Core Points - The company has received approval from the National Medical Products Administration for the listing application of the chemical raw material drug Dolutegravir Sodium [1][3] - Dolutegravir Sodium is part of the company's fundraising project focused on the R&D of high-end generic drugs for HIV [2][3] - The approval indicates that the raw material meets national drug review technical standards, allowing for its use in domestic formulations [3] Company Information - The production enterprise is Yangzhou Aidi Pharmaceutical Technology Co., Ltd., located at No. 6 Qiqiao Road, Yangzhou High-tech Industrial Development Zone [2] - The raw material is packaged in various specifications: 20kg, 5kg, 1kg, and 0.5kg [1] Impact on the Company - The approval of Dolutegravir Sodium is expected to enhance the supply and quality of raw materials, potentially lowering production costs [3] - If the generic version of Dolutegravir Sodium is approved for market, it will diversify the company's offerings in anti-HIV medications and complement existing products [3] - The company will continue to advance the registration and listing of the formulation following the approval of the raw material [3]

江苏艾迪药业集团股份有限公司（以下简称"公司"）及全资子公司成都艾 迪医药技术有限公司、南京艾迪医药科技有限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 28 日核准签发的《药物临床试验批准 通知书》（以下简称"通知书"），同意公司抗艾滋病领域在研 1 类新药 ADC118 片开展临床试验。现将相关情况公告如下： 一、通知书基本情况 江苏艾迪药业集团股份有限公司 关于 ADC118 片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。 证券代码：688488 证券简称：艾迪药业 公告编号：2025-064 药品名称：ADC118 片 受理号：CXHL2500787 申请事项：境内生产药品注册临床试验 以 HIV 整合酶抑制剂为核心药物的"鸡尾酒"治疗方案是国内外主流艾滋 病抗病毒治疗指南推荐方案之一。根据 Gilead、GSK 和 MSD 公司历年年度财报， HIV 整合酶抑制剂产品全球销售额持续增长，2024 年含 HIV 整合酶抑制剂的产 品 ...

Core Viewpoint - The company, Aidi Pharmaceutical, has received approval from the National Medical Products Administration for clinical trials of its new drug ADC118 in the field of HIV treatment, marking a significant milestone in its research and development efforts [1] Company Summary - Aidi Pharmaceutical's revenue composition for the year 2024 is as follows: 71.59% from pharmaceutical 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 6.1 billion yuan [1] Industry Summary - The A-share market has recently surpassed 4000 points, indicating a resurgence after a decade of stagnation, with technology leading the market's transformation into a new "slow bull" pattern [1]

Core Viewpoint - The company, Aidi Pharmaceutical (688488.SH), has received approval from the National Medical Products Administration for clinical trials of its new drug ADC118 in the field of HIV treatment [1] Group 1 - Aidi Pharmaceutical and its wholly-owned subsidiaries, Chengdu Aidi Pharmaceutical Technology Co., Ltd. and Nanjing Aidi Pharmaceutical Technology Co., Ltd., have been granted a clinical trial approval notice [1] - The approval was issued on October 28, 2025, allowing the company to proceed with clinical trials for its investigational first-class new drug ADC118 [1]

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 ...

格隆汇10月24日丨艾迪药业(688488.SH)公布，公司及控股子公司南京南大药业有限责任公司收到国家 药品监督管理局于2025年10月24日核准签发的《药物临床试验批准通知书》（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。适应症：用于急性缺血性卒中患者的溶 栓治疗。 ...

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 ...