江苏艾迪药业集团股份有限公司的全资子公司——扬州艾迪医药科技有限 公司（以下统称"公司"）收到国家药品监督管理局（以下简称"国家药监局"） 于 2025 年 10 月 27 日核准签发的《化学原料药上市申请批准通知书》（以下简称 "通知书"）。现将相关情况公告如下： 证券代码：688488 证券简称：艾迪药业 公告编号：2025-063 江苏艾迪药业集团股份有限公司 关于多替拉韦钠原料药获得上市申请批准通知书的 自愿性披露公告 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。 一、原料药基本信息 登记号：Y20240000542 化学原料药名称：多替拉韦钠（Dolutegravir Sodium） 包装规格：20kg/桶、5kg/桶、1kg/桶、0.5kg/桶 申请事项：境内生产化学原料药上市申请 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，本品 符合药品注册的有关要求，批准注册。质量标准、标签及生产工艺照所附执行。 生产企业：扬州艾迪医药科技有限公司 生产地址：扬州高新技术产业开发区戚桥路 6 号 二、原 ...

Core Viewpoint - Aidi Pharmaceutical has received approval for the listing application of the raw material drug Dolutegravir Sodium, which is part of its high-end generic drug development project for HIV [1] Group 1: Company Developments - Aidi Pharmaceutical's wholly-owned subsidiary, Yangzhou Aidi Pharmaceutical Technology Co., Ltd., has been granted the "Chemical Raw Material Drug Listing Application Approval Notice" by the National Medical Products Administration [1] - The approved raw material Dolutegravir Sodium is intended for use in domestic formulations, ensuring the supply and quality of the raw material while reducing production costs [1] - If the generic version of Dolutegravir Sodium tablets is approved for market launch, it will enhance the variety of anti-HIV drugs and clinical options offered by the company [1]

Core Viewpoint - The approval of the chemical raw material drug, Dolutegravir Sodium, by the National Medical Products Administration is a significant milestone for the company, enhancing its competitive edge in the HIV treatment market [1] Group 1: Regulatory Approval - The company's wholly-owned subsidiary, Yangzhou Aidi Pharmaceutical Technology Co., Ltd., received the approval notice for the listing application of Dolutegravir Sodium on October 27, 2025 [1] - The registration number for the raw material drug is Y20240000542 [1] Group 2: Product Details - Dolutegravir Sodium is part of the company's fundraising project focused on the R&D of high-end generic drugs for HIV, specifically as a raw material for the formulation project ADC201 [1] - The drug is indicated for use in combination with other antiretroviral medications for the treatment of HIV infection in adults and children aged 12 and older [1] Group 3: Impact on the Company - The approval is expected to ensure the supply and quality of the raw material, reduce production costs, and enhance the company's core competitiveness [1] - It is anticipated that this approval will not have a significant impact on the company's recent operations [1]

证券代码：688488 证券简称：艾迪药业 公告编号：2025-062 自愿性披露公告 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。 关于注射用 ADB116 获得药物临床试验批准通知书的 江苏艾迪药业集团股份有限公司（以下简称"公司"）及控股子公司南京南 大药业有限责任公司收到国家药品监督管理局（以下简称"国家药监局"）于 2025 年 10 月 24 日核准签发的《药物临床试验批准通知书》（以下简称"通知 书"），同意公司在研 2 类化学改良型新药——注射用 ADB116 开展临床试验。 现将相关情况公告如下： 一、通知书基本情况 药品名称：注射用 ADB116 受理号：CXHL2500785 申请事项：境内生产药品注册临床试验 申请人：江苏艾迪药业集团股份有限公司、南京南大药业有限责任公司 江苏艾迪药业集团股份有限公司 适应症：用于急性缺血性卒中患者的溶栓治疗 根据通知书要求，公司将在进一步开展相关研究的基础上开展I期临床试验。 若未来成功获批上市，注射用 ADB116 将为脑卒中患者带来更多的治疗选 择；公司产品 ...

Core Viewpoint - The company, Aidi Pharmaceutical (688488.SH), has received approval from the National Medical Products Administration for clinical trials of its new drug, ADB116, aimed at treating acute ischemic stroke patients [1] Group 1 - The company and its subsidiary, Nanjing Nanda Pharmaceutical Co., Ltd., have been granted a Clinical Trial Approval Notice for the investigational drug [1] - ADB116 is classified as a type 2 chemically modified new drug [1] - The indication for ADB116 is for thrombolytic therapy in patients with acute ischemic stroke [1]

