Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of its product GR1802 injection for the indication of seasonal allergic rhinitis in adolescents [1] Group 1: Product Development - GR1802 injection is a recombinant fully human anti-IL-4Rα monoclonal antibody developed by the company, targeting IL-4Rα [1] - The product has previously received clinical trial approval for multiple indications, including moderate to severe atopic dermatitis in adults, chronic sinusitis with nasal polyps, chronic spontaneous urticaria, and allergic rhinitis, all of which are currently in Phase III clinical trials [1] - The asthma indication is in Phase II clinical trials, while the indication for atopic dermatitis in children/adolescents is in Phase Ib/II clinical trials [1]

Core Points - Zhixiang Jintai (688443.SH) closed at 33.05 yuan, with a decline of 3.42%, currently in a state of breaking issue [1] - The company was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on June 20, 2023, with a public offering of 91.68 million shares at an issue price of 37.88 yuan per share [1] - The total amount raised from the initial public offering (IPO) was 347.28 million yuan, with a net amount of 329.14 million yuan after deducting issuance costs, which is 68.86 million yuan less than the originally planned amount [1] - The company aimed to raise 398 million yuan for projects including the expansion of the antibody industrialization base, research and development of antibody drugs, and to supplement working capital [1] Financial Summary - The total issuance costs for the IPO amounted to 18.14 million yuan (excluding tax), with underwriting fees accounting for 16.50 million yuan [2]

Group 1 - The company has completed communication with the National Medical Products Administration (NMPA) regarding the initiation of a Phase III clinical trial for GR1802 injection in patients with seasonal allergic rhinitis [1][2] - GR1802 injection is a recombinant fully human anti-IL-4Rα monoclonal antibody, targeting IL-4Rα, which inhibits Th2-type inflammatory responses mediated by IL-4 or IL-13 [1] - The drug has received clinical trial approval for multiple indications, including moderate to severe atopic dermatitis, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria, with allergic rhinitis now entering Phase III trials [2] Group 2 - As of the announcement date, only two drugs targeting the same receptor have been approved for marketing in China [3] - The drug must complete clinical trials and submit a new drug application to obtain a marketing authorization before it can be sold [3]

Group 1 - Ruikang Pharmaceutical's executive Li Zhe has had his detention changed to a notice of investigation, indicating a shift in the investigation phase [1] - The change from detention to a notice of investigation suggests a reduced level of coercion, highlighting the importance of internal control and compliance systems in listed companies [1] Group 2 - Zhixiang Jintai has initiated a Phase III clinical trial for GR1802 injection for allergic rhinitis, following communication with the National Medical Products Administration [2] - GR1802 is slightly behind in clinical progress compared to two other approved drugs targeting the same indication, but successful commercialization could lead to competition with Dupilumab [2] Group 3 - Rongchang Biopharmaceutical's innovative drug RC18 (Taitaxip) for primary Sjögren's syndrome has met its primary endpoint in Phase III clinical trials, marking a potential first in the global market for this indication [3] - If approved, this drug could provide a breakthrough treatment for millions of patients in China and strengthen Rongchang's position in the autoimmune field [3] Group 4 - Hengrui Medicine's SHR-A2102, a targeted antibody-drug conjugate (ADC) for Nectin-4, has received approval for clinical trials in combination with Atezolizumab for recurrent/metastatic head and neck squamous cell carcinoma [4] - There is currently only one similar product on the market, Padcev, which is projected to generate $1.949 billion in sales in 2024, indicating significant market potential for this target [4] Group 5 - BeiGene has launched the first domestic Phase III clinical trial for subcutaneous Tislelizumab, a PD-1 inhibitor, for use in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [5] - The subcutaneous formulation is becoming a competitive area for PD-1/PD-L1 inhibitors, with three other subcutaneous PD-1/L1 products already approved globally [5]

Group 1 - The company, Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd., has announced the initiation of a Phase III clinical trial for GR1802 injection, targeting allergic rhinitis [1][2] - GR1802 injection is a recombinant fully human anti-IL-4Rα monoclonal antibody, designed to specifically bind to the IL-4Rα on cell surfaces, blocking the binding of IL-4 and IL-13, thereby inhibiting Th2-mediated inflammatory responses [1][2] - The drug has already received clinical trial approval for multiple indications, including moderate to severe atopic dermatitis, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria, with asthma currently in Phase II and pediatric atopic dermatitis in Phase Ib/II trials [2] Group 2 - As of the announcement date, only two other drugs targeting the same receptor have been approved for marketing in China [2] - The company emphasizes the importance of adhering to regulatory requirements for drug registration and the lengthy, complex process of drug development, which is subject to various uncertainties [2]

