重庆智翔金泰生物制药股份有限公司2025 年半年度报告 公司代码：688443 公司简称：智翔金泰 重庆智翔金泰生物制药股份有限公司 2025 年半年度报告 1 / 179 重庆智翔金泰生物制药股份有限公司2025 年半年度报告 重要提示 一、 本公司董事会、监事会及董事、监事、高级管理人员保证半年度报告内容的真实性、准确 性、完整性，不存在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 二、 重大风险提示 公司是一家创新驱动型生物制药企业，产品为自身免疫性疾病、感染性疾病和肿瘤等治疗领 域的单克隆抗体药物和双特异性抗体药物。2024 年 8 月，公司自主研发的创新药赛立奇单抗注射 液（商品名：金立希®）获国家药品监督管理局批准上市，为国产首款获批上市的全人源抗 IL-17A 单克隆抗体药物。2025 年 1 月，赛立奇单抗注射液用于成人常规治疗疗效欠佳的强直性脊柱炎（放 射学阳性中轴型脊柱关节炎）适应症获批上市，进一步拓展该产品的市场应用潜力。本报告期内， 公司实现产品销售收入 4,537.58 万元。 截至 2025 年 6 月 30 日，公司尚未盈利且存在累计未弥补亏损，主要由于新药研发、 ...

证券代码：688443 证券简称：智翔金泰 公告编号：2025-034 重庆智翔金泰生物制药股份有限公司 2025年半年度募集资金存放、管理与实际 使用情况的专项报告 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、准确性和完整性依法承担法律责任。 重庆智翔金泰生物制药股份有限公司（以下简称"智翔金泰"或"公司"） 董事会根据《上市公司募集资金监管规则》《上海证券交易所科创板上市公司自 律监管指引第 1 号——规范运作》和《上海证券交易所科创板股票上市规则》等 有关规定，编制了 2025 年半年度募集资金存放、管理与实际使用情况的专项报 告，内容如下： 一、募集资金基本情况 （一）募集资金金额、资金到账情况 根据中国证券监督管理委员会《关于同意重庆智翔金泰生物制药股份有限公 司首次公开发行股票注册的批复》（证监许可〔2023〕725 号），公司首次公开发 行人民币普通股 9,168.00 万股，发行价格为每股 37.88 元，共募集资金 3,472,838,400.00 元，扣除发行费用后募集资金净额为 3,291,401,425.54 元。信永 中和会计 ...

公司是一家创新驱动型生物制药企业，主营业务为抗体药物的研发、生产与销 售，公司在研产品为单克隆抗体药物和双特异性抗体药物。 公司在源头创新方面建立了基于新型噬菌体呈现系统的单抗药物发现技术平 台和双特异性抗体药物发现技术平台，在抗体药物结构拓展上开发了单域抗体药物 发现技术和新结构重组蛋白药物发现技术，在抗体药物靶点拓展上开发了胞内抗原 抗体药物发现技术；在药物开发环节建立了高效的重组抗体药物工艺开发平台。基 于上述技术平台和技术，公司立项开发了多款单克隆抗体药物和双特异性抗体药 物。 2025 年上半年公司研发投入 21,935.24 万元。截至本报告披露日，公司在研产 品 14 个，其中 2 个适应症已经获批上市，2 个适应症新药上市申请已获受理，6 个适应症处于 III 期临床试验阶段，公司 2 个在研产品被国家药品监督管理局药品 审评中心纳入突破性治疗品种名单。 （一）聚焦产品研发质效，多款产品积极进展 公司核心产品赛立奇单抗注射液的第二个适应症强直性脊柱炎适应症于 2025 年 1 月获批上市，成为国产首个获批该适应症的 IL-17A 靶点单克隆抗体药物，进 一步提升赛立奇单抗注射液的市场潜力；斯乐 ...

Market Overview - The biopharmaceutical sector experienced a decline of 2.85% on August 27, with Kanghua Biotech leading the drop [1] - The Shanghai Composite Index closed at 3800.35, down 1.76%, while the Shenzhen Component Index closed at 12295.07, down 1.43% [1] Individual Stock Performance - Wuwei Biotech (300357) saw a significant increase of 5.38%, closing at 30.95 with a trading volume of 299,000 shares and a transaction value of 915 million yuan [1] - Kanghua Biotech (300841) reported a notable decline of 8.89%, closing at 76.60 with a trading volume of 125,200 shares and a transaction value of 993 million yuan [2] - Anke Biotech (300009) also faced a drop of 5.59%, closing at 11.14 with a trading volume of 862,300 shares and a transaction value of 990 million yuan [2] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 1.853 billion yuan from institutional investors, while retail investors saw a net inflow of 1.543 billion yuan [2] - The capital flow for individual stocks indicates that Hualan Biotech (002007) had a net inflow of 32.28 million yuan from institutional investors, while it faced a net outflow of 40.67 million yuan from speculative funds [3] - The overall trend shows that retail investors are actively investing in the sector despite the institutional outflows [2][3]

