智通财经APP讯，亿帆医药(002019.SZ)公告，公司全资子公司合肥亿帆生物制药有限公司于2025年9月 15日收到国家药品监督管理局核准签发的注射用硫酸艾沙康唑《药品注册证书》。注射用硫酸艾沙康唑 为抗感染药物，适用于治疗成人患者下列感染：侵袭性曲霉病、侵袭性毛霉病。 ...

证券代码：002019 证券简称：亿帆医药 公告编号：2025-059 亿帆医药股份有限公司 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2025年9月15日收到国家药品监督管理局核准签发的注射用硫酸艾沙 康唑《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：注射用硫酸艾沙康唑 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4类 5、规格：0.2g（按C22H17F2N5OS计） 6、药品受理号：CYHS2401734 7、证书编号：2025S02842 8、药品批准文号：国药准字H20255440 品注册证书》。 9、药品批准文号有效期：至2030年09月08日 10、上市许可持有人：合肥亿帆生物制药有限公司 11、生产企业：合肥亿帆生物制药有限公司 12、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 本品符合药品注册的有关要求，批准注册，发给药品注册证书。 二、产品简介 ...

Group 1 - The core point of the article is that Yifan Pharmaceutical (002019) announced the approval of its subsidiary Hefei Yifan Biopharmaceutical Co., Ltd. for the injection of Sulfate Isavuconazole by the National Medical Products Administration [1] - The approved drug, Sulfate Isavuconazole, is an anti-infective medication [1] - It is indicated for the treatment of adult patients with invasive fungal infections, specifically invasive aspergillosis and invasive mucormycosis [1]

Group 1 - The first Guangdong Quality Products Exhibition opened in Guangzhou, attracting 1,086 participating companies and 2,175 domestic and international professional buyers [1][2] - The exhibition covers an area of 50,000 square meters and includes five industry exhibition areas: home appliances and electronics, clothing and beauty, toys and cultural creativity, health food, and furniture and home [1][2] - The event aims to accelerate the integration of domestic and foreign trade, support enterprises in expanding domestic sales markets, and strengthen the domestic circulation [2] Group 2 - The exhibition features nearly 10,000 consumer products from well-known and emerging Guangdong enterprises, including brands like Midea, TCL, and Wanglaoji [2] - Guangdong has a complete industrial system with high-quality products, and it is a major province for quality product output, with a real-time population of 150 million and a retail sales total that has ranked first in the country for 42 consecutive years [2] - The event is expected to enhance the visibility of Guangdong's quality products and meet the growing demand for high-quality and high-value products among consumers [2]

Core Viewpoint - In the first half of 2025, the company's total revenue reached 2.635 billion yuan, a year-on-year increase of 0.11%, with innovative drugs Yilishu and Yinikang together generating sales growth of 169.57% compared to the same period last year. The net profit attributable to the parent company was 304 million yuan, up 19.91%, exceeding expectations [1][2][3]. Financial Performance - The company's total revenue for H1 2025 was 2.635 billion yuan, with a net profit of 304 million yuan, reflecting a year-on-year increase of 19.91%. The net profit excluding non-recurring items was 237 million yuan, up 32.21% [1][2]. - The pharmaceutical revenue was 2.254 billion yuan, accounting for 85.53% of total revenue, with a year-on-year growth of 3.99%. Raw material drug revenue was 302 million yuan, down 19.61% [2]. Product Performance - Sales of innovative drugs Yilishu and Yinikang increased significantly, with Yilishu's shipments growing by 96.02% and Yinikang's by 478.15% year-on-year [3]. - Yilishu has been approved in 34 countries and regions, with actual shipments in five countries. The product has received patent compensation approval in the Netherlands and Italy, extending its patent protection by five years [5]. R&D Progress - The company is advancing multiple research projects, including the innovative drug N-3C01, which is expected to enter the IND stage in Q3/Q4 2025 [7][19]. - The clinical trial results for the innovative drug Duanjin Jiedu Capsule have met expectations, indicating significant market potential [1][12][18]. Market Strategy - The company is focusing on global market commercialization and building a biopharmaceutical ecosystem, with a goal of achieving 1 billion yuan in sales for Yilishu in 2025 [17]. - The overseas pharmaceutical revenue reached 331.99 million yuan, a year-on-year increase of 6.46%, with significant contributions from key products [10]. Future Catalysts - Yilishu's sales are expected to reach 1 billion yuan in 2025, with a significant reduction in production costs anticipated after the approval of a new production site [17]. - The Duanjin Jiedu Capsule's clinical trial results are expected to facilitate the implementation of the next clinical plan [18].

