泰利奇拜单抗注射液(GR1802注射液)是一款由公司自主研发的重组全人源抗IL-4Rα单克隆抗体，作用 靶点为IL-4Rα。泰利奇拜单抗注射液能特异性结合细胞表面人IL-4Rα，阻断IL-4、IL-13与IL-4Rα的结 合，抑制下游STAT6磷酸化，抑制CD23上调，从而抑制由IL-4或IL-13介导的Th2型炎症反应。泰利奇拜 单抗注射液(GR1802注射液)的多个适应症处于临床试验阶段，慢性鼻窦炎伴鼻息肉、慢性自发性荨麻 疹、成人以及青少年季节性过敏性鼻炎适应症处于III期临床试验阶段，哮喘适应症处于II期临床试验阶 段，儿童/青少年特应性皮炎适应症处于Ib/IIa期临床试验阶段。 智翔金泰(688443.SH)发布公告，近日，公司的泰利奇拜单抗注射液(GR1802注射液)用于成人中、重度 特应性皮炎适应症III期临床试验达到了主要终点指标，公司向国家药品监督管理局(NMPA)药品审评中 心(CDE)提交了该适应症的新药上市申请并获得受理。 ...

人民财讯9月11日电，智翔金泰(688443)9月11日晚间公告，近日，公司的泰利奇拜单抗注射液(GR1802 注射液)用于成人中、重度特应性皮炎适应症III期临床试验达到了主要终点指标，公司向国家药品监督 管理局(NMPA)药品审评中心(CDE)提交了该适应症的新药上市申请并获得受理。截至本公告披露日， 泰利奇拜单抗注射液(GR1802注射液)同靶点药物仅有两款在国内获批上市。 ...

东方红医疗升级股票发起A（015052）基金经理为江琦。 截至发稿，江琦累计任职时间3年168天，现任基金资产总规模14.1亿元，任职期间最佳基金回报 70.01%， 任职期间最差基金回报67.12%。 从基金十大重仓股角度 数据显示，东证资管旗下1只基金重仓智翔金泰。东方红医疗升级股票发起A（015052）二季度减持9.27 万股，持有股数245.12万股，占基金净值比例为4.82%，位居第八大重仓股。根据测算，今日浮亏损失 约463.27万元。 9月11日，智翔金泰跌5.61%，截至发稿，报31.80元/股，成交3182.69万元，换手率0.84%，总市值 116.60亿元。 资料显示，重庆智翔金泰生物制药股份有限公司位于重庆市巴南区麻柳大道699号2号楼A区，成立日期 2015年10月20日，上市日期2023年6月20日，公司主营业务涉及抗体药物的研发、生产与销售。主营业 务收入构成为：销售药品99.96%，其他0.04%。 从智翔金泰十大流通股东角度 数据显示，东证资管旗下1只基金位居智翔金泰十大流通股东。东方红医疗升级股票发起A（015052） 二季度减持9.27万股，持有股数245.12万股，占流 ...

Core Viewpoint - Zhixiang Jintai has received approval from the National Medical Products Administration for the clinical trial application of its product GR1803 injection for systemic lupus erythematosus [2] Group 1 - The company announced the receipt of the clinical trial approval notice on the evening of September 10 [2] - The approved clinical trial is for the indication of systemic lupus erythematosus [2]

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]

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]

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]

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]

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， ...

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。 ...