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 ...

Core Viewpoint - The company 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 [1] Group 1 - The N-3C01 drug is a recombinant IL-15/IL-15Rα fusion protein developed using DNA recombinant technology, which can activate the proliferation and killing functions of NK cells and cytotoxic T cells to achieve immune activation for tumor eradication [1] - As of the announcement date, similar target drugs have been approved in the United States and the United Kingdom, while no products targeting the same pathway have been approved for market in China [1] - The development and production cycle for this drug is long and involves multiple stages, leading to uncertainty regarding future approval for market release by the National Medical Products Administration [1]

Group 1 - Company’s subsidiary, Hangzhou Xinfu Technology Co., Ltd., received approval from the National Health Commission for 2'-Fucosyllactose as a food nutrition enhancer [1][2] - 2'-Fucosyllactose is a significant oligosaccharide found in breast milk, known for its benefits in regulating gut microbiota, promoting brain development, and enhancing immunity [1] - The approval allows the use of 2'-Fucosyllactose in various infant formula products, including those for special medical purposes [2] Group 2 - The approval marks a significant advancement in the application of synthetic biology for the company, laying a solid foundation for future product commercialization [3] - The company has adjusted guarantee limits among its subsidiaries, reallocating unused guarantee amounts to support business development needs [5][6] - The company provided guarantees totaling RMB 15 million to China Bank and RMB 20 million to China Merchants Bank for its subsidiary Hefei Yifan Biopharmaceutical Co., Ltd. [7] Group 3 - The total external guarantee balance after the new guarantees is RMB 46.12 billion, representing 54.12% of the company's audited net assets for 2024 [27] - The guarantees are exclusively between the company and its subsidiaries, with no overdue guarantees or litigation-related guarantee amounts reported [27]

Core Viewpoint - Yifan Pharmaceutical reported that by the third quarter of 2025, the company expects to have ten pharmaceutical formulation products generating over 100 million RMB in revenue [2] Group 1 - As of the third quarter of 2025, the company anticipates ten products will exceed 100 million RMB in revenue [2] - The company will disclose the annual revenue of its main products in accordance with relevant laws and regulations [2]

Group 1: Major Transactions - Bohai Chemical is planning to sell 100% equity of Tianjin Bohai Petrochemical and acquire control of Anhui Taida New Materials through a combination of share issuance and cash payment, leading to a significant asset restructuring [1] - Zhongneng Electric is set to acquire 65% equity and debt from three companies, which may constitute a major asset restructuring but will not involve share issuance or change in control [4] - Hai Tai Development has decided to terminate the acquisition of controlling interest in Zhixueyun Technology due to disagreements on key terms, ensuring no adverse impact on normal business operations [5] Group 2: Performance Updates - Wen's shares reported a sales revenue of 3.324 billion yuan from meat chickens in November, marking a year-on-year increase of 10.18% [6] - Shuguang shares saw a 71.07% year-on-year increase in vehicle sales, totaling 207 units in November [6] - Muyuan shares experienced a decline in sales revenue from commodity pigs, reporting 9.39 billion yuan, a decrease of 20.43% year-on-year [6] - Pengding Holdings reported a 5.58% year-on-year decrease in consolidated revenue for November [6] Group 3: Industry Developments - Xiangxi Dairy reported a 6.3% month-on-month increase in fresh milk production in November, although it saw a year-on-year decline of 6.47% [7] - Baisheng Intelligent plans to acquire 51% equity in Zhongke Shengu, which focuses on the research and application of core technologies for embodied intelligent robots [7]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary, Hangzhou Xinfu Technology Co., Ltd., received an administrative license review conclusion notice from the National Health Commission of the People's Republic of China, approving the application for 2'-fucosyllactose, a significant human milk oligosaccharide with various health benefits [1] Group 1 - The National Health Commission issued the administrative license review conclusion notice on December 4, 2025 [1] - The approval is based on the Food Safety Law and the Management Measures for New Varieties of Food Additives [1] - 2'-fucosyllactose is known for its functions in regulating gut microbiota, promoting brain development, and enhancing immunity [1]