Core Insights - The biopharmaceutical sector is one of the fastest-growing areas in the pharmaceutical industry, driven by an aging population and increased public health awareness [1][5] - China's biopharmaceutical market is projected to grow from CNY 312 billion in 2019 to CNY 587.1 billion in 2024, and is expected to reach CNY 675.2 billion by 2025, with a potential to hit CNY 1.149 trillion in the next five years [1][5][6] - Innovation remains the core driver of growth in the biopharmaceutical industry, which is capital-intensive and requires significant R&D investment [1][6] Industry Definition and Classification - Biopharmaceuticals are medical products manufactured using biological methods, aimed at replicating the activity of natural substances [2][4] - They can be categorized into vaccines, blood products, biopharmaceutical drugs, diagnostic reagents, and others, with further subdivisions based on source or mechanism of action [2] Current Industry Status - The global biopharmaceutical market is expected to grow from USD 286.4 billion in 2019 to USD 461.6 billion in 2024, with the original biopharmaceutical market projected to increase from USD 268.9 billion to USD 427.9 billion in the same period [5] - China plays a significant role in the global biopharmaceutical market, with rapid growth driven by favorable policies, increased R&D investment, and advancements in biotechnology [5][6] Industry Development Environment - Policies - The Chinese government has implemented various laws and policies to encourage biopharmaceutical R&D, including the Drug Registration Management Measures and regulations for clinical research and application of biomedical technologies [7] Competitive Landscape - The biopharmaceutical sector is recognized as a "new frontier" in the pharmaceutical industry, with major global players actively entering the market [9] - Key companies in China's biopharmaceutical industry include WuXi AppTec, Hengrui Medicine, ZhiFei Biological, BeiGene, and others, with a competitive landscape characterized by differentiated strategies [9] Future Development Trends - Market demand for biopharmaceuticals is expected to continue growing, supported by policy backing, technological advancements, and increased health awareness [10] - Domestic companies are transitioning from biosimilars to First-in-Class drugs, with examples like Hengrui Medicine's ADC drug showing superior efficacy [10][11] - Personalized medicine based on genetic testing is anticipated to become a trend, with increasing international recognition of Chinese innovative drugs [11]

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11月30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12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 | | ...

| 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 | 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10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11 ...

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 FF301 呈交日期: 2025年10月2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. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- ...

Investment Rating - The industry investment rating is "Overweight" and has been maintained from the previous rating [7] Core Viewpoints - The blood purification industry in China is experiencing stable growth driven by strong supply and demand dynamics, with a market size CAGR of 5.67% from 2019 to 2023, and an expected CAGR of 21.52% from 2023 to 2027 [10] - The report emphasizes the potential for domestic manufacturers to replace imports, focusing on large single products, diversification, and international expansion [10] Industry Overview - The blood dialysis market is expanding, with the number of ESRD patients rapidly increasing, leading to a steady rise in dialysis demand. The number of patients receiving blood and peritoneal dialysis in China grew from 579,000 and 95,000 in 2018 to 917,000 and 153,000 in 2023, respectively [10][30] - The market for blood dialysis devices and consumables is expected to continue growing, with the blood dialysis machine market projected to reach 8.17 billion RMB by 2030 [22] Supply and Demand Dynamics - The demand side is supported by the increasing number of ESRD patients and improved medical payment capabilities, while the supply side benefits from the growing number of domestic manufacturers and supportive industry policies [10][30] - The report highlights that the domestic market is still dominated by foreign brands, but local companies are gradually increasing their market share [43][47] Investment Recommendations - The report suggests focusing on companies with strong international potential, comprehensive product matrices, and competitive single products, such as Sanwa, Baolait, Weigao Blood Purification, and others [10][30] - The report identifies three main investment themes: international expansion, product matrix improvement, and strong single product competitiveness [10] Policy Support - A series of government policies have been introduced to support the blood purification industry, including funding, tax incentives, and industry planning, which are expected to drive demand growth [55][57] - The report notes that centralized procurement of blood purification consumables has been implemented, leading to significant price reductions [57]

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8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9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 | 因本公 ...

