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9月10日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-10 10:38
Group 1 - Dematech won a 900 million yuan overseas smart logistics project from a well-known e-commerce giant in Latin America, focusing on intelligent logistics cross-belt sorting systems and related services [1] - Kang En Bei received approval for the registration of short-term financing bonds and medium-term notes, with a total registration amount of 1 billion yuan, valid for two years [1][2] - Zhi Xiang Jin Tai's GR1803 injection for systemic lupus erythematosus clinical trial has been approved by the National Medical Products Administration [2] Group 2 - Jin Da Wei's subsidiary received approval for a veterinary drug product, pyridone, valid from September 3, 2025, to September 2, 2030 [4] - Fu Li Wang's subsidiary plans to invest 500 million yuan in a high-end wire material project, focusing on high-strength prestressed steel strands for various applications [5] - He Li Biological's subsidiary's Class III medical device registration application has been accepted, focusing on natural bone repair materials [12] Group 3 - Lin Yang Energy won a 244 million yuan metering equipment project from Southern Power Grid, expected to positively impact its 2025 and 2026 performance [20] - Sanxia Water plans to absorb its wholly-owned subsidiary, Chongqing Changdian United Energy, with all assets and liabilities to be inherited by Sanxia Water [13] - Tian Cheng Technology canceled the use of 91 million yuan of raised funds for permanent working capital, ensuring no impact on the normal operation of investment projects [24] Group 4 - Baosteel received approval to publicly issue bonds totaling 20 billion yuan to professional investors, valid for 24 months [52] - Tian Kang Biological reported a 10.15% year-on-year increase in pig sales in August, with a total of 263,800 pigs sold [53] - Xinjiang Construction won multiple major projects totaling 4.506 billion yuan, including a 2.4 billion yuan photovoltaic hydrogen synthesis project [18]
智翔金泰(688443.SH):公司GR1803注射液系统性红斑狼疮适应症的临床试验申请获得批准
Xin Lang Cai Jing· 2025-09-10 10:13
Core Viewpoint - The company, Zhixiang Jintai (688443.SH), has received approval from the National Medical Products Administration for the clinical trial of GR1803 injection for systemic lupus erythematosus (SLE) [1] Group 1: Product Development - GR1803 injection is a bispecific antibody drug developed by the company, targeting BCMA and CD3, classified as a Class 1 therapeutic biological product [1] - As of the announcement date, GR1803 injection is in the Phase II clinical trial stage for the indication of relapsed/refractory multiple myeloma [1] Group 2: Market Context - There are currently two imported BCMA×CD3 targeted antibody drugs conditionally approved for market in China, but there are no products targeting the same SLE indication available [1]
智翔金泰:GR1803注射液系统性红斑狼疮适应症获批临床试验
Zhi Tong Cai Jing· 2025-09-10 09:59
Core Viewpoint - Zhixiang Jintai (688443.SH) has received approval from the National Medical Products Administration for the clinical trial of its product GR1803 injection for systemic lupus erythematosus (SLE) [1] Group 1: Company Developments - The clinical trial application for GR1803 injection targeting SLE has been approved [1] - As of the announcement date, GR1803 injection is in the Phase II clinical trial stage for the indication of relapsed/refractory multiple myeloma [1] Group 2: Industry Context - There are currently two imported BCMA×CD3 targeted antibody drugs conditionally approved for marketing in China, but no products targeting SLE with the same mechanism have been launched [1]
智翔金泰(688443.SH):GR1803注射液系统性红斑狼疮适应症获批临床试验
智通财经网· 2025-09-10 09:57
Group 1 - The core point of the article is that Zhixiang Jintai (688443.SH) has received approval from the National Medical Products Administration for the clinical trial of its product GR1803 injection for systemic lupus erythematosus (SLE) [1] - As of the announcement date, GR1803 injection is in the Phase II clinical trial stage for relapsed/refractory multiple myeloma [1] - There are currently two imported BCMA×CD3 targeted antibody drugs conditionally approved for marketing in China, but no products targeting the same SLE indication have been launched [1]
智翔金泰(688443) - 自愿披露关于GR1803注射液系统性红斑狼疮适应症获得药物临床试验批准通知书的公告
2025-09-10 09:45
近日,重庆智翔金泰生物制药股份有限公司(以下简称"公司")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》,公司在研产品 GR1803 注射液系统性红斑狼疮适应症的临床试验申请获得批准。现将相关情况公告如下: 证券代码:688443 证券简称:智翔金泰 公告编号:2025-039 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1803注射液系统性红斑狼疮适应症 获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 GR1803 注射液是一款由公司自主研发的双特异性抗体药物,作用靶点为 BCMA 和 CD3,注册分类为治疗用生物制品 1 类。系统性红斑狼疮(systemic lupus erythematosus,SLE)是一种系统性自身免疫性疾病,以全身多个系统和脏器受 累、反复复发与缓解、体内存在大量自身抗体为主要临床特点,自身免疫性 B 细胞在 SLE 的发生和发展中发挥了重要作用。GR1803 注射液可通过将 CD3+T 细胞招募到 BCMA+B 细胞附近,引起 T 细胞活化, ...
