YIFAN PHARMACEUTICAL(002019)
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亿帆医药(002019) - 关于在下属子公司之间调剂担保额度及为全资子公司提供担保的进展公告
2025-12-05 09:16
证券代码:002019 证券简称:亿帆医药 公告编号:2025-066 亿帆医药股份有限公司 关于在下属子公司之间调剂担保额度及为全资子公司提供担保 的进展公告 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。 过的为资产负债率未超过 70%的子公司提供担保额度内,将宿州亿帆药业有限公 司(以下简称"宿州亿帆")未使用的担保额度 15,000 万元调剂至合肥亿帆生 物制药有限公司(以下简称"亿帆制药")。公司本次调剂担保额度在股东会授 权范围内,无需提交公司董事会及股东会审议。 上述担保额度内部调剂完成后,公司为亿帆制药提供的担保额度由 90,000 万元调增至 125,000 万元;公司为宿州亿帆提供的担保额度由 15,000 万元调减至 0 元。截至公告披露日,公司为亿帆制药提供的担保余额为 121,000 万元;为宿 州亿帆提供的担保余额为 0 元。 二、担保情况概述 (一)担保基本情况 公司因全资子公司亿帆制药业务发展需要,于2025年12月5日与中国银行股 份有限公司合肥庐阳支行(以下简称"中国银行庐阳支行")签订《保证合同》, 同意为亿帆制药向中国银 ...
亿帆医药(002019) - 关于公司产品获批的公告
2025-12-05 09:16
亿帆医药股份有限公司(以下简称"公司")全资子公司杭州鑫富科技有限 公司于2025年12月4日收到中华人民共和国国家卫生健康委员会(以下简称"国 家卫健委")下发的《行政许可审查结论通知书》(卫食添通字[2025]第0030号), 根据《食品安全法》和《食品添加剂新品种管理办法》,公司提交的关于2'-岩 藻糖基乳糖行政许可申请经国家卫健委审查通过。现将相关情况公告如下: 一、产品基本信息 1、中文名称:2'-岩藻糖基乳糖 4、生产菌信息: 证券代码:002019 证券简称:亿帆医药 公告编号:2025-065 亿帆医药股份有限公司 关于公司产品获批的公告 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。 根据国家卫健委 2023 年第 8 号公告,2'-岩藻糖基乳糖被批准作为食品营养 强化剂,可用于调制乳粉(仅限儿童用乳粉)、婴儿配方食品、较大婴儿和幼儿 配方食品以及特殊医学用途婴儿配方食品等。该公告同时提及美国食品药品管理 2、英文名称:2'-Fucosyllactose,2'-FL 3、功能分类:食品营养强化剂 局、欧盟委员会、澳大利亚和新西兰食品标准局等允 ...
亿帆医药(002019.SZ):2’-岩藻糖基乳糖获国家卫健委审查通过
智通财经网· 2025-12-05 09:12
Core Viewpoint - The company Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary, Hangzhou Xinfu Technology Co., Ltd., received an administrative license review conclusion from the National Health Commission of the People's Republic of China for its application regarding 2'-fucosyllactose [1] Group 1 - The National Health Commission approved the application for 2'-fucosyllactose, a significant human milk oligosaccharide [1] - 2'-fucosyllactose is known for its functions in regulating gut microbiota, promoting brain development, and enhancing immunity [1]
亿帆医药(002019.SZ):2’-岩藻糖基乳糖获批
Ge Long Hui A P P· 2025-12-05 09:12
Core Viewpoint - Yifan Pharmaceutical (002019.SZ) has received approval from the National Health Commission of the People's Republic of China for its application regarding 2'-fucosyllactose, which is recognized as a food nutrition enhancer for infant formula and other related products [1] Group 1: Regulatory Approval - The company's wholly-owned subsidiary, Hangzhou Xinfu Technology Co., Ltd., received 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] Group 2: Product Information - 2'-fucosyllactose is a major oligosaccharide found in human breast milk, known for its functions in regulating gut microbiota, promoting brain development, and enhancing immunity [1] - According to the National Health Commission's announcement No. 8 in 2023, 2'-fucosyllactose is approved for use as a food nutrition enhancer in infant formula, including special medical purpose infant formula [1] Group 3: International Standards - The announcement also notes that 2'-fucosyllactose is permitted for use in infant formula and other food categories by regulatory bodies such as the U.S. Food and Drug Administration, the European Commission, and the Food Standards Australia New Zealand [1]
亿帆医药:公司产品2’-岩藻糖基乳糖获国卫健委审查通过
Mei Ri Jing Ji Xin Wen· 2025-12-05 09:12
每经AI快讯,12月5日,亿帆医药(002019.SZ)公告称,公司全资子公司杭州鑫富科技有限公司收到国家 卫健委下发的《行政许可审查结论通知书》,公司提交的2'-岩藻糖基乳糖行政许可申请经审查通过。 2'-岩藻糖基乳糖是母乳中一种主要的母乳低聚糖,具有调节肠道菌群、促进大脑发育和提升免疫力等 功能,可用于调制乳粉(仅限儿童用乳粉)、婴儿配方食品等。该产品获国卫健委审查通过,为公司后 续推进产品产业化奠定了坚实基础,但未来产品的具体投产及上市时间、销售情况及业绩表现仍可能受 到市场需求变化、政策法规调整等不确定性因素影响。 ...
