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]

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]

Company Overview - Zhixiang Jintai (688443) closed at 29.74 yuan on May 30, 2025, up 7.75% from 27.6 yuan the previous week, with a total market capitalization of 10.905 billion yuan, ranking 24th in the biopharmaceutical sector and 1422nd in the A-share market [1] Key Developments - The company is actively preparing for national medical insurance negotiations for the monoclonal antibody injection, Geniuxi, aiming for early inclusion in the insurance scheme to benefit more patients [1][4] - The GR1802 injection for moderate to severe atopic dermatitis is expected to complete its Phase III clinical trial enrollment by August 2024, currently in the Phase III trial stage [1][2] - The company has established a commercial team of approximately 200 people to promote the commercialization of Geniuxi [2][4] Product Pipeline - The company has two indications for Geniuxi approved for market, while GR1801 and GR2001 injection applications have been accepted, and GR1802 is in Phase III trials for three indications [2][3] - The GR2001 injection new drug application was accepted in May 2025 and is currently awaiting review [3] Strategic Focus - The company is focusing on strategic collaborations with leading domestic distributors and platforms to quickly achieve market coverage and penetration for its products [2] - The company plans to maintain high expenditure levels to support the advancement of its product pipeline and ensure a competitive edge in the market [3] Industry Context - The biopharmaceutical industry is characterized by high investment, high technology, high risk, and long cycles, requiring sustained investment over many years to achieve profitability [2] - The industry is experiencing accelerated high-quality development, driven by favorable policies and increased R&D investments, leading to innovative drug development that addresses unmet clinical needs [3]