Investment Rating - The report maintains a "Buy" rating for the company [1][2]. Core Views - The company has entered the commercialization phase with the approval of IL-17A monoclonal antibody for moderate to severe plaque psoriasis, marking a significant milestone [1]. - The company has a robust pipeline with 15 products under development, including GR1801, which is the first dual antibody for rabies virus in China, and GR1802, which is in Phase III clinical trials for multiple indications [1][2]. - Revenue projections for 2024-2026 are approximately 0.6 billion, 3.2 billion, and 7 billion respectively, indicating strong growth potential driven by its innovative drug pipeline [2]. Summary by Sections Financial Performance - The company reported a net profit attributable to shareholders of -3.6 billion in the first half of 2024 [1]. - Revenue for 2024 is expected to grow significantly, with a projected increase of 5035.07% in 2024 compared to the previous year [3]. Product Pipeline - The company has a total of 15 products in development, with 9 already approved for clinical trials. Key products include: - GR1501 (IL-17A monoclonal antibody) approved in August 2024 for moderate to severe plaque psoriasis [1]. - GR1801, the first dual antibody for rabies virus, is in Phase III clinical trials [1]. - GR1802 is in Phase III for moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps [1]. Market Position - The company is well-positioned in the autoimmune disease market, with a commercial team that has extensive experience in promoting innovative drugs [1]. - The total market capitalization of the company is approximately 9.67 billion [3].

[ T able_StockInfo] 2024 年 08 月 31 日 证券研究报告•2024 半年报点评 买入 （维持） 当前价：26.36 元 智翔金泰（688443）医药生物 目标价：——（6 个月） IL-17A 单抗获批上市，迈入商业化阶段 [Table_Summary 事件：公司发布] 2024 半年报，实现归属于上市公司股东净利润-3.6 亿元。 2024 年 8 月，赛立奇单抗(GR1501)中重度斑块状银屑病适应症获批上市，公 司正式迈入商业化进程。公司自身免疫性疾病产品线商业化团队已初具规模， 核心管理人员具备丰富的创新药和自身免疫疾病领域药品推广和商业化经验， 公司将会持续稳步推进商业化团队建设，以满足公司上市产品的商业化推广需 求。 IL-4单抗中重度特应性皮炎、慢性鼻窦炎伴鼻息肉处于 III期临床。GR1802注 射液为 IL-4Rα 单抗，已有 7个适应症处于临床阶段，中重度特应性皮炎、慢性 鼻窦炎伴鼻息肉处于 III 期临床阶段，慢性自发性荨麻疹、哮喘、过敏性鼻炎处 于 II 临床阶段，青少年、儿童特应性皮炎处于 I 临床阶段。 GR1801是国内首家进入 III 期临床的抗狂 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of CNY 40.07, down from the previous target of CNY 54.07 [2][9] Core Views - The company's core product, IL-17 monoclonal antibody GR1501, has been approved for commercialization, targeting adult moderate-to-severe plaque psoriasis, with strong clinical trial results showing a 90.7% PASI 75 response rate at 12 weeks and a low 0.4% recurrence rate at 52 weeks [9] - The company has a rich pipeline of 15 products in development across autoimmune, oncology, and anti-infective fields, with several key clinical milestones expected in the near future [9] - The company's commercialization team is actively promoting market access and academic activities to drive product sales [9] Financial Performance - The company reported no revenue in H1 2024, with a net loss of CNY -362 million, slightly improved from the previous year due to reduced financial expenses and share-based payment costs [9] - The company's R&D investment in H1 2024 was CNY 286 million, with 439 R&D personnel, accounting for 65.13% of total employees [9] - The company's market capitalization is CNY 9,666 million, with a current share price of CNY 26.36 [5] Pipeline Progress - GR1501 (IL-17 monoclonal antibody): Approved for psoriasis in August 2024, with NDA submitted for axial spondyloarthritis in January 2024, expected approval in 2025 [9] - GR1802 (IL-4R monoclonal antibody): Phase III initiated for CRSwNP in August 2024, IND approved for allergic rhinitis in February 2024, and IND approved for pediatric atopic dermatitis in August 2024 [9] - GR1603 (IFANR1 monoclonal antibody): Completed Phase II enrollment for SLE in April 2024 [9] - GR1801 (rabies bispecific antibody): Entered Phase III in September 2023, expected to complete Phase III and submit NDA in H2 2024 [9] - GR2001 (tetanus monoclonal antibody): Phase III initiated in August 2024, with potential NDA submission in 2025 [9] - GR1803 (BCMAxCD3 bispecific antibody): Phase I data presented at EHA in May 2024, Phase II initiated in July 2024 [9] Valuation - The company's fair equity value is estimated at CNY 14.694 billion, with a target price of CNY 40.07 based on a DCF valuation model [12] - Key valuation assumptions include a risk-free rate of 2.17%, market return of 8.44%, beta of 1.80, and a perpetual growth rate of 3% [12][13]

