亿帆医药股份有限公司 YIFAN PHARMACEUTICAL CO.,LTD. 证券简称：亿帆医药 证券代码：002019 董 事 长：程先锋 披露日期：2025 年 08 月 15 日 公司董事会、监事会及董事、监事、高级管理人员保证半年度报告内容 的真实、准确、完整，不存在虚假记载、误导性陈述或者重大遗漏，并承担 个别和连带的法律责任。 公司负责人程先锋、主管会计工作负责人张大巍及会计机构负责人(会计 主管人员)王恺声明：保证本半年度报告中财务报告的真实、准确、完整。 所有董事均已出席了审议本次半年报的董事会会议。 报告中涉及的未来发展规划及事项的陈述，属于计划性事项，不构成对投 资者的实质承诺，投资者及相关人士均应对此保持足够的风险认识，并且应 当理解计划、预测与承诺之间的差异。 报告期内，不存在对公司生产经营产生实质性影响的特别重大风险。公司 已在本报告中详细阐述公司在生产经营过程中可能面临的各种风险，包括国 际贸易风险、研发不达预期风险、商誉减值风险、汇率波动风险、国际化经 营风险和安全生产与环保风险等，详情请查阅本报告第三节 管理层讨论与分 析中"十、公司面临的风险和应对措施"。 公司计划不派发 ...

Core Insights - The article highlights the significant progress of Chinese innovative pharmaceuticals, particularly focusing on the outbound licensing strategy and business development (BD) as key drivers for growth in the global market [1][2][3] Group 1: Company Developments - Heng Rui Pharmaceutical has completed 13 outbound licensing deals from 2018 to 2024, involving 16 molecular entities with a potential total transaction value of approximately $14 billion and upfront payments totaling around $600 million [1] - In 2025, Heng Rui's momentum continues with a $19.7 billion deal with Merck for its Lp(a) oral small molecule project and a partnership with GSK that brings in $5 billion upfront and a potential future revenue of $12 billion [1] - The company reported a revenue of 27.985 billion yuan in 2024, a year-on-year increase of 22.63%, and a net profit of 6.337 billion yuan, up 47.28% [9] Group 2: Industry Trends - The Chinese innovative pharmaceutical sector is experiencing a surge in outbound licensing deals, with the total value of BD transactions reaching $64.08 billion in 2024, marking a historical high [4][5] - The global pharmaceutical industry is facing a "patent cliff" with a total risk exposure of $354 billion due to patent expirations, creating a heightened demand for quality innovative assets from China [3][4] - The number of active innovative drug R&D pipelines in China reached 3,575 in 2024, surpassing the U.S. for the first time, with a significant increase in the number of first-in-class (FIC) drugs [8] Group 3: Strategic Shifts - The BD model has evolved from a tactical choice to a core pillar of globalization strategy for Chinese pharmaceutical companies, enabling them to secure immediate funding and share risks [5][6] - Companies like Bai Li Tian Heng and Kang Ning Jie Rui have achieved remarkable revenue growth through strategic partnerships, with Bai Li Tian Heng reporting a staggering 1,685.19% year-on-year increase in revenue following a major licensing deal [5][6] - The article emphasizes the importance of building strong commercialization capabilities as a foundation for long-term competitiveness, moving beyond reliance on BD for survival [9][10] Group 4: Policy and Capital Support - The growth of BD transactions is supported by a decade of favorable policies and capital influx, including reforms in drug approval processes and financing mechanisms for biotech companies [7][8] - The Chinese pharmaceutical industry has seen a significant increase in the number of companies going public, with over 56 firms raising more than 110 billion HKD since the introduction of new listing rules [7] - The article notes that the combination of policy support and capital investment has led to a qualitative leap in innovative drug development in China [8][9] Group 5: Future Outlook - The future of Chinese innovative pharmaceuticals is characterized by a focus on global clinical trials, tighter international collaborations, and the emergence of differentiated products [15] - The industry is moving towards a more collaborative ecosystem, aiming for a balance between individual company growth and collective industry advancement [15] - The article concludes that the ongoing transformation in the Chinese pharmaceutical sector is paving the way for a historic leap from "global follower" to "global leader" in innovation [10][15]

