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6月4日收到国家药品监督管理局核准签发的注射用盐酸表柔 比星、注射用阿糖胞苷《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 （一）注射用盐酸表柔比星 1、药品名称：注射用盐酸表柔比星 证券代码：002019 证券简称：亿帆医药 公告编号：2025-037 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。 4、注册分类：化学药品4类 5、规格：10mg 6、药品受理号：CYHS2400442 7、证书编号：2025S01500 8、药品批准文号：国药准字H20254277 9、药品批准文号有效期：至2030年05月26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 2、剂型：注射剂 3、申请事项：药品注册（境内生产） 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）注射用阿糖胞苷 ...

Core Viewpoint - Yifan Pharmaceutical (002019) announced that its wholly-owned subsidiary Hefei Yifan Biopharmaceutical received approval from the National Medical Products Administration for the registration certificates of injectable hydrochloride of gemcitabine and injectable cytarabine [1] Group 1: Product Approvals - The injectable hydrochloride of gemcitabine is indicated for the treatment of malignant lymphoma, breast cancer, and lung cancer, with an estimated domestic sales of approximately 456 million yuan in the first half of 2024 [1] - The injectable cytarabine is suitable for the induction and maintenance treatment of acute non-lymphocytic leukemia in adults and children, with an estimated domestic sales of approximately 188 million yuan in the first half of 2024 [1] Group 2: R&D Investment - The company invested approximately 11.96 million yuan in the research and development of injectable hydrochloride of gemcitabine [1] - The company invested approximately 16.93 million yuan in the research and development of injectable cytarabine [1]

Group 1 - The core viewpoint of the news is that Yifan Pharmaceutical is actively engaging with investors regarding its innovative drug Yilishu, focusing on its market launch in the US and sales expectations in China [1][2] - Yilishu is expected to achieve significant sales in China, with over 270,000 units projected for 2024 and net sales exceeding 500 million yuan [1] - The US market launch, initially planned for July 2024, has been delayed due to packaging issues and supply chain challenges, with a new shipment expected to arrive by mid-June 2025 [1][2] Group 2 - Acrotech, Yifan's partner, has revised its market expectations for Yilishu in the US after conducting detailed market research, leading to a binding purchase order for over 40,000 units for 2025 [2] - The terminal sales price (WAC) for Yilishu in the US has been significantly increased compared to previous expectations, with the final announcement to be made on the product's launch day [2] - Yifan is also exploring markets outside the US, with plans for Europe and Japan, where partnerships are being established for distribution and clinical trials [2]

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Group 1: Core Product - Yilishu - Yilishu successfully passed the national medical insurance negotiation by the end of 2023, with expected domestic net sales exceeding 500 million CNY in 2024, and over 270,000 units to be shipped [3] - The initial plan for Yilishu's U.S. market launch was set for July 2024, but delays occurred due to packaging issues and supply chain challenges, with successful shipment to the U.S. from Germany by the end of May 2025 [3][4] - Acrotech, the partner company, has issued binding purchase orders for over 40,000 units of Yilishu for 2025, reflecting an improved market outlook [4] Group 2: International Expansion - In Europe, distribution rights for Yilishu are granted to partners, with sales contingent on obtaining medical insurance status [5] - The Japanese partner will independently conduct clinical trials for Yilishu, focusing on differentiated administration methods [5] - Other markets, including the Middle East and Southeast Asia, are in the stages of partner selection or product registration [5] Group 3: Supply Chain Optimization - The current supply chain for Yilishu involves complex coordination across China, the U.S., and Germany, leading to high production costs and long lead times [6] - Efforts are underway to optimize the supply chain, aiming to reduce costs by consolidating production within a single country [6] Group 4: Other Products and Innovations - The company is advancing the Dandjin Detox Capsule, currently in the data analysis phase after completing Phase 1 clinical trials, with plans to communicate with the CDE for the next trial phase [7] - The product Yinikang has seen lower-than-expected sales of over 40 million CNY in 2024, but significant growth is anticipated in 2025 [8] - The synthetic biology segment is expected to contribute positively to the company's performance, with new products anticipated in the second half of the year [10] Group 5: Research and Development Strategy - The company is cautious about the risks associated with developing innovative drugs, particularly First in Class (FIC) products, and is continuously evaluating the opportunities and risks of its pipeline [11] - Future clinical research for the drug F-652 will be prioritized in the U.S., while domestic trials will focus on specific indications [11] Group 6: Sales and Marketing Strategy - The company has established a global commercial division and BD center to enhance compliance and expand market reach [13] - New product introductions and partnerships are ongoing, including the acquisition of marketing rights for Bayer's products, aiming to diversify the oncology portfolio [13]

