FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 艾美疫苗股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 呈交日期: 2025年8月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06660 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 507,673,711 | RMB | | 1 RMB | | 507,673,711 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 507,673,711 | RMB | | 1 RMB | | 507,673,711 | | 2 ...

Group 1 - The National Healthcare Security Administration announced that drug procurement will no longer simply reference the lowest bid, indicating a shift in policy that could benefit companies with strong quality systems and cost advantages [1] - The recent announcement led to a significant increase in Hong Kong's biopharmaceutical stocks, particularly in the vaccine sector, with notable gains for companies such as Ai Mei Vaccine (+13.5%) and CanSino Biologics (+9.03%) [1] - The 11th batch of centralized procurement has been initiated, with new rules optimizing the calculation of price differences and requiring transparency from the lowest bidders regarding the rationality of their pricing [1] Group 2 - The vaccine sector has shown remarkable performance due to multiple favorable factors, including a warning from the World Health Organization regarding mosquito-borne diseases, which has boosted market sentiment [2] - Ai Mei Vaccine has successfully commercialized eight vaccines, including leading products like rabies and hepatitis B vaccines, and has a robust pipeline of 21 vaccines in development, with three key products nearing market launch [2] - The vaccine sector is seen as having significant potential for valuation recovery, as many companies' pipeline values have not yet been fully reflected in their market valuations [2]

Group 1 - The majority of Hong Kong pharmaceutical stocks are experiencing declines, with Hansoh Pharmaceutical falling over 4% [1] - Hansoh Pharmaceutical (03692.HK) decreased by 4.45%, while other companies like Aimeijia Vaccine (06660.HK) and CSPC Pharmaceutical Group (01093.HK) also saw significant drops of 3.98% and 2.72% respectively [1] - Kanglong Chemical (03759.HK) reported a decline of 1.83%, indicating a broader trend of weakness in the sector [1]

Group 1 - The company has received clinical trial approval for its mRNA shingles vaccine from the National Medical Products Administration, following FDA approval for clinical trials in March 2025, demonstrating the strength of its mRNA technology platform [1] - The mRNA shingles vaccine shows significantly higher specific T cell immunity, specific IgG antibody titers, and fluorescent antibody titers compared to international recombinant subunit vaccine controls in preclinical trials [1] Group 2 - Shingles is caused by the reactivation of the varicella-zoster virus, with an infection rate of over 90% in adults, and the incidence rate is increasing by 2.5% to 5.0% annually [2] - Vaccination against shingles is an effective measure to prevent the disease and its complications, with a target to inhibit the reactivation of the virus [2] Group 3 - Currently, there are no approved mRNA shingles vaccines globally, and the vaccination rate in the target population in China is less than 1%, indicating significant growth potential [3] - The global sales of GSK's shingles vaccine are projected to be approximately $4.31 billion in 2024, with the market size in China expected to reach around RMB 20 billion by 2030 [3] - The company is one of the earliest developers of mRNA vaccines in China, with a mature mRNA vaccine R&D system and a complete industrialization process, enabling rapid commercialization post-clinical trials [3] - The company aims to focus on key technologies of the mRNA platform and accelerate the development and registration of new products to enhance its innovation capability and competitiveness [3]

Financial Performance - The company achieved a total revenue of approximately RMB 1,285.0 million for the year ending December 31, 2024, representing an increase of 8.2% compared to RMB 1,187.5 million in 2023[28]. - The company's main business revenue for 2024 was RMB 1,285.0 million, an increase of RMB 97.5 million or 8.2% compared to RMB 1,187.5 million in 2023, primarily driven by sales growth in hepatitis B, hepatitis A, and quadrivalent meningococcal vaccines[72]. - Sales revenue from Class I vaccines reached RMB 140.2 million in 2024, up from RMB 72.8 million in 2023[29]. - Sales revenue from Class II vaccines was RMB 1,121.3 million in 2024, slightly increasing from RMB 1,114.7 million in 2023[29]. - Gross profit for 2024 was RMB 953.5 million, an increase of RMB 52.5 million or 5.8% from