Group 1 - The National Healthcare Security Administration (NHSA) has established a "first launch price mechanism" for new drugs to encourage innovation in drug development, marking a shift from a cost-control approach to one that promotes high-quality innovation [1][2][3] - The NHSA aims to support high-level innovative drugs by ensuring that their initial pricing reflects the high investment and risk associated with their development, and proposes a price stability period for these drugs [1][3] - The NHSA is facilitating the approval process for innovative drugs through a "joint review and approval" model, which allows for quicker clinical access to new drugs [1][5] Group 2 - The introduction of the first launch price mechanism addresses the previous ambiguity surrounding the pricing of innovative drugs in China, which often led to challenges in market entry and pricing for companies [2][3] - The NHSA's new pricing guidelines include over 100 new pricing projects for innovative products and devices, establishing a parallel structure for pricing and technological innovation [2] - The proposed pricing mechanism allows companies to self-assess their drugs based on clinical value and evidence, which can influence their initial pricing and market entry strategy [4][5] Group 3 - The NHSA's approach is seen as a structural response to enhance the incentive mechanisms for drug development, potentially establishing a "real market price" for innovative drugs before they enter negotiations for inclusion in the healthcare insurance catalog [3][4] - The new pricing model includes a five-year price stability period for high-scoring drugs, which will not be subject to centralized procurement during this time, allowing companies to recover their investments more effectively [5] - Industry experts express optimism about the evolving policy environment for innovative drugs, anticipating that these changes will enhance investment returns and strengthen the position of Chinese markets in global pharmaceutical strategies [6]

Core Viewpoint - The National Healthcare Security Administration (NHSA) is establishing a "first launch price mechanism" for new drugs to encourage innovation and ensure that high-quality innovative drugs can achieve returns that correspond to their high investment and risk levels [1][2][3]. Group 1: Policy Changes - The NHSA has developed a "first launch price mechanism" for new drugs, marking a shift from a cost-control approach to one that encourages high-quality innovation [1][2]. - The NHSA aims to streamline the approval process for innovative drugs through a "joint review and approval" model, facilitating faster clinical access [1][5]. - The upcoming policy will allow companies to self-assess their drugs based on a scoring system that considers pharmaceutical, clinical value, and evidence, impacting the pricing flexibility of new drugs [4][5]. Group 2: Market Impact - The lack of a clear first launch price mechanism has previously hindered innovative drugs from realizing their market potential, particularly affecting small biotech companies [2][3]. - The new pricing mechanism is expected to provide a reference for establishing "real market prices" for innovative drugs before entering negotiations with the NHSA [3][4]. - Companies are optimistic about the evolving policy environment, which is anticipated to enhance investment returns for new drug development and improve China's position in global pharmaceutical strategies [6]. Group 3: Industry Reactions - Industry experts believe that the new pricing policies will protect the innovation incentives for pharmaceutical companies and address previous negotiation challenges with the NHSA [3][6]. - The introduction of a five-year price stability period for high-scoring drugs is seen as a significant support measure for companies during the early stages of product life cycles [5]. - The NHSA's approach is viewed as a necessary step to balance commercial demands with the need for innovation value returns [6].

