证券代码：300122 证券简称：智飞生物 公告编号：2025-29 重庆智飞生物制品股份有限公司 关于公司控股股东部分股份质押的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司（以下简称"公司"）近日接到公司控股 股东、实际控制人蒋仁生先生的通知，获悉蒋仁生先生将其所持有的本公司部 分股份进行了质押，具体事项如下： 一、控股股东股份质押的基本情况 | 股东 名称 | 是否为 控股股 东或第 一大股 | 本次质押 股数 | 占其所 持股份 比例 | 占公司 总股本 比例 | 是否 为限 | 是否 为补 充质 | 质押起始日 质押到期日 | 质权人 | 质押 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 东及其 | （股） | | | 售股 | | | | 用途 | | | 一致行 | | （%） | （%） | | 押 | | | | | | 动人 | | | | | | | | | | | | | | | | | | 重庆农 村商业 | ...

Core Insights - The Chinese pharmaceutical industry is undergoing a significant transformation driven by demographic changes, evolving healthcare demands, and regulatory reforms [2] - The 2025 China Market Enterprise Transformation Index highlights three key success factors for leading pharmaceutical companies: drug research and development pipeline, R&D investment, and business resilience [2] - Despite challenges such as institutionalized drug procurement affecting profit margins, companies with strong balance sheets and diverse product portfolios are better positioned to adapt to regulatory changes [2] Industry Trends - The government's strategic initiatives, such as the "Action Plan for High-Quality Development of the Pharmaceutical Industry (2023-2025)," play a crucial role in supporting pharmaceutical innovation [2] - The increasing focus on preventive healthcare post-pandemic has created new opportunities, particularly in the vaccine and biopharmaceutical sectors [2] Company Performance - Novo Nordisk has significantly improved its ranking, moving from 13th in 2024 to 1st in 2025, driven by R&D investment and diversification into the obesity treatment market [6] - Jiangsu Hengrui Medicine ranked 3rd in 2025, reflecting its strong financial stability and competitive drug R&D pipeline, with a revenue of 22.82 billion RMB in 2023, a 7.26% increase year-on-year [7] - China National Pharmaceutical Group (CSPC) moved from 8th to 4th place, focusing on expanding its R&D pipeline and global research initiatives [8] - Chongqing Zhifei Biological Products Co., Ltd. saw the largest ranking increase, from 15th to 5th, capitalizing on the growing demand for HPV and respiratory vaccines [8] - Pfizer dropped from 1st to 7th place due to decreased post-pandemic product demand and intensified competition from domestic firms [9] Key Factors for Success - Strong R&D capabilities are essential for market leadership, as evidenced by the significant advancements of companies like Novo Nordisk and Hengrui [10] - Financial strength is critical for navigating policy changes, with companies like Hengrui demonstrating resilience through effective cash flow management [10] - A diverse R&D pipeline enhances market resilience, allowing companies to better withstand regulatory changes [10] - Vaccines are becoming a major growth driver, with increased investment in preventive healthcare reshaping the pharmaceutical landscape [10] - Accessibility to healthcare drives market opportunities, with companies balancing innovation and cost-effectiveness to meet the needs of the growing middle class and aging population [11]

Core Viewpoint - The performance of major Chinese vaccine companies, including Wantai Biological Pharmacy (万泰生物), Zhifei Biological Products (智飞生物), and Watson Bio (沃森生物), has significantly declined in Q1 2025, primarily due to a shrinking self-paid market for HPV vaccines amid economic pressures [1] Group 1: Company Performance - Wantai Biological reported a revenue of 401 million yuan in Q1 2025, a year-on-year decrease of 46.76%, with a net loss of 52.78 million yuan [1] - Zhifei Biological's revenue fell to 2.374 billion yuan, down 79.16% year-on-year, resulting in a net loss of 305 million yuan [1] - Watson Bio achieved a revenue of 462 million yuan, a decline of 22.93%, with a net profit of 2.65 million yuan, down 81.27% [1] Group 2: Market Dynamics - The HPV vaccine market is experiencing a significant contraction, with a 61.57% year-on-year drop in the total number of HPV vaccine batches approved for sale in 2024 [3] - The two-valent HPV vaccine's sales revenue for Wantai Biological plummeted by 84.69% to 606 million yuan in 2024, influenced by price reductions and increased competition from the nine-valent HPV vaccine [3][4] - The price of HPV vaccines has drastically decreased, with the two-valent vaccine's procurement price dropping from over 300 yuan to 27.5 yuan in Shandong province, reflecting a nearly 90% decline [7] Group 3: Competitive Landscape - The introduction of the nine-valent HPV vaccine has intensified competition, with consumers favoring higher-priced vaccines, leading to a sharp decline in demand for the two-valent vaccine [4] - Zhifei Biological, as the exclusive agent for Merck's HPV vaccines, faced a 95.49% drop in the issuance of four-valent HPV vaccines in 2024, exacerbated by Merck's suspension of supplies to China [4][5] - The price war in the HPV vaccine market has severely compressed profit margins, with Wantai Biological's vaccine segment gross margin falling from 91.6% in 2022 to 70.4% in 2024 [7] Group 4: Future Outlook - The development of domestic nine-valent HPV vaccines is accelerating, with several companies, including Wantai Biological, advancing their clinical trials [8] - The potential introduction of male-targeted HPV vaccines may open new growth avenues, as Merck's four-valent HPV vaccine has been approved for male use [9]

