公告中提到，ISS是常见的儿童内分泌疾病，定义为身高在同年龄、性别和种族身高参考值-2SD（标准 差）以下，排除生长激素缺乏、小于胎龄儿、其他内分泌或系统性疾病、染色体异常、骨骼发育不良等 因素所致的身材矮小。GS3-007a干混悬剂通过每日一次口服给药，可刺激内源性生长激素释放，为有 促生长需求的矮小儿童提供更多的治疗选择。 近日，长春高新（000661）发布公告称，控股子公司金赛药业的GS3-007a干混悬剂境内生产药品注册 临床试验申请获得国家药品监督管理局的受理。 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 于特发性身材矮小（ISS）的治疗。 ...

审批结论：经审查，决定予以受理 适应症：特发性身材矮小（ISS） 登录新浪财经APP 搜索【信披】查看更多考评等级 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"）控股子公司一一长春金赛药业有限 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干混悬剂的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：CXHL2600135 申请人：长春金赛药业有限责任公司 公司将积极推进上述研发项目，并严格按照有关规定及时对项目后续进展情况履行信息披露义务。 特此公告 长春高新技术产业（集团）股份有限公司 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 于特发性身材矮小（ISS）的治疗。 ISS是常见的儿童内分泌疾病，定义为身高在同年龄、性别和种族身高参考值-2 SD（标准差 ...

公告显示，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，拟用于特发性身材矮小（ISS）的治疗。 北京商报讯（记者 丁宁）2月2日晚间，长春高新（000661）发布公告称，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干混悬剂的境内生产药品注册临床试验申请获得受理。 ...

Mergers and Acquisitions - Changling Hydraulic plans to acquire 12% of the company's shares at an offer price of 35.82 yuan per share [1] - Chip导科技 intends to purchase 100% equity of Jishun Technology for 403 million yuan and 17.15% equity of Shunlei Technology [2] Share Buybacks - Lexin Technology plans to repurchase shares worth between 50 million to 100 million yuan for employee stock ownership or equity incentives [3] - XGIMI Technology intends to repurchase shares worth between 50 million to 100 million yuan [3] - Lingyun Optical plans to change the purpose of 348.08 million shares for repurchase and cancel them [3] - Midea Group has spent 1.998 billion yuan to repurchase 0.35% of its shares [4] - GoerTek has spent 1.108 billion yuan to repurchase 1.14% of its shares [4] External Investments and Daily Operations - Weiyuan Co. has launched a 250,000 tons/year electrolyte solvent project [5] - Far East Co. signed contracts worth 3.075 billion yuan in January through its subsidiary [6] - Changchun Gaoxin's subsidiary GS3-007a has received approval for clinical trial application for a drug [7] - Aorui De plans to invest approximately 145 million yuan in purchasing computing power equipment to provide services to clients [7] - Electric Power Water Power intends to raise funds not exceeding 3.604 billion yuan through acquisition loans [7] - Guoneng Rixin plans to increase investment of 17.625 million yuan in controlling Sanas Zhihui to enhance new energy asset operation service capabilities [7] - Science plans to engage in molybdenum processing and sales to secure a stable resource supply for rhenium recycling [7] - Panlong Pharmaceutical has received approval for clinical trials of the drug Fluorobiphenyl Patch [8] - Hongxiang Co. plans to transfer 100% equity of Nantong Hanlan New Energy for 120 million yuan [9] - Daon Co. intends to acquire equity in a Vietnamese company for a total purchase price of approximately 15.737 million USD [10] Performance Changes - Shanghai Yizhong expects a net profit of 64.132 million yuan in 2025, a year-on-year increase of 819.42%, with its core product, injectable paclitaxel polymer micelles, included in the national medical insurance directory [11] - Lianyun Technology anticipates a 20.36% year-on-year increase in net profit in 2025, driven by growth in data storage main control chips [12]