Core Viewpoint - The article highlights the challenges faced by Yifan Pharmaceutical, including regulatory scrutiny, financial volatility, and risks associated with debt and share pledges, despite showing strong growth in innovative drug sales. Regulatory Scrutiny - Yifan Pharmaceutical underwent a flying inspection by the Anhui Provincial Drug Administration, resulting in a "pending rectification assessment," indicating compliance issues that need to be addressed [1][2] - The inspection suggests potential deficiencies in Good Supply Practice (GSP), possibly related to storage, transportation, and sales management of pharmaceuticals [2] - The company has previously faced regulatory concerns, including a lack of inspection notifications from EMA and FDA, raising doubts about its international expansion [2] Financial Performance - The company's financial performance has been volatile, with a significant loss in 2023, where net profit dropped to -551 million yuan, a year-on-year decline of 388.19% [3] - In 2024, Yifan Pharmaceutical reported a revenue of 5.16 billion yuan, a year-on-year increase of 26.84%, and a net profit of 386 million yuan, marking a turnaround [3] - For the first half of 2025, the company achieved a revenue of 2.635 billion yuan and a net profit of 304 million yuan, reflecting a year-on-year growth of 19.91% [3] - Sales of innovative drugs, particularly Yilishu and Yinikang, surged by 169.57% in the first half of 2025, driving the company's recovery [3] Debt and Pledge Risks - Yifan Pharmaceutical faces significant share pledge risks, with 70 million shares pledged, accounting for 5.75% of total shares, and a cumulative pledge value of 1.091 billion yuan [4] - The company has short-term debt pressures, with cash holdings of 786 million yuan against short-term borrowings of 1.115 billion yuan, indicating liquidity concerns [4] Strategic Transformation - The company is undergoing a strategic transformation from a generic drug manufacturer to an innovative pharmaceutical enterprise, emphasizing "innovation + internationalization" [6] - Over the past decade, Yifan Pharmaceutical has invested 4.465 billion yuan in drug innovation research and development, highlighting its commitment to R&D [6] - The company has received approvals for its innovative drug Yilishu in 34 countries, including China, the US, the EU, and Brazil, showcasing its global expansion efforts [6] - A global business development center was established in 2025 to enhance its international footprint, although historical challenges in management capacity remain a concern [6]

Group 1 - The core point of the news is that the Hefei Xinzhu Biotechnology project has recently commenced production, with two biosimilar products currently in trial production [2][3]. Group 2 - Hefei Xinzhu Biotechnology's production line has been put into operation, indicating a significant development in the company's manufacturing capabilities [2]. - The company, Yifan Pharmaceutical (002019.SZ), confirmed the initiation of production at the Hefei Xinzhu facility on September 9, highlighting its commitment to expanding its product offerings in the biosimilar market [2].

