海通证券股份有限公司 关于重庆智翔金泰生物制药股份有限公司 2023 年度持续督导现场检查报告 上海证券交易所： 经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）批复，重庆智翔 金泰生物制药股份有限公司（以下简称"智翔金泰"、"上市公司"、"公司"）首 次公开发行股票 9,168.00 万股，每股面值人民币 1 元，每股发行价格人民币 37.88 元，募集资金总额为人民币 347,283.84 万元，扣除发行费用后，实际募集资金净 额为人民币 329,140.14 万元。本次发行证券已于 2023 年 6 月 20 日在上海证券交 易所上市。海通证券股份有限公司（以下简称"海通证券"、"保荐机构"）担任 其持续督导保荐机构，持续督导期间为 2023 年 6 月 20 日至 2026 年 12 月 31 日。 根据《证券发行上市保荐业务管理办法》、《上海证券交易所股票上市规则》 《上海证券交易所上市公司自律监管指引第 11 号——持续督导》《上海证券交易 所科创板股票上市规则》《上海证券交易所科创板上市公司自律监管指引第 1 号 ...

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook for future performance [6]. Core Views - The company is expected to achieve a revenue of 1.2115 billion yuan in 2023, representing a year-on-year increase of 154.92%, primarily driven by technical service income [6]. - The company anticipates a loss of 800.1 million yuan in 2023, which is a 39.03% increase in loss compared to the previous year [6]. - The research pipeline is progressing efficiently, with core products advancing ahead of competitors, and the company is poised to enter a commercial phase in 2024 [6]. Financial Performance - The company reported a significant increase in R&D expenses, expected to reach 620 million yuan in 2023, up 36.50% year-on-year [6]. - The projected revenue for 2024 is 900 million yuan, reflecting a staggering year-on-year growth of 7324.5% [9]. - The net profit for 2024 is expected to improve to a loss of 556 million yuan, a reduction in loss compared to 2023 [9]. Clinical Development - The company's product GR1501 is anticipated to be the first domestically produced IL-17A monoclonal antibody, with promising clinical efficacy [6]. - GR1501 has shown significant results in clinical trials for moderate to severe plaque psoriasis, with a 90.7% response rate at 12 weeks [6]. - The company has multiple products in clinical stages, including GR1802 and GR2002, which are advancing in autoimmune and infectious disease areas [6]. Market Position - The company is strategically positioned with a forward-looking commercial layout, aiming for a strong market entry in 2024 [6]. - The report highlights the competitive edge of the company's pipeline, suggesting that it is ahead of domestic peers in terms of clinical progress [6].