证券代码：688443 证券简称：智翔金泰 公告编号：2024-027 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。 一、董事会会议召开情况 重庆智翔金泰生物制药股份有限公司（以下简称"公司"）第一届董事会第 十五次会议于 2024 年 8 月 28 日下午 14 时 30 分以现场结合通讯的方式召开。 会议应出席董事 9 人，实际出席董事 9 人。会议由董事长单继宽主持，记录人员 为董事会秘书李春生。会议的召集及召开程序符合《中华人民共和国公司法》等 法律、法规和《重庆智翔金泰生物制药股份有限公司章程》的有关规定，合法有 效。 二、董事会会议审议情况 经与会董事审议表决，形成的会议决议如下： （一）审议通过《关于公司<2024 年半年度报告>及其摘要的议案》 公司依法编制了《2024 年半年度报告》及其摘要，相关内容真实、准确、完 整，反映了公司 2024 年半年度的实际情况，不存在虚假记载、误导性陈述或重 大遗漏。经审议，一致表决通过。 表决结果：同意票为 9 票，反对票为 0 票，弃权票为 0 票。 具体内容请详见 ...

Financial Performance - The company has not yet commenced commercial production and sales of its products, resulting in ongoing losses and cumulative unabsorbed losses [2]. - The company's operating revenue for the reporting period was CNY 12,660.54, a significant decrease compared to CNY 132,804.13 in the same period last year [14]. - The net profit attributable to shareholders of the listed company was a loss of CNY 361,933,163.38, representing a 6.76% improvement from a loss of CNY 388,154,683.30 in the previous year [14]. - The net cash flow from operating activities was a negative CNY 264,351,596.91, which is a 44.50% increase in outflow compared to CNY 182,942,333.55 in the same period last year [14]. - The total assets at the end of the reporting period were CNY 3,306,777,828.18, down 8.01% from CNY 3,594,596,738.24 at the end of the previous year [14]. - The net assets attributable to shareholders of the listed company decreased by 10.25% to CNY 2,498,886,695.70 from CNY 2,784,232,358.39 at the end of the previous year [14]. - The basic earnings per share for the reporting period was -CNY 0.99, a 29.79% improvement from -CNY 1.41 in the same period last year [15]. - The weighted average return on net assets was -13.51%, a decrease of 2,211.69 percentage points compared to 2,198.18% in the previous year [15]. - The company has not yet received approval for its products to be sold, resulting in minimal revenue from other business activities [15]. - The company has not yet achieved profitability and continues to incur cumulative losses, with ongoing high R&D expenditures expected to persist [57]. Research and Development - The company maintains a high level of investment in clinical project research and innovative product development, with multiple products in the pipeline making positive progress [2]. - The company has developed a total of 15 research products, all of which are self-developed, covering treatment areas such as autoimmune diseases, infectious diseases, and tumors [21]. - The company has established four R&D modules, including early discovery, process development, clinical research, and process scale-up and validation [22]. - The company has initiated clinical trials for GR1901, the first bispecific antibody targeting CD3×CD123, and GR2002, the first TSLP dual-epitope bispecific antibody approved for clinical trials globally [20]. - The company has developed a rapid antibody discovery process that shortens the candidate molecule discovery cycle to 6-9 months, allowing for 2-3 innovative products to enter preclinical development each year [49]. - The company has established a comprehensive R&D system with centers in Beijing, Shanghai, and Chongqing, enhancing the efficiency of drug development from discovery to commercialization [47]. - The company has completed the purification process development for multiple monoclonal and bispecific antibody projects, achieving scalability for commercial production [39]. - The company has filed for 7 new invention patents and obtained 3 during the reporting period, bringing the total to 110 applications and 39 granted [40]. Market Environment - The biopharmaceutical industry is characterized by long R&D cycles, high investment, and significant risks, which may lead to further short-term losses [2]. - The Chinese biopharmaceutical market is expected to reach ¥1,319.8 billion by 2030, with a compound annual growth rate (CAGR) of 14.4% from 2018 to 2030 [31]. - The global biopharmaceutical market is projected to reach $665.1 billion by 2030, with a CAGR