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]

Core Viewpoint - The performance of several vaccine companies in China is significantly declining in 2024 due to industry policy adjustments, decreased public willingness to vaccinate, and changing market demands, leading to a challenging environment for the industry [1] Financial Performance - The average revenue of vaccine companies in 2024 is 7.131 billion yuan, down 21.63% from 9.099 billion yuan in 2023, while the average net profit is 788 million yuan, a decrease of 35.60% from 1.222 billion yuan in 2023 [1] - Companies like Zhifei Biological, Wantai Biological, and Hualan Biological reported revenue declines exceeding 50%, while Watson Biological, Baike Biological, and Jindike saw declines of over 30% [1] - Kangxino's revenue increased by over 130% due to its quadrivalent meningococcal conjugate vaccine, benefiting from the resolution of global public health events [1] Price Competition Impact - The price war among vaccine products, particularly HPV, influenza, and pneumonia vaccines, has severely impacted net profits, with Wantai Biological, Kangtai Biological, Hualan Biological, and Zhifei Biological experiencing declines of 91.49%, 76.59%, 76.10%, and 74.99% respectively [2] - Wantai Biological's revenue for 2024 is 2.245 billion yuan, down 59.25%, and its net profit is 106 million yuan, down 91.49% [6] - Watson Biological's revenue is 2.821 billion yuan, a decline of 31.41%, with a net profit of 142 million yuan, down 66.10% [6] Market Dynamics - The domestic vaccine market is becoming increasingly competitive, with many companies focusing on traditional products and facing challenges from product homogeneity and market saturation [3] - The overall vaccination rate in China is low, with only about 3% for influenza vaccines, indicating significant growth potential in the market despite current pressures [7] R&D and Innovation - Companies are increasing R&D investments, with Zhifei Biological investing 1.391 billion yuan in 2024, and several companies allocating over 20% of their revenue to R&D [8] - New vaccine technologies, including mRNA and DNA vaccines, are emerging, which could lead to breakthroughs in disease prevention and treatment [9] International Expansion - Many vaccine companies are pursuing international markets, with Kangxino and Baike Biological successfully exporting products to various countries [10][11] - Watson Biological reported overseas revenue of 570 million yuan in 2024, a year-on-year increase of approximately 98% [11] - The global human vaccine market is projected to grow significantly, with emerging markets providing opportunities for Chinese vaccine companies due to their competitive pricing [12][13]

以下文章来源于MedTrend医趋势 ，作者更多精彩资讯 MedTrend医趋势 . 关注我们，带你洞见医疗的未来！MedTrend医趋势——专注于医疗医药、生命科学、医院领域，为您 提供及时、实用的热点资讯、市场概况、行业趋势等精彩内容，旨在建设全面、周到、专业的信息分享 与交流平台。 作者 | MedTrend医趋势 来源 | MedTrend医趋势 导语 ：没有任何一个赛道能逃过中国的内卷。 默沙东应该急了。 4月24日，默沙东公布2025 Q1业绩，总体营收小幅下锉，主要原因是两大支柱产品全球药王K药和 HPV疫苗佳达修（Gardasil/Gardasil 9）都未及销售预期。 另外两个数字则惨烈得多——佳达修Q1销售额仅为13.27亿美元，同比大幅下滑41%；其中，默沙 东中国区收入同比下滑62%至6.68亿美元，在默沙东全球的业务份额降至不足5%，跌幅远超公司平 均水平。 | | 2025 | | | 2024 | | | % Change | | --- | --- | --- | --- | --- | --- | --- | --- | | | 10 | 10 | 20 | 3Q | 40 ...

