YIFAN PHARMACEUTICAL(002019)
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亿帆医药押注脑瘤新药 引进ACT001独家商业化权益
Zhong Zheng Wang· 2026-01-06 05:08
Core Viewpoint - Yifan Pharmaceutical has signed exclusive agreements to develop, produce, and commercialize the innovative drug ACT001 for small cell lung cancer brain metastasis in specific regions, marking a significant step in its internationalization strategy [1][2] Group 1: Agreement Details - Yifan Pharmaceutical's subsidiary Hefei Yifan Biopharmaceutical has obtained exclusive rights for ACT001 in mainland China, South Korea, and several Southeast Asian countries [1] - The agreement includes an upfront payment of 100 million RMB and a commitment to invest 100 million RMB as a cornerstone investor if the partner achieves an overseas IPO by June 30, 2027 [1] - Yifan will also pay a milestone fee of 50 million RMB if certain clinical trial endpoints are met, along with a tiered sales revenue share based on net sales [1] Group 2: Product Information - ACT001 is a next-generation immune modulator developed by Shangde Yaoyuan, designed to enhance treatment outcomes for brain metastases in conjunction with chemotherapy and immunotherapy [2] - The drug received "breakthrough therapy" designation from the National Medical Products Administration in January 2025 and has enrolled 52 patients in its Phase III clinical trial by the end of 2025 [2] - There are currently no approved products specifically for small cell lung cancer brain metastasis, making ACT001 one of the fastest progressing candidates in this field [2] Group 3: Strategic Implications - This collaboration is a key move in Yifan Pharmaceutical's innovation and internationalization strategy, allowing for rapid expansion of its oncology pipeline with controlled risk [2] - The partnership aligns well with Yifan's existing sales network in Southeast Asia, facilitating faster international market entry for the product [2] - Yifan will independently handle the commercial production of ACT001 in the designated regions, ensuring supply chain autonomy and potentially enhancing its production standards to meet international benchmarks [2]
默沙东欣瑞来在华获批;亿帆医药子公司与尚德药缘达成合作
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-06 00:05
Group 1: Regulatory Developments - The National Healthcare Security Administration (NHSA) is seeking public opinions on the draft guidelines for the real-world comprehensive value assessment of medical services, aiming to establish a unified evaluation system across the country [1] - CanSino Biologics has received approval for clinical trials of its 24-valent pneumococcal polysaccharide conjugate vaccine, which targets major circulating serotypes and is intended for individuals aged 2 months and older [2] - Merck has announced that its breakthrough therapy, Sotatercept, has been approved in China for treating adult patients with pulmonary arterial hypertension (PAH), based on data from the STELLAR Phase III clinical trial [3] - ST. Renfu has received approval for clinical trials of HW221043 tablets, intended for the treatment of advanced solid tumors, with no similar drugs currently approved in the market [4] - Heng Rui Medicine has received approval for clinical trials of HRS-4357 injection and HRS-5041 tablets, aimed at treating PSMA-positive prostate cancer [5] Group 2: Market Activities - Shenzhou Cell has received approval from the China Securities Regulatory Commission for its application to issue stocks to specific investors [6] - Tianchen Medical has signed a strategic cooperation agreement with Inspur Digital Technology to promote innovation in medical intelligent manufacturing and robotics [7] - Zhonghong Medical's subsidiary has participated in a bidding project for centralized procurement of medical consumables, with some products expected to be selected, enhancing market presence [8] - Yifan Pharmaceutical's subsidiary has signed an exclusive agreement with Shangde Yaoyuan for the ACT001 drug, involving a total payment of 1 billion yuan [9] - Yijiahe is exploring the application of "brain-computer interface + embodied intelligent robots" technology in smart healthcare scenarios, having signed a strategic cooperation agreement with Mairande [10]
晚间公告|1月5日这些公告有看头
Di Yi Cai Jing· 2026-01-05 15:18
Group 1 - Victory Energy announced that its stock price increased by 213.97% from December 12 to December 29, 2025, leading to a review of trading fluctuations, with stock resuming trading on January 6, 2026 [2] - Tianqi Materials plans to conduct maintenance on its 150,000-ton liquid lithium hexafluorophosphate production line for 20 to 30 days, ensuring no significant impact on operations [3] - Yingfang Micro is planning to acquire controlling stakes in several companies, leading to a significant asset restructuring, with stock suspension starting January 6, 2026 [4] Group 2 - Weigao Blood Purification intends to acquire 100% of Weigao Purui for 8.511 billion yuan, which will enhance its product offerings in medical packaging [6] - Zhongtian Rocket reported losses in its carbon/carbon thermal field materials business due to intensified competition in the photovoltaic industry, significantly impacting its consolidated financial statements [7] - Fulin Precision plans to invest 6 billion yuan in a project to produce 500,000 tons of high-end lithium iron phosphate for energy storage, alongside additional projects for precursor materials [8] Group 3 - Deyun Co. announced that its actual controller was arrested for illegal public deposit collection, but this will not significantly affect the company's governance or operations [9] - Jushen Co. signed a 1.34 billion USD bauxite transfer agreement, which is expected to positively impact future financial performance [10] - Sanxia New Materials intends to acquire a 40% stake in a subsidiary for 0 yuan, which is classified as a related party transaction [11] Group 4 - Kelun Pharmaceutical plans to repurchase shares worth 50 million to 100 million yuan for employee stock ownership plans, with a maximum price of 35 yuan per share [13] - Juxing Technology expects a net profit increase of 5.00% to 20.00% for 2025, projecting a profit of 2.419 billion to 2.764 billion yuan [15] - China National Materials Technology anticipates a net profit increase of 73.79% to 118.64% for 2025, driven by improved product structure and sales growth [16] Group 5 - Chifeng Gold forecasts a net profit increase of 70% to 81% for 2025, with gold product sales prices rising approximately 49% [17] - Dingtai High-Tech expects a net profit of 410 million to 460 million yuan for 2025, reflecting an 81% to 103% increase due to rising demand in high-end PCB markets [18] - Zhonggang Luoyang announced plans for shareholders to reduce their stakes by up to 1% of total shares [20]
布局小细胞肺癌脑转移治疗市场 亿帆医药全资子公司签署独家商业合作协议
Quan Jing Wang· 2026-01-05 12:36
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].
亿帆医药子公司与尚德药缘、天津尚德就ACT001达成合作
Bei Jing Shang Bao· 2026-01-05 12:00
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]
亿帆医药:控股子公司在研产品F-652获得临床试验批准通知书
Zheng Quan Shi Bao Wang· 2026-01-05 10:08
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]
亿帆医药子公司亿帆制药签署关于一项创新药独家协议
Zhi Tong Cai Jing· 2026-01-05 10:02
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]
亿帆医药(002019.SZ):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
Ge Long Hui A P P· 2026-01-05 09:59
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。 ...
亿帆医药(002019.SZ):子公司签署独家商业合作协议及相关
Ge Long Hui A P P· 2026-01-05 09:59
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]
亿帆医药(002019.SZ)子公司亿帆制药签署关于一项创新药独家协议
智通财经网· 2026-01-05 09:58
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]