RMB 901.0 million in 2023, with a gross margin of 74.2%, down from 75.9% in 2023[75]. - Other income and gains decreased to RMB 32.8 million in 2024, down RMB 18.8 million or 36.4% from RMB 51.6 million in 2023, primarily due to reduced government subsidies and bank interest income[76]. - Research and development expenses for 2024 were RMB 363.1 million, a decrease of RMB 273.3 million or 42.9% from RMB 636.4 million in 2023, mainly due to reduced overseas clinical trial expenses[78]. - Selling and distribution expenses increased to RMB 542.7 million in 2024, up RMB 48.7 million or 9.9% from RMB 494.0 million in 2023, due to enhanced marketing activities for vaccine products[79]. - Administrative expenses rose to RMB 282.7 million in 2024, an increase of RMB 28.4 million or 11.2% from RMB 254.3 million in 2023, primarily due to increased depreciation and amortization costs[81]. - The company reported a loss of RMB 278.4 million in 2024, a decrease of RMB 1,671.8 million or 85.7% from a loss of RMB 1,950.2 million in 2023, attributed to the absence of significant impairment losses on intangible assets and goodwill[86]. Vaccine Development and Innovation - The company is focusing on the development of iterative vaccines, including rabies, pneumonia, and mRNA vaccines, with a significant product matrix ready for launch[10]. - The rabies vaccine series includes the world's first serum-free rabies vaccine, which has received production approval and is in the final stages of market entry[11]. - The 23-valent polysaccharide pneumonia vaccine is in the III clinical trial phase, while the 13-valent conjugate pneumonia vaccine has received production approval and is also nearing market entry[11]. - The mRNA RSV vaccine has received clinical trial approval in both China and the U.S., and the mRNA shingles vaccine has also been approved for clinical trials in the U.S.[11]. - The company has developed 21 major vaccine products covering the top 10 global vaccines, positioning itself as an industry innovator[15]. - The focus on iterative vaccine development is seen as the true growth engine for the company's future, representing a significant transformation and renewal[16]. - The company emphasizes that innovation is the only path forward amidst risks and challenges in the market[18]. - The company is committed to expanding its market presence and leveraging innovative strategies to ensure long-term sustainability[16]. - The company has established a strong foundation for future growth through its commitment to research and development in the vaccine sector[12]. - The company has 21 vaccine products in the research pipeline, with 13-valent pneumococcal conjugate vaccine and serum-free iterative rabies vaccine having completed Phase III clinical trials and submitted for market registration[23][24]. - The company has obtained 20 clinical approvals and is actively pursuing international market expansion, with products like the freeze-dried rabies vaccine and quadrivalent meningococcal vaccine entering markets in countries such as Pakistan and Egypt[24][27]. - The new generation mRNA technology platform has received clinical approval for mRNA shingles vaccine and mRNA respiratory syncytial virus vaccine in the US, with the latter also approved in China[23][27]. - The company is focusing on temperature monitoring products for vaccines to enhance safety and quality management, catering to diverse customer needs[28]. - The company is actively developing a series of upgraded rabies vaccines through continuous technological innovation[44]. - The mRNA technology platform has been validated through clinical trial data from over 10,000 subjects, confirming the safety and efficacy of the mRNA rabies vaccine, which shows significant reductions in vaccination doses and faster production of neutralizing antibodies compared to traditional vaccines[45]. - The quadrivalent meningococcal conjugate vaccine (MCV4) has completed all basic phase vaccinations in the II clinical trial, targeting high-risk infants under 12 months[49]. - The EV71-CA16 bivalent hand-foot-mouth disease vaccine is the first of its kind aimed at providing immunity against both EV71 and CA16 strains, with clinical approval already obtained[50]. - The company possesses five validated human vaccine platform technologies, including mRNA and genetic engineering vaccines, enabling the development of stable and scalable vaccine products[51]. Market Trends and Opportunities - The Chinese vaccine market (excluding COVID-19 vaccines) grew from RMB 85.07 billion to RMB 101.77 billion from 2022 to 2023, representing a year-on-year growth of 