of 16% from 2018 to 2030 [31]. - The monoclonal antibody market in China grew to ¥92.4 billion in 2022, accounting for 17.9% of the Chinese biopharmaceutical market, with a CAGR of 50.92% from 2017 to 2022 [36]. - The global monoclonal antibody market size was $217.5 billion in 2022, representing 51.38% of the global biopharmaceutical market, with a CAGR of 11.48% from 2017 to 2022 [33]. - The global monoclonal antibody market is expected to grow to $277 billion by 2025, with a CAGR of 10.15% from 2020 to 2025 [34]. - The Chinese monoclonal antibody market is projected to reach ¥181.6 billion by 2025, with a CAGR of 34.67% from 2020 to 2025 [36]. - The biopharmaceutical market growth is driven by an expanding patient population and increased payment capabilities [32]. Risk Factors - The company has detailed potential risk factors in its report, emphasizing the importance of investor awareness regarding investment risks [2]. - The company faces risks related to the approval of its products, clinical trial outcomes, and potential loss of key technical personnel, which could impact its R&D and commercialization goals [59]. - The company faces risks from market competition, particularly for its products GR1501, GR1802, and GR1801, which have similar competing products already approved in the market [60]. - The company is exposed to potential price reduction risks for its future products due to national medical insurance price negotiations and centralized procurement policies [61]. Environmental Management - The company has established mechanisms for environmental protection and is classified as a key pollutant discharge unit, complying with monitoring requirements [76]. - The company operates 4 wastewater treatment facilities and 7 air pollution control systems to manage environmental pollutants [80]. - The company has implemented measures to reduce noise pollution through equipment layout and soundproofing techniques [79]. - The company has a comprehensive waste management strategy that includes classification and collection of hazardous and non-hazardous waste [79]. - The company has committed to fulfilling various promises related to share restrictions and related party transactions, ensuring compliance with regulations [90]. Shareholder Commitments - The company has committed to not transferring or managing shares for 12 months post-IPO, ensuring stability in shareholding [93]. - The commitments made by shareholders are irrevocable and take effect immediately upon signing [92]. - The company will not reduce its pre-IPO shares for 3 full accounting years if it is not profitable at the time of listing [92]. - The company will adhere to legal regulations regarding share lock-up periods and transfer conditions [92]. - The controlling shareholder's commitments are irrevocable and take effect immediately upon signing [92]. Financial Management - The company has established a fundraising management method to ensure the proper use of raised funds, which will be stored in a special account approved by the board of directors [106]. - The company plans to implement a stable and scientific profit distribution policy to ensure reasonable returns to shareholders [107]. - The company guarantees that the public offering of shares does not involve any fraudulent issuance, and if found guilty, it will initiate a buyback of all newly issued shares within five working days [105]. - The company will enhance shareholder returns through specific measures and has outlined a three-year dividend plan post-listing [107].

重庆智翔金泰生物制药股份有限公司 第一届监事会第十四次会议决议公告 本公司监事会及全体监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。 证券代码：688443 证券简称：智翔金泰 公告编号：2024-028 （一）审议通过《关于公司<2024 年半年度报告>及其摘要的议案》 公司依法编制了《2024 年半年度报告》及其摘要，相关内容真实、准确、完 整，反映了公司 2024 年半年度的实际情况，不存在虚假记载、误导性陈述或重 大遗漏。经审议，一致表决通过。 表决结果：同意票为 3 票，反对票为 0 票，弃权票为 0 票。 具体内容请详见公司披露于上海证券交易所网站（www.sse.com.cn）及指定 信息披露媒体上的《2024 年半年度报告》。 一、监事会会议召开情况 重庆智翔金泰生物制药股份有限公司（以下简称"公司"）第一届监事会 第十四次会议于 2024 年 8 月 28 日下午 15 时 30 分以现场结合通讯的方式召 开。会议应出席监事 3 人，实际出席 3 人。会议由监事会主席杨佳倩主持，记 录人员为监事寇敏。会议的召集召开程序符合 ...

