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 ...

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 ...

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 ...

证券代码：688443 证券简称：智翔金泰 公告编号：2024-023 GR1803 注射液是一款由公司自主研发的双特异性抗体药物，作用靶点为 BCMA 和 CD3，注册分类为治疗用生物制品 1 类。GR1803 注射液是基于共同轻 链构建的双特异性抗体分子，其结构与正常的单抗分子结构高度类似，不仅便于 其制备工艺的开发，而且减少了因结构差异而导致免疫原性的可能性。GR1803 注射液能够同时结合抗原 BCMA 和 CD3，其结合 BCMA 的亲和力（10-10M）较 结合 CD3 的亲和力（10-8M）高两个数量级。这种非对称的亲和力设计在保证此 双特异性抗体分子募集并激活 T 细胞杀伤肿瘤细胞的同时，可以有效减少因 CD3 抗体导致的 T 细胞非特异性激活，从而降低 GR1803 注射液在体内的毒副作用。 根据《国家药监局关于发布<突破性治疗药物审评工作程序（试行）>等三个 文件的公告》（2020 年第 82 号），经 CDE 审核，同意将本品适应症"既往至少 接受过 3 线治疗的复发难治性多发性骨髓瘤"纳入突破性治疗药物程序。 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1803注射液纳入突破性治 ...

证券研究报告 | 公司深度 | 生物制品 智翔金泰(688443) | --- | --- | |--------------------------------|-------------------------| | | 报告日期:2024年08月08日 | | 自免布局多维度，双抗平台渐兑现 | | | 智翔金泰深度报告 | | 投资要点 0 我们认为公司核心产品正在进入快速兑现期,公司深耕自免领域布局 IL-17A、 IL-4R、TSLP 等多靶点的多个创新产品,双抗平台中 GR1801和 GR1803 数据 突出,验证双抗平台价值. 我们看好公司大品种和大适应庭 2024年起陆续进入 商业化阶段,首次覆盖并给予"买入"评级。 赛立奇单抗(GR1501):数据优异,国产首个 NDA 的 IL-17单抗 赛立奇单抗是公司自主研发的国产首个 NDA的抗IL-17 单克隆抗体。其重度班块 状银周病适应症 2023年3月 NDA 获受理,放射学阳性中轴型脊柱关节炎适应症 于 2024年1月 NDA 获受理。重度班块状银周病中,赛立奇单抗与同轮点司库奇 尤单抗和依奇珠单抗对比疗效数据绝对值优异,进度为国内在研产 ...

剂型：注射液 证券代码：688443 证券简称：智翔金泰 公告编号：2024-022 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR1802注射液启动慢性鼻窦炎伴 鼻息肉适应症III期临床试验的公告 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"）就"一项 评价 GR1802 注射液在慢性鼻窦炎伴鼻息肉患者中的有效性、安全性和免疫原性 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。 一、药品基本信息 药品名称：GR1802 注射液 三、风险提示 根据国家药品注册管理相关法规，该药品完成临床试验后还需提交新药上市 申请，取得药品注册证书后才可上市销售。 创新药产品具有高科技、高风险、高附加值的特点，药品的前期研发以及产 品从研制、临床试验报批到投产的周期长、环节多，容易受到一些不确定性因素 的影响 ...