Group 1 - The company announced that some of its products have been included in the 2025 National Medical Insurance Directory, which is expected to enhance market expansion and product sales [1][2] - The innovative drug Aibegersitin α injection and the imported product Dihyaluronic Acid Sodium Injection have been renewed for inclusion, while the compound Huangdai Tablets have been adjusted to the regular national medical insurance directory [1] - The 2025 National Medical Insurance Directory will be officially implemented on January 1, 2026, with specific reimbursement standards and details to be announced by relevant government departments [2] Group 2 - The company’s subsidiary Hefei Xinzhu Biotechnology has received approval for clinical trials of the innovative macromolecule drug N-3C01 injection, targeting advanced solid tumors and non-muscle invasive bladder cancer [4][5] - N-3C01 is a recombinant IL-15/IL-15Rα fusion protein designed to activate immune cells for tumor destruction, showing promising preclinical results in activating NK cells and CD8+ T cells [6] - The approval for clinical trials indicates that the drug meets the necessary requirements for drug registration, although further steps are needed before it can be marketed [5][6]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that certain self-owned or imported products from its wholly-owned or controlled subsidiaries have been included in the "National Medical Insurance Catalog (2025)" published by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security on December 7, 2025 [1] Group 1 - The innovative drug Aibegesitin α injection (Yilishu®) has been renewed for inclusion in the National Medical Insurance Catalog [1] - The imported general agent product Dihyaluronic Acid Sodium Injection (Yinikon®) has also been renewed for inclusion [1] - The compound Huangdai tablets (Baisuekang®) have been adjusted to the regular National Medical Insurance Catalog [1]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) has received approval from the National Medical Products Administration for clinical trials of its innovative macromolecule drug N-3C01 injection, aimed at treating advanced solid tumors and non-muscle invasive bladder cancer (NMIBC) [1] Group 1: Drug Development - The drug N-3C01 is a recombinant IL-15/IL-15Rα fusion protein developed using DNA recombinant technology [1] - N-3C01 activates NK cells and CD8+ T cells, enhancing their anti-tumor efficacy, as demonstrated in preclinical studies [1] - The drug has shown a dose-dependent ability to inhibit tumor growth in mouse models [1] Group 2: Safety and Efficacy - N-3C01 has demonstrated good safety profiles in short-term and long-term safety trials conducted on rats and monkeys [1] - The mechanism of action involves simulating the binding of IL-15 to immune effector cell receptors, thereby activating immune responses against tumors [1]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary Hefei Xinzhu Biotechnology Co., Ltd. received approval from the National Medical Products Administration for clinical trials of the innovative macromolecule drug N-3C01 injection, aimed at treating advanced solid tumors and non-muscle invasive bladder cancer (NMIBC) [1] Group 1: Drug Development - N-3C01 is a recombinant IL-15/IL-15Rα fusion protein produced using DNA recombinant technology [1] - The drug activates NK cells and cytotoxic T cells, enhancing their anti-tumor efficacy through the binding of IL-15 with immune effector cell receptors [1] - Preclinical studies indicate that N-3C01 can activate human NK cells and CD8+ T cells in vitro, and it shows a dose-dependent tumor growth inhibition in mouse models [1] Group 2: Safety and Efficacy - N-3C01 demonstrated good safety profiles in short-term and long-term safety trials conducted on rats and monkeys [1]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that certain self-owned or imported products from its wholly-owned or controlled subsidiaries have been included in the National Medical Insurance Catalog for 2025, which is expected to facilitate market expansion and increase product sales, although it will not have a significant impact on the company's performance in the short term [1] Group 1 - The innovative drug Aibegesitin α injection (Yilishu), imported general agent product Dihyaluronic Acid Sodium Injection (Yinikon), and Compound Huangdai Tablets (Baixuekang) are included in the catalog [1] - The inclusion of these products in the medical insurance catalog is beneficial for market development and sales growth [1] - The impact on the company's performance will be limited in the short term [1]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary Hefei Xinzhu Biotechnology Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of the innovative macromolecule drug N-3C01 injection, aimed at treating advanced solid tumors and non-muscle invasive bladder cancer (NMIBC) [1] Group 1 - The approval allows Hefei Xinzhu to conduct clinical trials for N-3C01 [1] - N-3C01 is positioned to address significant medical needs in the treatment of advanced solid tumors and NMIBC [1]

