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2月10日重要公告一览
Xi Niu Cai Jing· 2026-02-10 02:35
Group 1 - Fangda Carbon plans to acquire 100% equity of Tianjin Tongda Huanyu Logistics Co., Ltd. for 319 million yuan [1] - Xiamen Tungsten intends to acquire 39% equity of Jiujiang Dadi Mining Development Co., Ltd. and has signed an intention agreement with a transferor [6] - Wenkai Co. has won a bid for a landscape project worth 50.8162 million yuan [7] Group 2 - Changchun High-tech's subsidiary Jin Sai Pharmaceutical received approval for a clinical trial application for GenSci136, a treatment for IgA nephropathy [3] - China National Pharmaceutical has received drug registration certificates for fumaric acid volnoral tablets, used for treating reflux esophagitis [12] - Zhenhua Group plans to issue convertible bonds not exceeding 1.2 billion yuan [26] Group 3 - CSG Holding's stock may undergo a control change due to share pledge judicial transfer [30] - Ningbo Yunsheng plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange [19] - Keda Guochuang's controlling shareholder intends to transfer 5% of the company's shares through an agreement [28] Group 4 - A number of companies, including Finer Pharma, Yixing Guoyuan Investment, and others, have announced plans to reduce their shareholdings by various percentages [2][4][9][11][15][16][20][21][22][23][25][29] - Highweida plans to repurchase shares worth 30 to 35 million yuan [17] - ST Zhongzhu is under investigation by the China Securities Regulatory Commission for suspected information disclosure violations [24] Group 5 - A number of companies, including Jiekang Equipment and others, have faced legal issues or penalties [27][40] - Aclaris Therapeutics has clarified that reports regarding its robotic products entering mass production were misinterpreted [41]
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批准的公告
Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial application of the injectable GenSci136 drug, which is intended for the treatment of Immunoglobulin A Nephropathy (IgAN) [1][2]. Group 1: Drug Information - The product name is injectable GenSci136, and it is a Class 1 biological product developed by Jinsai Pharmaceutical for the treatment of IgAN [1]. - The clinical trial application was approved under acceptance number CXSL2600033, allowing the drug to proceed with clinical trials [1]. Group 2: Disease Context - IgAN is the most common primary glomerulonephritis globally and accounts for 39.73% of primary glomerulonephritis cases in China, primarily affecting individuals aged 30 to 40 [2]. - The disease progresses slowly but has a poor prognosis, with 20%-50% of patients eventually progressing to renal failure, posing a significant burden on families and the healthcare system [2]. - There is a substantial unmet clinical need for effective treatments for IgAN, as existing therapies have limitations in efficacy and safety [2]. Group 3: Drug Mechanism and Potential - Injectable GenSci136 is designed as a B-cell maturation antigen (BCMA) trimeric fusion protein, which enhances the blocking activity against endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells [3]. - The drug aims to provide a new, safe, and effective first-line targeted treatment option for IgAN patients, with the potential for long-term application without the need for preventive anti-infection treatment [3].
长春高新(000661.SZ):金赛药业注射用GenSci136境内生产药品注册临床试验申请获得批准
智通财经网· 2026-02-09 14:08
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its self-developed drug, GenSci136, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - GenSci136 is a class 1 therapeutic biological product designed to treat IgAN, showcasing the company's commitment to innovative drug development [1] - The drug is a B-cell maturation antigen (BCMA) trimeric fusion protein, which utilizes novel molecular design to enhance the blocking activity against endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells [1] - GenSci136 is expected to provide a new, safe, and effective first-line targeted treatment option for IgAN patients, significantly improving their long-term prognosis [1] Group 2 - The design of GenSci136 includes an anti-human serum albumin heavy chain single-domain antibody to extend its half-life in the body, suggesting a potential for efficient and sustained therapeutic effects [1] - The drug aims to address various autoimmune diseases caused by pathogenic antibodies, indicating its broader therapeutic potential beyond IgAN [1] - The approval of the clinical trial marks a significant milestone for the company, reflecting its ongoing efforts in advancing biopharmaceutical innovations [1]
长春高新:金赛药业注射用GenSci136境内生产药品注册临床试验申请获得批准
Zhi Tong Cai Jing· 2026-02-09 14:04
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its self-developed drug, GenSci136, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - GenSci136 is a class 1 therapeutic biological product designed to treat IgAN, showcasing innovative molecular design that mimics the natural extracellular domain of B-cell maturation antigen (BCMA) [1] - The drug enhances the blocking activity against various endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells, thus addressing multiple autoimmune diseases caused by pathogenic antibodies [1] - GenSci136 is engineered with an anti-human serum albumin heavy chain single-domain antibody to extend its half-life in the body, suggesting a potential for effective and long-lasting treatment with improved convenience for patients [1] Group 2 - The drug is expected to provide a new, safe, and long-term targeted treatment option for IgAN patients without the need for prophylactic anti-infection therapy, aiming to significantly improve the long-term prognosis of these patients [1]
长春高新注射用GenSci136临床试验申请获批
Bei Jing Shang Bao· 2026-02-09 12:12
Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), received approval from the National Medical Products Administration for the clinical trial application of its injectable drug GenSci136, which is intended for the treatment of Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - Jinsai Pharmaceutical's injectable GenSci136 is a self-developed Class 1 biological product [1] - The clinical trial application for GenSci136 has been approved for use in treating IgAN and generalized myasthenia gravis [1]
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批准的公告
2026-02-09 10:30
证券代码:000661 证券简称:长春高新 公告编号:2026-009 审批结论:经审查,同意本品开展临床试验 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 获得批准的公告 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《药物临床试验批准通知书》,金赛药业注射用 GenSci136 境 内生产药品注册临床试验申请获得批准,现将相关情况公告如下: 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:CXSL2600033 申请人:长春金赛药业有限责任公司 适应症:用于免疫球蛋白 A 肾病(IgAN) 二、药品的其它情况 注射用 GenSci136 是金赛药业自主研发的一款治疗用生物制品 1 类药物,拟 用于治疗免疫球蛋白 A 肾病(IgAN)。 IgAN 是全球范围内最常见的原发性肾小球肾炎之一,在 ...