医药生物/生物制品 公 司 研 究 智翔金泰（688443.SH） 2024 年 08 月 27 日 赛立奇单抗正式获批，公司将迎来发展新阶段 ——公司信息更新报告 类新药赛立奇单抗注射液正式获 NMPA 批准上市， 用于中、重度斑块状银屑病的治疗。赛立奇单抗是公司自主研发的重组全人源抗 ，可特异性结合血清中 IL-17A 蛋白，阻断 IL-17A 的结合，抑制炎症的发生和发展。同时，赛立奇单抗针对强直性脊 ，整体进度靠前。公司其它核心管线 IL-4R NDA。我们看好 公司长期发展，预计 2024-2026 年公司营业收入为 0.52/2.67/7.55 亿元，EPS 为 -2.19/-2.83/-2.27，当前股价对应 PS 为 186.2/36.3/12.8 倍，维持"买入"评级。 | --- | --- | --- | --- | |-------------------------------|-------------|--------------------------------------------------------------|--------------------------- ...

证券代码：688443 证券简称：智翔金泰 公告编号：2024-026 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中重度斑块状银屑病适应 症获批上市的公告 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。 今日，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《药品注册证书》，批准公司自主研发用于治疗中重 度斑块状银屑病适应症的 1 类新药赛立奇单抗注射液（商品名：金立希®）上市。 现将相关情况公告如下： 一、药品基本信息 药品名称：赛立奇单抗注射液 商品名：金立希® 剂型：注射液 规格：1ml：100mg（预充式注射器） 上市许可持有人：重庆智翔金泰生物制药股份有限公司 药品批准文号：国药准字 S20240036 重庆智翔金泰生物制药股份有限公司董事会 适应症：用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病成人患者 二、药品其他相关情况 赛立奇单抗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-17 ...

证券代码：688443 证券简称：智翔金泰 公告编号：2024-025 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1802注射液儿童和青少年特应性皮 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 注射液儿童和青少年特应性皮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 适应症：儿童/青少年特应性皮炎 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，同意本品开展儿童和青少年特应 性皮炎适应症的临床试验 二、药品其他相关情况 此前，GR1802 注射液已获得 5 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处于Ⅲ期临床试验阶段，慢 申请事项：境内生产药品注册临床试验 ...

证券代码：688443 证券简称：智翔金泰 公告编号：2024-024 药品名称：GR2001 注射液 剂型：注射液 注册分类：治疗用生物制品 1 类 适应症：预防破伤风 二、药品其他相关情况 GR2001 注射液是一款公司自主研发的重组人源化抗破伤风毒素（tetanus toxin,TeNT）的单克隆抗体，注册分类为治疗用生物制品 1 类，作用靶点为 TeNT 的重链 C 端。GR2001 于 2023 年 1 月获得国家药品监督管理局的药物临床试验 批准通知书，同意开展预防破伤风适应症的临床研究。 TeNT 是一条 150kDa 的单链蛋白，经过翻译后修饰，形成由重链和轻链组 成的活性毒素。TeNT 的重链分为 2 个结构域：C 端（TeNT-Hc 或 C 片段）和 N 端（TeNT-HN 或 B 片段）。TeNT 通过运动神经元内的逆向轴突运输进入脊髓和 脑干后，进入邻近的抑制性中间神经元，对参与神经胞吐的膜蛋白产生裂解作用， 阻滞神经传递，从而导致破伤风症状。GR2001 能特异性结合破伤风神经毒素重 链 C 端，阻断其进入神经元细胞，预防破伤风。 破伤风是由破伤风梭菌引起的急性感染性、特异性、中毒性 ...