Core Viewpoint - Changchun Gaoxin (000661) is expected to report a significant decline in net profit for the year 2025, with projections indicating a drop of 91.48% to 94.19% compared to the previous year [1] Financial Performance - The company anticipates a net profit ranging from 150 million to 220 million yuan for 2025 [1] - The net profit excluding non-recurring gains and losses is projected to be between 437 million and 507 million yuan, reflecting a year-on-year decrease of 82.09% to 84.56% [1]

Core Viewpoint - Changchun Gaoxin (000661.SZ) expects a significant decline in net profit attributable to shareholders for 2025, projecting a range of 150 million to 220 million yuan, representing a decrease of 91.48% to 94.19% compared to the previous year [1] Group 1: Financial Performance - The company anticipates a net profit of 150 million to 220 million yuan for 2025, indicating a substantial decline from the previous year [1] - The expected decline in profit is attributed to increased research and development expenses as the company advances its product pipeline [1] Group 2: Business Focus and Strategy - The company continues to focus on traditional strengths in endocrine metabolism and women's health, while also exploring innovative directions related to oncology, respiratory, and immune-related products [1] - Ongoing R&D efforts are aimed at developing differentiated products with global market potential, with several products entering clinical stages [1] Group 3: Industry Challenges - The company faces intensified competition within the industry, which is expected to impact its financial performance [1] - Changchun Baike Biotechnology Co., a subsidiary, is projected to incur losses in 2025, contributing to the overall decrease in the company's performance [1]

Core Viewpoint - Changchun Gaoxin has announced a significant decline in its expected net profit for 2025, projecting a decrease of 91.48% to 94.19% year-on-year, primarily due to increased R&D expenses and market challenges in the pharmaceutical industry [1] Group 1: Financial Projections - The company expects a net profit attributable to shareholders of 150 million to 220 million yuan for 2025, representing a year-on-year decrease of 91.48% to 94.19% [1] - The projected net profit after deducting non-recurring gains and losses is estimated to be between 437 million and 507 million yuan, reflecting a year-on-year decline of 82.09% to 84.56% [1] Group 2: Reasons for Profit Decline - Increased R&D expenses due to the company's focus on traditional areas such as endocrine metabolism and women's health, as well as innovative directions related to oncology, respiratory, and immune diseases [1] - The launch of new products, including the first domestic innovative biological agent for acute gouty arthritis, has led to increased sales and marketing expenses, necessitating a market cultivation period for new products [1] - Adjustments in sales policies and pricing in response to industry policy changes and market conditions have resulted in reduced revenue and net profit [1] - The company’s subsidiary, Changchun Baike Biotechnology Co., is expected to incur losses in 2025, further impacting overall performance [1] Group 3: Licensing Agreement - The company’s subsidiary, Shanghai Saizeng Medical Technology Co., has entered into an exclusive licensing agreement for the GenSci098 injection project, which is expected to yield a total of $1.2 billion in upfront and milestone payments [1] - The agreement includes a non-refundable upfront payment of $70 million and an additional $50 million in milestone payments, with potential for up to $1.365 billion in further milestone payments and over 10% in sales royalties post-product launch [1] - The financial impact of this licensing agreement will not be reflected in the current reporting period due to accounting policy requirements [1]

本次业绩预告的相关数据未经会计师事务所审计，公司已就业绩预告有关事 项与会计师事务所进行了预沟通，双方在业绩预告方面不存在重大分歧。 证券代码：000661 证券简称：长春高新 公告编号：2026-006 长春高新技术产业（集团）股份有限公司 2025 年度业绩预告 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。 一、本期业绩预告情况 （一）业绩预告期间：2025 年 1 月 1 日至 2025 年 12 月 31 日 （二）业绩预告情况：预计净利润为正值且属于同向下降 50%以上情形 | 项目 | | 本报告期 | | 上年同期 | | | --- | --- | --- | --- | --- | --- | | 归属于上市公司股东的净利润 | 盈利：15,000 | 万元-22,000 | 万元 | 盈利：258,306 | 万元 | | | 比上年同期下降：91.48%-94.19% | | | | | | 扣除非经常性损益后的净利润 | 盈利：43,700 | 万元-50,700 | 万元 | 盈利：283,045 | 万元 | | | 比上年同期下 ...

Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection for domestic production [1] Group 1: Product Information - Fuxin Qibai monoclonal antibody is a fully human anti-IL-1β monoclonal antibody that specifically blocks the binding of IL-1β to its receptor, thereby inhibiting the activation of downstream signaling pathways [1] - The drug is primarily used for the treatment of non-infectious uveitis, and there are currently no similar drugs approved for the same disease area in both domestic and international markets [1]

Market Overview - The biopharmaceutical sector experienced a decline of 1.3% on January 29, with Hualan Vaccine leading the drop [1] - The Shanghai Composite Index closed at 4157.98, up 0.16%, while the Shenzhen Component Index closed at 14300.08, down 0.3% [1] Individual Stock Performance - Weigao Bio (002880) saw a closing price of 30.07, with an increase of 4.59% and a trading volume of 88,100 shares, totaling a transaction value of 266 million yuan [1] - Changchun High-tech (000661) closed at 98.30, up 0.92%, with a trading volume of 64,700 shares and a transaction value of 629 million yuan [1] - Other notable performers include Boya Bio (300294) and Zhifei Biological (300122), both with a closing price increase of 0.92% and 0.73% respectively [1] Declining Stocks - Hualan Bio (301207) reported a significant decline of 9.05%, closing at 22.62, with a trading volume of 300,600 shares and a transaction value of 689 million yuan [2] - Junshi Biosciences (688180) fell by 6.02%, closing at 36.82, with a trading volume of 266,100 shares and a transaction value of 1 billion yuan [2] - Other stocks such as Jinkang (688670) and Bohui Innovation (300318) also experienced declines of 5.81% and 4.95% respectively [2] Capital Flow Analysis - The biopharmaceutical sector saw a net outflow of 866 million yuan from institutional investors, while retail investors contributed a net inflow of 682 million yuan [2] - Notable net inflows from retail investors were observed in stocks like Shanghai Laishi (002252) and Weigao Bio (002880) [3] - Conversely, stocks such as Zhixiang Quantai (688443) and Weigao Bio (002880) experienced significant net outflows from institutional and speculative investors [3]

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection, aimed at treating non-infectious uveitis [1][2]. Group 1: Drug Information - The drug Fuxin Qibai monoclonal antibody injection is a fully human anti-IL-1β monoclonal antibody developed by Jinsai Pharmaceutical, intended for the treatment of non-infectious uveitis [1][2]. - The clinical trial application has been accepted under the registration numbers CXSL2600136 and CXSL2600137, indicating a positive step towards further development [1][2]. - There are currently no similar drugs approved for the same indication in the domestic and international markets, highlighting the potential market opportunity for Fuxin Qibai [1][2]. Group 2: Disease Context - Non-infectious uveitis is a heterogeneous inflammatory disease affecting the uveal tract and surrounding tissues, with a global annual incidence rate of 17 to 52 per 100,000 and a prevalence rate of 115 to 204 per 100,000, representing a significant public health burden [2]. - Existing biological agents approved for this indication are primarily anti-TNFα drugs, with many patients experiencing inadequate response or intolerance, indicating a strong demand for safer and more effective treatment options [2]. Group 3: Company Impact - If the clinical trial progresses smoothly, it will help the company expand its business structure, optimize its product portfolio, and enhance its core competitiveness [3]. - The company is committed to actively advancing the research and development projects and will fulfill its information disclosure obligations regarding the project's progress [4].

Group 1 - The core point of the article is that Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection [1] Group 2 - The acceptance of the clinical trial application indicates a significant step forward for the company's product development in the domestic market [1] - This development may enhance the company's position in the pharmaceutical industry, particularly in the monoclonal antibody segment [1] - The news reflects the ongoing regulatory support for innovative drug development in China [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received a notice of acceptance from the National Medical Products Administration for the clinical trial application of Fuxin Qibai monoclonal antibody injection, which is intended for the treatment of non-infectious uveitis [1] Group 1 - The clinical trial application for Fuxin Qibai monoclonal antibody has been accepted, indicating progress in the drug development process [1] - Fuxin Qibai is a fully human anti-IL-1β monoclonal antibody developed by Changchun Jinsai Pharmaceutical, designed to specifically block the binding of IL-1β to its receptor IL-1R [1] - Currently, there are no similar drugs approved for the same disease area in both domestic and international markets, highlighting a potential market opportunity for the company [1]

证券代码：000661 证券简称：长春高新 公告编号：2026-005 长春高新技术产业（集团）股份有限公司 关于子公司伏欣奇拜单抗注射液境内生产药品注册临床试验申请 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。 获得受理的公告 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 监督管理局的《受理通知书》，金赛药业伏欣奇拜单抗注射液的境内生产药品注 册临床试验申请获得受理，现将相关情况公告如下： 批的生物制剂仅有抗 TNFα类药物，且仍有相当一部分患者应答不佳或不耐受， 因此，对于安全性更好、疗效更佳以及依从性更优的新机制药物始终存在需求。 综上所述，伏欣奇拜单抗具有潜在治疗非感染性葡萄膜炎的临床价值，本次 临床试验申请受理可以推动后续该产品针对非感染性葡萄膜炎人群的临床开发。 此前，伏欣奇拜单抗注射液（水剂）已获批开展子宫内膜异位症的临床试验， 其用于急性痛风性关节炎适应症的上市申请已于 2025 年 1 月获得受理；注射用 伏欣奇拜单抗（粉剂）已获批开展用于结缔组织 ...