长春高新:持续提升公司核心竞争力,最终实现高质量稳健发展
Core Viewpoint - The company is currently experiencing short-term profit impacts due to increased investments in new product development and global expansion, but management remains focused on enhancing core competitiveness through innovation in the biopharmaceutical sector to achieve sustainable high-quality growth [1] Group 1 - The company is investing heavily in new product layouts and global expansion, which is affecting net profit in the short term [1] - Management emphasizes a commitment to focusing on the biopharmaceutical core business and deepening innovation-driven strategies [1] - The goal is to continuously improve the company's core competitiveness for stable and high-quality development in the long run [1]
长春高新:公司相关人员薪酬会严格按照薪酬制度考核确认
Zheng Quan Ri Bao Wang· 2026-02-06 11:48
Group 1 - The core viewpoint of the article is that Changchun Gaoxin (000661) emphasizes strict adherence to its compensation system for assessing the salaries of relevant personnel [1] Group 2 - The company responded to investor inquiries on its interactive platform regarding its compensation practices [1]
长春高新:公司三费投入均围绕生物医药主业发展、研发创新、市场拓展及合规运营开展
Zheng Quan Ri Bao· 2026-02-06 11:41
Core Viewpoint - Changchun High-tech emphasizes its commitment to balancing operational development and shareholder returns through strict internal control and auditing mechanisms for all expenditures [2] Group 1: Financial Management - The company states that its three major expenses are focused on the development of the biopharmaceutical industry, research and innovation, market expansion, and compliance operations [2] - All expenditures are subject to strict internal control approval, audit supervision, and information disclosure mechanisms [2] Group 2: Shareholder Returns - The company adheres to profit distribution rules while considering the industry's development stage for comprehensive planning [2] - Future efforts will focus on enhancing the precision of expense management and improving capital efficiency [2] - The company aims to balance long-term development of its core business with reasonable returns for shareholders, ensuring the interests of all shareholders are maintained [2]
“东北药茅”长春高新经营业绩大幅下滑 第四季预亏10亿
Chang Jiang Shang Bao· 2026-02-05 09:29
Group 1 - Changchun High-tech is expected to incur a loss of 1 billion in the fourth quarter due to product price adjustments, while investing over 2 billion annually in R&D to reduce reliance on growth hormones [1] - Vanke's losses are deepening, with a projected loss of 82 billion by 2025, and a bond extension of 6.8 billion as it seeks financial support [1] - GAC Group has issued a rare profit warning, expecting a loss between 8 billion to 9 billion, as CEO Feng Xingya emphasizes the "three major battles" for a turnaround [1] Group 2 - Nanhai Rural Commercial Bank was fined 3.8 million, with its net interest margin dropping to 1.15% after eight years of no results in the A-share market [1] - Yuanji Food is closing one out of every three new stores, with related party transactions amounting to 130 million involving the wife of its founder [1] - "Cheese Queen" Chai Xiu faced backlash from aggressive marketing strategies, leading to a 70% drop in the stock price of Miao Ke Lan Duo, with Mengniu taking full control [1] Group 3 - Zijin Mining is investing an additional 28 billion in overseas ventures, projecting a profit of 51 billion by 2025, with its market value stabilizing above 1 trillion [1] - Hunan Gold is restructuring 2.7 billion in assets to increase resource reserves, benefiting from rising prices of antimony and tungsten, achieving record profits exceeding 1.27 billion [1] - A major shareholder, Yu Han, was fined over 1 billion for manipulating stock prices, while Doctor Glasses spent 50 million on traffic acquisition but only 3 million on R&D [1] Group 4 - SAIC-GM-Wuling's debt ratio has risen to 85.24%, despite a 20.5% increase in sales, still falling short by 535,000 units compared to peak levels [1] - Su Nong Bank's "village reform branch" faced 18% opposition from minority shareholders, with total assets at 231.1 billion and revenue growth of only 0.41% [1] - Mingming Hen Mang opened 21,000 stores and distributed a pre-IPO dividend of 526 million, with Zhao Ding cashing out 130 million [1] Group 5 - Xibei's new round of financing received support from Zhang Yong and Hu Xiaoming, but the dream of a 100 billion market value faces challenges [1] - China Duty Free Group is acquiring 2.7 billion to build an international business platform, with performance declining for six consecutive quarters, and collaboration with LVMH remains to be observed [1] - Hikvision has returned to growth with an annual profit of 14.2 billion, enhancing cash collection management and recovering 13.7 billion in nine months [1]