demand expected by the end of 2023, leading to a recovery in domestic head companies' orders in 2024 [5] - The domestic innovative drug assets are progressing into late clinical stages, with increasing validation of clinical data and a clear trend towards internationalization [5]

Core Viewpoint - The biopharmaceutical sector experienced a significant increase of 3.06% on September 5, with Sanofi leading the gains [1] Group 1: Market Performance - The Shanghai Composite Index closed at 3812.51, up 1.24% [1] - The Shenzhen Component Index closed at 12590.56, up 3.89% [1] Group 2: Individual Stock Performance - Sanofi (688336) closed at 61.60, with a rise of 11.80% and a trading volume of 165,400 shares, totaling a transaction value of 9.62 billion [1] - Changchun High-tech (000661) closed at 128.00, increasing by 7.53% with a trading volume of 270,100 shares [1] - Junshi Biosciences (688180) closed at 48.00, up 7.38% with a trading volume of 252,900 shares, totaling 1.17 billion [1] - Tibet Pharmaceutical (600211) closed at 50.48, rising by 7.13% with a trading volume of 220,200 shares, totaling 1.08 billion [1] - Other notable stocks include: - Rongan Bio (688331) at 92.17, up 4.32% [1] - Kexing Pharmaceutical (688136) at 42.27, up 4.14% [1] Group 3: Capital Flow - The biopharmaceutical sector saw a net inflow of 231 million from institutional investors, while retail investors experienced a net outflow of 25.77 million [1]

Core Viewpoint - Changchun High-tech is facing significant challenges with declining revenues and profits, indicating a struggle to maintain its market position amid increasing competition and pricing pressures in the pharmaceutical industry [1][6]. Financial Performance - In the first half of 2025, Changchun High-tech reported revenue of 6.603 billion yuan, a slight decrease of 0.54% year-on-year, while net profit attributable to shareholders fell sharply by 42.85% to 983 million yuan [1]. - For the full year of 2024, the company expects revenue to be 13.466 billion yuan, down 7.55% year-on-year, and net profit to drop by 43.01% to 2.583 billion yuan, marking the first annual revenue decline since 2004 [1]. - The first quarter of 2025 saw a further decline in net profit by 44.95%, with no signs of stabilization in performance [1]. Key Business Segments - Jinsai Pharmaceutical, a major profit source for Changchun High-tech, achieved revenue of 5.469 billion yuan in the first half of 2025, up 6.17% year-on-year, but net profit plummeted by 37.35% to 1.108 billion yuan, highlighting a significant disparity between revenue growth and profit decline [2]. - The core products of Jinsai Pharmaceutical, particularly growth hormone products, are facing challenges due to price pressures from collective procurement policies initiated in 2023, which have significantly impacted profit margins [2]. Cost Structure - Sales expenses for Changchun High-tech reached 2.386 billion yuan in the first half of 2025, an increase of 23.43% year-on-year, while management expenses rose by 31.26% to 724 million yuan, further straining profitability amid stagnant revenue [3]. - Research and development expenses amounted to 1.335 billion yuan, a 17.32% increase year-on-year, representing over 20% of revenue, with the approval of the IL-1β monoclonal antibody "Jinbeixin" marking a significant milestone in the company's biopharmaceutical innovation efforts [3]. Market Competition - The approval of Teva Biopharmaceutical's long-acting growth hormone product "Yipeisheng" in May 2025 has ended Jinsai Pharmaceutical's long-standing monopoly in the growth hormone market, leading to intensified competition [4]. - Other competitors, including international pharmaceutical giant Novo Nordisk, are also entering the market with competitive products, indicating a shift towards a more competitive landscape in the growth hormone sector [4]. Secondary Growth Drivers - The company's secondary growth driver, the shingles vaccine, has also underperformed, with revenue from its subsidiary Baike Bio falling by 53.93% to 285 million yuan in the first half of 2025, and a 71.54% decline expected in 2024 [4][5]. - The overall market for vaccines has been adversely affected by decreased public willingness to receive vaccinations post-COVID-19, compounding the challenges faced by Baike Bio [5]. Conclusion - The decline in net profits and the challenges faced by Changchun High-tech underscore the vulnerabilities of companies heavily reliant on single product lines amid regulatory and competitive pressures [6].

Group 1 - The core viewpoint of the news is the performance and financial status of Changchun High-tech Industry (Group) Co., Ltd, which saw a stock price increase of 5.01% to 125.00 CNY per share, with a total market capitalization of 509.92 billion CNY [1] - The company was established on June 10, 1993, and listed on December 18, 1996, primarily engaged in the research, production, and sales of biopharmaceuticals and traditional Chinese medicine, with a revenue composition of 92.83% from pharmaceuticals, 6.81% from real estate, and 0.36% from services [1] - The trading volume for the stock was 21.52 billion CNY, with a turnover rate of 4.39% [1] Group 2 - From the perspective of fund holdings, the Hongta Hongtu Fund has a significant position in Changchun High-tech, with its Hongta Hongtu Medical Selected Stock Fund A (020331) holding 6,000 shares, accounting for 4.67% of the fund's net value, ranking as the seventh largest holding [2] - The fund has achieved a year-to-date return of 44.17%, ranking 251 out of 4222 in its category, and a one-year return of 54.49%, ranking 1337 out of 3795 [2] - The fund manager, Cao Yang, has been in the position for nearly two years, with the fund's total asset size at 12.75 million CNY and a best return of 41.03% during his tenure [3]

New Stock Offerings - Fushun Special Steel (600399) is undergoing a tender offer period from August 12, 2025, to September 10, 2025[1] - *ST Tianmao (000627) has a cash option declaration period from September 15, 2025, to September 19, 2025[1] - Tianpu Co., Ltd. (605255) has announced its latest updates on September 4, 2025[1] Market Alerts - Kaipu Cloud (688228) has reported severe abnormal fluctuations as of August 30, 2025[1] - Siquan New Materials (301489) and Xinhua Jin (600735) also reported significant market movements on August 22 and August 30, 2025, respectively[1] - Multiple companies including *ST Baoying (002047) and Wantong Development (600246) have updates as of September 4, 2025[1] Trading Notifications - A total of 30 companies have issued trading notifications with specific dates for announcements and updates, indicating active market participation[1] - The report includes links to detailed announcements for each company, ensuring transparency and accessibility of information[1]