Core Viewpoint - The disease prevention and control industry in China is experiencing growth due to increased public awareness, government funding, and advancements in biotechnology and data analysis, leading to improved efficiency in disease management [1][13]. Summary by Sections Industry Overview - Disease prevention and control is a crucial part of public health, focusing on reducing the occurrence and spread of diseases through scientific methods [3]. - Effective disease control can lower healthcare costs, enhance quality of life, and support economic stability [3]. Industry Development - The scale of China's disease prevention and control industry has been on the rise, with central government funding for disease control projects increasing from 17.526 billion to 20.38 billion from 2020 to 2022, followed by a projected recovery to 20.881 billion in 2024, marking an 18.06% year-on-year increase [1][13]. - The number of disease control centers in China has grown from 3,376 in 2021 to 3,429 in 2024, enhancing public health emergency management capabilities [11]. Policy Initiatives - Recent policies emphasize strengthening disease control institutions, enhancing core functions, and promoting scientific research and public health cooperation [5][7]. - The 2024-2025 National Disease Prevention and Control Action Plan encourages local institutions to engage in applied research and technology transfer [5][7]. Competitive Landscape - The disease prevention market in China is competitive, with key players including Fosun Pharma, Kangtai Biological, and Zhifei Biological, which are focusing on innovation and service quality to capture market share [15][19]. Industry Trends - The chronic disease management market is expected to grow significantly due to the aging population and increasing prevalence of chronic diseases, which currently account for 88% of total deaths in China [21]. - Technological innovations such as big data, AI, and IoT are set to transform disease prevention and control, enhancing monitoring and decision-making processes [22]. - The integration of sports and health ("body-health integration") is emerging as a new trend, promoting physical activity as a preventive measure against chronic diseases [23].

Core Viewpoint - Zhifei Biological's subsidiary has received approval for clinical trials of a combined vaccine, which is expected to enhance vaccination compliance and reduce the number of doses required [1] Group 1: Company Developments - Zhifei Biological announced that its subsidiary, Zhifei Lvzhu, has obtained the clinical trial approval for an acellular combined vaccine targeting whooping cough, diphtheria, tetanus, and type B Haemophilus influenzae [1] - The approval from the National Medical Products Administration is a significant step in the company's product development strategy [1] - The clinical trial is not expected to have a major impact on the company's recent performance, but successful product development could enhance the company's product portfolio and profitability [1]

证券代码：300122 证券简称：智飞生物 公告编号：2025-28 重庆智飞生物制品股份有限公司 关于吸附无细胞百白破（组分）b 型流感嗜血杆菌（结合） 联合疫苗获得临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司（以下简称"公司"）于近日获悉，由全资子 公司北京智飞绿竹生物制药有限公司（以下简称"智飞绿竹"）研发的吸附无细胞 百白破（组分）b 型流感嗜血杆菌（结合）联合疫苗（以下简称"组分百白破-Hib 四联疫苗"）获得国家药品监督管理局药物临床试验批准通知书（通知书编号： 2025LP01316），同意开展预防百日咳杆菌、白喉杆菌、破伤风梭状芽孢杆菌及 b 型流感嗜血杆菌引起的感染性疾病的临床试验。公司将根据临床试验批准通知 书的要求，尽快开展相关临床试验工作。 一、研发项目简介 百日咳是由百日咳杆菌引起的一种传染性极强的急性呼吸系统疾病。百日咳 在我国一年四季均可发病，春夏季发病较多，农村发病率高于城市。白喉是由白 喉杆菌所引起的一种急性呼吸道传染病，以发热，气憋，声音嘶哑，咳嗽，咽、 扁桃体及其周 ...