Core Viewpoint - The HPV vaccine market is experiencing a significant downturn, with major player Zhifei Biological reporting a drastic decline in revenue and profit, indicating a challenging environment for the industry moving forward [1][2]. Financial Performance - Zhifei Biological's total revenue for 2024 was 26.07 billion yuan, a decrease of 50.74% year-on-year, while net profit fell by 74.99% to 2.018 billion yuan [1]. - The company's operating cash flow turned negative for the first time, reaching -4.414 billion yuan, and the debt-to-asset ratio increased to 62.3%, the highest in five years [1]. - In Q1 2025, Zhifei's revenue continued to plummet by 79.16% to 2.374 billion yuan, with a net loss of 305 million yuan, marking three consecutive quarters of losses [1]. Market Dynamics - The demand for HPV vaccines has sharply declined, leading to a supply-demand mismatch, exacerbated by Zhifei's decision to increase inventory levels despite a surplus in 2023 [2]. - As of the first three quarters of 2024, Zhifei's inventory reached 20.693 billion yuan, with accounts receivable at 21.393 billion yuan, indicating significant financial strain [2]. - Merck announced a suspension of supply for the four-valent and nine-valent HPV vaccines to China, expected to last until mid-year, which reflects a strategic adjustment in response to high inventory levels [2]. Competitive Landscape - The entry of domestic HPV vaccines is accelerating, with several companies like Wantai Biological and Watson Bio preparing to launch their products in 2025, which could further pressure the market [2]. - The pricing structure for HPV vaccines is being challenged, with high-priced vaccines seeing reduced demand and local governments pushing for free vaccination programs [3]. Strategic Shifts - In response to the industry challenges, Zhifei Biological is attempting to transition from a distributor to an innovative enterprise, with a 14.98% increase in revenue from self-developed vaccines, although this still only accounted for 4.53% of total revenue [5]. - The company has made a strategic acquisition of a 51% stake in Changan Biological for 593 million yuan, focusing on diabetes and obesity treatments, which may provide new growth avenues [6][7]. Research and Development - Zhifei's R&D investment for 2024 was 1.23 billion yuan, representing only 4.7% of total revenue, significantly lower than the 15%-20% standard of international vaccine giants [7]. - The company is developing a diverse pipeline of vaccines, including those for meningitis, influenza, pneumonia, tuberculosis, rabies, and norovirus [7].

Core Viewpoint - The Chinese vaccine industry is facing unprecedented challenges in 2024, with significant declines in market value and vaccine issuance, leading to a search for recovery strategies amidst a harsh environment [1] Group 1: Market Dynamics - The total market value of 11 A-share vaccine companies is less than the peak value of Zhifei Biological three years ago [1] - The issuance of HPV vaccines has plummeted by over 60%, while flu and rabies vaccines are embroiled in price wars [1] - The strategy of "exchanging price for volume" has failed, leading to high inventory pressures and cash flow issues for companies [1] Group 2: Structural Challenges - The industry faces a dual challenge of oversupply in low-end markets and a lack of high-end products, with over 10 companies competing in the rabies and flu vaccine markets [2] - High-end vaccines like shingles and multi-valent vaccines are still dominated by foreign companies such as GSK [2] - Companies are caught in a dilemma of high R&D costs, long return cycles, and rapid market changes [2] Group 3: Strategies for Survival - Companies are increasing investment in multi-valent vaccines, with Watson Bio and Kangtai Bio leading the charge [3] - Zhifei Biological is building a product matrix to reduce dependency on single products, while Kangtai Bio is developing 13 pipeline products [3] - Collaborations for international market access, such as Kanghua Bio's partnership with HilleVax, are emerging as a survival strategy for smaller firms [3] Group 4: Future Outlook - The current dark period for the vaccine industry may serve as a starting point for value reassessment [4] - Companies that possess strong technology, diverse product portfolios, and global market access are likely to survive the supply-side cleansing [4] - The potential for Chinese vaccine companies to develop world-class products will determine the industry's future [4]