智翔金泰:GR1803注射液系统性红斑狼疮适应症获得药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-09-10 09:37
Core Viewpoint - The company, Zhixiang Jintai (688443.SH), has received approval from the National Medical Products Administration for the clinical trial of its self-developed drug GR1803 injection for the treatment of systemic lupus erythematosus (SLE) [1] Group 1: Company Information - GR1803 injection is a bispecific antibody drug targeting BCMA and CD3, classified as a Class 1 therapeutic biological product [1] - The drug aims to treat autoimmune diseases mediated by B cells, specifically targeting the activation of CD3+ T cells to induce the lysis of BCMA+ cells [1] Group 2: Industry Context - Systemic lupus erythematosus (SLE) is a systemic autoimmune disease where autoimmune B cells play a significant role in its development [1]
智翔金泰:GR1803注射液系统性红斑狼疮适应症获得药物临床试验批准
Ge Long Hui A P P· 2025-09-10 09:37
格隆汇9月10日|智翔金泰公告,公司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》,公司在研产品GR1803注射液系统性红斑狼疮适应症的临床试验申请获得批准。GR1803注射液是 一款由公司自主研发的双特异性抗体药物,作用靶点为BCMA和CD3,注册分类为治疗用生物制品1 类。截至本公告披露日,GR1803注射液复发/难治性多发性骨髓瘤适应症处于II期临床试验阶段。经公 开信息查询,国内有两款进口的BCMA×CD3靶点抗体药物附条件批准上市,尚无同靶点SLE适应症产 品上市。 ...
重庆智翔金泰生物制药股份有限公司关于参加2025年半年度科创板创新药行业集体业绩说明会的公告
Core Viewpoint - The company, Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd., will participate in the 2025 semi-annual performance briefing for the innovative drug industry on September 16, 2025, to address investor concerns and provide insights into its financial performance and operational results for the first half of 2025 [2][3][7]. Group 1: Event Details - The performance briefing will be held on September 16, 2025, from 15:00 to 17:00 [4][5]. - The event will take place at the Shanghai Stock Exchange Roadshow Center and will be conducted in an interactive online format [4][6]. - Investors can log in to the Shanghai Stock Exchange Roadshow Center to participate and submit questions prior to the event [6]. Group 2: Participation Information - Investors are encouraged to submit questions by September 15, 2025, at 16:00 through the "Pre-Question Collection" section on the Roadshow Center website [2][6]. - The company will respond to commonly asked questions during the briefing [3][6]. - Contact information for inquiries includes the board office's phone number and email address [6].
智翔金泰(688443) - 关于参加2025年半年度科创板创新药行业集体业绩说明会的公告
2025-09-09 10:16
证券代码:688443 证券简称:智翔金泰 公告编号:2025-038 重庆智翔金泰生物制药股份有限公司 关于参加2025年半年度科创板创新药行业 集体业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示: 重庆智翔金泰生物制药股份有限公司(以下简称"公司")已于 2025 年 8 月 30 日于上海证券交易所网站(www.sse.com.cn)发布公司《2025 年半年度报告》, 为便于广大投资者更全面深入地了解公司 2025 年半年度经营成果、财务状况, 公司计划于 2025 年 9 月 16 日(星期二)15:00-17:00 参加 2025 年半年度科创板 创新药行业集体业绩说明会,就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开,公司将针对 2025 年半年度的经营 成果及财务指标的具体情况与投资者进行互动交流和沟通,在信息披露允许的范 围内就投资者普遍关注的问题进行回答。 会议召开时间:2025 年 9 月 16 日(星期二)15:00-17:00 会议召开 ...
智翔金泰(688443) - 自愿披露关于GR2303注射液获得药物临床试验批准通知书的公告
2025-09-08 08:45
一、药品基本信息 药品名称:GR2303 注射液 注册分类:治疗用生物制品 1 类 申请事项:境内生产药品注册临床试验 证券代码:688443 证券简称:智翔金泰 公告编号:2025-037 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR2303注射液获得药物临床试验 批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,重庆智翔金泰生物制药股份有限公司(以下简称"公司")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》,公司在研产品 GR2303 注射液的临床试验申请获得批准。现将相关情况公告如下: 根据国家药品注册管理相关法规,该药品完成临床试验后还需提交新药上市 申请,取得药品注册证书后才可上市销售。 创新药产品具有高科技、高风险、高附加值的特点,药品的前期研发以及产 品从研制、临床试验报批到投产的周期长、环节多,容易受到一些不确定性因素 的影响,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。敬请广大投资者谨慎决策,注意防范投资风险。 特此公告。 ...