作者具有中国证券业协会授予的证券投资咨询执业资格或相当的专业胜任能力，保证报告所采用的数据均来自合规渠道，分析 逻辑基于作者的职业理解，本报告清晰准确地反映了作者的研究观点，力求独立、客观和公正，结论不受任何第三方的授意或 影响，特此声明。 [Table_Page] 智翔金泰-U(688443) 本公司利用信息隔离墙控制内部一个或多个领域、部门或关联机构之间的信息流动。因此，投资者应注意，在法律许可的情 况下，本公司及其所属关联机构可能会持有报告中提到的公司所发行的证券或期权并进行证券或期权交易，也可能为这些公 司提供或者争取提供投资银行、财务顾问或者金融产品等相关服务。在法律许可的情况下，本公司的员工可能担任本报告所 提到的公司的董事。 分析师声明 若本公司以外的其他机构（以下简称"该机构"）发送本报告，则由该机构独自为此发送行为负责。通过此途径获得本报告的 投资者应自行联系该机构以要求获悉更详细信息或进而交易本报告中提及的证券。本报告不构成本公司向该机构之客户提供的 投资建议，本公司、本公司员工或者关联机构亦不为该机构之客户因使用本报告或报告所载内容引起的任何损失承担任何责任。 | --- | --- | ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [4][15]. Core Insights - The company is expected to enter a new development phase in 2024, with several key milestones ahead, including the NDA submission for GR1501 for moderate to severe plaque psoriasis, which is anticipated to be the first domestically approved anti-IL-17A monoclonal antibody [1][45]. - The company has a robust pipeline with eight products across 15 indications in clinical research, including GR1801, a dual antibody for rabies, which is expected to be commercialized by 2025 [1][10]. - The company is positioned to become a leading player in the biopharma sector, with a strong leadership team and innovative product pipeline [2][26]. Financial Projections and Valuation - Revenue projections for 2023E-2025E are estimated at 0 million, 110 million, and 437 million yuan respectively, with a DCF valuation suggesting a reasonable stock price of 53.7 yuan and a market value of 197 billion yuan [2][3]. - The peak sales potential for GR1501 is expected to exceed 2 billion yuan, supported by its first-mover advantage in dermatology and rheumatology [6][10]. Product Pipeline and Market Position - GR1501 is on track to become the first approved domestic IL-17A inhibitor, with significant market potential due to the high unmet needs in autoimmune diseases [1][35]. - The company has a competitive pipeline with products targeting autoimmune diseases, infections, and tumors, all derived from in-house research [7][73]. - The company’s dual-specific antibodies, such as GR1801 and GR1901, are positioned to fill significant treatment gaps in the market, particularly in rabies and acute myeloid leukemia [10][58]. R&D and Innovation - The company emphasizes a strong R&D focus, with over 85% of its workforce dedicated to research, and has established advanced platforms for antibody discovery and development [47][80]. - The innovative use of phage display technology allows for rapid development of antibody candidates, significantly shortening the discovery timeline [29][80]. - The leadership team possesses extensive experience in drug development, which is crucial for the company's long-term stability and growth [72][76].

请务必阅读正文之后的免责声明及其项下所有内容 ◼ GR1801是全球首个进入临床阶段的抗狂犬病病毒G蛋白双抗产品。GR1801针对狂犬病病毒G蛋白I和III表位，采用scFv+Fab结构的双 抗设计。Ph2临床数据显示出良好的广谱中和活性、安全性、有效性，目前Ph3临床已完成入组，预计2025Q4实现国内商业化，有望 进一步完善现有的狂犬病被动免疫策略。 2 02 自免：重磅靶点全面覆盖，IL-17A进度领先 05 盈利预测及投资建议 ■ 智翔金泰成立于2015年，总部位于重庆国际生物城，是一家以抗体药发现技术为驱动的创新型生物制药企业 。公司聚焦自身免疫性疾 病、感染性疾病以及肿瘤等治疗领域，现有在研管线12项。其中，GR1501（赛立奇单抗，商品名：金立希）针对中重度斑块状银屑病、 放射学阳性中轴型脊柱关节炎等2项适应症已提交新药上市申请并获受理; GR1801（重组全人源抗狂犬病病毒双特异性抗体）针对狂 犬病毒!!/级暴露后被动免疫适应症Ph3临床完成入组，GR1802中重度特应性皮炎适应症启动Ph3临床试验。 请务必阅读正文之后的免责声明及其项下所有内容 ■ 蒋仁生先生通过智睿投资间接持有智翔金泰54 ...

Investment Rating - The report assigns a "Buy" rating for Zhixiang Jintai (688443.SH) [1] Core Insights - The company is positioned to launch its first domestic IL-17A monoclonal antibody, GR1501, which has received acceptance for its marketing application for moderate to severe plaque psoriasis in March 2023 and is expected to be approved in the first half of 2024 [3][52] - GR1801, a dual-specific antibody targeting rabies virus, is in Phase III clinical trials and is anticipated to be approved by the end of 2025 [4] - The market for psoriasis treatment in China is significant, with approximately 6.5 million patients suffering from the condition, and the current usage rate of biologics remains low at around 7%, indicating substantial growth potential [25][43] Summary by Sections Company Overview - Zhixiang Jintai, established in 2015 and listed on the STAR Market in 2023, focuses on the research, development, production, and sales of antibody drugs, utilizing five innovative technology platforms for drug discovery [16][20] Product Pipeline - GR1501 is the first domestic IL-17A monoclonal antibody, with applications for moderate to severe plaque psoriasis and axial spondyloarthritis, both of which are in advanced stages of regulatory approval [39][52] - GR1802, a fully human anti-IL-4Rα monoclonal antibody, is in Phase III trials for moderate to severe atopic dermatitis and is also being developed for asthma and chronic rhinosinusitis with nasal polyps [21][54] Market Potential - The report highlights the unmet medical needs in the psoriasis treatment market, with a significant portion of patients expressing dissatisfaction with current therapies, suggesting a strong demand for new biologic treatments [27][41] - The competitive landscape is intensifying, with several imported IL-17 monoclonal antibodies already approved, and domestic competitors like Zhixiang Jintai and Heng Rui Pharma making rapid progress towards market entry [43][44]