19.6%[56]. - The pneumonia vaccine market in China reached RMB 10.75 billion in 2022, with a projected compound annual growth rate of 22.7%, expected to reach RMB 24 billion by 2025[61]. - The market potential for the 13-valent pneumococcal conjugate vaccine in China is expected to exceed RMB 20 billion by 2030, with a penetration rate of 25.9% for the approved age group[40]. - The company has identified a global shortfall of 180 million doses for the 13-valent pneumococcal conjugate vaccine, positioning itself as a key supplier post-launch[41]. - The market size for rabies vaccines in China is expected to reach RMB 22 billion by 2030, driven by the increasing awareness of high-quality vaccine uptake and economic growth[62]. - The market share of serum-free rabies vaccines in China is projected to be approximately 35.0% by 2030, due to their stable components and higher safety[62]. - The mRNA rabies vaccine is anticipated to capture about 21.2% of the Chinese market by 2030, offering significant advantages in immunization efficiency and production simplicity[62]. - The RSV vaccine market in China is expected to exceed RMB 15.4 billion by 2030, with strong demand due to the absence of approved RSV vaccines[63]. - The global market for shingles vaccines is projected to reach USD 23.9 billion by 2030, with China's market expected to approach RMB 20 billion due to low current vaccination rates[64]. - The total market size of China's vaccine industry grew by RMB 61.7 billion from 2015 to 2022, with a compound annual growth rate of approximately 19.4%[65]. - By 2030, the vaccine industry in China is forecasted to grow at a compound annual growth rate of 12.3%, reaching approximately RMB 220.3 billion[65]. Corporate Governance and Management - The company has a management team with extensive experience in the biopharmaceutical industry, including investment and management roles[106]. - The company has appointed several key executives with significant backgrounds in investment management and financial services to strengthen its leadership team[110][111]. - The company emphasizes internal control systems and risk management effectiveness, as highlighted by Pei's role as chairman of the audit committee[119]. - The board includes members with significant experience in investment banking and corporate finance, which supports the company's growth strategies[120][125]. - The company is committed to maintaining high standards of corporate governance and transparency in its financial reporting[137]. - The management team has a diverse background in various industries, contributing to a well-rounded approach to business strategy and market expansion[136]. - The company has a strong board with members holding advanced degrees in finance and management, enhancing its strategic decision-making capabilities[131][132][133][134]. - The company is focused on enhancing its operational efficiency and strategic decision-making through experienced board members and executives[110][112]. - The company has a comprehensive quality management system in place, overseen by the Chief Quality Officer since April 2022[143]. Shareholder Information - As of December 31, 2024, the company's total issued share capital consists of 1,211,062,599 shares, with 59.36% being domestic shares and 40.64% being H shares[158]. - The company does not plan to declare a final dividend for the twelve months ending December 31, 2024[150]. - The company has established a dividend policy that considers financial performance, cash flow, business conditions, and future operational needs[161][162]. - The employee stock incentive plan was adopted on November 30, 2020, and revised on February 16, 2022, with a maximum issuance of 12,106,666 shares, representing approximately 1% of the total share capital as of the report date[194]. - As of January 1, 2024, 78 participants, including 4 senior management members, were granted options to purchase a total of 3,351,000 shares under the incentive plan[195]. - The exercise price for the options is set at RMB 6.98 per share, with adjustments possible due to dividends, stock splits, or capital restructuring[194]. - The total number of options exercised during the year was zero, with 3,006,000 options expiring and 345,000 options canceled due to employee resignations[196]. - The options granted to senior management included 120,000 shares each for two individuals and 90,000 shares each for two others, all of which were unexercised by year-end[196]. - The company aims to align the interests of option holders with those of shareholders to promote sustainable and long-term development[194].

