Core Insights - 2025 marks a milestone year for China's innovative pharmaceuticals, with a significant increase in the number of approved drugs and vaccines, driven by supportive policies, international expansion, and expedited review processes [1][2] Group 1: Drug Approvals and Market Trends - In 2025, China approved 76 innovative drugs, surpassing the 48 approved in 2024, setting a historical record [1] - The number of approved innovative drugs in China exceeded that of the US FDA, which approved 46 new drugs in the same year [1] - China saw the approval of 11 First-in-class drugs, with 4 being independently developed domestically [1] - The total value of licensing transactions for innovative drugs exceeded $130 billion, with over 150 deals made, marking another historical high [1] Group 2: Breakthrough Therapies and Innovations - Among the 76 approved drugs, 17 were recognized as breakthrough therapies, with 13 focused on oncology [2] - Notable drug launches included the first stem cell therapy in China, marking a historic breakthrough in stem cell treatment [2] - The launch of targeted HER2 drugs for non-small cell lung cancer and cholangiocarcinoma signifies a new phase in precision treatment for solid tumors in China [2] Group 3: Disease-Specific Developments - In oncology, 34 new drugs were approved, with breast cancer treatments leading at 9 new drugs, followed by 6 for lung cancer and 8 for hematological malignancies [3] - Two CAR-T cell therapies targeting CD19 were approved, bringing the total number of domestic CAR-T therapies to 7 [3] Group 4: Innovations in Other Therapeutic Areas - In the influenza treatment sector, four new drugs were launched, addressing public health needs during peak flu seasons [4] - The innovative vaccine sector saw significant advancements, including the launch of China's first nine-valent HPV vaccine and a 13-valent pneumococcal conjugate vaccine [5] - The emergence of a serum-free rabies vaccine is expected to fill a market gap, showcasing China's growing capabilities in biopharmaceutical innovation [5]

Company Progress - The company has made significant progress in its research pipeline, with its first global serum-free rabies vaccine successfully passing the National Medical Products Administration's registration site inspection on February 5, 2026, bringing the product closer to market launch [2] - Several key products, including the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23), are in the final stages before market launch [2] Stock Performance - Despite the advancements, the stock price of the company (06660.HK) has recently experienced a decline, closing at HKD 3.03 on February 12, 2026, down 5.90% for the day and a cumulative drop of 18.98% over the past 20 trading days [3] - The stock price fluctuations may be influenced by several factors, including the overall market environment, with the Hong Kong stock market showing volatility and the Hang Seng Index declining during the same period [3] - Short-term performance pressures are evident, with the company's revenue for the first half of 2025 at RMB 515 million, a slight decrease of 4.2% year-on-year, primarily due to a decline in revenue from its core rabies vaccine [3] - Although losses have narrowed year-on-year, short-term performance volatility may affect market sentiment, and the company continues to require ongoing investment in R&D before significant revenue contributions from new products can be realized [3]

Core Viewpoint - The demand for safer and more effective rabies vaccines is increasing due to a rise in rabies cases and deaths, highlighting the urgency for innovative solutions in the market [1][2]. Group 1: Product Development - Aimee Vaccine's serum-free iterative rabies vaccine has successfully passed clinical trial inspections by the National Medical Products Administration, indicating it is closer to market launch [1]. - The Phase III clinical trial results show that the serum-free iterative rabies vaccine has good safety, immunogenicity, and durability, meeting all preset evaluation standards [1]. - Unlike traditional rabies vaccines, Aimee's serum-free vaccine does not contain animal serum, significantly improving safety and reducing adverse reactions [1]. Group 2: Market Context - Rabies remains a severe public health challenge globally, with approximately 40 million people exposed to rabies in China each year, and the vaccination rate for exposed individuals is only about 35% [2]. - After four consecutive years of decline, rabies cases and deaths in China are projected to rise again starting in 2024, with 244 reported cases and 233 deaths in 2025, marking the highest figures since 2020 [2]. - The increase in rabies cases indicates a persistent and urgent need for upgraded rabies vaccines in the market [2]. Group 3: Market Position and Strategy - Aimee Vaccine is the second-largest rabies vaccine producer globally, with a comprehensive product matrix covering various technologies, including serum-free and mRNA vaccines, positioning the company as a dominant player in the domestic market [2]. - The company has established a sales network covering all 31 provinces in China, facilitating rapid market penetration for new products [3]. - Aimee Vaccine is also expanding into international markets, exporting rabies vaccines to emerging markets such as Pakistan, Egypt, Tajikistan, and Côte d'Ivoire, which may provide new growth opportunities [3]. Group 4: Financial Outlook - Aimee Vaccine is entering a critical phase with the upcoming launch of innovative products, supported by its strong R&D, production, and commercialization capabilities [4]. - Analysts predict the company's net profit could reach 883 million yuan and 1.52 billion yuan by 2027, indicating potential for significant growth as multiple innovative vaccines enter the market [4]. - The company is expected to play an increasingly important role in both the domestic and global high-end vaccine markets as it achieves substantial performance growth [4].

