Core Viewpoint - 康希诺 is actively advancing its vaccine development pipeline, focusing on innovative products and expanding its market presence both domestically and internationally [1][2][3] Group 1: Vaccine Development and Commercialization - 康希诺's 13-valent pneumonia conjugate vaccine PCV13i has significant advantages in product characteristics and production processes, showing excellent clinical results and safety profiles [3][4] - The company is targeting the commercialization of PCV13i, which overlaps with its existing product MCV4, enhancing marketing efficiency [4] - The four-valent meningococcal conjugate vaccine MCV4 has received acceptance for age expansion applications for 4-6 years and plans to submit for 18-59 years within the year [5] Group 2: Research and Development Progress - 康希诺 has established five major R&D platforms, with multiple products at various stages of development, including Tdcp for adolescents and adults, which has completed Phase III clinical trials [2][7] - The company is exploring therapeutic vaccine development and has a positive attitude towards expanding into innovative fields [8] - The infant DTcP vaccine's application for market approval has been accepted and is undergoing priority review, with plans for clinical trials for a combination vaccine [6][9] Group 3: Financial Position and Future Plans - As of March 2025, 康希诺 has approximately 34 billion RMB in funds, sufficient for current development needs, with no large-scale investment plans outside of its vaccine industrial park project [2][10] - Future financing plans will be considered based on market conditions and company development stages, with timely announcements to be made if necessary [10]

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 | 2025年6月30日 | | --- | | 狀態: | | 截至月份: 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 呈交日期: 2025年7月3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) | 06185 | 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 | | | 132,670,900 | RMB | | 1 | RMB | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | | | RMB | | 0 | | 本月底結存 | | | 132,670,900 | RMB | | 1 | RMB | | 1 ...

Core Viewpoint - The Chinese vaccine industry is transitioning from scale expansion to value creation, driven by national immunization strategies and WHO vaccine prioritization policies, with local companies leveraging technological innovation to enhance multi-valent vaccines and lifecycle protection strategies [1] Group 1: Product Development and Innovation - CanSino Biologics' 13-valent pneumonia vaccine PCV13i has been approved for market launch, representing a significant step in the globalization of domestic vaccines [2] - The core value of PCV13i is based on three pillars: technological breakthroughs, clinical validation, and application optimization [2] - The vaccine employs a unique dual carrier technology using a non-toxic mutant of diphtheria toxin (CRM197) and tetanus toxin (TT), enhancing immunogenicity and reducing interference with other vaccines [3] Group 2: Clinical Data and Efficacy - Clinical data shows that PCV13i significantly outperforms control groups in inducing high levels of specific antibodies against key serotypes that are prevalent in China, confirming its regional adaptability [4] - The safety profile of PCV13i is comparable to that of control vaccines, with adverse reactions primarily being mild, facilitating its commercial application [4] Group 3: Market Demand and Commercialization - The urgency for pneumonia vaccines is underscored by the high mortality rates associated with pneumonia in children under five, particularly in China, where vaccination rates are below 18% [6][8] - The global market for pneumonia vaccines is robust, with the 13-valent pneumonia vaccine consistently ranking among the top-selling vaccines, indicating significant market potential [9] Group 4: Strategic Market Positioning - PCV13i is positioned to leverage existing distribution networks and cold chain logistics established by CanSino's previous vaccine, enhancing market penetration efficiency [10] - The vaccine's production process meets EU GMP standards and is suitable for halal certification, providing a competitive edge in Southeast Asian markets [10] Group 5: Long-term Value Creation - CanSino's vaccine matrix, including products for polio and DTP, is establishing a comprehensive defense against bacterial diseases in children, aligning with international quality standards [11] - The launch of PCV13i is expected to catalyze short-term performance while the ongoing innovation in the product matrix builds long-term value, suggesting potential for re-evaluation in market valuation [12]

Industry Overview - Vaccines are essential biological products for preventing and controlling infectious diseases, representing a core defense in public health systems [1][5] - The Chinese vaccine industry is experiencing rapid growth, with the market size projected to increase from 306.22 billion yuan in 2015 to 1,762.19 billion yuan in 2024, and expected to exceed 300 billion yuan by 2031 [1][5] Industry Chain - The upstream of the vaccine industry includes raw material supply, such as microcarriers, human serum albumin, and packaging materials [3] - The midstream involves vaccine research and production, with key players including Sinopharm, Sinovac, CanSino, Zhifei, and Watson [3] - The downstream consists of vaccine distribution and consumption, reaching end consumers through health service centers and medical institutions [3] Current Industry Status - As of December 31, 2024, 47 companies in China have received vaccine batch approvals, totaling 543 million doses, with a decrease of 5.6% compared to 2023 [7] - The most approved vaccines in 2024 were influenza and rabies vaccines, each exceeding 80 million doses, accounting for 30% of total approvals [9] Market Competition - The Chinese vaccine market is characterized by a diverse competitive landscape, with local companies like Sinopharm and Zhifei rising against foreign giants like Merck and Pfizer [11] - Zhifei has achieved significant growth in international markets, with a 300% increase in exports of its WHO-precertified 23-valent pneumococcal polysaccharide vaccine [11] - Innovative companies like CanSino and Watson are making breakthroughs in mRNA and recombinant protein vaccines, enhancing their market presence [11][12] Future Trends - Technological innovation is driving the vaccine industry forward, with new platforms like mRNA and gene-engineered vaccines emerging [17] - The adult vaccine market is growing, with a 45% increase in HPV vaccine uptake in 2024, indicating a shift in public health awareness [18] - Chinese vaccine companies are expanding internationally, with over 2.5 billion doses of COVID-19 vaccines supplied abroad, focusing on markets in Africa and Southeast Asia [19]