Core Insights - The company has been focusing on vaccine innovation for 14 years, achieving significant milestones in mRNA vaccine development and aiming for a specialized market approach [1] - The company believes that focusing on iterative vaccine series development will be the true growth engine for the future [1] Group 1: Company Overview - The company was established in 2011 and specializes in the research, production, and sales of human vaccines [1] - It became the second-largest vaccine company in China by market share, holding 7.4% as of 2021, excluding COVID-19 vaccines [1] - The company's flagship product, the freeze-dried human rabies vaccine, has maintained a 100% pass rate in quality audits for several years [1] Group 2: Rabies Vaccine Development - The company has received clinical trial approval for its high-efficacy human diploid rabies vaccine, which overcomes traditional production limitations [2] - The new vaccine shows significantly higher antibody levels compared to existing market products under the same dosage conditions [2] - The company is exploring innovative immunization schedules to enhance patient compliance, which could provide a competitive edge in a crowded market [2] Group 3: mRNA Vaccine Focus - The company is one of the earliest developers of mRNA vaccines in China, with multiple products approved for clinical trials, including mRNA rabies and RSV vaccines [4] - It has established a comprehensive mRNA vaccine development and production lifecycle, supported by proprietary technology [4] - The company is leveraging AI to enhance vaccine design and stability, aiming to optimize mRNA sequences for better efficacy [4][5]

Core Viewpoint - The company reported a revenue of approximately 1.285 billion yuan for 2024, marking an 8.2% year-on-year increase, driven by sales growth in hepatitis B, hepatitis A, and quadrivalent meningococcal vaccines [1] Financial Performance - Revenue for 2024 was approximately 1.285 billion yuan, up 8.2% year-on-year - Gross profit was about 953.5 million yuan, reflecting a 5.8% increase year-on-year - Net loss narrowed to approximately 278 million yuan, a reduction of 85.7% year-on-year - Net cash inflow from operating activities was nearly 100 million yuan [1] Research and Development - R&D expenditure was 363 million yuan, down 42.9% year-on-year, primarily due to reduced overseas clinical trial costs - The company has completed Phase III clinical trial site work for its serum-free rabies vaccine and 23-valent pneumococcal polysaccharide vaccine, with the former already submitted for market registration [1] - The company is actively pursuing international market registrations for its products in Southeast Asia, Africa, South America, and the Middle East [1] Product Pipeline and Market Strategy - The company is advancing its product pipeline in line with international market demands, focusing on high-priority vaccines such as the 13-valent pneumococcal conjugate vaccine and quadrivalent meningococcal conjugate vaccine [2] - The company is also developing vaccines for respiratory syncytial virus and shingles, which are in high demand in international markets [2] - Existing products like hepatitis A, hepatitis B, and rabies vaccines are prioritized by the World Health Organization and are well-received in international markets [2] Production Capacity - The GMP workshops for iterative pneumonia and rabies vaccines have been completed in phases, meeting international standards - Clinical trial samples and process validation samples for the 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, and serum-free rabies vaccine are produced in these workshops, ensuring readiness for international market entry [3]

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 1,285,031 thousand, representing an increase of 8.2% compared to RMB 1,187,468 thousand in 2023[4] - Gross profit for the same period was RMB 953,508 thousand, up 5.8% from RMB 901,016 thousand in 2023[4] - Loss attributable to equity holders of the parent company significantly decreased to RMB 277,234 thousand, a reduction of 78.7% from RMB 1,301,005 thousand in the previous year[4] - The company reported a net loss of RMB 278,469 thousand for the year, compared to a net loss of RMB 1,950,241 thousand in 2023[5] - Other income and gains for the year ended December 31, 2024, totaled RMB 32,847 thousand, a decrease of 36.4% from RMB 51,658 thousand in 2023[43] - Financing costs for the year ended December 31, 2024, amounted to RMB 60,796 thousand, an increase of 