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]

New Stock Offerings - Fushun Special Steel (600399) has 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) announced significant trading activity on September 3, 2025[1] Market Volatility - Kaipu Cloud (688228) reported severe abnormal fluctuations on August 30, 2025[1] - Xinhua Jin (600735) experienced significant trading activity on August 30, 2025[1] - ST Chuntian (600381) had notable trading activity on September 3, 2025[1] Other Notable Announcements - ST Er Ya (600107) reported trading activity on September 3, 2025[1] - Shanghai Electric Power (600021) had significant trading activity on September 3, 2025[1] - ST Gao Hong (000851) reported trading activity on September 3, 2025[1]

Investment Rating - The investment rating for the company is "Buy" with a target price of 144.48 RMB [7][5]. Core Views - The company's revenue for 1H25 was 6.603 billion RMB, with a net profit attributable to the parent company of 0.983 billion RMB, reflecting a year-on-year decline of 0.5% and 42.85% respectively. The revenue stability is attributed to steady sales of growth hormone and stable performance in the real estate sector, while the profit decline is mainly due to increased sales, management, and R&D expenses during the innovation transition [1][5]. - The company is expected to stabilize its revenue in 2025, driven by an increase in long-acting growth hormone revenue and the expansion of non-growth hormone product sales. The approval and rapid market entry of IL-1β is also anticipated to contribute positively [1][5]. - The long-term growth trajectory is supported by the commercialization of pipelines in various therapeutic areas, including oncology, autoimmune diseases, pediatrics, and gynecology [1][5]. Summary by Sections Financial Performance - In 1H25, the company reported revenue of 6.603 billion RMB and a net profit of 0.983 billion RMB, with a year-on-year decline of 0.5% and 42.85% respectively. The decline in profit is primarily due to increased expenses related to the company's innovation transition [1][5]. - The company expects revenue to stabilize in 2025, with a projected net profit decline due to ongoing investments in sales and management during the transition period [1][5]. Product Development - The company has established multiple technology platforms for drug development, including ADC, small nucleic acids, long-acting release, and dual antibodies/multifunctional macromolecules. Currently, 8 molecules across 11 indications are in clinical III phase and NDA stages [3]. - Key therapeutic areas for future growth include endocrine disorders, immunology, and oncology, with several promising candidates in the pipeline [3]. Market Outlook - The company anticipates steady revenue growth in 2025, driven by the expansion of growth hormone sales and the introduction of new products in gynecology, pediatrics, and oncology [2][5]. - The approval of the IL-1β drug is expected to generate significant sales in its first year, with further growth anticipated as additional indications are pursued [2][5].

Market Overview - The Shanghai Composite Index fell by 0.45% to close at 3858.13 points, with a high of 3885.31 points [1] - The Shenzhen Component Index decreased by 2.14% to 12553.84 points, reaching a maximum of 12857.16 points [1] - The ChiNext Index dropped by 2.85% to 2872.22 points, peaking at 2979.73 points [1] Margin Trading and Securities Lending - The total margin trading and securities lending balance in the Shanghai and Shenzhen markets was 22811.21 billion yuan, with a financing balance of 22650.35 billion yuan and a securities lending balance of 160.85 billion yuan [2] - The margin trading and securities lending balance decreased by 85.37 billion yuan compared to the previous trading day [2] - The Shanghai market's margin trading balance was 11692.6 billion yuan, down by 25.08 billion yuan, while the Shenzhen market's balance was 11118.61 billion yuan, down by 60.29 billion yuan [2] Top Margin Buying Stocks - The top three stocks by margin buying amount were: - Xinyi Technology (51.06 billion yuan) [3] - Zhongji Xuchuang (50.48 billion yuan) [3] - Shenghong Technology (50.25 billion yuan) [3] Fund Issuance - Two new funds were issued yesterday: - China Merchants Balanced Optimal Mixed A [4] - China Merchants Balanced Optimal Mixed C [4] Top Net Buying Stocks on the Dragon and Tiger List - The top ten net buying stocks on the Dragon and Tiger list were: - Julun Intelligent (437.29 million yuan) [6] - Changchun High-tech (274.93 million yuan) [6] - Gongxiao Daji (258.11 million yuan) [6] - Jianghai Shares (252.47 million yuan) [6] - Baiyin Youse (129.70 million yuan) [6]