Group 1 - Far East Holdings announced that its subsidiary won a contract order worth 3.075 billion yuan, including contracts for green building cables and smart manufacturing cables [1] - Yifan Pharmaceutical received a drug registration certificate for Vitamin K1 injection, which is used to treat vitamin K deficiency-related bleeding [2] - Guangdong Electric Power A's Maoming Bohua Power Plant's Unit 4 has successfully commenced commercial operation, with a total investment of 7.484 billion yuan and an expected annual power generation of 8.6 billion kWh [4] Group 2 - Longfly Fiber reported that the global fiber optic cable industry market environment is normal, with product price fluctuations needing comprehensive assessment [25] - Shanghai Yizhong's net profit for 2025 increased by 819.42%, with total revenue of 317 million yuan, a growth of 82.72% [22] - Guizhou Power's subsidiary received a government subsidy of 200 million yuan [8] Group 3 - Zhongxing Communications plans to invest 117 million yuan in the Jianxing Zhanlu Fund, which focuses on new information technology and advanced manufacturing [10] - Suwen Electric Power's subsidiary established a joint investment fund with a total commitment of 68.5 million yuan, with Suwen contributing 5 million yuan [26] - ST Kaiyuan announced that its stock may face delisting risk due to expected negative net assets for 2025 [27]

公告显示，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，拟用于特发性身材矮小(ISS)的治疗。 智通财经APP讯，长春高新(000661.SZ)公告，公司控股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GS3-007a干混悬剂的境内生产药品 注册临床试验申请获得受理。 ...

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 干混悬剂的境内生 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： 证券代码：000661 证券简称：长春高新 公告编号：2026-007 一、药品的基本情况 长春高新技术产业（集团）股份有限公司 产品名称：GS3-007a 干混悬剂 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 申请事项：境内生产药品注册临床试验 受理号：CXHL2600135 此前，GS3-007a 干混悬剂已获批用于开展因内源性生长激素缺乏所引起的儿 童生长缓慢（PGHD）的临床试验，目前临床试验正在进行中。具体内容详见公司 于 2025 年 11 月 15 日在巨潮资讯网披露的《关于子公司 GS3-007a 干混悬剂境内 生产药品临床试验申请获得批准的公告》（公告编号 2025-148）。 申请 ...

Group 1 - The company Changchun Gaoxin (000661) expects a significant decline in net profit for the fiscal year 2025, projecting a range of 150 million to 220 million yuan, representing a decrease of 91.48% to 94.19% [1] - The net profit after deducting non-recurring gains and losses is anticipated to be between 437 million and 507 million yuan, reflecting a year-on-year decline of 82.09% to 84.56% [1] - Basic earnings per share are expected to be between 0.37 yuan and 0.55 yuan, a substantial drop from 6.42 yuan per share in the same period last year [1] Group 2 - The decline in net profit is attributed to increased R&D expenses as the company focuses on traditional strengths in endocrine metabolism and women's health, as well as innovative directions related to tumors, respiratory, and immune systems [1] - The company has launched its first domestic treatment for acute gouty arthritis, the innovative biological agent Jinbeixin (Fuxin Qibai monoclonal antibody), along with several other new products, leading to increased sales expenses [1] - The company's subsidiary, Changchun Baike Biotechnology Co., Ltd., is expected to report losses for the fiscal year 2025, which will further impact the company's overall performance [1] Group 3 - Changchun Jinsai Pharmaceutical Co., Ltd., a subsidiary of the company, has authorized its wholly-owned subsidiary Shanghai Saizeng Medical Technology Co., Ltd. to enter into an exclusive licensing agreement with Yarrow Bioscience, Inc. for the GenSci098 injection project [2] - The licensing agreement's related payments will not be recognized in the current reporting period due to accounting policy requirements and actual payment timelines, thus not affecting the current period's performance [2]