38.7% compared to RMB 43,832 thousand in 2023[44] - The group reported a pre-tax loss of RMB 290,718 thousand for the year ended December 31, 2024, significantly improved from a loss of RMB 2,270,645 thousand in 2023[50] - The company’s income tax expense for 2024 was RMB 12.2 million, a decrease of RMB 308.2 million or 96.2% compared to RMB 320.4 million in 2023, primarily due to a reduction in pre-tax losses[125] - The company's loss for 2024 was RMB 278.4 million, down RMB 1,671.8 million or 85.7% from RMB 1,950.2 million in 2023, mainly due to the absence of significant impairment losses on intangible assets and goodwill, along with an increase in revenue[126] Assets and Liabilities - Total non-current assets as of December 31, 2024, amounted to RMB 4,926,924 thousand, an increase from RMB 4,779,059 thousand in 2023[8] - Current assets totaled RMB 2,387,397 thousand, a decrease from RMB 2,482,936 thousand in the previous year[8] - Total current liabilities increased to RMB 3,090,268 thousand from RMB 2,601,899 thousand in 2023, indicating a rise in short-term financial obligations[8] - The company’s cash and cash equivalents were RMB 494,265 thousand, down from RMB 583,143 thousand in 2023, reflecting liquidity challenges[8] - As of December 31, 2024, the net current liabilities of the group amounted to RMB 702,871,000, a significant increase from RMB 118,963,000 as of December 31, 2023[15] - Total assets less current liabilities were reported at RMB 4,224,053,000, down from RMB 4,660,096,000 in the previous year[15] - The total non-current liabilities decreased to RMB 612,945,000 from RMB 770,519,000 year-over-year[15] - The net asset value of the company was RMB 3,611,108,000, compared to RMB 3,889,577,000 in 2023, indicating a decline[15] - The company has a total equity of RMB 3,611,108,000, which includes RMB 1,211,063,000 in share capital and RMB 2,154,457,000 in reserves[15] Research and Development - Research and development expenses were RMB 363,126 thousand, down from RMB 636,401 thousand in 2023, indicating a strategic focus on cost management[5] - The company has 21 vaccine products in the research pipeline, with 13-valent pneumococcal conjugate vaccine and non-serum iterative rabies vaccine having completed Phase III clinical trials[69] - The company has submitted registration applications for the 13-valent pneumococcal conjugate vaccine and non-serum iterative rabies vaccine to the National Medical Products Administration[64] - The company has received clinical trial approvals for four products from the National Medical Products Administration, including mRNA RSV vaccine and iterative high-efficiency rabies vaccine[65] - The company is actively expanding into international markets, with plans to introduce freeze-dried rabies vaccine and quadrivalent meningococcal vaccine in countries like Pakistan and Egypt[65] - The company has launched a series of temperature monitoring products for vaccines to enhance quality management and market competitiveness[66] - The company has established a centralized marketing model to optimize sales efficiency and achieve high cost-effectiveness[67] - The company has a robust pipeline of vaccines, including a six-valent meningococcal vaccine and an mRNA rabies vaccine, currently in various stages of development[79] Market and Sales - Vaccine sales accounted for RMB 1,261,446 thousand of total revenue, up from RMB 1,187,468 thousand in the previous year[41] - Revenue from mainland China was RMB 1,278,217 thousand, representing a growth from RMB 1,187,468 thousand in 2023[38] - The company reported no single customer contributing more than 10% of total revenue for the year[39] - Sales revenue from Class I vaccines reached RMB 140.2 million in 2024, up from RMB 72.8 million in 2023[68] - Sales revenue from Class II vaccines was RMB 1,121.3 million in 2024, slightly increasing from RMB 1,114.7 million in 2023[68] - The pneumonia vaccine market in China reached RMB 10.75 billion in 2022, projected to grow at a CAGR of 22.7% to RMB 24 billion by 2025[101] - The market for rabies vaccines in China is expected to grow to RMB 22 billion by 2030, driven by increased awareness and economic growth[102] - The Chinese vaccine market (excluding COVID-19 vaccines) grew from RMB 85.07 billion to RMB 101.77 billion between 2022 and 2023, representing a year-on-year increase of 19.6% driven by the launch of innovative vaccine products[96] Corporate Governance and Structure - The company was established on November 9, 2011, and is a limited company registered