亿帆医药:公司产品2’-岩藻糖基乳糖获批
Xin Lang Cai Jing· 2025-12-05 09:03
亿帆医药公告,全资子公司杭州鑫富科技有限公司于2025年12月4日收到国家卫生健康委员会下发的 《行政许可审查结论通知书》,公司提交的关于2'-岩藻糖基乳糖行政许可申请经国家卫健委审查通 过。2'-岩藻糖基乳糖是母乳中一种主要的母乳低聚糖,具有调节肠道菌群、促进大脑发育和提升免疫 力等功能。根据国家卫健委2023年第8号公告,2'-岩藻糖基乳糖被批准作为食品营养强化剂,可用于调 制乳粉(仅限儿童用乳粉)、婴儿配方食品、较大婴儿和幼儿配方食品以及特殊医学用途婴儿配方食品 等。 ...
亿帆医药:德国F627医保报销价格为1085.35欧元/支
Sou Hu Cai Jing· 2025-12-05 09:00
(记者 曾健辉) 免责声明:本文内容与数据仅供参考,不构成投资建议,使用前核实。据此操作,风险自担。 每经AI快讯,有投资者在投资者互动平台提问:请问F627德国进入医保后,定价多少一支? 亿帆医药(002019.SZ)12月5日在投资者互动平台表示,感谢您的关注与提问。德国医保报销价格为 1085.35欧元/支。 每日经济新闻 ...
亿帆医药:德国医保报销价格为1085.35欧元/支
Sou Hu Cai Jing· 2025-12-05 07:47
证券之星消息,亿帆医药(002019)12月05日在投资者关系平台上答复投资者关心的问题。 以上内容为证券之星据公开信息整理,由AI算法生成(网信算备310104345710301240019号),不构成 投资建议。 投资者提问:请问F627德国进入医保后,定价多少一支? 亿帆医药回复:感谢您的关注与提问。德国医保报销价格为1085.35欧元/支。谢谢! ...
利好创新药 中国药品价格登记系统上线
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-03 23:05
Core Viewpoint - The launch of the China Drug Price Registration System marks a significant step towards a globalized pricing framework for innovative drugs, enhancing market-oriented pricing capabilities for pharmaceutical companies and supporting the development of a new pricing ecosystem that aligns drug prices with innovation value and market demand [1][2][6]. Group 1: Drug Price Registration System - The new system allows domestic and international pharmaceutical companies to independently register drug prices, ensuring accountability for price authenticity [1][3]. - The system operates under the principle of "one location acceptance, nationwide sharing, global openness," and is managed by a state-owned enterprise in Beijing [1][3]. - The first batch of companies to register prices includes major players such as China National Pharmaceutical Group, Beijing Tongrentang, and Roche, indicating strong industry participation [3]. Group 2: Impact on Pharmaceutical Industry - The system is expected to enhance the pricing strategies of pharmaceutical companies, allowing them to adjust prices based on clinical value, supply-demand dynamics, and competitive landscape [3][4]. - The dual mechanism of registration and query will promote transparency in drug pricing, moving away from previous opaque practices [4]. - The establishment of this system is anticipated to create a comprehensive pricing structure that encompasses innovative drugs, insurance payment prices, and generic drug prices, benefiting the innovative drug sector [5]. Group 3: Global Market Development - The China Drug Price Registration System is designed to facilitate the international expansion of Chinese innovative drugs and attract high-quality foreign drugs into the Chinese market [2][5]. - Data indicates that the total amount of overseas licensing transactions by Chinese pharmaceutical companies exceeded $92 billion in the first three quarters of 2025, highlighting the growing global presence of Chinese innovative drugs [2]. - The system aims to address significant price discrepancies between domestic and international markets, influenced by factors such as currency exchange rates and pricing mechanisms [5]. Group 4: Long-term Industry Implications - The implementation of the drug price registration system is expected to enhance the global competitiveness of China's biopharmaceutical industry and drive high-quality innovation within the sector [6].
鼓励创新药出海,中国药品价格登记系统上线:我国药企授权出海交易超920亿美元
Mei Ri Jing Ji Xin Wen· 2025-12-03 13:24
Core Insights - The launch of the Chinese Drug Price Registration System on December 2 is seen as a significant positive development for the innovative drug sector, facilitating the international expansion of domestic innovative drugs [1][4]. Group 1: Drug Price Registration System - The Chinese Drug Price Registration System was launched on December 2, with nine pharmaceutical companies participating in the initial registration, including both multinational and traditional Chinese medicine firms [2]. - The system currently includes limited information, with only 10 drug entries available, indicating a nascent stage of development [2]. - The system allows for independent pricing by companies outside of the National Medical Insurance (NMI) framework, which is a notable shift in policy [1][5]. Group 2: Innovative Drugs Highlighted - Four drugs showcased on the system are recognized as either the first of their kind in China or globally, including innovative treatments like Toripalimab and Icaritin [3]. - For instance, Toripalimab is the first Chinese PD-1 monoclonal antibody approved in both Europe and the U.S., while Icaritin is the first CAR-T therapy targeting BCMA approved in China [3]. Group 3: Market Implications - The establishment of the registration system is expected to enhance the global pricing framework for Chinese innovative drugs and attract high-quality foreign drugs to the Chinese market [4][5]. - Data indicates that in the first three quarters of 2025, Chinese pharmaceutical companies completed 103 license-out transactions totaling $92.03 billion, highlighting the growing importance of the Chinese market in the global pharmaceutical industry [4]. - The NMI's non-interference in pricing for the non-NMI market is seen as a positive step towards respecting market dynamics and enhancing the pricing power of domestic companies in international markets [5].