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亿帆医药:关于获得药品注册证书的公告
Zheng Quan Ri Bao· 2026-01-23 12:17
(文章来源:证券日报) 证券日报网讯 1月23日,亿帆医药发布公告称,公司全资子公司合肥亿帆生物制药有限公司于2026年1 月22日收到国家药品监督管理局核准签发的注射用硫酸多黏菌素B《药品注册证书》。 ...
亿帆医药:注射用硫酸多黏菌素B获药品注册证书
人民财讯1月23日电,亿帆医药(002019)1月23日公告,全资子公司合肥亿帆生物制药有限公司于2026 年1月22日收到国家药品监督管理局核准签发的注射用硫酸多黏菌素B的药品注册证书。注射用硫酸多 黏菌素B主要用于治疗碳青霉烯类耐药革兰氏阴性杆菌引起的严重感染的成年患者,包括铜绿假单胞菌 敏感菌株引起的脑膜炎和菌血症。 ...
亿帆医药(002019.SZ):注射用硫酸多黏菌素B获得药品注册证书
Ge Long Hui A P P· 2026-01-23 08:03
格隆汇1月23日丨亿帆医药(002019.SZ)公布,全资子公司合肥亿帆生物制药有限公司于2026年1月22日 收到国家药品监督管理局核准签发的注射用硫酸多黏菌素B《药品注册证书》。注射用硫酸多黏菌素B 主要用于治疗碳青霉烯类耐药革兰氏阴性杆菌引起的严重感染的成年患者,包括铜绿假单胞菌敏感菌株 引起的脑膜炎和菌血症。 ...
亿帆医药(002019) - 关于获得药品注册证书的公告
2026-01-23 08:00
证券代码:002019 证券简称:亿帆医药 公告编号:2026-007 亿帆医药股份有限公司 5、规格:50万单位 6、药品受理号:CYHS2402222 7、证书编号:2026S00108 关于获得药品注册证书的公告 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")全资子公司合肥亿帆生物制药 有限公司于2026年1月22日收到国家药品监督管理局核准签发的注射用硫酸多黏 菌素B《药品注册证书》。现将相关情况公告如下: 一、药品注册证书主要信息 1、药品名称:注射用硫酸多黏菌素B 2、剂型:注射剂 3、申请事项:药品注册(境内生产) 4、注册分类:化学药品3类 《药品注册证书》。 截至本报告披露日,除本公司外,中国境内注射用硫酸多黏菌素 B 有 6 家 企业获批上市,另有多家企业处于审评阶段。 根据米内网数据显示,注射用硫酸多黏菌素B 2024年上半年国内销售额为 3.50亿元。 8、药品批准文号:国药准字H20263089 9、药品批准文号有效期:至2031年01月13日 10、上市许可持有人:合肥亿帆生物制药有限公司 ...
亿帆医药:亿立舒美国合作伙伴的采购量依据协议及订单而定
Core Viewpoint - Yifan Pharmaceutical's product Yilishu is still in the early stages of market introduction in the United States, with procurement volumes dependent on agreements and orders rather than actual terminal sales [1] Group 1 - Yifan Pharmaceutical responded to investor inquiries on January 19, indicating that the procurement volume of Yilishu's U.S. partner is based on agreements and orders [1] - The company noted that Yilishu has been on the U.S. market for less than a year and is currently in the initial ramp-up phase [1]
亿帆医药:截至2025年12月31日公司股东人数为49452户
Zheng Quan Ri Bao Wang· 2026-01-19 12:13
Core Viewpoint - Yifan Pharmaceutical (002019) has indicated that the number of its shareholders is expected to reach 49,452 by December 31, 2025 [1] Group 1 - The company is actively engaging with investors through interactive platforms [1] - The projected number of shareholders reflects the company's growth and investor interest [1]
亿帆医药(002019):目前HMO正在进行单机调试
Ge Long Hui· 2026-01-19 07:55
Group 1 - The core point of the article is that Yifan Pharmaceutical (002019) is currently conducting single-machine debugging for HMO [1]
中国药械出海进阶再提速
3 6 Ke· 2026-01-19 07:35
Core Insights - The article discusses the recent meeting held by the National Healthcare Security Administration (NHSA) in Beijing, focusing on how to better utilize the medical insurance drug and device procurement platform to support the international expansion of Chinese pharmaceuticals and medical devices [1] - Chinese innovative pharmaceuticals and medical devices are gaining recognition in developed markets like Europe and the US, establishing a strong "China Creation" label in the global healthcare sector [1] Regulatory Support - The rapid development of China's pharmaceutical and medical device industry is attributed to the support from regulatory bodies, which have optimized approval processes and established quality standards aligned with international norms [2] - NHSA's Director Wang Xiaoning emphasized the importance of improving mechanisms, innovating methods, and promoting system collaboration to support the internationalization of Chinese pharmaceuticals [2] Pricing and Evaluation Systems - NHSA is working on a unified medical service pricing system to facilitate patient reimbursement and remove barriers for innovative medical technologies [3] - The establishment of the China Drug Price Registration System aims to provide a transparent pricing framework for Chinese drugs in international markets, enhancing their competitiveness [3][8] International Collaboration - Various government departments, including the Ministry of Industry and Information Technology and the Ministry of Commerce, are implementing policies to enhance