Overview - The monoclonal antibody (mAb) market in China is still in its early stages, with many overseas mAbs not yet approved domestically. The high cost of these drugs limits accessibility for many patients with lower payment capabilities. However, the market penetration of mAbs is gradually increasing due to their significant advantages over traditional drugs, updates to the national medical insurance catalog, and rising national income levels. The market size of China's mAb industry is projected to reach 131.5 billion yuan in 2024, representing a year-on-year growth of 30.85% [1][5]. Industry Chain - The upstream of the mAb industry includes suppliers of raw materials such as cell culture media, enzymes, antibodies, reagents, consumables, and packaging materials, as well as core equipment suppliers like bioreactors and purification devices. The midstream consists of mAb research and production companies, while the downstream includes hospitals, DTP pharmacies, retail pharmacies, and online channels. Hospitals are the most critical distribution channel for mAbs in China, especially for drugs listed in the medical insurance catalog [3][5]. Development Background - The application of mAbs in cancer treatment is widespread, with the number of new cancer cases in China projected to reach 5.064 million in 2024, a year-on-year increase of 2.61%. This growing cancer population drives the demand for mAbs. Additionally, mAbs have shown efficacy in treating other diseases, such as asthma and inflammatory bowel diseases, providing new development opportunities for the mAb industry [4][5]. Current Status - Since the launch of the first therapeutic mAb in 1986, the mAb market has rapidly developed, with significant products like trastuzumab and adalimumab emerging. By 2024, the global mAb market size is expected to reach 273.3 billion USD, with a year-on-year growth of 9.15% [4][5]. Competitive Landscape - In the global pharmaceutical market, mAbs are becoming a cornerstone of biopharmaceuticals, with 8 mAbs appearing in the top 20 global drug sales rankings in 2024. The success of mAbs in treating tumors and immune diseases is notable, and advancements in biopharmaceutical technology may expand their role in treating infectious diseases [5][6]. Domestic Market Dynamics - In 2024, only 7 mAbs are among the top 30 chemical and biological drugs sold in Chinese hospitals, indicating significant room for growth in the domestic mAb market. The market is expected to expand further as domestic companies gain market share [7][8]. Company Analysis - Domestic companies like BeiGene, Innovent Biologics, Junshi Biosciences, and others are increasingly capturing market share previously dominated by multinational corporations. For instance, BeiGene's Tislelizumab leads in the PD-1 mAb market in China, while Innovent's Sintilimab and Junshi's Toripalimab also hold significant positions [8][9]. Future Trends - The quality and efficacy of domestic mAbs are expected to improve with ongoing advancements in research and production technologies. This may lead to a further increase in market share, breaking the monopoly of multinational companies. Additionally, the application of mAbs is anticipated to expand beyond cancer and autoimmune diseases to include infectious and transmissible diseases [11].

Core Points - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial application of its product GR1802 injection for the indication of seasonal allergic rhinitis in adolescents [1][2] Group 1: Drug Information - The drug GR1802 injection is a recombinant fully human anti-IL-4Rα monoclonal antibody targeting IL-4Rα, which specifically binds to the cell surface human IL-4Rα, blocking the binding of IL-4 and IL-13, thereby inhibiting downstream STAT6 phosphorylation and CD23 upregulation, thus suppressing Th2-type inflammatory responses mediated by IL-4 or IL-13 [2] - GR1802 injection has previously received clinical trial approval for multiple indications, including moderate to severe atopic dermatitis in adults, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, allergic rhinitis, currently in phase III clinical trials, and asthma in phase II clinical trials, with atopic dermatitis in children/adolescents in phase Ib/II clinical trials [2] Group 2: Market Context - As of the date of this announcement, only two other drugs targeting the same receptor have been approved for marketing in China [3]

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]

证券代码：688443 证券简称：智翔金泰 公告编号：2025-033 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1802注射液青少年季节性过敏性鼻 炎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。 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 药品名称：GR1802 注射液 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 ...

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]

Core Viewpoint - The company Zhixiang Jintai (688443.SH) has received approval from the National Medical Products Administration for the clinical trial of its product GR1802 injection, aimed at treating seasonal allergic rhinitis in adolescents [1] Group 1: Product Development - GR1802 injection is a recombinant fully human anti-IL-4Rα monoclonal antibody developed independently by the company [1] - The target of GR1802 injection is IL-4Rα, which specifically binds to the cell surface human IL-4Rα [1] - The mechanism of action involves blocking the binding of IL-4 and IL-13 to IL-4Rα, inhibiting downstream STAT6 phosphorylation, and suppressing CD23 upregulation, thereby reducing Th2-type inflammatory responses mediated by IL-4 or IL-13 [1]