Group 1 - The nomination of Kevin Warsh as the next Federal Reserve Chairman by President Trump has sparked hawkish expectations, leading to a significant sell-off in the global precious metals market, with silver dropping over 35% and gold nearly 13% [3][5] - The Federal Reserve's policy framework may see a notable shift if Warsh assumes leadership, as Deutsche Bank suggests a unique combination of "rate cuts and balance sheet reduction" could emerge under his guidance [3] - The U.S. Treasury Department reported a projected decline in national fiscal revenue for 2025, with total revenue expected to be 21.6 trillion yuan, a decrease of 1.7% year-on-year [4] Group 2 - The World Trade Organization ruled that U.S. clean energy subsidy measures violate WTO rules in the dispute initiated by China regarding the Inflation Reduction Act [4] - The China-UK economic relationship is set to deepen with the signing of four economic cooperation documents, focusing on "Export to China" initiatives and service trade agreements [4] - The Panama Supreme Court ruled that the contract for the operation of ports along the Panama Canal held by CK Hutchison is invalid, prompting a response from the Chinese government to protect its legitimate rights [4] Group 3 - The China Securities Regulatory Commission (CSRC) is working to enhance the attractiveness and flexibility of refinancing systems to support the capital market's stable growth [6] - The A-share market experienced a decline, with the Shanghai Composite Index falling by 0.96% and significant sell-offs in gold stocks [6] - The CSRC is revising the registration management measures for listed companies to clarify the types of strategic investors and enforce a minimum holding requirement of 5% [6] Group 4 - The regulatory body has issued new guidelines for fund sales and marketing practices, prohibiting collaborations with unqualified internet influencers and requiring the removal of misleading features from fund platforms [7] - The Hong Kong Securities and Futures Commission is addressing issues related to the surge in IPO applications expected in 2025, highlighting deficiencies in the preparation of listing documents [8] - The Shanghai Stock Exchange is monitoring stocks with abnormal fluctuations and has reported several cases of suspected violations to the CSRC [8]

Core Viewpoint - The company, Changchun High-tech (SZ000661), has issued a shocking earnings forecast for 2025, predicting a significant decline in net profit compared to the previous year, primarily due to increased R&D expenses, adjustments in sales strategies following the inclusion of long-acting growth hormone products in the national medical insurance catalog, and losses from its subsidiary [2][3]. Group 1: Earnings Forecast - For 2025, the company expects a net profit attributable to shareholders between 150 million to 220 million yuan, a drastic decrease of 91.48% to 94.19% from 2.583 billion yuan in 2024 [2]. - The forecasted net profit excluding non-recurring items for 2025 is estimated to be between 437 million to 507 million yuan, down 82.09% to 84.56% from 2.830 billion yuan in the previous year [2]. Group 2: Reasons for Profit Decline - The decline in profit is attributed to multiple factors, including increased R&D expenses as several products enter clinical stages and higher sales expenses for promoting new products [3]. - The company adjusted its sales strategies and pricing for long-acting growth hormone products after they were included in the national medical insurance catalog, which negatively impacted revenue and profit [3]. - Losses from the subsidiary, Changchun Baike Biotechnology Co., further contributed to the overall decline in performance [3]. Group 3: Market Position and Challenges - The company holds a 100% market share in the pegylated recombinant human growth hormone injection and a 68.4% market share in short-acting growth hormone products, indicating a strong competitive position [4]. - However, starting in 2024, the company began experiencing a downward trend in performance, with revenues and net profits decreasing by 7.55% and 43.01%, respectively, in 2024 [5]. - The introduction of price reductions for growth hormones in 2025 is expected to exert additional pressure on revenue growth [5]. Group 4: Strategic Initiatives - The company is increasing its R&D investment, which rose by 23% to 1.733 billion yuan in the first three quarters of 2025, representing 17.68% of total revenue [5]. - A recent business development transaction with Yarrow Bioscience, Inc. is expected to yield significant future payments, although these revenues will not be recognized in the 2025 financial statements [6]. - The company is also focusing on expanding its overseas market presence and has submitted an application for listing on the Hong Kong Stock Exchange to support this initiative [6].