Core Viewpoint - The company Zhixiang Jintai announced the initiation of a Phase III clinical trial for GR1802 injection in patients with seasonal allergic rhinitis, following a successful communication with the National Medical Products Administration (NMPA) [1] Group 1 - The clinical trial is randomized, double-blind, placebo-controlled, and multi-center [1] - The trial aims to evaluate the efficacy and safety of GR1802 injection combined with background therapy [1] - The meeting with the Center for Drug Evaluation (CDE) marked the completion of the end of Phase II and the start of Phase III clinical trials [1]

Group 1 - Kaizhong Precision plans to invest up to 250 million yuan to establish a subsidiary and build a production base in Thailand, focusing on overseas connector and precision component business [1] - Longbo Technology reported a 60.18% year-on-year increase in net profit for the first half of 2025, with revenue of 122 million yuan, up 18.03% [2] - Dingyang Technology achieved a net profit of 76.88 million yuan in the first half of 2025, a year-on-year increase of 31.54%, with revenue of 279 million yuan, up 24.61% [4] Group 2 - Heng Rui Pharmaceutical received approval for clinical trials of two drugs, SHR-A2102 and Adebeli monoclonal antibody injection [6] - Maolai Optical plans to use up to 100 million yuan of idle funds for entrusted wealth management to improve fund utilization efficiency [8] - Shiji Information signed a major contract with MGM Grand, providing a next-generation cloud-based hotel information management system [7] Group 3 - Yunnan Germanium's subsidiary received a government subsidy of 6.8 million yuan related to revenue [9] - Jizhi Co. received a warning letter from the Zhejiang Securities Regulatory Bureau for failing to disclose significant government subsidies [10] - Dongfang Precision reported a net profit of approximately 397 million yuan for the first half of 2025, a year-on-year increase of 142.52% [11] Group 4 - Aolaide expects a net profit decrease of 68.41% to 72.77% for the first half of 2025, with revenue projected between 270 million and 290 million yuan [12] - Feilong Co. used 111 million yuan of idle funds for cash management through structured deposit products [13] - Anhui Construction won two major projects with a total investment exceeding 6.6 billion yuan [15] Group 5 - Yunnan Germanium's subsidiary received a government subsidy of 6.8 million yuan related to revenue [9] - Jizhi Co. received a warning letter from the Zhejiang Securities Regulatory Bureau for failing to disclose significant government subsidies [10] - Dongfang Precision reported a net profit of approximately 397 million yuan for the first half of 2025, a year-on-year increase of 142.52% [11] Group 6 - China Medical's subsidiary received approval for the listing of fumaric acid volnora raw materials [20] - Huayuan Vaccine's subsidiary received approval for clinical trials of Hib vaccine [29] - Ganfeng Lithium plans to integrate lithium salt lake projects in Argentina and provide financial support of up to 130 million USD [41]

证券代码：688443 证券简称：智翔金泰 公告编号：2025-032 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1802注射液启动过敏性鼻炎适应症 III期临床试验的公告 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。 敬请广大投资者谨慎决策，注意防范投资风险。 近日，重庆智翔金泰生物制药股份有限公司（以下简称"公司"）就"一项 评价 GR1802 注射液联合背景治疗在季节性过敏性鼻炎患者中的有效性和安全 性的随机、双盲、安慰剂对照、多中心 III 期临床试验"的开展，完成与国家药 品监督管理局药品审评中心（CDE)EOP2（II 期临床试验结束/III 期临床试验启 动前）的会议沟通，公司将正式启动该 III 期临床试验。 一、药品基本信息 药品名称：GR1802 注射液 剂型：注射液 注册分类：治疗用生物制品 1 类 适应症：过敏性鼻炎 二、药品其他相关情况 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。GR1802 注射液能特异性结合细胞表面人 IL ...

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。GR1802 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。 格隆汇8月13日丨智翔金泰(688443.SH)公布，公司就"一项评价GR1802注射液联合背景治疗在季节性过 敏性鼻炎患者中的有效性和安全性的随机、双盲、安慰剂对照、多中心III期临床试验"的开展，完成与 国家药品监督管理局药品审评中心（CDE)EOP2（II期临床试验结束/III期临床试验启动前）的会议沟 通，公司将正式启动该III期临床试验。 ...

8月13日，智翔金泰(688443.SH)公告称，公司近日完成与国家药品监督管理局药品审评中心的会议沟 通，将正式启动GR1802注射液过敏性鼻炎适应症III期临床试验。GR1802注射液为公司自主研发的重组 全人源抗IL-4Rα单克隆抗体，已获得多个适应症的临床试验批准通知书，除过敏性鼻炎外，其余适应症 包括中、重度特应性皮炎、慢性鼻窦炎伴鼻息肉、慢性自发性荨麻疹、哮喘以及儿童/青少年特应性皮 炎。GR1802注射液同靶点药物在国内仅有两款获批上市。 （文章来源：每日经济新闻） ...