Group 1 - The core point of the news is the introduction of an executive order by President Trump aimed at lowering prescription drug prices in the U.S. through a "most-favored-nation pricing" model, aligning local drug prices with those in other developed countries [1][5] - Following the announcement, the domestic innovative drug sector in China experienced a significant market reaction, with related ETFs rising nearly 2% after an initial drop [1][5] - The executive order is perceived to favor generic drugs and biosimilars, potentially lowering entry barriers and increasing competition in the U.S. market [6][7] Group 2 - From 2007 to 2023, 350 innovative drugs from 177 Chinese pharmaceutical companies were studied in 691 clinical trials in the U.S., with 7 products approved for market [2][4] - Notable approved Chinese innovative drugs include BeiGene's BTK inhibitor, Legend Biotech's CAR-T therapy, and Junshi Biosciences' PD-1 inhibitor, with significant sales growth reported for these products in the U.S. market [4][5] - The impact of the drug pricing executive order on Chinese innovative drug companies is mixed; while some companies may face pressure on pricing, others may benefit from reduced competition in the generic drug space [7][8] Group 3 - Investment sentiment towards Chinese innovative drug companies remains cautiously optimistic, with some investors believing the impact of the pricing policy may not be as severe as anticipated [7][8] - The market share of U.S. sales is significant for many Chinese companies, with one leading company reporting a 107.5% year-on-year increase in sales for its core product in the U.S. [4][8] - The overall effect of the executive order on the pharmaceutical landscape is still uncertain, with companies advised to closely monitor developments [8][9]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of May 11, 2025 [1]. Core Insights - The A-share innovative drug sector saw a weekly increase of 2.33%, outperforming the CSI 300 index by 0.33 percentage points, while the biopharmaceutical sector rose by 0.75% [2][17]. - In the past six months, the A-share innovative drug sector has cumulatively increased by 5.43%, outperforming the CSI 300 index by 9.13 percentage points, whereas the biopharmaceutical sector has decreased by 10.55% [2][17]. - The Hong Kong innovative drug sector experienced a decline of 2.14%, underperforming the Hang Seng Index by 3.75 percentage points, with a cumulative increase of 22.08% over the past six months [2][20]. - The XBI index in the US fell by 8.59% this week, with a cumulative decline of 22.72% over the past six months [2][23]. Summary by Sections Domestic Key Innovative Drug Progress - In May, one new drug was approved for market launch in China, with no new indications approved [3][41]. Overseas Key Innovative Drug Progress - In May, there were no NDA or BLA approvals in the US, Europe, or Japan for innovative drugs [4][45]. Global Key Innovative Drug Transaction Progress - A total of 12 key transactions occurred globally this week, with one disclosed transaction amounting to 415 million USD between Alchemab Therapeutics and Eli Lilly [5]. Market Performance - The report indicates that 39 stocks in the innovative drug sector rose while 67 fell during the week, with the top gainers being HaiChuang Pharmaceutical-U (22.76%), Changchun High-tech (8.99%), and Zhongsheng Pharmaceutical (8.98%) [2][16]. - The top decliners included Fuhong Hanlin (-12.64%), Connaught-B (-12.40%), and Boan Biotechnology (-11.77%) [2][16]. Clinical Trials and Approvals - In May, there were 23 newly announced clinical trials in China, including 17 in BE/I phase, 4 in II phase, and 2 in III phase [31].

Group 1 - The annual American Society of Clinical Oncology (ASCO) meeting is set to showcase a record number of clinical studies from China National Pharmaceutical Group, with 12 oral presentations and 40 innovative results overall [1][2] - Among the highlighted studies, the combination of Bemarituzumab and Anlotinib is particularly notable, with four presentations focusing on its efficacy against PD-L1 positive advanced non-small cell lung cancer (NSCLC) [2][3] - The ASCO meeting will also feature significant data on Anlotinib, which has been involved in nine studies, marking a milestone for domestic innovative drugs [4] Group 2 - The HER2 bispecific antibody ADC, TQB2102, will present its first human study data at ASCO, with no similar products currently on the market [5] - The CCR8 monoclonal antibody, LM108, will also be discussed, highlighting its potential in pancreatic cancer treatment [5] - The ASCO meeting will take place from May 30 to June 3 in Chicago, with over 50 studies from 22 Chinese pharmaceutical companies included in the oral presentation segment [6]