Summary of the Earnings Call for Yifan Pharmaceutical Company Overview - **Company**: Yifan Pharmaceutical - **Key Product**: Yili Shu (Recombinant Human Follicle Stimulating Hormone-Fc Fusion Protein Injection) Industry Insights - **Market Dynamics**: The domestic market for Yili Shu has seen significant growth after entering the medical insurance system, with sales expected to double in 2025 compared to 2024, driven primarily by the domestic market [2][3] - **International Market**: In the U.S., Yili Shu is promoted by Acrotech, with initial orders indicating a shipment volume of over 40,000 units in 2025, which is double the original expectations [2][4] Financial Performance - **Cash Flow**: Yifan Pharmaceutical maintained a net operating cash flow of over 500 million yuan in 2024, despite slightly lower-than-expected performance [2][6] - **Sales Projections**: The company anticipates a significant increase in sales for Yili Shu, with a projected shipment volume of 270,000 units in 2024 and over 500 million yuan in net sales [2][3] Product Development and Strategy - **New Product Launches**: The company plans to launch new products, including synthetic biology applications, in Q4 2025, aiming to reduce production costs by at least 50% [4][12] - **Sales Model Transition**: Yifan Pharmaceutical is considering shifting from a distribution model to a direct sales model for certain products, which could enhance market share over the next few years [18] Market Challenges and Opportunities - **Sales Strategy Adjustments**: The sales of Dinggan Cross-linked Sodium Hyaluronate (Yili Kang) fell short of expectations in 2024, but a significant increase in shipments is anticipated in 2025 [16][17] - **Competitive Landscape**: The company has a favorable window to establish market strategies as long-acting products are limited in the market for the next few years [19] Collaborations and Partnerships - **Aptech Collaboration**: Yifan has signed an agreement with Aptech, which is optimistic about the on-body device development, potentially increasing market share in the U.S. [8][9] - **Milestone Payments**: The company expects to receive approximately $2 million in milestone payments upon the U.S. market launch of Yili Shu, with additional payments tied to sales milestones [9] Future Outlook - **Growth Projections**: The company is optimistic about achieving over 3 billion yuan in sales and over 300 million yuan in net profit if market expectations are met [27] - **R&D Pipeline**: Yifan is advancing several early-stage R&D products, including a first-in-class product and interleukin therapies, with potential IND applications in 2025 [26] Conclusion - **Overall Sentiment**: Yifan Pharmaceutical is positioned for growth with a strong focus on product launches, market expansion, and strategic partnerships, while navigating challenges in sales and market competition [28]

Investment Rating - The report assigns a "Buy-A" investment rating for the company, with a target price of 15.00 CNY for the next six months [5]. Core Insights - The company is gradually becoming an international innovative pharmaceutical enterprise, with its innovative pipeline entering a harvest period, focusing on large molecules, small molecules, and traditional Chinese medicine [10][30]. - The company has made significant progress in its research and development pipeline, particularly with its product Yilishu, which has been approved for sale in 34 countries, including China, the US, and the EU [30][46]. - The company expects to achieve a net profit of 609 million CNY in 2025, with a year-on-year growth of 57.8% [7][72]. Summary by Sections 1. Company Overview - The company focuses on research and innovation in the pharmaceutical health sector, with a diverse product pipeline in areas such as hematological oncology, inflammation, metabolism, dermatology, gynecology, and pediatrics [10]. - The controlling shareholder, Cheng Xianfeng, holds 42.85% of the company's shares [13]. 2. Large Molecule Innovative Drugs - The company has made progress in its research pipeline, with Yilishu being a new generation G-CSF long-acting preparation that has been approved in multiple countries [30][33]. - The domestic market is expected to see rapid sales growth for Yilishu due to a commercial cooperation agreement with Zhengda Tianqing [50]. - The global G-CSF drug market is projected to grow steadily, with the company having established sales in 34 countries [51][54]. 3. Small Molecule Drugs - The company has differentiated its product offerings in the small molecule drug sector, focusing on unique and specialized products [57]. - Sales of small molecule drugs have shown significant growth, with revenue increasing from 453 million CNY in 2021 to 887 million CNY in 2023 [59]. 4. Traditional Chinese Medicine - The company has a wide range of traditional Chinese medicine products, with several exclusive varieties that contribute to steady growth in this segment [60][61]. - Revenue from traditional Chinese medicine increased from 643 million CNY in 2021 to 934 million CNY in 2023 [68]. 5. Raw Material Business - The company maintains a leading position in the vitamin B5 (calcium pantothenate) market, with stable demand expected to drive growth [65]. - The price of calcium pantothenate is currently at a historical low, with limited downside risk [69]. 6. Profit Forecast and Valuation Analysis - The company is projected to achieve revenues of 60.42 billion CNY, 70.30 billion CNY, and 81.29 billion CNY from 2025 to 2027, with corresponding net profits of 6.09 billion CNY, 7.40 billion CNY, and 8.88 billion CNY [72].