一、药品基本信息 证券代码：688443 证券简称：智翔金泰 公告编号：2024-004 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR2102注射液获得药物临床试验 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 GR2102 注射液的临床试验申请获得批准。现将相关情况公告如下： 药品名称：GR2102 注射液 受理号：CXSL2300806 适应症：预防呼吸道合胞病毒感染 审评结论：根据《中华人民共和国药品管理法》及有关规定，经审查，GR2102 注射液临床试验申请符合药品注册的有关要求，同意本品开展预防呼吸道合胞病 毒感染的临床试验。 呼吸道合胞病毒（Respiratory syncytial virus，RSV）是一种包膜单股负链 RNA 病毒，由脂膜内的核衣壳和 3 个跨膜表面糖蛋白（附着蛋白 G、融合蛋白 F 和小 疏水蛋白 SH）组成。根据 G 蛋白的不同，R ...

证券代码：688443 证券简称：智翔金泰 公告编号：2024-003 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 申请事项：境内生产药品注册临床试验 申请人：重庆智翔金泰生物制药股份有限公司 受理号：CXSL2300805 适应症：过敏性鼻炎 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，同意本品开展过敏性鼻炎的临床 试验。 二、药品其他相关情况 GR1802 注射液是公司自主研发的新型重组全人源抗白细胞介素 4-受体 α （IL-4Rα）单克隆抗体注射液，可通过选择性结合 ...

重庆智翔金泰生物制药股份有限公司 自愿披露关于赛立奇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"）赛立奇单 抗注射液放射学阳性中轴型脊柱关节炎（强直性脊柱关节炎）适应症 III 期临床 试验达到了主要疗效终点，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。 证券代码：688443 证券简称：智翔金泰 公告编号：2024-001 受理号：CXSS2400001 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。 一、药品基本信息 药品名称：赛立奇单抗注射液 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 二、药品其他相关情况 赛立奇单抗注射液（GR1501 注射液）是一款由公司自主研发的重组全人源 抗 IL-17A 单克隆抗体，注册分类为治疗用生物制品 1 类，作用靶点为 IL-17A。 该产品可通过抗体特异性结合血清 ...

证券代码：688443 证券简称：智翔金泰 公告编号：2023-024 重庆智翔金泰生物制药股份有限公司 关于实际控制人增持公司股份的进展公告 本公司董事会及全体董事保证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。 重要内容提示： 增持计划的主要内容：重庆智翔金泰生物制药股份公司（以下简称"公 司"）于 2023 年 11 月 17 日披露了《关于实际控制人增持公司股份计划的公告》， 公司实际控制人蒋仁生先生拟使用其自有资金或自筹资金，自 2023 年 11 月 17 日起六个月内，通过上海证券交易所系统允许的方式（包括但不限于集中竞价、 连续竞价和大宗交易）增持公司股份，增持金额不低于人民币 3,000 万元且不超 过人民币 5,000 万元。 增持计划的进展情况：2023 年 11 月 17 日至 2023 年 12 月 25 日期间， 蒋仁生先生通过上海证券交易所交易系统以集中竞价方式增持公司股份 475,582 股，约占公司已发行股本总数的 0.13%，合计增持金额约 1,704.49 万元。 本次增持计划可能存在因证券市场情况发生变化或政 ...