Core Viewpoint - The biotechnology sector in Hong Kong is experiencing a surge, with companies like Ai Mei Vaccine gaining significant attention due to their stable performance and innovative technologies [1] Group 1: Company Performance - Ai Mei Vaccine reported steady revenue growth for the first half of 2025, with key innovative products nearing market launch, leading to expectations of improved performance and valuation [1][2] - The company has four major innovative products entering the market, including the 13-valent pneumococcal conjugate vaccine, which has a significant market potential in China, projected to exceed RMB 20 billion by 2030 [2][3] Group 2: Product Development - Ai Mei Vaccine is advancing in the rabies vaccine sector with multiple products, including a serum-free rabies vaccine and an mRNA rabies vaccine, positioning itself as a leader in a market expected to reach RMB 20 billion by 2030 [3] - The company holds 20 vaccine candidates in development across 12 disease areas, with 23 clinical approvals and 24 clinical trials ongoing, including seven innovative vaccines [3] Group 3: Market Potential and Valuation - The 13-valent pneumococcal conjugate vaccine is anticipated to capture a significant market share, with a penetration rate in China estimated at 25.9%, compared to over 80% in the U.S., indicating substantial growth opportunities [2] - DBS Bank's report suggests that Ai Mei Vaccine's current stock price is at the lower end of its peers' valuation range, with a projected fair target price of HKD 8.3 per share by 2026, indicating a potential upside of nearly 600% [4]

Group 1 - The Hong Kong stock market's innovative pharmaceutical sector has significantly outperformed the market since 2025, with 49 biopharmaceutical companies seeing stock price increases exceeding 100% [1] - Among the top 10 companies with the highest stock price increases, all have seen their prices multiply several times [1] - The recent listing of Zhonghui Biotech has catalyzed a bullish trend in multiple biopharmaceutical stocks, including vaccine stocks [1] Group 2 - Aimei Vaccine (06660) reported steady revenue in its half-year report for 2025, with major products entering the market and reduced R&D expenses [2] - The company has 20 vaccine products in development across 12 disease areas, with a pipeline covering the top ten global vaccine products [2] - Aimei's mRNA technology platform has received international recognition, with two major vaccine products approved for clinical trials in both China and the U.S. [2] Group 3 - Aimei is advancing several key vaccine products towards market launch, including the 13-valent pneumococcal conjugate vaccine and a serum-free rabies vaccine [3] - The 13-valent pneumococcal conjugate vaccine has a significant market potential, with a global shortfall of 180 million doses [3] - The serum-free rabies vaccine represents a major technological upgrade, enhancing safety and reducing adverse reactions [3] Group 4 - DBS Bank maintains an optimistic outlook for Aimei, projecting a 39% reduction in R&D expenses following the completion of major clinical trials in 2025 [4] - The company is expected to achieve profitability in 2026, with a projected annual sales growth rate of 45% from 2025 to 2027 [4] - Aimei's vaccines demonstrate superior efficacy compared to competitors, reinforcing the company's R&D capabilities and market position [4]

Group 1 - The Hong Kong innovative drug sector has significantly outperformed the market since 2025, with 49 pharmaceutical companies seeing stock price increases exceeding 100% [1] - The recent listing of Zhonghui Biotech has catalyzed a bullish trend in multiple biopharmaceutical stocks, including vaccine companies [1] - Chinese innovative drug companies are actively developing original innovative drugs, which are expected to create sustainable overseas opportunities [1] Group 2 - Aimee Vaccine (06660) reported stable revenue in its semi-annual report for the first half of 2025, with reduced R&D expenses and optimized operating costs [1] - The company has 20 vaccine products in development across 12 disease areas, with a pipeline covering the top ten global vaccine products [1] - Aimee has received clinical approval for two mRNA vaccines in both China and the U.S., validating its innovative capabilities and global market strategy [2] Group 3 - Aimee Vaccine is leading in the mRNA technology field, with its platform validated through extensive clinical trials, ensuring safety and efficacy [2] - The company has several key vaccine products nearing market launch, indicating an upcoming performance improvement [2] - The 13-valent pneumococcal conjugate vaccine is one of the broadest vaccines available, with a significant global market gap of 180 million doses [3] Group 4 - The innovative drug sector in Hong Kong is experiencing a new wave of development opportunities, with Aimee Vaccine positioned for rapid performance improvement due to its innovative vaccine R&D capabilities [4] - The company's stock price has strong upward momentum driven by industry growth and its improving fundamentals [4]