Core Viewpoint - The vaccine industry is undergoing significant adjustments, and the company is focusing on high R&D investment, risk mitigation, and diversified business layout to navigate through the industry volatility and share in the market recovery benefits [1][2]. Financial Performance - In 2024, the company achieved operating revenue of 26.07 billion yuan and a net profit attributable to shareholders of 2.018 billion yuan; in Q1 2025, the operating revenue was 2.374 billion yuan [2]. - The company's self-developed product revenue reached 1.182 billion yuan in 2024, a year-on-year increase of 14.98%; the net cash flow from operating activities in Q1 2025 was 304 million yuan, up 107.12% year-on-year [3]. - The accounts receivable balance decreased from 27.059 billion yuan at the beginning of 2024 to 14.645 billion yuan in Q1 2025, addressing a common industry issue [3]. R&D Investment and Product Pipeline - The company invested 1.391 billion yuan in R&D in 2024, with the number of R&D personnel increasing to 1,072, and cumulative R&D investment exceeding 5.1 billion yuan over the past five years [3]. - Significant progress has been made in self-developed pipelines, including the approval of the quadrivalent influenza virus split vaccine and the acceptance of production registration applications for the freeze-dried human rabies vaccine and trivalent influenza virus split vaccine [3][4]. Market Strategy and Risk Mitigation - The company has optimized its strategic cooperation with GlaxoSmithKline (GSK) to enhance flexibility in procurement and supply of the shingles vaccine, extending exclusive rights until the end of 2034 [5][6]. - Adjustments in collaboration with Merck have been made to phase the delivery schedule based on consumer demand, improving supply chain efficiency and risk resilience [6]. - The company has taken significant steps to gain control over Chanan Bio, expanding its pipeline in GLP-1 and insulin analogs to mitigate single-business risks [6][7]. Global Expansion - The company is actively pursuing overseas clinical trials and registrations, with products like the tuberculosis diagnostic reagent "Yika" approved in Indonesia and the 23-valent pneumonia vaccine receiving GMP certification in the Philippines [7].

Core Viewpoint - The financial report for 2024 reveals that Zhifei Biological (300122) experienced a significant decline in both revenue and net profit, attributing the downturn to decreased public vaccination willingness and changing market demands [1][2]. Financial Performance - Revenue for 2024 was 26.07 billion yuan, a year-on-year decrease of 50.74%, while net profit was 2.018 billion yuan, down 74.99% [2]. - The company has reported losses for three consecutive quarters, with losses of 83.6964 million yuan and 132 million yuan in the third and fourth quarters, respectively, and a loss of 305 million yuan in the first quarter [2]. - The revenue contribution from agency products accounted for 94.61% of total revenue, with the annual procurement amount from Merck for HPV vaccines being 26.377 billion yuan, representing 86.94% of the total procurement [3]. Market Dynamics - The market for HPV vaccines has become increasingly competitive, with the supply of four-valent and nine-valent HPV vaccines rising, leading to a decline in their issuance by 95.49% and 14.80%, respectively [4]. - The procurement agreements with Merck for HPV vaccines have been adjusted, indicating a forecasted peak in sales for 2024, followed by a gradual decrease in procurement amounts [4]. - The company has also signed a supplementary agreement with GlaxoSmithKline (GSK) to extend the cooperation period for shingles vaccines while adjusting the procurement plan, resulting in a lower average annual procurement amount [5]. Operational Challenges - The company is facing challenges with inventory and accounts receivable turnover, with inventory turnover days increasing to 296.69 days and accounts receivable turnover days reaching 299.18 days [7]. - Despite a 35.27% increase in vaccine sales, production volume decreased by 52.28%, leading to a 13.20% reduction in vaccine inventory [7]. R&D and Future Outlook - Zhifei Biological has invested 1.391 billion yuan in R&D for 2024, with total R&D investment exceeding 5.1 billion yuan over the past five years, although the contribution from self-developed products remains limited at 1.182 billion yuan, accounting for only 4.53% of total revenue [8]. - The company is exploring international markets, with its tuberculosis diagnostic reagent approved for sale in Indonesia and use in Macau, although exports currently represent only 0.07% of total revenue [8].