Group 1 - The company Yifan Pharmaceutical (002019.SZ) has signed exclusive agreements with Shangde Yaoyuan and Tianjin Shangde, granting Yifan the exclusive rights to develop, produce, and commercialize the drug ACT001 in specified regions and fields [1] - Yifan Pharmaceutical will pay a total of 1 billion yuan as an upfront payment, with options for additional payments based on milestones or net sales revenue sharing [1] - The drug ACT001, developed by Shangde Yaoyuan, is a novel class 1 innovative drug that has undergone multiple clinical trials in China, the US, and Australia, targeting small cell lung cancer brain metastases and gliomas [2] Group 2 - ACT001 has received "breakthrough therapy" designation from the National Medical Products Administration for its indication in small cell lung cancer brain metastases and is currently in phase III clinical trials [2] - The drug works by inhibiting NF-κB and STAT3 signaling pathways in the tumor microenvironment, reducing DNA repair capabilities of tumor cells, and enhancing the effects of chemotherapy and immunotherapy [2] - The introduction of this innovative anti-tumor drug will effectively supplement the company's oncology pipeline while avoiding the high costs and time associated with developing new drugs from scratch [2]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its subsidiaries, Yiyisheng Biopharmaceutical Development (Shanghai) Co., Ltd. and Yiyisheng Biopharmaceutical (Beijing) Co., Ltd., have received approval from the National Medical Products Administration for a clinical trial of their investigational product, F-652, aimed at treating graft-versus-host disease (GVHD) in a Phase II clinical trial [1] Group 1 - The company has received the Clinical Trial Approval Notice for F-652 from the National Medical Products Administration [1] - The product F-652 is a recombinant human interleukin 22-Fc fusion protein [1] - The clinical trial will focus on treating graft-versus-host disease (GVHD) [1]

每经AI快讯，1月5日，亿帆医药（002019）(002019.SZ)公告称，公司控股子公司亿一生物医药开发(上 海)有限公司、亿一生物制药(北京)有限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》，同意亿一生物就在研产品注射用重组人白介素22-Fc融合蛋白(F-652)开展治疗移植物抗宿主病 (GVHD)II期临床试验。该药物注册分类为治疗用生物制品1类。截至本报告披露日，国内外未有相同靶 点产品获批上市，亦未有相同靶点产品正在进行GVHD适应症的临床开发。 ...

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its subsidiaries, Yiyisheng Biopharmaceutical Development (Shanghai) Co., Ltd. and Yiyisheng Biopharmaceutical (Beijing) Co., Ltd., have received approval from the National Medical Products Administration for a clinical trial of their investigational product, F-652, aimed at treating graft-versus-host disease (GVHD) in a Phase II clinical trial [1] Group 1 - The company has received the Clinical Trial Approval Notice for F-652 from the regulatory authority [1] - The product F-652 is a recombinant human interleukin 22-Fc fusion protein [1] - The clinical trial will focus on treating graft-versus-host disease (GVHD) [1]

证券代码：002019 证券简称：亿帆医药 公告编号：2026-002 亿帆医药股份有限公司 关于全资子公司签署独家商业合作协议及相关协议的公告 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。 重要内容提示： 1、签署协议内容： 公司全资子公司亿帆制药分别与尚德药缘、天津尚德签订《独家协议》，《独 家协议》约定尚德药缘有偿将其自主开发的标的产品药物活性成分为二甲胺基含 笑内酯富马酸盐一水合物在合作区域合作领域范围内授予亿帆制药可分许可的、 不可撤销的独占性的权利和许可，亿帆制药可以自行在合作区域及合作领域范围 内使用许可知识产权开发、生产以及商业化标的产品，同时，授予标的产品在合 作区域内其他适应症进行生产和商业化权利的独占优先谈判权。亿帆制药需向尚 德药缘支付10,000万元的首付款、10,000万元基石投资款或5,000万元里程碑付款 （二选一）、分级的净销售额分成，及中国区以外的分许可收入分成（如有）。 2、特别风险提示： （1）截至本公告披露日，标的产品在合作领域的适应症在中国境内处于III 期临床试验入组阶段，尚需完成临床开发、注册等诸多环节，因此， ...

证券代码：002019 证券简称：亿帆医药 公告编号：2026-003 亿帆医药股份有限公司 产品名称：注射用重组人白介素 22-Fc 融合蛋白 申请的适应症：移植物抗宿主病 剂型：注射用冻干粉针剂 受理号：CXSL2500929 关于控股子公司在研产品F-652国内新增适应症移植物抗宿 主病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"）控股子公司亿一生物医药开发（ 上海）有限公司、亿一生物制药（北京）有限公司（上述子公司以下合称"亿一生 物"）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》， 同意亿一生物就在研产品注射用重组人白介素22-Fc融合蛋白（以下简称"F-652"） 开展治疗移植物抗宿主病（GVHD）II期临床试验。现将相关情况公告如下： 一、基本情况 通知书编号：2025LP03614 申请类型：新药 注册分类：治疗用生物制品 1 类 申请人：亿一生物医药开发（上海）有限公司、亿一生物制药（北京）有限 公司 审批结论：根据《中华人民共和国药品管理法》及有关规 ...

