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 ...

深耕肺炎疫苗领域多年，康希诺已积累扎实的技术积淀。2025年9月，公司自主研发的13价肺炎球菌多 糖结合疫苗优佩欣®（PCV13i）正式上市供应，该产品是我国首款采用CRM197与破伤风类毒素（TT） 双载体技术的肺炎球菌结合疫苗。通过创新双载体设计，优佩欣®有效规避了单一载体过量引发的不良 反应风险，减少与其他疫苗共注射时的免疫干扰，显著提升免疫原性，尤其对我国儿童疾病负担最重的 19F、19A、7F、3型等血清型实现精准防护。 在优佩欣®成功上市的基础上，康希诺加速推进高价次疫苗研发进程。此次获批的PCV24疫苗实现关键 技术突破，不仅覆盖当前肺炎球菌主要流行血清型，更延续了双载体技术优势，采用多糖抗原与蛋白载 体共价结合工艺，完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺及成品处方的开发与确 认。该疫苗拟适用于2月龄（最小6周）及以上全人群接种，可有效预防24种肺炎球菌血清型引发的感染 性疾病，有望进一步填补高价次肺炎疫苗的市场空白。 2026年新年伊始，康希诺生物(688185)传来研发进展：公司自主研发的24价肺炎球菌多糖结合疫苗 （CRM197/破伤风类毒素，简称"PCV24"）正式获得国 ...

康希诺生物(06185)发布公告，公司研发的24价肺炎球菌多糖结合疫苗(CRM197╱破伤风类毒素) (PCV24)已获得中国国家药品监督管理局批准，可以开展相关临床试验。 公司PCV24覆盖当前肺炎球菌主要流行血清型，採用多糖抗原与蛋白载体共价结合的方式，以及双载体 技术，拟适用于2月龄(最小6周)及以上人群接种，以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。于本公告日 期，24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 ...

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]