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长春高新技术产业(集团)股份有限公司关于子公司注射用GenSci136 境内生产药品注册临床试验申请获得受理的公告
Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received a clinical trial application acceptance notice from the National Medical Products Administration for the domestically produced drug, GenSci136, intended for the treatment of generalized myasthenia gravis (gMG) [1][4]. Group 1: Drug Information - Product Name: GenSci136, an injectable drug developed by Jinsai Pharmaceutical [1] - Application: Acceptance of clinical trial application for domestic production [1] - Indication: Treatment of generalized myasthenia gravis [1][2] Group 2: Disease Background - gMG is an autoimmune disease characterized by neuromuscular transmission disorders, with a global prevalence of approximately 12.4 per 100,000 people and an incidence rate in China of about 0.68 per 100,000 [2] - Traditional treatments include cholinesterase inhibitors, corticosteroids, and immunosuppressants, but about 20% of patients do not respond well to these therapies [2] Group 3: Drug Mechanism and Research - GenSci136 features a novel drug structure and dual-target mechanism, designed to enhance its blocking activity and prolong its half-life in the body [3] - Non-clinical pharmacology, pharmacokinetics, and toxicology studies indicate that GenSci136 has good efficacy and safety, potentially offering a better treatment option for patients with gMG in China [3] Group 4: Company Impact - Successful progress of the clinical trial application could help the company expand its business structure, optimize product offerings, and enhance its core competitiveness [4]
长春高新:关于子公司注射用GenSci136境内生产药品注册临床试验申请获得受理的公告
Zheng Quan Ri Bao· 2026-02-03 13:14
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 GenSci136 injection, marking a significant step in the drug registration process [2] Group 1 - The acceptance notice indicates that the clinical trial application for GenSci136 has been officially recognized by regulatory authorities [2] - This development may enhance the company's product pipeline and potential market offerings in the pharmaceutical sector [2] - The approval process reflects the company's commitment to advancing its research and development initiatives [2]
2月3日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-03 10:11
Group 1 - Fulin Precision's subsidiary Jiangxi Shenghua invested 270 million yuan to establish a joint venture for a 500,000-ton ferrous oxalate project, with a total investment of 1.5 billion yuan expected to be completed by September 30, 2026 [1] - Xuguang Electronics plans to raise up to 1 billion yuan through a private placement to fund high-voltage vacuum arc extinguishing chamber expansion and other projects [2] - Minexplosion Optoelectronics intends to acquire 100% equity of Xiazhi Precision, with the transaction subject to shareholder and regulatory approvals [3] Group 2 - Shangluo Electronics' controlling shareholder plans to reduce his stake by up to 3% due to personal financial needs [4] - Babi Food reported a 1.3% decline in net profit for 2025, despite an 11.22% increase in revenue [5] - Pengding Holdings' subsidiary acquired industrial land in Huai'an for 66.14 million yuan [6] Group 3 - Zhuoyue New Energy's net profit for 2025 increased by 14.16%, despite a 17.43% decline in revenue [7] - Zhongyuan Media's net profit grew by 30.99% in 2025, with revenue decreasing by 5.13% [8] - Huangshan Tourism plans to invest approximately 530 million yuan in a hotel project with a 24-month construction period [9] Group 4 - *ST Jinling's restructuring plan was approved by the court, which may improve the company's financial situation [11] - Jichuan Pharmaceutical's subsidiary paid 80 million yuan for exclusive commercialization rights of a drug [12] - Pilin Bio's subsidiary received a notice for the acceptance of a drug supplement application [13] Group 5 - Nepe Mining terminated its investment in Swiss Veritas Resources AG due to changes in conditions [14] - Jinhui Wine announced a cash dividend of 0.20 yuan per share for the first three quarters of 2025 [15] - Hualan Biological's clinical trial for a new drug received approval for an