Core Viewpoint - Despite facing significant pressure on revenue and net profit in 2024 due to industry adjustments and changes in consumer demand, the company is determined to transform into a comprehensive biopharmaceutical enterprise through innovation, optimized strategies, and international collaboration [1] Group 1: Innovation and Product Development - The company has achieved key breakthroughs in its vaccine pipeline, including the approval of a quadrivalent influenza vaccine and the acceptance of the application for a human diploid rabies vaccine [2] - The company aims to launch 1-2 self-developed products annually over the next 2-3 years to optimize its revenue structure [2] - The metabolic disease treatment sector is emerging as a new growth area, with significant progress in GLP-1 and insulin analogs, including the submission of liraglutide for market approval [2] Group 2: Risk Management Strategies - The company has implemented various measures to mitigate operational risks since the second quarter of the previous year, including enhancing communication with partners and adjusting promotional policies [3] - The company is focusing on inventory management and has initiated a "de-inventory" campaign to improve sales and reduce operational risks [4] - As of the end of Q1 2024, the company's accounts receivable have decreased to 14.6 billion, with ongoing efforts to manage aging receivables [4] Group 3: Shareholder Returns and Future Outlook - The company has prioritized shareholder returns by implementing a mid-term dividend of 479 million and completing over 300 million in share buybacks, reflecting its commitment to shareholder interests [5] - Management's proactive attitude and robust measures are expected to instill confidence in investors, with a focus on continuous R&D innovation and market expansion [5] - The company aims to achieve steady growth in performance and is committed to becoming a world-class biopharmaceutical enterprise [5]

Summary of Zhifei Biological Conference Call Company Overview - **Company**: Zhifei Biological Products Co., Ltd. - **Industry**: Biopharmaceuticals, specifically focusing on vaccines and metabolic disease treatments Key Points and Arguments Financial Performance - **Revenue Decline**: Starting from Q2 2024, the company experienced a significant decline in performance, particularly in HPV vaccine sales, attributed to economic cycles, reduced consumer willingness, and vaccine hesitancy [2][3][4] - **Losses**: The company reported three consecutive quarters of losses as of Q1 2025, with accounts receivable dropping from 30 billion to 14 billion, but with extended turnover days [3][10] - **Cash Dividends**: In 2024, the company distributed a total cash dividend of 2.394 billion, alongside a stock buyback exceeding 300 million [6][11] Strategic Measures - **Response to Challenges**: The company is actively seeking new growth points and has adjusted procurement plans with partners like GSK and Merck to align with market demand [2][4] - **Inventory Management**: Focus on reducing inventory levels, particularly for HPV and shingles vaccines, which are significant contributors to the current stock levels [8][9] - **Sales Promotion**: Enhanced marketing policies and public awareness campaigns to increase vaccination rates [4][9] Research and Development - **R&D Progress**: The company has 34 self-developed projects, with 19 in clinical trials or registration stages, including advancements in pneumonia, meningitis, and adult vaccines [5][15] - **Expansion into Metabolic Diseases**: Acquisition of a controlling stake in Cheng'an Biological, gaining access to GLP-1 receptor agonists, thus expanding into the metabolic disease sector [5][15] Corporate Governance and Social Responsibility - **Sustainability Report**: The company released its first sustainability report, emphasizing R&D, governance, quality management, and community engagement [12][13] - **Charitable Contributions**: Participation in 12 charitable projects with total donations exceeding 400 million, showcasing commitment to social responsibility [7][13] Future Outlook - **Operational Focus for 2025**: Key initiatives include inventory reduction, debt recovery, and risk management, with a strong emphasis on HPV and shingles vaccine sales [8][9] - **Market Expansion**: Plans to enhance international market presence and expedite the registration of new vaccine products [9][10] Market Challenges - **Industry Downturn**: The company is navigating a challenging environment characterized by high investment requirements and long product cycles, necessitating a focus on maintaining operational stability [11][15] Conclusion - **Long-term Vision**: Zhifei Biological aims to solidify its position as a leading biopharmaceutical company through innovation, strategic partnerships, and a commitment to sustainable practices, while addressing immediate operational challenges [6][15]