[Company Information](index=3&type=section&id=Company%20Information) This section details changes in the company's board, supervisory committee, and key personnel, along with auditor and contact information [Directors, Supervisors, and Committee Members](index=3&type=section&id=Directors%2C%20Supervisors%2C%20and%20Committee%20Members) During the reporting period, the company's board, supervisory committee, and various committees saw multiple changes, including the resignations of Non-executive Director Ms. Wang Aijun and Independent Non-executive Director Mr. Ouyang Hui, and the appointments of Ms. Wen Jie, Mr. Jia Shaojun, and Mr. Zhou Xin to different committees - Non-executive Director Ms. Wang Aijun resigned on **April 13, 2025**[6](index=6&type=chunk) - Independent Non-executive Director Mr. Ouyang Hui resigned on **April 13, 2025**[6](index=6&type=chunk) - Ms. Wen Jie was appointed as a member of the Audit Committee and Nomination Committee on **April 17, 2025**[6](index=6&type=chunk) - Mr. Jia Shaojun and Mr. Zhou Xin were appointed as members of the Strategy Committee on **April 17, 2025**[6](index=6&type=chunk) [Company Secretary, Authorized Representatives, and Other Key Information](index=4&type=section&id=Company%20Secretary%2C%20Authorized%20Representatives%2C%20and%20Other%20Key%20Information) Changes occurred in the company's joint company secretary and authorized representatives, with Ms. Lam Wing Chi resigning and Ms. Wong Pui Kiu appointed; the company's auditor is Ernst & Young, and information on its registered office, headquarters, principal place of business in Hong Kong, H-share registrar, and principal bankers was disclosed - Joint Company Secretary Ms. Lam Wing Chi resigned on **June 13, 2025**, and Ms. Wong Pui Kiu was appointed[8](index=8&type=chunk) - Authorized Representative Ms. Lam Wing Chi resigned on **June 13, 2025**, and Ms. Wong Pui Kiu was appointed[8](index=8&type=chunk) - The company's auditor is **Ernst & Young**[8](index=8&type=chunk) - The company's stock code is **06660**, and its website is **www.aimbio.com**[10](index=10&type=chunk) [Management Discussion and Analysis](index=6&type=section&id=Management%20Discussion%20and%20Analysis) This section provides an overview of the company's business, R&D pipeline, production capabilities, industry landscape, future prospects, and financial performance for the reporting period [Business Overview and Outlook](index=6&type=section&id=Business%20Overview%20and%20Outlook) Aim Vaccine, a leading Chinese vaccine enterprise, covers the entire value chain from R&D to commercialization, possessing five major technology platforms and seven R&D teams, with 8 commercialized and 20 pipeline products, including 4 core products expected to launch in 2025, while actively expanding internationally, despite a **4.2% year-on-year revenue decrease in H1 2025** - The company possesses five human vaccine technology platforms: bacterial, viral, genetic engineering, combination, and mRNA[12](index=12&type=chunk) - The company has **8 commercialized products** for **6 diseases**, with sales covering all **31 provinces, municipalities, and autonomous regions** in China[12](index=12&type=chunk) - The company has **20 R&D vaccine products** for **12 disease areas**, with **4 core products** (13-valent pneumococcal conjugate vaccine, serum-free rabies vaccine, 23-valent pneumococcal polysaccharide vaccine, high-titer human diploid cell rabies vaccine) in the final stages of market launch[13](index=13&type=chunk) - In H1 2025, the company's quadrivalent meningococcal polysaccharide vaccine entered the **African market**, and its rabies vaccine entered the **Central American market**[16](index=16&type=chunk) 2025 H1 Sales Revenue by Product Category | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | YoY Change (%) | | :--- | :----------------- | :----------------- | :----------- | | Total Vaccine Product Sales Revenue | 514,657 | 537,178 | -4.2% | | Class I Vaccine Sales Revenue | 55,876 | 54,100 | +3.3% | | Class II Vaccine Sales Revenue | 458,781 | 483,078 | -5.0% | [Our Products and R&D Pipeline](index=8&type=section&id=Our%20Products%20and%20R%26D%20Pipeline) The company has commercialized eight vaccine products, with recombinant hepatitis B vaccine and lyophilized human rabies vaccine being market leaders; its rich R&D pipeline includes multivalent pneumococcal vaccines, iterated rabies vaccines, mRNA RSV, and shingles vaccines, with many products in late-stage clinical trials or marketing application, supported by AI technology and a professional internal R&D team - The company has commercialized **eight vaccine products** for **six disease areas**, with recombinant hepatitis B vaccine and lyophilized human rabies vaccine being the main commercialized vaccines[18](index=18&type=chunk) - The recombinant hepatitis B vaccine (Hansenula polymorpha) is China's **first and only company** to achieve stable production and batch release of hepatitis B vaccine using Hansenula polymorpha for antigen expression, possessing a