Core Insights - The demand for safer and more effective rabies vaccines is increasing due to a rise in rabies cases and deaths in recent years [1][2] Group 1: Product Development - Aimee Vaccine's serum-free iterative rabies vaccine has successfully passed clinical trial inspections by the National Medical Products Administration, indicating it is closer to market launch [1] - The Phase III clinical trial results show that the serum-free iterative rabies vaccine has good safety, immunogenicity, and durability, meeting all preset evaluation standards [1] - Unlike traditional rabies vaccines, the serum-free version does not contain animal serum, significantly improving safety and reducing adverse reactions [1] Group 2: Market Context - Rabies remains a severe public health challenge globally, with approximately 40 million people exposed to rabies in China each year, and only about 35% of exposed individuals receiving vaccination [2] - After four consecutive years of decline, rabies cases and deaths in China are projected to rise again starting in 2024, with 244 reported cases and 233 deaths in 2025, the highest since 2020 [2] - This trend indicates a persistent and urgent need for upgrades in the rabies vaccine market [2] Group 3: Competitive Position - Aimee Vaccine is the second-largest rabies vaccine producer globally, with a comprehensive product matrix covering various technologies, including serum-free and mRNA vaccines [2] - The company has established a nationwide sales network across 31 provinces in China, facilitating rapid market penetration for new products [3] - Aimee Vaccine is also expanding into international markets, exporting rabies vaccines to emerging markets such as Pakistan, Egypt, Tajikistan, and Côte d'Ivoire, which may provide new growth opportunities [3] Group 4: Financial Outlook - Aimee Vaccine is entering a critical phase with the upcoming launch of innovative products, supported by its strong R&D, production, and commercialization capabilities [4] - Analysts predict the company's net profit could reach 883 million RMB and 1.52 billion RMB by 2027, indicating potential for significant growth [4] - The introduction of multiple innovative vaccines is expected to lead to a substantial increase in performance, positioning Aimee Vaccine as a key player in both domestic and global high-end vaccine markets [4]

Core Viewpoint - The company has achieved a significant technological breakthrough with its serum-free iterative rabies vaccine, which is expected to fill a market gap as it is the first of its kind to be approved for sale globally [1][2] Group 1: Product Development and Approval - The company's subsidiary, Aimeirongyu (Ningbo) Biopharmaceutical Co., Ltd., has successfully passed the clinical trial site inspection and drug registration production site inspection for its serum-free iterative rabies vaccine [1] - The Phase III clinical study results indicate that the vaccine demonstrates good safety, immunogenicity, and durability, meeting all preset evaluation standards [1] - The company has obtained the necessary production license for the serum-free iterative rabies vaccine, positioning itself for a market launch [1] Group 2: Market Potential and Competitive Advantage - China is the largest rabies vaccine market globally, projected to reach 14.8 billion yuan by 2030, driven by product updates and increased vaccine adoption [2] - The new vaccine's lack of animal serum significantly enhances safety and reduces the likelihood of adverse reactions, making it a preferred choice for vaccination institutions [2] - As the second-largest supplier of rabies vaccines globally, the company aims to lead in the deep technological iteration and upgrade of rabies vaccines, with the capability for large-scale production once the product is approved [2]

Core Viewpoint - The company has made significant progress in the development of a serum-free rabies vaccine, which is expected to fill a market gap as no serum-free rabies vaccines are currently approved globally [1][2]. Group 1: Product Development - The company's wholly-owned subsidiary, Aimei Honor (Ningbo) Biopharmaceutical Co., Ltd., has successfully passed the clinical trial site inspection and drug registration production site inspection for the serum-free rabies vaccine [1]. - The Phase III clinical trial results indicate that the serum-free rabies vaccine demonstrates good safety, immunogenicity, and durability, meeting the preset evaluation standards [1]. - The company has obtained the necessary production license for the serum-free rabies vaccine, marking a major technological breakthrough in the field [1]. Group 2: Market Opportunity - Rabies is a disease with a nearly 100% fatality rate once symptoms appear, making post-exposure vaccination critical [2]. - Currently, there are no registered serum-free rabies vaccines available in the market, with existing options being serum-based vaccines, which can cause allergic reactions [2]. - The Chinese rabies vaccine market is projected to reach 14.8 billion yuan by 2030, driven by product updates and increased vaccination rates [2]. Group 3: Competitive Position - The company is the second-largest supplier of rabies vaccines globally and aims to lead in the deep technological iteration and upgrade of rabies vaccines [3]. - A production facility that meets international standards for the serum-free rabies vaccine has been completed, and commercial-scale production has been validated, allowing for rapid market entry upon approval [3]. - The anticipated approval and market launch of the serum-free rabies vaccine are expected to significantly enhance the company's performance [3].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不對因本公告全部或任何部份內容而產生或因倚賴該等內容而引致的 任 何 損 失 承 擔 任 何 責 任。 AIM Vaccine Co., Ltd. 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） 全球首研的 無血清迭代狂犬疫苗順利通過註冊現場檢查 本 公 告 由 艾 美 疫 苗 股 份 有 限 公 司（「本公司」，連 同 其 附 屬 公 司 統 稱「本 集 團」）自 願 作 出，以 告 知 本 公 司 股 東 及 潛 在 投 資 者 本 集 團 的 最 新 業 務 發 展。 本 集 團 全 資 子 公 司 艾 美 榮 譽（寧 波）生 物 製 藥 有 限 公 司（以 下 簡 稱「艾美榮 譽」）全 球 自 主 首 研 的 無 血 清 迭 代 狂 犬 疫 苗，根 據 國 家 藥 品 監 督 管 理 局 藥 品 審 評 中 心 出 具 的《藥 審 中 心 關 於 無 血 清 迭 代 狂 犬 疫 ...

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]