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，概不就因本公告全部 或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責任。 CanSino Biologics Inc. 康希諾生物股份公司 （於中華人民共和國註冊成立的股份有限公司） 本 公 告 由 康 希 諾 生 物 股 份 公 司（「本公司」）自 願 作 出。 本公司欣然宣佈，本公司研發的24價 肺 炎 球 菌 多 糖 結 合 疫 苗（CRM197╱破傷風類 毒 素）（「PCV24」）已 獲 得 中 國 國 家 藥 品 監 督 管 理 局 批 准，可 以 開 展 相 關 臨 床 試 驗。 本公司PCV24覆 蓋 當 前 肺 炎 球 菌 主 要 流 行 血 清 型，採 用 多 糖 抗 原 與 蛋 白 載 體 共 價結合的方式，以及雙載體技術，擬適用於2月 齡（最 小6周）及 以 上 人 群 接 種，以 預防由24種 肺 炎 球 菌 血 清 型 引 起 的 感 染 性 疾 病。該 產 品 完 成 了24種血清型純化 多糖、多糖蛋白結合物原液生產工藝、成品處方的開發與確認。於本 ...

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12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: 康希諾生物股份公司 本月底法定/註冊股本總額： RMB 247,043,801 FF301 II. 已發行股份及/或庫存股份變動 | 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) | 06185 | 說明 | H 股 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 132,670,900 | | 0 | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 132,670,900 | | 0 | | 132,670,900 | | 2. 股份分類 | 普通股 | 股份類別 | ...

申请事项：境内生产药品注册临床试验 证券代码：688185 证券简称：康希诺 公告编号：2026-001 康希诺生物股份公司 关于24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素） 获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 康希诺生物股份公司（以下简称"公司"）于近日收到国家药品监督管理局 核准签发的关于24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）（以下简 称"PCV24"）的《药物临床试验批准通知书》。具体情况如下： 一、通知书基本情况 产品名称：24 价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素） 注册分类：预防用生物制品 1.4 类 特此公告。 申请人：康希诺生物股份公司、康希诺（上海）生物科技有限公司 通知书编号：2026LP00022 审批结论：根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理 法》及有关规定，经审查，PCV24 符合药品注册的有关要求，同意开展预防由 本品所含 24 种肺炎球菌血清型引起的感染性疾病的临床试验。 二、产品相关 ...

人民财讯1月5日电，康希诺(688185)1月5日公告，公司于近日收到国家药品监督管理局核准签发的关于 24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)(简称"PCV24")的《药物临床试验批准通知书》。 公司PCV24覆盖当前肺炎球菌主要流行血清型，采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。截 止本公告披露日，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 announcement by CanSino Biologics regarding the approval of a 24-valent pneumococcal polysaccharide conjugate vaccine signifies a significant advancement in the company's product pipeline and addresses a critical public health need, as there are currently no similar products available in the market [2] Group 1: Company Announcement - CanSino Biologics has received approval from the National Medical Products Administration for a clinical trial of its 24-valent pneumococcal polysaccharide conjugate vaccine [2] - The vaccine is designed to cover the major circulating serotypes of pneumococcus and utilizes a conjugation method with polysaccharide antigens and protein carriers [2] - The target population for this vaccine includes individuals aged 2 months and older, aimed at preventing infections caused by 24 serotypes of pneumococcus [2] Group 2: Market Context - Currently, there are no similar products available in both domestic and international markets, indicating a potential competitive advantage for CanSino Biologics [2]

公司 PCV24 覆盖当前肺炎球菌主要流行血清型，采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。 截止本公告披露日，24 价肺炎球菌多糖结合疫苗在国内外均无上市产品。 格隆汇1月5日丨康希诺(688185.SH)公布，公司于近日收到国家药品监督管理局核准签发的关于24价肺 炎球菌多糖结合疫苗(CRM197/破伤风类毒素)的《药物临床试验批准通知书》。 肺炎球菌性疾病是由肺炎链球菌引起的全球严重公共卫生问题之一。全球流行病学数据显示，肺炎链球 菌作为重要的呼吸道致病菌，目前确定的血清型已超过 100 种，所有血清型均可致病。肺炎球菌性疾病 亦是引起中国婴幼儿和老年人发病和死亡的重要病因。世界卫生组织(WHO)已将肺炎球菌性疾病列为 需"极高度优先"使用疫苗预防的疾病。 ...