patented process[19](index=19&type=chunk) - The lyophilized human rabies vaccine (Vero cell) has long held a leading market position, being the **second largest supplier** in the rabies vaccine market, maintaining a **100% pass rate** in batch release quality reviews for **18 years**[22](index=22&type=chunk) - The **13-valent pneumococcal conjugate vaccine (PCV13)** has submitted a marketing authorization application to the NMPA and completed on-site inspections[26](index=26&type=chunk) - The serum-free iterated rabies vaccine has officially submitted a marketing authorization application, with no serum-free rabies vaccines yet approved for market launch globally[31](index=31&type=chunk) - Both **mRNA RSV vaccine** and **mRNA shingles vaccine** have received clinical trial approvals in China and the United States[35](index=35&type=chunk) - The company is currently utilizing **AI** for vaccine antigen structure and mRNA sequence design, and is exploring AI assistance in vaccine process R&D[39](index=39&type=chunk) [Our Vaccine Products](index=9&type=section&id=Our%20Vaccine%20Products) The company's commercialized products include recombinant hepatitis B vaccine (Hansenula polymorpha, China's only), lyophilized human rabies vaccine (Vero cell, second largest market supplier), inactivated hepatitis A vaccine (human diploid cell), and ACYW135 group meningococcal polysaccharide vaccine (MPSV4), which hold leading market positions and unique advantages, such as the hepatitis B vaccine's patented process and the rabies vaccine's 100% batch release pass rate - The recombinant hepatitis B vaccine (Hansenula polymorpha) is produced using a patented process, free of preservatives, antibiotics, and bovine serum albumin, with an expiry date until **May 2032**[19](index=19&type=chunk) - Since its commercialization in **2007**, the lyophilized human rabies vaccine (Vero cell) has maintained a **100% pass rate** in batch release quality reviews by the National Institutes for Food and Drug Control[22](index=22&type=chunk) - The ACYW135 group meningococcal polysaccharide vaccine (MPSV4) contains no antibiotics or preservatives and has a shelf life of **three years**, making it the only one of its kind[24](index=24&type=chunk) [Our R&D Vaccines](index=11&type=section&id=Our%20R%26D%20Vaccines) The company's R&D vaccine pipeline covers pneumonia, rabies, hand-foot-and-mouth disease, influenza, shingles, and RSV, with multiple products in late-stage clinical trials or marketing application, particularly iterated pneumococcal and rabies vaccine series, and innovative mRNA-based vaccines, demonstrating strong R&D capabilities R&D Vaccine Portfolio Overview | Technology Platform | Indication | R&D Vaccine | Development Stage | | :--- | :--- | :--- | :--- | | Bacterial Vaccine | Pneumococcal Disease | 13-valent Pneumococcal Conjugate Vaccine (PCV13) | Marketing Authorization Application Submitted | | | | 20-valent Pneumococcal Conjugate Vaccine (PCV20) | Clinical Trial Application Submitted | | | | 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) | Pre-marketing Authorization Application Planned for 2025 | | Viral Vaccine | Rabies | Serum-free Iterated Rabies Vaccine | Marketing Authorization Application Submitted | | | | Novel Process High-titer Human Diploid Cell Rabies Vaccine | Phase III Clinical Trials Ongoing | | mRNA Vaccine | Shingles | mRNA Shingles Vaccine | Clinical Trial Approval Obtained (China & US) | | | Respiratory Syncytial Virus Infection | mRNA Respiratory Syncytial Virus (RSV) Vaccine | Clinical Trial Approval Obtained (China & US) | - The Phase III clinical study results for the company's **13-valent pneumococcal conjugate vaccine (PCV13)** demonstrated good immunogenicity and safety, meeting clinical endpoints[27](index=27&type=chunk) - The serum-free iterated rabies vaccine contains no animal serum, significantly enhancing safety and reducing the probability of adverse reactions[31](index=31&type=chunk) - The **EV71-CA16 bivalent hand-foot-and-mouth disease vaccine** is the world's first R&D vaccine designed to provide immunity against EV71 and CA16 virus strains, being the first to receive clinical approval[38](index=38&type=chunk) [Vaccine Development Platform Technologies and Internal R&D Team](index=15&type=section&id=Vaccine%20Development%20Platform%20Technologies%20and%20Internal%20R%26D%20Team) The company possesses five validated human vaccine platform technologies, including mRNA, genetic engineering, and combination vaccines, and utilizes AI to assist in vaccine antigen structure, mRNA sequence design, and process R&D, with an internal R&D team comprising three research institutions and four manufacturing subsidiaries' R&D centers, each with specialized focus - The company possesses **five validated human vaccine platform technologies**, including mRNA vaccine, genetic engineering vaccine, and combination vaccine technologies[39](index=39&type=chunk) - The company is currently utilizing **AI** for vaccine antigen structure and mRNA sequence design, and is exploring AI