Core Viewpoint - The company, Zhixiang Jintai, reported a strong revenue growth in the first half of 2025, achieving an operating income of 45.39 million yuan, while also narrowing its losses through continuous innovation and product development [1][2]. Group 1: Financial Performance - In the first half of 2025, the company achieved an operating income of 45.39 million yuan, indicating a rapid growth trend [1]. - The sales revenue from the product, Seclici Monoclonal Antibody Injection, reached 45.3758 million yuan, benefiting over 10,000 psoriasis patients [2]. Group 2: Product Development - The company has 14 products under research, with two indications of Seclici Monoclonal Antibody Injection approved for market, and two other products, Silevimi Monoclonal Antibody Injection and GR2001 Injection, having their NDA accepted [1]. - GR1802 Injection is currently in Phase III clinical trials for five indications, showcasing the company's commitment to addressing unmet clinical needs [1]. - The company has completed Phase II clinical trials for GR1603 Injection for systemic lupus erythematosus and is actively communicating about the Phase III trial plan [2]. Group 3: R&D Investment - The company recognizes that sustained high R&D investment is crucial for technological advancement and clinical breakthroughs, with a cumulative R&D expenditure of 1.685 billion yuan over the past three years [3]. - In the current reporting period, the R&D expenses amounted to 219 million yuan, providing solid support for innovative research and development [3].

登录新浪财经APP 搜索【信披】查看更多考评等级 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GR1802注射液青少年季节性过敏性鼻炎适应症的临床试 验申请获得批准。现将相关情况公告如下： 一、药品基本信息 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，GR1802注射液临床试验申请符 合药品注册的有关要求，同意本品开展青少年季节性过敏性鼻炎适应症的临床试验。 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-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。 此前，GR1802注射液已获得多个适应症的临床试验批准通知书，成人中、重度特应性皮炎适应症、慢 性 ...

Group 1 - The core point of the article is that Zhixiang Jintai has received approval from the National Medical Products Administration for the clinical trial of its product GR1802 injection for adolescent seasonal allergic rhinitis [2] - Zhixiang Jintai's revenue composition for the year 2024 is reported to be 99.92% from the pharmaceutical manufacturing industry and 0.08% from other businesses [2]

Core Viewpoint - The company, Zhixiang Jintai (688443.SH), has received approval from the National Medical Products Administration for the clinical trial of GR1802 injection for adolescent seasonal allergic rhinitis [1] Group 1: Company Developments - GR1802 injection is a recombinant fully human anti-IL-4Rα monoclonal antibody developed independently by the company [1] - The company has previously obtained clinical trial approval notifications for multiple indications for GR1802 injection [1] Group 2: Regulatory and Market Implications - Following the completion of clinical trials, the company must submit a new drug application and obtain a drug registration certificate before the product can be marketed [1]

格隆汇8月19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GR1802注射液青少年季节性过敏性鼻炎适应症的临床试验申请获得批准。 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。 ...

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GR1802注射液青少年季节性过敏性鼻炎适应症的临床试验申请获得批准。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。此前，GR1802注射液已获得多 个适应症的临床试验批准通知书，成人中、重度特应性皮炎适应症、慢性鼻窦炎伴鼻息肉适应症、慢性 自发性荨麻疹适应症、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/II期临床试验阶段。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 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-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。 GR1802注射液已获得多个适应症的临床试验批准通知书。继中、重度特应性皮炎适应症、慢性鼻窦炎 伴鼻息肉适应症、慢性自发性荨麻疹适应症进入Ⅲ期临床试验后，过敏性鼻炎适应症也将正式启动III期 临床试验。其余适应症：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/Ⅱ 期临床试验阶段。 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"）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 ...

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]

（编辑 任世碧） 证券日报网讯 8月13日晚间，智翔金泰发布公告称，近日，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。 ...