Core Viewpoint - The company Zhixiang Jintai (688443.SH) has achieved the primary endpoint in the Phase III clinical trial of its drug Taliqibai Injection (GR1802) for the treatment of moderate to severe atopic dermatitis in adults, and has submitted a new drug application to the National Medical Products Administration (NMPA) which has been accepted [1] Group 1: Drug Development - Taliqibai Injection (GR1802) is a recombinant fully human anti-IL-4Rα monoclonal antibody developed by the company, targeting IL-4Rα [1] - The drug specifically binds to the human IL-4Rα on cell surfaces, blocking the binding of IL-4 and IL-13, thereby inhibiting downstream STAT6 phosphorylation and CD23 upregulation, which suppresses Th2-type inflammatory responses mediated by IL-4 or IL-13 [1] Group 2: Clinical Trials - Multiple indications for Taliqibai Injection are in clinical trial stages, including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria, both in Phase III trials [1] - Seasonal allergic rhinitis in adults and adolescents is also in Phase III trials, while asthma is in Phase II trials, and atopic dermatitis in children/adolescents is in Ib/IIa trials [1]

证券代码：688443 证券简称：智翔金泰 公告编号：2025-040 重庆智翔金泰生物制药股份有限公司 自愿披露关于泰利奇拜单抗注射液新药上市申请获 得受理的公告 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"）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。 一、药品基本信息 受理号：CXSS2500091、CXSS2500092 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 药品名称：泰利奇拜单抗注射液 申请事项：境内生产药品注册上市许可 申请人：重庆智翔金泰生物制药股份有限公司 根据国家药品注册相关的法律法规要求，新药上市申请尚需经过审评、药品 临床试验现场检查、药品生产现场检查和审批等环节，产品能否成功上市及上市 时间存在不确定性。 公司将按有关规定对 ...

Core Viewpoint - Zhixiang Jintai (688443.SH) announced that its drug Talizhi Baikan (GR1802 injection) has achieved primary endpoint indicators in a Phase III clinical trial for moderate to severe atopic dermatitis in adults, and the company has submitted a new drug application to the National Medical Products Administration (NMPA) which has been accepted [1] Group 1 - Talizhi Baikan (GR1802 injection) is a fully humanized recombinant anti-IL-4Rα monoclonal antibody developed by the company, targeting IL-4Rα [1] - The drug specifically binds to human IL-4Rα on the cell surface, blocking the binding of IL-4 and IL-13 to IL-4Rα, thereby inhibiting downstream STAT6 phosphorylation and CD23 upregulation, which suppresses Th2-type inflammatory responses mediated by IL-4 or IL-13 [1] Group 2 - Multiple indications for Talizhi Baikan are in clinical trial stages, including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria in Phase III trials, seasonal allergic rhinitis in both adults and adolescents in Phase III trials, asthma in Phase II trials, and atopic dermatitis in children/adolescents in Ib/IIa trials [1]

Core Viewpoint - Zhixiang Jintai (688443) announced that its drug Talichibai Injection (GR1802) has met the primary endpoint in a Phase III clinical trial for moderate to severe atopic dermatitis in adults, and the new drug application has been accepted by the National Medical Products Administration (NMPA) [1] Group 1 - The Phase III clinical trial for Talichibai Injection (GR1802) achieved its primary endpoint [1] - The company has submitted a new drug application for the indication to the NMPA, which has been accepted [1] - As of the announcement date, only two other drugs targeting the same indication have been approved for marketing in China [1]

Group 1 - The core point of the article highlights the decline in the stock price of Zhixiang Jintai, which fell by 5.61% to 31.80 CNY per share, with a trading volume of 31.83 million CNY and a turnover rate of 0.84%, resulting in a total market capitalization of 11.66 billion CNY [1] - Zhixiang Jintai, established on October 20, 2015, and listed on June 20, 2023, is primarily engaged in the research, production, and sales of antibody drugs, with 99.96% of its main business revenue coming from drug sales [1] Group 2 - From the perspective of major circulating shareholders, Dongzheng Asset Management's fund is among the top shareholders of Zhixiang Jintai, having reduced its holdings by 92,700 shares in the second quarter, now holding 2.45 million shares, which accounts for 2.1% of circulating shares, resulting in an estimated floating loss of approximately 4.63 million CNY [2] - The fund, Oriental Red Medical Upgrade Stock Initiation A (015052), was established on March 29, 2022, with a latest scale of 481 million CNY, achieving a year-to-date return of 78.01% and a one-year return of 98.05% [2] Group 3 - The fund manager of Oriental Red Medical Upgrade Stock Initiation A is Jiang Qi, who has been in the position for 3 years and 168 days, managing a total fund size of 1.41 billion CNY, with the best fund return during his tenure being 70.01% and the worst being 67.12% [3] Group 4 - In terms of the fund's top heavy positions, Zhixiang Jintai is the eighth largest holding in the Oriental Red Medical Upgrade Stock Initiation A fund, with the fund holding 2.45 million shares, which represents 4.82% of the fund's net value, and an estimated floating loss of about 4.63 million CNY [4]

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]