in China[153] - The board of directors includes both executive and non-executive members, ensuring diverse governance[158] - The audit committee, consisting of three independent non-executive directors, reviewed the group's performance for the year ending December 31, 2024[146] - The company has undergone GMP inspections and holds valid production licenses for its manufacturing facilities[155] Future Outlook and Strategy - The company plans to continue focusing on market expansion and new product development to drive future growth[5] - The company plans to accelerate the commercialization of key products such as the 13-valent pneumonia combined vaccine and the rabies vaccine, leveraging its proprietary mRNA technology platform[111] - The company is actively developing high-priority vaccine products, including a 13-valent pneumonia combined vaccine and a quadrivalent meningococcal vaccine, in line with international market demands[108] - The company has established an international business department to accelerate its globalization efforts, preparing for overseas market entry and product registration[107] - The company aims to focus on unmet clinical needs in core disease areas to enhance innovation capabilities and competitiveness[89]

艾美疫苗mRNA带状疱疹疫苗获美国FDA批准开展 临床 其体液免疫、细胞免疫显著高于国际市售重组 亚单位疫苗产品 艾美疫苗mRNA带状疱疹疫苗已于近日获得美国食品和药品监督管理局 (FDA)临床试验许可，这是继 mRNA RSV疫苗后，本集团第二款获得美国FDA批准进入临床试验的创新疫苗产品，标志着本集团国 际化战略取得新的里程碑。 临床前试验中，第三方检测单位的检测结果显示：本集团mRNA带状疱疹疫苗特异性T细胞免疫、特异 性IgG抗体滴度、膜抗原荧光抗体(FAMA) 滴度，均显著高于国际市售重组亚单位对照疫苗。 带状疱疹（herpes zoster）是由长期潜伏在人体内的水痘-带状疱疹病毒（varicella-zoster virus，VZV） 经再激活引起的感染性皮肤病。人群对VZV普遍易感，血清学证据显示，成人VZV感染率高达90%以 上。带状疱疹的发病率为3‰~5‰ 人/年，亚太地区为3‰~10‰ 人/年，并逐年递增2.5% ~ 5.0%。VZV再 活化的危险因素包括：高龄、创伤、全身性疾病（如糖尿病、肾病、发热、高血压等）、人类免疫缺陷 病毒（HIV）感染、恶性肿瘤等导致的免疫抑制等。50岁后随年 ...

Core Viewpoint - The company aims to enhance its vaccine development and production processes by integrating the DeepSeek AI model across its entire business operations, focusing on cost reduction, quality improvement, and efficiency enhancement throughout the vaccine lifecycle [1][2][5]. Group 1: AI Integration in Operations - The company is fully integrating the DeepSeek AI model into its research, production, sales, and management processes, aiming to create an intelligent vaccine development system [2]. - By utilizing DeepSeek, the company plans to optimize mRNA vaccine sequence design and stability, improving the efficiency and quality of vaccine candidates [2][3]. - The integration of DeepSeek with clinical trial management systems is expected to streamline data collection and analysis, reducing clinical trial cycles while enhancing data accuracy and compliance [3]. Group 2: Production and Quality Management - The deployment of DeepSeek will enhance production and quality management by integrating with MES, LIMS, and SCADA systems, allowing for deep learning on production and inspection data [3]. - The company aims to build predictive models for production and quality inspection management, optimizing production processes and reducing energy consumption [3]. Group 3: Marketing and Management Enhancements - The integration of DeepSeek with CRM systems will improve data analysis efficiency and market data prediction, supporting strategic development and operational management [4]. - The company is also enhancing its management capabilities by building an enterprise-level knowledge base through the DeepSeek integration [4]. Group 4: Global Strategy and Market Potential - The company is advancing its global strategy by developing its mRNA vaccine pipeline, with the mRNA shingles vaccine recently submitted for clinical trials in the U.S. [5]. - Clinical trials have shown that the company's mRNA shingles vaccine has significantly higher immune response metrics compared to existing recombinant subunit vaccines [5]. - The global market for shingles vaccines is projected to reach approximately $23.9 billion by 2030, indicating substantial growth potential for the company’s mRNA shingles vaccine [5]. Group 5: Company Position and Future Outlook - The company is recognized as one of the earliest developers of mRNA vaccines in China, with a robust R&D system and a diverse product matrix [6]. - The company has established a comprehensive marketing network across China and has successfully exported vaccines to countries like Pakistan and Tajikistan, showcasing strong international expansion potential [6]. - Future product launches, including innovative vaccines, are expected to drive significant growth and value re-evaluation for the company [6].