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]

Core Viewpoint - The company, Zhifei Biological Products (300122), has announced that its wholly-owned subsidiary, Zhifei Longkema, is conducting Phase I/II clinical trials for a quadrivalent influenza vaccine in Hebei Province, which includes the company's self-developed adjuvant ZFA02 [1] Group 1 - The quadrivalent influenza vaccine aims to prevent influenza caused by vaccine-related strains of the virus [1] - There are currently no adjuvanted influenza vaccines approved for sale in China, while Seqirus has an adjuvanted influenza vaccine approved for use overseas [1] - If the project progresses smoothly, it will enhance the company's portfolio of viral vaccines, improve product layout, and strengthen market competitiveness [1]

证券代码：300122 证券简称：智飞生物 公告编号：2025-27 重庆智飞生物制品股份有限公司 关于四价流感病毒裂解疫苗（ZFA02 佐剂） 进入Ⅰ/Ⅱ期临床试验的公告 截至目前，经查询国家药品监督管理局网站，国内暂无佐剂流感疫苗正式获 批上市。海外有 Seqirus 公司的佐剂流感疫苗获批上市使用。 公司的佐剂四价流感疫苗开展Ⅰ/Ⅱ期临床试验，是公司新型佐剂技术平台的 应用，是公司聚焦创新技术、加速科研攻关的成果。若本项目进展顺利，将进一 1 步丰富公司病毒类疫苗品种，并与公司已获批上市的四价流感病毒裂解疫苗、处 于申报上市阶段的三价流感病毒裂解疫苗、四价流感病毒裂解疫苗（儿童型）， 及获批临床试验的三价流感病毒裂解疫苗（ZFA02 佐剂）形成协同效应，完善公 司产品布局，强化公司的市场竞争力。 三、Ⅰ/Ⅱ期临床试验相关情况 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 公司安徽智飞龙科马生物制药有限公司（以下简称"智飞龙科马"）研发的四价流 感病毒裂解疫苗（ZFA02 佐剂）（以下 ...

Industry Overview - The vaccine industry is experiencing a significant decline in 2024 and the first quarter of 2025, with total revenue dropping from 1,637 billion in 2023 to 1,283 billion in 2024, marking a year-on-year decrease of 21.6%, the first negative growth in five years [1] - Net profit in the industry has decreased from a peak of 309 billion in 2021 to 120 billion in 2024, a reduction of 61%, with profit margins declining from 21.7% in 2021 to 9.4% in 2024, indicating increased cost pressures [1] Company Performance - Leading companies show significant performance divergence; TianTan Bio and Tibet Pharmaceutical have reported growth, with TianTan Bio achieving 60 billion in revenue for 2024, a 17.6% increase, and a net profit of 15 billion, up 36.4% [3] - In contrast, Zhifei Biological and Wantai Biological have faced substantial declines due to intensified competition in the HPV vaccine market, with Zhifei's revenue plummeting from 529 billion in 2023 to 260 billion in 2024, a 50.8% drop, and net profit falling from 80 billion to 20 billion, a 75% decrease [3] - Wantai Biological's net profit decreased from 47 billion in 2022 to approximately 1 billion in 2024, with a drop in gross margin from 89% to 66% [3] Cost and Profitability Trends - The median sales expense ratio in the industry has increased from 48% in 2020 to 58% in 2024, with over half of the companies exceeding a 50% expense ratio [3] - Changchun High-tech's sales expense ratio rose from 44% in 2023 to 57% in 2024, with net profit margin declining from 31% to 18.7% [3] - Kanghua Biological maintained a high gross margin of 93%, but its expense ratio increased from 47% to 54%, leading to a decrease in net profit margin from 33% to 21% [3] Vaccine Approval Trends - In 2024, most vaccine varieties saw a decline in batch approvals, with Zhifei Biological's HPV vaccines experiencing significant drops in approvals, including a 95% decrease for the four-valent HPV vaccine [4] - The first quarter of 2025 showed a mixed performance in vaccine approvals, with the recombinant herpes vaccine seeing a 54% decline in batch approvals, while the two-valent HPV vaccine saw a 367% increase [4] Specific Vaccine Performance - Rabies vaccines showed good overall approval growth, with Vero cell rabies vaccines achieving 199 batch approvals, a 24% increase [5] - The flu vaccine approvals in the first quarter of 2025 saw a significant increase of 500%, with the three-valent flu vaccine experiencing a 1300% increase in approvals [5] - The 13-valent pneumonia vaccine approvals remained stable, while the 23-valent pneumonia vaccine saw a 71% decline [5]

Core Insights - The vaccine industry is currently facing significant challenges due to suboptimal vaccination rates, leading to decreased revenues for vaccine companies [1][2] - In 2024, out of 14 listed vaccine companies in the A-share market, 12 reported a decline in net profit attributable to shareholders [2] - By the first quarter of 2025, 8 companies continued to experience a decline in net profit, with some companies reporting over an 80% drop [2] Company Performance - Wantai Biological Pharmacy achieved a revenue of 401 million yuan in Q1 2025, a year-on-year decrease of 46.76%, and reported a net loss of 52.78 million yuan [2][3] - Wantai attributed its revenue decline to market adjustments, government procurement policies, and lower-than-expected sales of the nine-valent HPV vaccine [2] - Wantai also recorded impairment losses totaling 51.33 million yuan in Q1 2025, primarily from accounts receivable and inventory [3] Impairment and Credit Losses - Wantai's impairment losses included 45.83 million yuan from accounts receivable and 549,780 yuan from inventory [3] - The increase in accounts receivable impairment was due to delayed payments from local disease control centers, which are affected by tight fiscal conditions [3] - Other companies, such as Zhifei Biological Products, reported a revenue drop of 79.16% in Q1 2025, with a net loss of 305 million yuan [4] Industry Challenges - The primary challenge for vaccine companies is to increase vaccination rates among the population, particularly for self-paid vaccines [5] - Vaccination rates for self-paid vaccines, including flu and HPV vaccines, remain low in China, often in single-digit percentages [5] - There is a need for better communication and education regarding the benefits of vaccination, especially among chronic disease patients [6]