Core Points - The company Zhixiang Jintai announced that it has received approval from the National Medical Products Administration for the clinical trial of its product GR2301 injection [2] Group 1 - The clinical trial application for GR2301 injection has been approved [2]

Core Viewpoint - The company, Zhixiang Jintai (688443.SH), has received approval from the National Medical Products Administration for the clinical trial of its product GR2301 injection, a recombinant fully human anti-IL-15 monoclonal antibody aimed at treating autoimmune diseases like vitiligo caused by IL-15 expression imbalance [1] Group 1 - The clinical trial application for GR2301 injection has been approved, marking a significant milestone for the company [1] - GR2301 injection is designed to inhibit the downstream IAK-STAT signaling pathway by blocking IL-15 interactions, which is crucial for treating autoimmune diseases [1] - As of the announcement date, there are no approved antibody drugs targeting IL-15 globally, indicating a potential market opportunity for the company [1]

证券代码：688443 证券简称：智翔金泰 公告编号：2025-042 重庆智翔金泰生物制药股份有限公司 自愿披露关于GR2301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。 注册分类：治疗用生物制品 1 类 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：CXSL2500569 适应症：白癜风 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，GR2301 注射液临床试验申请符合药品注册的有关要求，同意本品开展临床试验。 二、药品其他相关情况 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 GR2301 注射液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：GR2301 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、 ...

为进一步提高辖区上市公司投资者关系管理水平，促进公司完善公司治理， 助力上市公司高质量发展，在重庆证监局指导下，重庆上市公司协会联合深圳市 全景网络有限公司举办辖区上市公司 2025 年投资者网上集体接待日暨半年度业 绩说明会活动。 重庆智翔金泰生物制药股份有限公司（以下简称"公司"）将参加本次投资 者网上集体接待日暨半年度业绩说明会活动。本次活动采用网络远程的方式举行， 投资者可登录"全景路演"网站（https://rs.p5w.net）参与本次活动，活动时间为 2025 年 9 月 25 日（星期四）下午，其中公司与投资者线上互动交流的时间为 15:00-17:00。 证券代码：688443 证券简称：智翔金泰 公告编号：2025-041 重庆智翔金泰生物制药股份有限公司 关于参加重庆辖区上市公司 2025 年投资者网上集体 接待日暨半年度业绩说明会活动的公告 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、准确性和完整性依法承担法律责任。 届时，公司相关高级管理人员将参加本次活动，就投资者关心的问题，与投 资者进行在线沟通与交流，欢迎广大投资者踊跃参 ...

Core Viewpoint - The company, Zhixiang Jintai (688443.SH), has received approval from the National Medical Products Administration for the clinical trial of its product GR2301 injection, which is a recombinant fully human anti-IL-15 monoclonal antibody aimed at treating autoimmune diseases like vitiligo caused by IL-15 expression disorders [1] Group 1 - The clinical trial application for GR2301 injection has been approved [1] - GR2301 injection is developed independently by the company [1] - The mechanism of GR2301 involves blocking IL-15 interactions, which may help in treating autoimmune diseases [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of its product GR2301 injection, which is a recombinant fully human anti-IL-15 monoclonal antibody aimed at treating autoimmune diseases like vitiligo caused by IL-15 expression dysregulation [1] Group 1 - The clinical trial application for GR2301 injection has been approved [1] - GR2301 injection is developed independently by the company [1] - The mechanism of GR2301 involves blocking IL-15 from binding to its receptors, thereby inhibiting the downstream IAK-STAT signaling pathway [1]

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]