Core Viewpoint - Yifan Pharmaceutical has signed an exclusive agreement for the commercialization of ACT001, a first-in-class drug developed by Shangde Yaoyuan, targeting small cell lung cancer brain metastases, marking a significant step in the company's innovation and internationalization strategy [1][2]. Group 1: Agreement Details - Yifan Pharmaceutical's subsidiary, Yifan Pharmaceutical Co., will pay a total of 100 million yuan as an upfront payment, with options for either a cornerstone investment of 100 million yuan or a milestone payment of 50 million yuan, along with a tiered revenue-sharing model [1]. - The agreement covers exclusive commercialization rights in mainland China and surrounding regions, including South Korea and Southeast Asia, leveraging Yifan's existing registration and sales network in Southeast Asia [3]. Group 2: Product and Market Potential - ACT001 has received "breakthrough therapy" designation from the National Medical Products Administration and is currently in Phase III clinical trials, showing significant clinical advantages by enhancing the efficacy of chemotherapy and immunotherapy [2]. - The drug addresses a critical clinical need in the treatment of small cell lung cancer brain metastases, where existing treatment options are limited, potentially leading to improved patient outcomes [2][3]. Group 3: Strategic Implications - This collaboration is seen as a practical step for Yifan Pharmaceutical to integrate innovative products into its portfolio, enhancing its capabilities in research, production, registration, and sales [2]. - While the transaction may increase short-term expenditures, successful commercialization of ACT001 is expected to contribute to sustainable business growth and performance in the long run [3].

Core Viewpoint - Yifan Pharmaceutical (002019) has signed an exclusive agreement with Shangde Yaoyuan and Tianjin Shangde, granting Yifan the exclusive rights to develop, produce, and commercialize the drug ACT001 within specified regions and fields [1] Group 1: Agreement Details - Yifan Pharmaceutical's wholly-owned subsidiary, Yifan Pharmaceutical, will pay a total of 100 million yuan as an upfront payment, with options for either a cornerstone investment of 100 million yuan or a milestone payment of 50 million yuan [1] - The agreement includes a tiered revenue-sharing model based on net sales and potential revenue sharing from sublicensing outside of China [1] Group 2: Product Information - ACT001 is a first-class innovative drug with a new mechanism, developed by Shangde Yaoyuan, which has undergone multiple clinical trials in China, the United States, and Australia over the past eight years [1] - The drug targets various indications, including small cell lung cancer brain metastases and gliomas [1]

Core Viewpoint - Yifan Pharmaceutical (002019) announced that its subsidiaries, Yiyisheng Biopharmaceutical Development (Shanghai) Co., Ltd. and Yiyisheng Biopharmaceutical (Beijing) Co., Ltd., 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) [1] Group 1 - The approved product, F-652, is a recombinant human interleukin 22-Fc fusion protein [1] - The clinical trial is a Phase II study specifically targeting GVHD [1] - No similar products targeting the same mechanism have been approved for market or are currently in clinical development for GVHD in both domestic and international markets [1]

Group 1 - The core point of the news is that Yifan Pharmaceutical has signed exclusive agreements with Shangde Yaoyuan and Tianjin Shangde to obtain exclusive rights for the drug ACT001, which is a novel mechanism Class 1 innovative drug targeting small cell lung cancer brain metastasis [1][2] - Yifan Pharmaceutical will pay a total of 1 billion yuan as an upfront payment, with options for additional payments based on milestones or sales revenue sharing [1] - The drug ACT001 has undergone multiple clinical trials in China, the US, and Australia over the past eight years, and has received "breakthrough therapy" designation from the National Medical Products Administration for its indication in small cell lung cancer brain metastasis [2] Group 2 - ACT001 works by inhibiting the NF-κB and STAT3 signaling pathways in the tumor microenvironment, which reduces the DNA repair capability of tumor cells and enhances the effects of chemotherapy and immunotherapy [2] - The introduction of ACT001 is expected to effectively supplement Yifan Pharmaceutical's oncology pipeline while avoiding the high costs and time associated with developing new drugs from scratch [2]

F-652是一款通过基因工程技术在CHO细胞中表达的重组人白细胞介素22-Fc（IgG2）融合蛋白，由公司 依托自主知识产权Di-KineTM双分子技术平台研发，为全球首创（1类创新）生物药。其活性机理上模 拟人体天然白介素22，而融合的Fc片段可显著延长药物半衰期，进而大幅提升临床疗效。 格隆汇1月5日丨亿帆医药(002019.SZ)公布，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 （简称"F-652"）开展治疗移植物抗宿主病（GVHD）II期临床试验。 ...

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) has signed exclusive agreements with Shangde Yaoyuan and Tianjin Shangde, granting Yifan the exclusive rights to develop, produce, and commercialize a specific drug compound within designated areas and fields [1] Group 1 - Yifan Pharmaceutical's wholly-owned subsidiary, Yifan Pharmaceutical Co., has entered into exclusive agreements with Shangde Yaoyuan and Tianjin Shangde [1] - The agreements allow Yifan to use the licensed intellectual property to develop, produce, and commercialize the drug compound, which is a derivative of dimethylaminomethyl-1,2,3,4-tetrahydroisoquinoline fumarate monohydrate [1] - Yifan is required to pay an upfront fee of 100 million yuan, with options for a cornerstone investment of 100 million yuan or milestone payments of 50 million yuan, along with a tiered revenue-sharing model based on net sales [1]

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]