国泰海通证券股份有限公司 | 保荐机构名称：国泰海通证券股份有限公司 | 被保荐公司简称：智翔金泰 | | --- | --- | | 保荐代表人姓名：王永杰、刘丹 | 被保荐公司代码：688443 | 重大事项提示 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。2025 年上半年，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、生产、商业化是一个投资大、周期长、风险高的过程，公司在药物早 期发现、临床前研究、临床研究、工艺开发、生产、商业化推广等多个环节持 续投入，营业收入尚不能覆盖研发费用及其他开支。 关于重庆智翔金泰 ...

Investment Rating - The industry rating is "Positive" for the next 12 months, expecting a growth rate exceeding 10% relative to the CSI 300 index [67][79]. Core Insights - The report highlights the impressive research outcomes of Chinese pharmaceutical companies showcased at the 2025 World Lung Cancer Conference (WCLC), emphasizing the strength of innovation in the sector. It also notes that Heng Rui has further advanced its overseas licensing strategy through the NewCo model [9][67]. - The report suggests continuous monitoring of the R&D progress of Chinese pharmaceutical companies, particularly in innovative drugs and related industrial chains, benefiting from optimized procurement rules in the pharmaceutical and medical device sectors, as well as the recovery of traditional Chinese medicine and medical services due to domestic demand [9][67]. Industry News - Bai Li Tian Heng's dual-target ADC for EGFR/HER3 has shown promising results at WCLC, with a 100% overall response rate in a study involving 154 patients [18]. - BeiGene presented the latest findings from its RATIONALE studies at WCLC, demonstrating significant survival benefits for its drug in treating non-small cell lung cancer [19]. - Kangfang Biotech updated data from its HARMONi study, showing improved overall survival rates, particularly in North America [20]. Company Announcements - Heng Rui Pharma signed a licensing agreement with Braveheart Bio for the HRS-1893 project, with an upfront payment of $65 million and potential milestone payments totaling up to $1.013 billion [35]. - The new drug application for KN026 by CSPC has been accepted by the National Medical Products Administration (NMPA) [39]. - Junshi Biosciences reported positive results from its Phase III clinical trial for an anti-IL-17A monoclonal antibody [40]. Market Review - The Shanghai Composite Index rose by 2.91%, while the Shenzhen Component Index increased by 7.11%. The pharmaceutical and biological sector saw a 1.76% increase, with most sub-sectors showing positive performance [53][57]. - As of September 11, 2025, the TTM P/E ratio for the pharmaceutical and biological industry was 31.56, with a valuation premium of 148% relative to the CSI 300 [57]. Weekly Strategy - The report recommends focusing on investment opportunities in innovative drugs and medical devices, as well as sectors benefiting from domestic demand recovery, while maintaining a "Positive" industry rating [67].

Core Viewpoint - Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. has submitted a new drug application for its Talizumab injection (GR1802) for the treatment of moderate to severe atopic dermatitis, which has achieved its primary endpoint in Phase III clinical trials [1][2]. Group 1: Drug Information - The drug Talizumab injection (GR1802) is a fully humanized monoclonal antibody targeting IL-4Rα, designed to inhibit Th2-type inflammatory responses by blocking the binding of IL-4 and IL-13 to IL-4Rα [2]. - Talizumab injection is currently undergoing clinical trials for multiple indications, including chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and seasonal allergic rhinitis in adults and adolescents, all in Phase III trials, while asthma is in Phase II, and pediatric/adolescent atopic dermatitis is in Phase Ib/IIa [2]. Group 2: Regulatory Status - As of the announcement date, only two other drugs targeting the same pathway have been approved for marketing in China [3]. - The new drug application has been accepted by the National Medical Products Administration (NMPA) and is currently under review [1].

Group 1 - China Shipbuilding has completed the share swap absorption merger with China Shipbuilding Industry Corporation, with 3.053 billion new shares listed on September 16, 2025 [1] - Transsion Holdings' shareholder plans to transfer 2% of the company's shares, amounting to approximately 22.807 million shares [1] Group 2 - Chipone Technology reported a record high in new orders from July 1 to September 11, 2025, totaling 1.205 billion yuan, with AI computing orders accounting for about 64% [2] - Chipone Technology's total order amount reached 3.025 billion yuan by the end of the second quarter of 2025, indicating a significant increase [2] Group 3 - Chipone Technology plans to acquire 97.0070% equity of Chipai Technology through a combination of share issuance and cash payment, with the stock resuming trading on September 12 [3] Group 4 - Xinjun Network received a notice of share reduction from its major shareholder, Shanghai Senxiao Investment Center, which reduced its holdings by 1.6271 million shares, bringing its ownership down to 5.29% [4] Group 5 - Yangjie Technology intends to acquire 100% equity of Better Electronics for 2.218 billion yuan, with a profit commitment of no less than 555 million yuan from 2025 to 2027 [5] Group 6 - Shoukai Co. announced that its subsidiary, Yingxin Company, indirectly holds approximately 0.3% equity in Yushu Technology, indicating a low ownership stake [6] Group 7 - Xiamen Airport reported a total passenger throughput of 2.707 million in August, representing a year-on-year increase of 5.18% [9] - *ST Tianshan experienced a significant decline in livestock sales revenue, down 95.80% year-on-year in August [9] Group 8 - Taihe Intelligent's shareholder plans to transfer 5.79% of the company's shares to Sunshine New Energy [9] - Jilin Expressway's subsidiary won a construction project worth 9.592 billion yuan [9] - Tianyong Intelligent secured a project with SAIC Group for engine assembly line renovation [9]