the international competitiveness of the pharmaceutical industry [5][6] - The National Medical Products Administration is reforming drug lifecycle supervision to stimulate innovation and facilitate international market entry for Chinese drugs [7] Company Strategies - Companies like Heng Rui Medicine and United Imaging Healthcare are exploring diverse paths for international expansion, focusing on core technology development and strategic partnerships [10][11] - Heng Rui Medicine has established a significant presence in over 40 countries, leveraging a collaborative model to enhance its international footprint [10] - United Imaging Healthcare emphasizes a comprehensive approach to internationalization, integrating R&D, production, and service to adapt to local markets [11] Future Directions - NHSA plans to enhance the international procurement model for medical devices and pharmaceuticals, focusing on regional advantages and tailored development strategies [8] - The China Drug Price Registration System is expected to play a crucial role in providing a "price passport" for innovative drugs, facilitating their entry into global markets [9]
亿帆医药涨2.31%,成交额5070.07万元,主力资金净流入190.40万元
Xin Lang Cai Jing· 2026-01-19 02:18
Group 1 - The core viewpoint of the news is that Yifan Pharmaceutical's stock has shown fluctuations in price and trading volume, with a recent increase of 2.31% on January 19, reaching a price of 12.84 CNY per share [1] - As of January 19, the total market capitalization of Yifan Pharmaceutical is 15.618 billion CNY, with a trading volume of 50.70 million CNY and a turnover rate of 0.47% [1] - The net inflow of main funds is 1.904 million CNY, with significant buying and selling activities observed in large orders [1] Group 2 - Yifan Pharmaceutical's stock price has increased by 7.36% since the beginning of the year, but has decreased by 1.38% in the last five trading days [2] - The company reported a revenue of 3.923 billion CNY for the period from January to September 2025, representing a year-on-year growth of 1.67%, and a net profit of 388 million CNY, with a growth of 5.84% [2] - The main business revenue composition includes self-owned pharmaceutical products (75.52%), vitamins (11.47%), other pharmaceutical products (9.52%), high polymer materials (3.00%), and pharmaceutical services (0.49%) [2] Group 3 - Yifan Pharmaceutical has distributed a total of 1.328 billion CNY in dividends since its A-share listing, with 243 million CNY distributed in the last three years [3] - As of September 30, 2025, the second-largest circulating shareholder is Hong Kong Central Clearing Limited, holding 27.3592 million shares, an increase of 1.7773 million shares from the previous period [3]
亿帆医药股份有限公司关于调剂担保额度及为全资子公司提供担保的进展公告
Group 1 - The company has approved a total credit limit of up to RMB 650 million (or equivalent foreign currency) for itself and its subsidiaries, with a guarantee limit of up to RMB 600 million (or equivalent foreign currency) [1][4] - The company has adjusted the unused guarantee limit of RMB 24 million to its wholly-owned subsidiary Fisiopharma S.r.l., increasing the guarantee from RMB 0 to RMB 24 million [2][3] - The company will provide a joint liability guarantee of up to EUR 2.7 million for Fisiopharma's financing needs from Intesa Sanpaolo S.p.A and Banco BPM S.p.A [3][8] Group 2 - Fisiopharma S.r.l. is a wholly-owned subsidiary of the company, established in 1989, with a registered capital of EUR 2.645 million, focusing on the research, production, and sales of sterile preparations and other pharmaceuticals [5][6] - The company has confirmed that the financial risks associated with the guarantee are within its control, and the guarantee complies with relevant regulations [11] - As of the report date, the total external guarantee balance of the company and its subsidiaries is RMB 5.252 billion, accounting for 61.63% of the company's audited net assets for 2024 [13]