Workflow
Chongqing Genrix Biopharmaceutical (688443)
icon
Search documents
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]
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
登录新浪财经APP 搜索【信披】查看更多考评等级 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。 二、说明会召开的时间、地点 副总经理、董事、董事会秘书:李春生先生 ● 会议召开时间:2025年 ...
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。 ...
智翔金泰:GR2303注射液获得药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-09-08 08:36
每经AI快讯,9月8日,智翔金泰(688443.SH)公告称,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。GR2303注射液是一款 由公司自主研发的重组全人源抗肿瘤坏死因子样配体1A(TL1A)单克隆抗体,适应症为炎症性肠病。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。截至本公告披露日,暂无GR2303注射液同靶点药物在国内获批上市。 ...
智翔金泰:GR2303注射液获药物临床试验批准
Xin Lang Cai Jing· 2025-09-08 08:34
智翔金泰公告,近日,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。GR2303注射液是公司自主研发的重组全人源抗肿瘤坏 死因子样配体1A(TL1A)单克隆抗体,本品可通过靶向结合TL1A,阻断TL1A与死亡受体3(DR3)的 结合,进而抑制TL1A引起的下游通路信号传导,减少促炎因子(如TNF-α、IL-17、IFN-γ)的释放,达 到治疗炎症性肠病的效果。 ...
智翔金泰(688443.SH):GR2303注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-08 08:34
格隆汇9月8日丨智翔金泰(688443.SH)公布,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。GR2303注射液是一款由公司自主研 发的重组全人源抗肿瘤坏死因子样配体1A(TumorNecrosisfactor-likeligand1A,TL1A)单克隆抗体,本 品可通过靶向结合TL1A,阻断TL1A与死亡受体3(DR3,Deathreceptor3)的结合,进而抑制TL1A引起 的下游通路信号传导,减少促炎因子(如TNF-α、IL-17、IFN-γ)的释放,达到治疗炎症性肠病的效 果。 ...
智翔金泰跌2.04%,成交额1.27亿元,主力资金净流出443.04万元
Xin Lang Cai Jing· 2025-09-04 03:31
Core Viewpoint - The stock of Zhixiang Jintai has experienced fluctuations, with a recent decline of 2.04% on September 4, 2023, while the company has shown significant growth in stock price and revenue year-to-date [1][2]. Company Overview - Zhixiang Jintai, established on October 20, 2015, and listed on June 20, 2023, is located in Chongqing and specializes in the research, production, and sales of antibody drugs, with 99.92% of its revenue coming from this segment [2]. - The company operates within the pharmaceutical and biotechnology sector, specifically in the bioproducts category, and is associated with concepts such as innovative drugs and biopharmaceuticals [2]. Stock Performance - Year-to-date, Zhixiang Jintai's stock price has increased by 37.62%, with recent performance showing an 8.14% rise over the last five trading days, a 4.32% increase over the last 20 days, and a 10.64% increase over the last 60 days [2]. - As of September 4, 2023, the stock was trading at 34.53 CNY per share, with a total market capitalization of 12.661 billion CNY [1]. Financial Performance - For the first half of 2025, Zhixiang Jintai reported a revenue of 45.3918 million CNY, reflecting a staggering year-on-year growth of 358,429.65%, while the net profit attributable to shareholders was -289 million CNY, showing a 20.07% increase compared to the previous period [2]. Shareholder Structure - As of June 30, 2025, the top shareholder is ICBC Frontier Medical Stock A, holding 6.66 million shares, an increase of 1.66 million shares from the previous period [3]. - Other notable shareholders include Penghua Medical Technology Stock A and Dongfanghong Medical Upgrade Stock A, with varying changes in their holdings [3].
智翔金泰连亏4年半 2023年上市募34.7亿国泰海通保荐
Zhong Guo Jing Ji Wang· 2025-09-02 06:13
Core Viewpoint - Zhixiang Jintai (688443.SH) reported significant revenue growth in the first half of 2025, with operating income reaching 45.39 million yuan compared to 12,660.54 yuan in the same period last year, although the company continues to face net losses [1][3]. Financial Performance - The company achieved operating income of 45.39 million yuan in H1 2025, a substantial increase from 12,660.54 yuan in H1 2024, indicating a growth rate that is not applicable due to the low base [1][3]. - The net profit attributable to shareholders was -289.29 million yuan, an improvement from -361.93 million yuan in the previous year [1][3]. - The net cash flow from operating activities was -116.06 million yuan, an improvement from -264.35 million yuan year-on-year [1][3]. - The net assets attributable to shareholders decreased by 13.87% to 1.83 billion yuan compared to the end of the previous year [3]. - Total assets slightly decreased by 0.91% to 3.12 billion yuan [3]. Historical Performance - Zhixiang Jintai has reported net losses for four consecutive years from 2021 to 2024, with net profits attributable to shareholders of -322 million yuan, -576 million yuan, -801 million yuan, and -797 million yuan respectively [3][4]. - The company’s net profit excluding non-recurring gains and losses also showed a consistent decline over the same period [3][4]. IPO and Fundraising - The company went public on the Shanghai Stock Exchange's Sci-Tech Innovation Board on June 20, 2023, raising a total of 3.47 billion yuan, with a net amount of 3.29 billion yuan after deducting issuance costs [5]. - The initial fundraising target was 3.98 billion yuan, aimed at projects related to antibody industrialization and working capital [5].
智翔金泰股价跌5.08%,天治基金旗下1只基金重仓,持有1.75万股浮亏损失3.29万元
Xin Lang Cai Jing· 2025-09-02 06:02
Group 1 - The core point of the article highlights the recent decline in the stock price of Zhixiang Jintai, which fell by 5.08% to 35.14 CNY per share, with a trading volume of 221 million CNY and a turnover rate of 5.26%, resulting in a total market capitalization of 12.885 billion CNY [1] - Zhixiang Jintai Biopharmaceutical Co., Ltd. is located in Chongqing and was established on October 20, 2015, with its listing date on June 20, 2023. The company's main business involves the research, production, and sales of antibody drugs, with 99.92% of its revenue coming from antibody drugs and 0.08% from other supplementary sources [1] Group 2 - From the perspective of fund holdings, Tianzhi Fund has one fund heavily invested in Zhixiang Jintai. Tianzhi New Consumption Mixed Fund (350008) held 17,500 shares in the second quarter, accounting for 2.59% of the fund's net value, ranking as the tenth largest holding. The estimated floating loss today is approximately 32,900 CNY [2] - Tianzhi New Consumption Mixed Fund (350008) was established on August 4, 2011, with a latest scale of 18.7694 million CNY. Year-to-date returns are 11.21%, ranking 5600 out of 8184 in its category, while the one-year return is 7.51%, ranking 7154 out of 7971. Since its inception, the fund has experienced a loss of 8.54% [2] - The fund manager of Tianzhi New Consumption Mixed Fund is Liang Li, who has been in the position for 4 years and 142 days. The total asset scale under management is 71.0539 million CNY, with the best fund return during the tenure being 11.55% and the worst being -59.11% [2]