YIFAN PHARMACEUTICAL(002019)
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亿帆医药: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
Xin Lang Cai Jing· 2025-12-08 10:26
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]
亿帆医药股份有限公司关于公司产品获批的公告
Shang Hai Zheng Quan Bao· 2025-12-05 19:28
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]
亿帆医药:截至2025年三季报 公司医药制剂产品过亿元人民币收入有10个
Zheng Quan Ri Bao· 2025-12-05 15:43
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]
渤海化学筹划重大资产重组 下周一起停牌;海泰发展终止收购丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-05 15:11
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]
亿帆医药:2’-岩藻糖基乳糖获国家卫健委审查通过
Zhi Tong Cai Jing· 2025-12-05 09:16
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]
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。 ...