Core Viewpoint - The company Yifan Pharmaceutical (002019.SZ) has received approval from the National Medical Products Administration for clinical trials of its innovative macromolecule drug N-3C01, aimed at treating advanced solid tumors and non-muscle invasive bladder cancer (NMIBC) [1] Group 1 - Yifan Pharmaceutical's wholly-owned subsidiary Hefei Xinzhu Biotechnology Co., Ltd. has been granted a clinical trial approval notice for N-3C01 [1] - The clinical trials will focus on advanced solid tumors and NMIBC, indicating the company's commitment to oncology research [1]

Core Viewpoint - Yifan Pharmaceutical (002019) announced that some of its wholly-owned or controlled subsidiaries' self-owned or imported general distribution products have been included in the "2025 National Medical Insurance Directory" [1] Group 1: Product Inclusion - The innovative drug Aibegesitin α injection (Yilishu) and the imported general distribution product Dihyaluronic Acid Sodium Injection (Yinikon) have been renewed for inclusion in the directory [1] - The compound Huangdai tablets (Baixuekang) have been adjusted to the regular national medical insurance directory [1] - Other products already included in the national medical insurance directory by the company's subsidiaries did not experience any adjustments [1] Group 2: Clinical Trials - The company's wholly-owned subsidiary has received a clinical trial approval notice for the in-development product N-3C01 injection, allowing it to conduct clinical trials in patients with advanced solid tumors and non-muscle invasive bladder cancer [1]

证券代码：002019 证券简称：亿帆医药 公告编号：2025-068 亿帆医药股份有限公司 关于全资子公司在研产品 N-3C01 注射液获得临床试验批准 通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 亿帆医药股份有限公司（以下简称"公司"）全资子公司合肥欣竹生物科技 有限公司（以下简称"合肥欣竹"）于近日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》，同意合肥欣竹就在研创新大分子药物N-3C01注 射液（以下简称"N-3C01"）开展治疗晚期实体瘤和治疗非肌层浸润性膀胱癌 （NMIBC）的临床试验。现将相关情况公告如下： 注册分类：治疗用生物制品1类 一、药物临床试验批准通知书主要内容 产品名称：N-3C01注射液 产品研究代号：N-3C01 申请的适应症：晚期实体瘤、非肌层浸润性膀胱癌 剂型：注射液 申请事项：境内生产药品注册临床试验 申请类型：新药 受理号：CXSL2500832（晚期实体瘤）、 CXSL2500834（非肌层浸润性膀 胱癌） 通知书编号：2025LP03292（晚期实体瘤）、2025LP03298（非肌层浸 ...

证券代码：002019 证券简称：亿帆医药 公告编号：2025-067 亿帆医药股份有限公司 特此公告。 亿帆医药股份有限公司董事会 一、本次纳入国家医保目录药品基本情况 二、 对公司的影响及风险提示 上述产品继续纳入《2025年国家医保目录》，有利于促进开拓市场，提升产 品销量，短期内不会对公司的业绩产生重大影响，未来对公司经营业绩的影响目 前暂无法估计。除上述产品外，公司全资或控股子公司其他已纳入国家医保目录 的产品本次未发生调整变动。 《2025年国家医保目录》将于2026年1月1日起正式实施，医保支付标准、医 保报销细则等相关信息，需以国家医疗保障局等相关政府部门公示信息为准。敬 请广大投资者谨慎投资，注意防范投资风险。 关于公司产品纳入国家医保目录的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 根据2025年12月7日国家医保局、人力资源社会保障部发布的《国家基本医 疗保险、生育保险和工伤保险药品目录（2025年）》（以下简称"《2025年国家 医保目录》"），亿帆医药股份有限公司（以下简称"公司"）全资或控股子公 司部分自有或进口总经销产品 ...