Core Viewpoint - The company has developed an upgraded 20-valent pneumococcal conjugate vaccine based on the existing 13-valent vaccine, which has received approval for clinical trials from the National Medical Products Administration [1][4]. Group 1: Vaccine Development - The new 20-valent pneumococcal conjugate vaccine includes 7 additional serotypes, covering a total of 20 serotypes that are currently prevalent, aimed at preventing invasive diseases such as pneumonia, meningitis, and bacteremia [3]. - The vaccine is intended for administration to individuals aged 2 months and older, targeting infections caused by the 20 serotypes included in the vaccine [3]. Group 2: Public Health Significance - Pneumococcal diseases are a significant global public health issue, being a major cause of morbidity and mortality among children and adults in China [2]. - The World Health Organization (WHO) classifies pneumococcal diseases as requiring "extremely high priority" for vaccine prevention, highlighting the urgent need for effective vaccination strategies [2]. Group 3: Market Position and Future Plans - The approval of the 20-valent vaccine for clinical trials enhances the company's pipeline in the pneumococcal vaccine sector, indicating a commitment to addressing unmet clinical needs in core disease areas [4]. - The company aims to continue advancing innovative vaccine development to improve its innovation capabilities, core competitiveness, and overall strength in the market [4].

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。 – 1 – 全 部 位 於 非 洲 和 亞 洲，佔 全 球 總 病 例 數 的66%，而 中 國 位 列 第 二，佔 全 球 總病例數的12%。WHO對 可 用 疫 苗 預 防 的 疾 病 的 分 級 中，將 肺 炎 球 菌 性 疾 病 定 為 需「極 高 度 優 先」使 用 疫 苗 預 防 的 疾 病。 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） （股 份 代 號：06660） 自願性公告 20價肺炎球菌多糖結合疫苗 獲批開展臨床試驗 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 ...

Core Viewpoint - The approval of the 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) by the National Medical Products Administration marks a significant advancement in the vaccine development pipeline of the company, enhancing the high-valent pneumococcal vaccine product matrix in China [1][2] Group 1: Vaccine Development Progress - The company has received approval to conduct clinical trials for its PCV24 vaccine, which is a key step in expanding its vaccine offerings against pneumococcal diseases [1] - The PCV24 vaccine aims to prevent infections caused by 24 different serotypes of pneumococcus, addressing a significant public health need in China [2] Group 2: Market Context and Public Health Impact - Pneumococcal diseases are a major global public health challenge, with approximately 1.6 million deaths annually, particularly affecting infants and the elderly [1] - In China, around 550,000 children under five are affected by pneumococcal pneumonia each year, with a high proportion of severe cases [1] - The increasing antibiotic resistance among pneumococci exacerbates the difficulty in disease prevention, highlighting the importance of vaccination as an effective preventive measure [1] Group 3: Technological Innovations - The company has developed the first 13-valent pneumococcal conjugate vaccine in China, which utilizes a dual carrier technology to enhance immunogenicity and reduce adverse reactions [2] - The PCV24 vaccine continues to leverage the dual carrier technology, ensuring a comprehensive approach to immunization against prevalent serotypes [2] Group 4: Future Directions - The company plans to continue its focus on unmet public health needs to drive innovation in vaccine development, aiming to improve the overall prevention and control of pneumococcal diseases in China [2]

Core Viewpoint - The company, CanSino Biologics (06185), has received approval from the National Medical Products Administration of China to conduct clinical trials for its 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) [1] Group 1: Product Development - The PCV24 vaccine covers the major circulating serotypes of pneumococcus and utilizes a covalent binding method of polysaccharide antigens with protein carriers, along with a dual carrier technology [1] - The vaccine is intended for administration to individuals aged 2 months (minimum 6 weeks) and older to prevent infectious diseases caused by 24 serotypes of pneumococcus [1] - The product has completed the development and confirmation of the production process for purified polysaccharides from 24 serotypes, polysaccharide-protein conjugate bulk, and the final formulation [1] Group 2: Market Context - As of the date of this announcement, there are no marketed products for the 24-valent pneumococcal polysaccharide conjugate vaccine both domestically and internationally [1]

Core Viewpoint - The company Zhifei Biological (300122) has announced that its wholly-owned subsidiary, Beijing Zhifei Green Bamboo Biological Pharmaceutical Co., Ltd., has independently developed a 26-valent pneumococcal conjugate vaccine, which is currently undergoing Phase I clinical trials in Australia [1] Group 1: Company Developments - The 26-valent pneumococcal conjugate vaccine is designed to prevent invasive diseases caused by various serotypes of Streptococcus pneumoniae, covering the most common serotypes [1] - The vaccine aims to address a significant health issue, as Streptococcus pneumoniae is a major pathogen responsible for acute respiratory infections in infants and the elderly [1] Group 2: Industry Context - According to the Global Burden of Disease (GBD) study, in 2021, Streptococcus pneumoniae was responsible for approximately 97.9 million cases of illness and 500,000 deaths globally [1]

Group 1 - The core product of the company is the globally first innovative non-toxic dual protein carrier 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24), which has received clinical approval for all population indications [1][2] - The company has completed a Series A+ financing round of several tens of millions of yuan, with previous funding of 290 million yuan from Changchun High-tech and its subsidiary Baike Biotech [1] - The financing will primarily support the clinical research and market launch of PCV24 for adult and infant indications, with adult Phase II trials completed and Phase III trials upcoming [1][2] Group 2 - PCV24 is developed based on the epidemiological characteristics of pathogenic pneumococcal serotypes in China, aiming to improve protection coverage from 75% to over 90%, effectively addressing the growing issue of drug resistance [2] - The Phase II clinical trial results indicate that PCV24 shows excellent safety and immunogenicity in adults, achieving the expected outcomes across multiple immunogenicity evaluation indicators [2] - To establish a full industry chain layout, the company invested over 120 million yuan to create a high-standard GMP-level pilot research and production workshop in Shanghai, covering an area of 5,026 square meters [2][3]