证券代码：002019 证券简称：亿帆医药 公告编号：2026-001 亿帆医药股份有限公司 亿帆医药股份有限公司董事会 二、董事会会议审议情况 经全体董事认真审议，会议以投票表决的方式形成以下决议： （一）会议以6票同意、0票反对、0票弃权的结果，审议通过了《关于全资 子公司签署独家商业合作协议及相关协议的议案》 具体内容详见公司同日在巨潮资讯网（http://www.cninfo.com.cn）披露的《关 于全资子公司签署独家商业合作协议及相关协议的公告》。 三、备查文件 1、《公司第九届董事会第三次（临时）会议决议》 特此公告。 第九届董事会第三次（临时）会议决议公告 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。 一、董事会会议召开情况 亿帆医药股份有限公司（以下简称"公司"）第九届董事会第三次（临时） 会议于 2025 年 12 月 31 日以邮件的方式发出通知，于 2026 年 1 月 5 日以现场加 通讯表决的方式在公司六楼会议室召开，其中以通讯表决方式参加会议的董事为 周本余先生、林行先生、曾玉红女士、刘梅娟女士。会议应出席董事 6 名，实际 ...

Core Viewpoint - Yifan Pharmaceutical's subsidiary Yiyisheng Biotechnology has received approval from the National Medical Products Administration for the clinical trial of F-652, a novel drug aimed at treating graft-versus-host disease (GVHD) [1] Group 1: Product Development - F-652 is a recombinant human interleukin 22-Fc fusion protein developed using the company's proprietary Di-KineTM dual-molecule technology platform [1] - The drug is the first of its kind (Class 1 innovative biopharmaceutical) and is designed to mimic the activity of natural interleukin 22 in the body [1] - The Fc fragment fused to the drug significantly extends its half-life, thereby enhancing clinical efficacy [1] Group 2: Clinical Trial Approval - The National Medical Products Administration has granted a Clinical Trial Approval Notice for the Phase II clinical trial of F-652 [1] - This approval marks a significant milestone in the development of F-652 for treating GVHD [1]

Group 1 - Yifan Pharmaceutical's stock increased by 5.1%, reaching 12.57 CNY per share, with a trading volume of 204 million CNY and a turnover rate of 1.96%, resulting in a total market capitalization of 15.29 billion CNY [1] - The company, established on November 10, 2000, and listed on July 13, 2004, is located in Lin'an District, Hangzhou, Zhejiang Province, and primarily engages in the production and sale of active pharmaceutical ingredients and high polymer materials [1] - The revenue composition of Yifan Pharmaceutical includes self-owned pharmaceutical products (including imports) at 75.52%, vitamins at 11.47%, other pharmaceutical products at 9.52%, high polymer materials at 3.00%, and pharmaceutical services at 0.49% [1] Group 2 - Jin Yuan Shun An Fund has a significant holding in Yifan Pharmaceutical, with the Jin Yuan Shun An Baoshi Dynamic Mixed Fund (620001) holding 112,000 shares, accounting for 3.48% of the fund's net value, making it the eighth largest holding [2] - The Jin Yuan Shun An Baoshi Dynamic Mixed Fund was established on August 15, 2007, with a latest scale of 44.6294 million CNY, achieving a year-to-date return of 11.82% and a one-year return of 11.82%, ranking 5551 out of 8155 in its category [2] Group 3 - The fund manager of Jin Yuan Shun An Baoshi Dynamic Mixed Fund is Kong Xiangpeng, who has been in the position for 8 years and 194 days, with a total fund asset size of 14.3 million CNY, and has experienced a best return of -1.71% and a worst return of -11.58% during his tenure [3] - Co-manager Shang Changceng has been in the role for 2 years and 72 days, managing assets of 44.6291 million CNY, with a best return of 14.04% and a worst return of 0.05% during his tenure [3]

Core Insights - The article discusses the successful international pricing strategy of Chinese innovative drug Yili Shu, which is priced at approximately $4,600 in the U.S. compared to its domestic price of 2,388 yuan, indicating a shift in the global valuation of Chinese innovative drugs [3][4][5] - The recognition of the value of Chinese innovative drugs in the global market is attracting multinational pharmaceutical companies to engage more deeply in the development of this industry [3][4] Group 1: Pricing and Market Strategy - Yili Shu's pricing in the U.S. reflects its integration into the global mainstream market value pricing system, moving beyond cost-based pricing [3][4] - The core of product pricing in the U.S. is based on clinical value, safety, and convenience rather than domestic costs, leading to significant price differences across markets [5] - The essence of premium pricing lies in the product's replicability and sustainability in supply and usage, rather than a one-time high price [5][6] Group 2: International Collaboration and Growth - By 2025, the total amount of foreign licensing for Chinese innovative drugs is expected to reach a historical high, with a shift from single product licensing to joint research and development [3][8] - The partnership between Heng Rui Pharmaceutical and GSK, involving a potential total amount of $12 billion, highlights the growing recognition of the global competitiveness of Chinese innovative drugs [8] - The NewCo model is emerging as a new path for Chinese innovative drug companies to enter international markets, allowing for better decision-making and sharing of long-term benefits [8][9] Group 3: Challenges and Future Directions - The Chinese innovative drug industry is transitioning from merely entering the U.S. and European markets to establishing a sustainable competitive presence [9][10] - Key challenges include developing a comprehensive intellectual property defense system, ensuring long-term compliance efficiently, and understanding cultural and commercial differences in the global market [9][10] - Future trends indicate a shift from selling products to exporting technological capabilities, with a focus on joint development and early involvement in global research decisions [10]