2025-062 证券代码：688488 证券简称：艾迪药业 公告编号： 药品名称：注射用 ADB116 受理号：CXHL2500785 申请事项：境内生产药品注册临床试验 申请人：江苏艾迪药业集团股份有限公司、南京南大药业有限责任公司 适应症：用于急性缺血性卒中患者的溶栓治疗 通知书编号：2025LP02789 江苏艾迪药业集团股份有限公司 关于注射用 ADB116 获得药物临床试验批准通知书的 自愿性披露公告 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。 江苏艾迪药业集团股份有限公司（以下简称"公司"）及控股子公司南京南 大药业有限责任公司收到国家药品监督管理局（以下简称"国家药监局"）于 2025 年 10 月 24 日核准签发的《药物临床试验批准通知书》（以下简称"通知 书"），同意公司在研 2 类化学改良型新药——注射用 ADB116 开展临床试验。 现将相关情况公告如下： 一、通知书基本情况 中国卒中学会发布的数据显示，中国居民一生中罹患脑卒中的风险高达 40%，在全世界 197 个国家中排在首位，中国每年新 ...

Group 1 - The core point of the article is that Aidi Pharmaceutical has received approval from the National Medical Products Administration to conduct clinical trials for its new drug ADB116, which is a modified chemical drug [1] - Aidi Pharmaceutical's revenue composition for the year 2024 is as follows: 71.59% from drug manufacturing, 27.07% from biopharmaceutical raw materials, 0.8% from medical devices, and 0.54% from other businesses [1] - As of the report date, Aidi Pharmaceutical has a market capitalization of 5.9 billion yuan [1] Group 2 - The article mentions that Chinese innovative drugs have generated $80 billion in overseas licensing this year, indicating a vibrant secondary market for biopharmaceuticals [1] - There is a discussion on the contrasting situation in the primary market, where fundraising has encountered challenges despite the active secondary market [1]

Core Viewpoint - The company and its subsidiary, Nanjing Nanda Pharmaceutical, have received approval from the National Medical Products Administration for clinical trials of a new drug, ADB116, aimed at treating acute ischemic stroke patients [1] Group 1: Drug Development - The approved drug, ADB116, is a high molecular weight urokinase preparation intended for thrombolytic therapy in acute ischemic stroke patients [1] - The company will conduct Phase I clinical trials based on further research as required by the approval notice [1] Group 2: Business Impact - If ADB116 is successfully approved for market launch, it will provide more treatment options for stroke patients [1] - The product line of the company will be significantly expanded, leading to a more comprehensive layout in the main business areas of anti-HIV and human-derived proteins [1] - The diversification of business and revenue sources will be enhanced [1]

Market Overview - The biopharmaceutical sector experienced a decline of 0.57% on October 22, with Aopumai leading the drop [1] - The Shanghai Composite Index closed at 3913.76, down 0.07%, while the Shenzhen Component Index closed at 12996.61, down 0.62% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Wendi Pharmaceutical (688488) with a closing price of 14.77, up 4.01% [1] - Dongbao Bio (300239) at 5.78, up 2.66% [1] - Jinke (688670) at 17.03, up 2.59% [1] - Major decliners included: - Aopumai (688293) at 55.19, down 4.40% [2] - Wofu Bio (300357) at 31.63, down 3.18% [2] - Sanofi (688336) at 59.60, down 2.39% [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 192 million yuan from institutional investors, while retail investors contributed a net inflow of 53.82 million yuan [2] - Specific stock capital flows included: - Te Bao Bio (688278) with a net inflow of 19.00 million yuan from institutional investors [3] - Hualan Bio (002007) with a net inflow of 12.05 million yuan from institutional investors [3] - Aopumai (688293) with a net outflow of 4.40% from institutional investors [3]

Core Insights - The biopharmaceutical sector experienced a slight increase of 0.14% on October 20, with Iwu Biologics leading the gains [1] - The Shanghai Composite Index closed at 3863.89, up 0.63%, while the Shenzhen Component Index closed at 12813.21, up 0.98% [1] Biopharmaceutical Sector Performance - Iwu Biologics (300357) saw a significant rise of 10.07%, closing at 32.90 with a trading volume of 228,200 shares and a transaction value of 737 million [1] - Other notable gainers included Olin Biologics (6168889) with a 4.58% increase, closing at 23.96, and Kangchen Pharmaceutical (603590) with a 4.00% increase, closing at 51.19 [1] - The sector also had some underperformers, such as Novavax (688105) which fell by 3.56%, closing at 21.96 [2] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 239 million from institutional investors, while retail investors saw a net inflow of 270 million [2] - The data indicates that retail investors are actively buying into the sector despite the overall net outflow from larger institutional players [2] Individual Stock Capital Flow - Iwu Biologics had a net inflow of 23.19 million from institutional investors, while it faced a net outflow of 17.27 million from speculative funds [3] - Notably, Huashan Biologics (002007) had a net inflow of 42.16 million from institutional investors, indicating strong institutional interest [3]