Investment Rating - The report does not explicitly state an investment rating for the vaccine industry Core Insights - The overall trend in the vaccine industry shows a decline in batch approvals for most vaccine types in Q1 2025, with some exceptions showing recovery or growth in demand [7][29][46] Summary by Category Multi-Component Vaccines - In Q1 2025, multi-component vaccines saw a total of 17 batch approvals, a decrease of 26% compared to the previous year [11][15] - The five-component vaccine maintained its batch approval at 17, while the four-component vaccine had no approvals [15][12] Pneumonia Vaccines - Total batch approvals for pneumonia vaccines in Q1 2025 were 23, down 30% year-on-year [19][21] - The 13-valent pneumonia vaccine had 19 approvals, remaining stable, while the 23-valent vaccine saw a significant drop to 4 approvals, down 71% [24][19] HPV Vaccines - HPV vaccine approvals increased to 57 batches in Q1 2025, a growth of 63% [29][27] - The two-valent HPV vaccine saw a remarkable increase of 367%, with all approvals coming from Wantai Biological Pharmacy [29][32] Influenza Vaccines - Influenza vaccine approvals totaled 29 batches, a significant increase of 263% year-on-year [34][38] - The three-valent influenza vaccine had 28 approvals, while the four-valent vaccine had only 1 approval, down 67% [38][41] Rabies Vaccines - Batch approvals for rabies vaccines increased to 223 in Q1 2025, a growth of 37% [46][48] - The freeze-dried rabies vaccine accounted for the majority of approvals, with Chengda Biological achieving 105 approvals, a 110% increase [48][46] Varicella Vaccines - Varicella vaccine approvals slightly decreased to 83 batches, down 2% [53][54] - The largest contributor was Baike Biological, with 33 approvals, marking a 38% increase [54][53] Hib Vaccines - Hib vaccine approvals fell to 7 batches, a decrease of 50% [59][58] EV71 Vaccines - EV71 vaccine approvals continued to decline, with only 4 batches approved, down 69% [64][63] Rotavirus Vaccines - Rotavirus vaccine approvals totaled 21 batches, a decrease of 46% [68][67] DTP Vaccines - DTP vaccine approvals increased to 18 batches, a growth of 167% [72][73] Meningitis Vaccines - Meningitis vaccine approvals totaled 85 batches, down 34% [78][79] - The AC polysaccharide vaccine accounted for 55 approvals, a decrease of 47% [84][79] Hepatitis B Vaccines - Hepatitis B vaccine approvals increased to 87 batches, a growth of 28% [91][90] IPV Vaccines - IPV vaccine approvals totaled 22 batches, a decrease of 33% [93][92]

Financial Performance - In 2024, the company's operating revenue was 26.07 billion, a decrease of 50.74% year-on-year [15] - Net profit for 2024 was 2.018 billion, down 74.99% compared to the previous year [15] - The decline in performance is attributed to economic cycles, structural changes, industry adjustments, and increased vaccine hesitancy [15] Challenges and Responses - The company has faced significant operational difficulties since Q2 2023, with a notable drop in sales of core products like HPV vaccines [2][3] - Measures taken include enhancing communication with partners, adjusting promotional policies, and increasing public awareness of disease prevention [3] - As of Q1 2024, accounts receivable decreased to 14.6 billion, with ongoing efforts to manage aging receivables [4] Inventory and Debt Management - The increase in inventory is primarily due to reduced sales of key products, with a focus on managing raw materials and finished goods [6][7] - The company aims to reduce inventory risks through collaboration with partners and improving market promotion [7] - Short-term borrowings have increased to support normal operations, with a focus on debt structure optimization [7] Market and Value Management - The company has implemented a market value management system, with a planned cash dividend of 2.394 billion for 2024, including a mid-year dividend of 479 million [8] - Since its listing in 2010, the company has distributed over 7.318 billion in dividends and conducted multiple share buybacks [8] ESG and Sustainability Efforts - The company released its first sustainability report, highlighting its commitment to environmental, social, and governance (ESG) practices [10] - It has engaged in 12 public welfare projects, donating over 10.96 million in the past year [10] - The company received an AA rating in MSCI ESG ratings, showcasing its leadership in governance and social impact [11] Future Outlook and Strategic Initiatives - The company aims to transition into the therapeutic biopharmaceutical field, with a focus on metabolic diseases [13] - It has a robust pipeline of products, including several in clinical trials, to support future growth [13][15] - The vision is to become a world-class biopharmaceutical enterprise, leveraging innovation and market expansion [14]