additional indication [16] Group 6 - Industrial Fulian reported a total of 247 million yuan spent on share buybacks as of January 31, 2026 [17] - Yitong Century was pre-selected for a 107 million yuan project with China Tower [18] - Wanfeng Co. noted uncertainty in future price changes for disperse dyes [19] Group 7 - Bibet's clinical trial application for a new drug was approved by the National Medical Products Administration [21] - Chengbang Co. signed new project contracts worth 40.03 million yuan in Q4 2025 [22] - *ST Hengji received a court ruling for a performance compensation of 175 million yuan [23] Group 8 - Jihua Group is planning a change in control, leading to continued stock suspension [24] - Ningbo Port expects a container throughput of 5.03 million TEUs in January 2026, a 9.5% increase [25] - Hengli Petrochemical's actual controller increased his stake by 3.3 million shares [26] Group 9 - Hongfuhan signed a sales contract worth 480 million yuan with Guangdong Quanxiang [27] - All New Good's shareholder lifted a judicial freeze on 4.36% of the company's shares [28] - Changchun High-tech's subsidiary's clinical trial application for a new drug was accepted [29] Group 10 - Xingqi Eye Medicine's clinical trial for a new drug entered the first/second phase [31] - Hanma Technology reported a 140.04% increase in new energy heavy truck production in January 2026 [32] - Hengfeng Paper plans to invest 349 million yuan in a new green printing project [33] Group 11 - Zhifei Biological's mRNA vaccine for shingles received clinical trial approval [34] - Yutong Bus reported a 15.35% decrease in production in January 2026 [35] - StarNet Ruijie plans to sign a lease contract with an affiliate for a total rent of up to 110 million yuan [36] Group 12 - Hacheng Bonda's director completed a 0.97% share reduction [37] - Hendi Pharmaceutical's application for a new drug was approved [38] - Xinhua Medical's subsidiary received a medical device registration certificate [40] Group 13 - Yaokang Bio reported a 31.49% increase in net profit for 2025 [41] - Gaotie Electric reported a 14.02% increase in net profit for 2025 [42]
长春高新(000661) - 关于子公司注射用GenSci136境内生产药品注册临床试验申请获得受理的公告
2026-02-03 08:15
关于子公司注射用 GenSci136 境内生产药品注册临床试验申请 获得受理的公告 证券代码:000661 证券简称:长春高新 公告编号:2026-008 长春高新技术产业(集团)股份有限公司 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》,金赛药业注射用 GenSci136 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:注射用 GenSci136 申请事项:境内生产药品注册临床试验 受理号:CXSL2600163 申请人:长春金赛药业有限责任公司 审批结论:经审查,决定予以受理 比 80%,该病被纳入《第一批罕见病目录》。乙酰胆碱受体(acetylcholine receptor, AChR)抗体是最常见的致病性抗体,影响 AChR 的功能及神经-肌肉接头信号传 递,参与 MG 的发生发展。传统治疗主要包括胆碱酯酶抑制剂、糖皮质激素、 ...
长春高新:子公司注射用GenSci136临床试验申请获受理
Xin Lang Cai Jing· 2026-02-03 08:08
Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has had its clinical trial application for the domestically produced injectable GenSci136 accepted by the National Medical Products Administration, marking a significant step in the development of a new treatment for myasthenia gravis [1] Group 1: Product Development - GenSci136 is a Class 1 biological product designed to treat generalized myasthenia gravis, featuring a novel drug structure and a dual-target mechanism of action [1] - The drug aims to provide better treatment options for patients with myasthenia gravis in China [1] Group 2: Business Impact - The progress of this application is expected to broaden the company's business structure and enhance its core competitiveness [1] - The clinical trial process, however, still carries uncertainties that could affect the timeline and outcomes [1]
长春高新:口服小分子生长激素促分泌药物临床申请获受理,适应症为特发性身材矮小
Cai Jing Wang· 2026-02-03 06:08
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。 ...
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
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 ...
长春高新GS3-007a干混悬剂临床试验申请获受理
Bei Jing Shang Bao· 2026-02-02 12:23
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。 ...
2月2日晚间公告 | 长岭液压拟获新进大股东要约收购12%股份;美的集团、歌尔股份已耗资数十亿元回购
Xuan Gu Bao· 2026-02-02 12:15
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]
2月2日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-02 10:16
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]