Core Viewpoint - The company Zhixiang Jintai (688443.SH) has achieved the primary endpoint in the Phase III clinical trial of its drug Taliqibai Injection (GR1802) for the treatment of moderate to severe atopic dermatitis in adults, and has submitted a new drug application to the National Medical Products Administration (NMPA) which has been accepted [1] Group 1: Drug Development - Taliqibai Injection (GR1802) is a recombinant fully human anti-IL-4Rα monoclonal antibody developed by the company, targeting IL-4Rα [1] - The drug specifically binds to the human IL-4Rα on cell surfaces, blocking the binding of IL-4 and IL-13, thereby inhibiting downstream STAT6 phosphorylation and CD23 upregulation, which suppresses Th2-type inflammatory responses mediated by IL-4 or IL-13 [1] Group 2: Clinical Trials - Multiple indications for Taliqibai Injection are in clinical trial stages, including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria, both in Phase III trials [1] - Seasonal allergic rhinitis in adults and adolescents is also in Phase III trials, while asthma is in Phase II trials, and atopic dermatitis in children/adolescents is in Ib/IIa trials [1]

证券代码：688443 证券简称：智翔金泰 公告编号：2025-040 重庆智翔金泰生物制药股份有限公司 自愿披露关于泰利奇拜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"）的泰利奇 拜单抗注射液（GR1802 注射液）用于成人中、重度特应性皮炎适应症 III 期临 床试验达到了主要终点指标，公司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。 一、药品基本信息 受理号：CXSS2500091、CXSS2500092 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。 药品名称：泰利奇拜单抗注射液 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 根据国家药品注册相关的法律法规要求，新药上市申请尚需经过审评、药品 临床试验现场检查、药品生产现场检查和审批等环节，产品能否成功上市及上市 时间存在不确定性。 公司将按有关规定对 ...

泰利奇拜单抗注射液(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。泰利奇拜单抗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。泰利奇拜 单抗注射液(GR1802注射液)的多个适应症处于临床试验阶段，慢性鼻窦炎伴鼻息肉、慢性自发性荨麻 疹、成人以及青少年季节性过敏性鼻炎适应症处于III期临床试验阶段，哮喘适应症处于II期临床试验阶 段，儿童/青少年特应性皮炎适应症处于Ib/IIa期临床试验阶段。 智翔金泰(688443.SH)发布公告，近日，公司的泰利奇拜单抗注射液(GR1802注射液)用于成人中、重度 特应性皮炎适应症III期临床试验达到了主要终点指标，公司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。 ...

人民财讯9月11日电，智翔金泰(688443)9月11日晚间公告，近日，公司的泰利奇拜单抗注射液(GR1802 注射液)用于成人中、重度特应性皮炎适应症III期临床试验达到了主要终点指标，公司向国家药品监督 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。截至本公告披露日， 泰利奇拜单抗注射液(GR1802注射液)同靶点药物仅有两款在国内获批上市。 ...

Group 1 - The core point of the article highlights the decline in the stock price of Zhixiang Jintai, which fell by 5.61% to 31.80 CNY per share, with a trading volume of 31.83 million CNY and a turnover rate of 0.84%, resulting in a total market capitalization of 11.66 billion CNY [1] - Zhixiang Jintai, established on October 20, 2015, and listed on June 20, 2023, is primarily engaged in the research, production, and sales of antibody drugs, with 99.96% of its main business revenue coming from drug sales [1] Group 2 - From the perspective of major circulating shareholders, Dongzheng Asset Management's fund is among the top shareholders of Zhixiang Jintai, having reduced its holdings by 92,700 shares in the second quarter, now holding 2.45 million shares, which accounts for 2.1% of circulating shares, resulting in an estimated floating loss of approximately 4.63 million CNY [2] - The fund, Oriental Red Medical Upgrade Stock Initiation A (015052), was established on March 29, 2022, with a latest scale of 481 million CNY, achieving a year-to-date return of 78.01% and a one-year return of 98.05% [2] Group 3 - The fund manager of Oriental Red Medical Upgrade Stock Initiation A is Jiang Qi, who has been in the position for 3 years and 168 days, managing a total fund size of 1.41 billion CNY, with the best fund return during his tenure being 70.01% and the worst being 67.12% [3] Group 4 - In terms of the fund's top heavy positions, Zhixiang Jintai is the eighth largest holding in the Oriental Red Medical Upgrade Stock Initiation A fund, with the fund holding 2.45 million shares, which represents 4.82% of the fund's net value, and an estimated floating loss of about 4.63 million CNY [4]

Core Viewpoint - Zhixiang Jintai has received approval from the National Medical Products Administration for the clinical trial application of its product GR1803 injection for systemic lupus erythematosus [2] Group 1 - The company announced the receipt of the clinical trial approval notice on the evening of September 10 [2] - The approved clinical trial is for the indication of systemic lupus erythematosus [2]