Market Overview - The A-share market experienced an overall increase on May 29, with the Shanghai Composite Index closing at 3363.45 points, up 0.7%, the Shenzhen Component Index at 10127.2 points, up 1.24%, and the ChiNext Index at 2012.55 points, up 1.37%. The North Star 50 Index rose by 2.73%. Total trading volume reached 12136.01 billion yuan, an increase of 1795.28 billion yuan compared to the previous trading day [1]. Capital Flow - The net inflow of main funds in the A-share market was 74.33 billion yuan, with an opening net outflow of 19.58 billion yuan and a closing net inflow of 23.89 billion yuan [2]. - The net inflow for the CSI 300 was 12.91 billion yuan, while the ChiNext saw a net inflow of 42.65 billion yuan, and the STAR Market experienced a net outflow of 17.3 billion yuan [4]. Sector Performance - Among the 23 sectors, the computer industry led with a net inflow of 191.73 billion yuan, followed by the electronics sector with 124.39 billion yuan, and the pharmaceutical and biological sector with 112.04 billion yuan. The non-bank financial sector saw a net inflow of 47.51 billion yuan, while the communication sector had 34.87 billion yuan [6][7]. - The sectors with the largest net outflows included food and beverage with -21.56 billion yuan, basic chemicals with -12.02 billion yuan, and banking with -8.89 billion yuan [7]. Individual Stock Activity - The stock with the highest net inflow was Shanzhi Gaoke, with 7.11 billion yuan [8]. - Institutional investors showed significant interest in several stocks, with Wangzi New Materials receiving a net buy of 41.11 million yuan, and Sifang Precision receiving 36.17 million yuan [11][12]. Institutional Focus - Recent institutional ratings highlighted several stocks, including Huichuan Technology with a target price of 73.00 yuan, indicating an upside potential of 8.83%, and Longying Precision with a target price of 24.70 yuan, suggesting a 19.73% upside [14].

Investment Rating - The report assigns a "Buy-A" investment rating for the company, with a target price of 15.00 CNY for the next six months [5]. Core Insights - The company is transitioning into an international innovative pharmaceutical enterprise, with its innovative pipeline gradually entering a harvest period [10]. - The company has made significant progress in its large molecule innovative drugs, particularly with the product Yilishu, which has received approval for sale in 34 countries [30][54]. - The small molecule drug segment focuses on differentiation through a strategy of "small, sharp, and special," with a stable growth in sales [59]. - The traditional Chinese medicine segment has a wide range of products, including several exclusive varieties, contributing to steady growth [62]. Summary by Sections 1. Company Overview - The company focuses on research and innovation in the pharmaceutical health sector, with a diverse product pipeline in various therapeutic areas [10]. - The controlling shareholder holds 42.85% of the company's shares, indicating strong ownership [13]. 2. Large Molecule Innovative Drugs - The company has made advancements in its research pipeline, with Yilishu being a key product that has received approvals in multiple countries [30]. - The domestic market strategy includes a commercial partnership with Zhengda Tianqing to enhance sales [51]. - The global market for G-CSF drugs is expected to grow, with the company positioned to benefit from this trend [52]. 3. Small Molecule Drugs - The company has established a differentiated product layout in the small molecule drug sector, focusing on key products that have shown stable sales growth [59]. 4. Traditional Chinese Medicine - The company has a broad layout in traditional Chinese medicine, with several exclusive products contributing to its revenue growth [62]. 5. Raw Material Business - The company maintains a leading position in the vitamin B5 market, with stable demand expected to drive growth [67]. 6. Profit Forecast and Valuation Analysis - The company is projected to achieve revenues of 60.42 billion CNY, 70.30 billion CNY, and 81.29 billion CNY from 2025 to 2027, with corresponding net profits of 6.09 billion CNY, 7.40 billion CNY, and 8.88 billion CNY [74].

Group 1 - The National Vaccine and Biotechnology Index (980015) has seen a strong increase of 2.39% as of May 29, 2025, with notable gains in constituent stocks such as Zhaoyan New Drug (603127) up 9.99%, Yifan Pharmaceutical (002019) up 9.17%, and Dizhe Pharmaceutical (688192) up 8.73% [1] - The Biovaccine ETF (159657) rose by 2.28%, with the latest price reported at 0.63 yuan [2] - The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting will take place from May 30 to June 3, 2025, in Chicago, showcasing the development of oncology research in China, with over 70 studies from Chinese scholars selected for presentation [2] Group 2 - The top ten weighted stocks in the National Vaccine and Biotechnology Index (980015) as of April 30, 2025, include Fosun Pharma (600196), Changchun High-tech (000661), and others, collectively accounting for 63.18% of the index [3] - The Biovaccine ETF closely tracks the National Vaccine and Biotechnology Index, which consists of 50 companies involved in the biotechnology industry, reflecting the overall performance of quality listed companies in the sector [2]