Core Viewpoint - The company announced that its 24-valent pneumococcal polysaccharide conjugate vaccine has received approval from the National Medical Products Administration for clinical trials aimed at preventing infections caused by 24 serotypes of pneumococcus [1] Group 1 - The vaccine, referred to as PCV24, covers the main circulating serotypes of pneumococcus [1] - It utilizes a covalent binding method between polysaccharide antigens and protein carriers, employing a dual carrier technology [1] - The vaccine is intended for administration to individuals aged 2 months (minimum 6 weeks) and older to prevent infections caused by the specified pneumococcal serotypes [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of a 24-valent pneumococcal polysaccharide conjugate vaccine, indicating progress in vaccine development aimed at preventing infections caused by 24 serotypes of pneumococcus [1] Group 1 - The vaccine utilizes a covalent combination of polysaccharide antigens and protein carriers, employing dual carrier technology [1] - It is intended for administration to individuals aged 2 months (minimum 6 weeks) and older [1] - The development of the vaccine is characterized by significant challenges and lengthy timelines, requiring clinical trial applications, execution of clinical trials, and drug registration approval before market launch [1]

Core Insights - The Chinese innovative pharmaceutical industry is experiencing significant growth driven by supportive policies that connect R&D breakthroughs, capital vitality, and market demand [3][4]. Group 1: Industry Development - The "New Quality Productivity Research Tour" aims to explore the practical pathways for innovative drugs transitioning from laboratories to global markets, analyzing how policy dividends activate industry potential [3]. - By 2025, the internationalization of China's innovative pharmaceutical industry is expected to accelerate, with the total amount of business development (BD) transactions involving domestic innovative drug companies increasing from $5.06 billion in 2020 to $41.76 billion by August 2025 [4]. Group 2: Policy Support - The Chinese government has introduced comprehensive measures to support the high-quality development of innovative drugs, addressing various aspects such as R&D support, medical insurance access, clinical application, and payment capabilities [5]. - Local policies are also actively addressing industry bottlenecks, with cities like Chongqing and Tianjin implementing specific measures to facilitate the application and production of innovative drugs [5]. Group 3: Market Dynamics - In the first half of 2025, the BD transaction volume for Chinese innovative drug companies surged, with upfront payments reaching 24.1 billion yuan, accounting for 28% of the total financing for domestic companies during the same period [5]. - The industry is shifting from a reliance on domestic sales to a dual-driven model of "domestic sales + external licensing," indicating a transformation in business models [5]. Group 4: Future Outlook - Despite the challenges of high investment, risk, and long cycles in innovative drug development, the integration of artificial intelligence in drug research is emerging as a significant breakthrough [6]. - By 2026, the benefits of policy support are expected to translate into tangible gains for companies, with streamlined approval processes and innovative payment methods facilitating the commercialization of innovative drugs [6].

Core Insights - The "Golden Award" annual excellence company selection by Gelonghui will announce its results on December 22, highlighting companies recognized for their outstanding information disclosure capabilities [1][2] - Six companies, including Fuhong Hanlin, Gekewei, CanSino Biologics, TCL Technology, Weishi Jiajie, and Yonghe Medical, received the "Annual Information Disclosure Award" [1] Group 1 - The "Annual Information Disclosure Award" aims to recognize companies with the best information disclosure practices in the capital market [1] - Effective information disclosure serves as a bridge between companies and investors, enhancing mutual understanding and promoting better development paths for enterprises [1] - The evaluation criteria for the award include frequency, accuracy, and timeliness of information disclosure, with results derived from quantitative data analysis and expert review [1] Group 2 - Gelonghui's selection process aims to create a valuable reference list of listed companies and unicorns, covering all companies listed on major exchanges including HKEX, SSE, SZSE, NYSE, and NASDAQ [2]