Company Overview - Yifan Pharmaceutical Co., Ltd. is located in Lin'an District, Hangzhou, Zhejiang Province, established on November 10, 2000, and listed on July 13, 2004 [1] - The company primarily engages in the production and sales of active pharmaceutical ingredients and high polymer materials, with revenue composition as follows: proprietary pharmaceutical products (including imports) 75.52%, vitamins 11.47%, other pharmaceutical products 9.52%, high polymer materials 3.00%, and pharmaceutical services 0.49% [1] Financial Performance - As of August 29, 2025, Yifan Pharmaceutical achieved a revenue of 2.635 billion yuan, representing a year-on-year growth of 0.11%, and a net profit attributable to shareholders of 304 million yuan, reflecting a year-on-year increase of 19.91% [2] - The company has distributed a total of 1.328 billion yuan in dividends since its A-share listing, with 243 million yuan distributed over the past three years [3] Stock Performance - On September 9, Yifan Pharmaceutical's stock price decreased by 2.04%, trading at 15.38 yuan per share, with a total market capitalization of 18.708 billion yuan [1] - Year-to-date, the stock price has increased by 44.82%, with a recent decline of 2.53% over the last five trading days, a 3.15% increase over the last 20 days, and a 10.97% increase over the last 60 days [1] Shareholder Information - As of August 29, 2025, the number of shareholders increased to 42,900, a rise of 3.38%, while the average circulating shares per person decreased by 3.27% to 19,634 shares [2] - As of June 30, 2025, Hong Kong Central Clearing Limited is the second-largest circulating shareholder, holding 25.5819 million shares, an increase of 2.4783 million shares from the previous period [3]

Group 1 - Ryzneuta® (marketed as "亿立舒®" in China) has successfully completed its second shipment to the U.S. market, marking significant progress in its commercialization journey [1] - The drug was approved for sale in the U.S. in January 2023, and by May 2025, the first shipment to the U.S. market was completed, indicating a rapid acceleration in its commercialization process [1] - Acrotech, the U.S. partner, has increased its procurement volume and sales targets for Ryzneuta® based on optimistic clinical data and market potential, and plans to independently invest in research for an automatic injection version of the drug [1][2] Group 2 - Ryzneuta® is a novel long-acting G-CSF product and the only one in China that has undergone head-to-head clinical comparisons with both long-acting and short-acting reference products [2] - The drug has demonstrated superior clinical data, reducing the risk of neutropenia while significantly decreasing the frequency of administration for patients [2] - The U.S. market pricing for Ryzneuta® is set at $4,600 per unit, approximately 14 times the domestic price, reflecting the global market's recognition of the value of Chinese innovative drugs [2] Group 3 - Ryzneuta® was officially launched in the U.S. market in July 2023, and the second shipment occurred just two months later, driven by the partner's confidence in the drug's competitive advantages and market potential [3] - The drug is expected to gradually replace traditional G-CSF products, addressing market demands for long-acting and high-efficacy options [3] - In the first half of 2024, the sales revenue from the innovative drug business of the company increased by 169.57%, with Ryzneuta® alone achieving a shipment volume of over 220,000 units, a year-on-year increase of 96.02% [3]

Group 1 - The Guangdong Quality Products Exhibition aims to establish a new platform for integrated domestic and foreign trade, focusing on connecting production and sales for exhibitors [3][6] - The exhibition will adopt a "showcase-sales integration" model to create precise matching scenarios for domestic and foreign buyers, promoting Guangdong's quality manufacturing [3][6] - The event will take place from September 12 to 14 at the Guangzhou Import and Export Fair Complex, featuring five major exhibition areas and over 1,000 exhibitors [9][4] Group 2 - A total of 2,175 professional buyers have been invited, including 1,682 from within the province, 336 from outside, and 157 from overseas, with notable companies like Walmart and Amazon participating [6][9] - The exhibition will feature a "Star Carnival Concert" with six popular artists, enhancing brand exposure through a combination of live performances and product displays [6][7] - Attendees will benefit from special dining vouchers and exclusive discounts during the exhibition, aimed at boosting consumer engagement [10][12] Group 3 - The event is positioned as a practical platform for the "dual circulation" strategy, facilitating the transition of foreign trade products to domestic sales channels [14] - The exhibition is expected to attract over 100,000 professional visitors and consumers, highlighting its significance in promoting Guangdong's manufacturing capabilities [7][9] - The press conference served as both an information release and a confidence-building event, emphasizing the importance of quality and brand in domestic sales [12][14]