Macro Dynamics - In the first five months of 2025, China attracted foreign investment amounting to 358.19 billion RMB, a year-on-year decrease of 13.2% [1] - The number of newly established foreign-invested enterprises reached 24,018, marking a 10.4% increase year-on-year [1] - High-tech industries saw a significant increase in foreign investment, with e-commerce services up 146%, aerospace manufacturing up 74.9%, chemical pharmaceuticals up 59.2%, and medical equipment manufacturing up 20% [1] - Investment from ASEAN countries grew by 20.5%, while Japan, the UK, South Korea, and Germany saw increases of 70.2%, 60.9%, 10.3%, and 7.1% respectively [1] Financial Data - From January to May, the total stamp duty on securities transactions reached 66.8 billion RMB, a 52.4% increase year-on-year [2] - The overall stamp duty collected during the same period was 178.7 billion RMB, reflecting an 18.8% year-on-year growth [2] Industry Policies - The "old-for-new" subsidy policy for consumer goods will continue, with central funds being allocated in batches throughout the year [3] - A total of 300 billion RMB in national bond funds will be directed to support local governments in implementing the "old-for-new" policy [3] Energy Consumption - In May, China's total electricity consumption reached 809.6 billion kWh, a year-on-year increase of 4.4% [5] - Cumulative electricity consumption from January to May was 39,665 billion kWh, reflecting a 3.4% year-on-year growth [5] Company Dynamics - Ele.me's logistics head has been investigated for alleged job-related crimes, with the company cooperating with law enforcement [11] - Huizhou Yuantong was fined 24.31 million RMB by the People's Bank of China for multiple regulatory violations [13] - CanSino Biologics received a drug registration certificate for its 13-valent pneumococcal polysaccharide conjugate vaccine [14] - Zhang Xiaoqin's controlling shareholder has entered restructuring proceedings as approved by the local court [15] - Douyin has initiated a special action to combat corporate defamation and protect the rights of businesses and entrepreneurs [16] - Hainan Huatie clarified that it is not involved in stablecoin business and has no formal agreements with Ant Group regarding RWA [18]

证券代码：688185 证券简称：康希诺 公告编号：2025-017 康希诺生物股份公司 关于13价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素） 获得药品注册证书的公告 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。 一、药品相关情况 药品名称：13 价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素） 剂型：注射剂 申请事项：药品注册（境内生产） 注册分类：预防用生物制品 批准文号：国药准字 S20250033 上市许可持有人：康希诺生物股份公司 生产企业：康希诺生物股份公司 二、药品的其他相关情况 肺炎球菌性疾病是全球严重的公共卫生问题之一。肺炎链球菌是引起儿童肺 炎、脑膜炎、菌血症等严重疾病的主要病原菌，也是引起急性中耳炎和鼻窦炎等 的常见病因。 康希诺生物股份公司（以下简称"公司"）已获得国家药品监督管理局（以 下简称"国家药监局"）下发的 13 价肺炎球菌多糖结合疫苗（CRM197/破伤风 类毒素）（以下简称"PCV13i"）《药品注册证书》，现将相关情况公告如下： 在生产工艺上，公司采用了更加安全的生产工 ...

港股康希诺生物(06185.HK)直线拉升，涨超10%；康希诺A股涨3.8%。 ...

Market Overview - The Shanghai Composite Index closed at 3393.26 points, above the six-month moving average, with a change of 0.23% [1] - The total trading volume of A-shares reached 838.618 billion yuan [1] Stocks Breaking Six-Month Moving Average - A total of 184 A-shares have surpassed the six-month moving average today [1] - Notable stocks with significant deviation rates include: - Qitian Technology: 11.69% deviation, closing price 14.38 yuan, with a daily increase of 20.03% and turnover rate of 15.50% [1] - Haochen Medical: 8.62% deviation, closing price 3.12 yuan, with a daily increase of 9.86% and turnover rate of 6.44% [1] - Jinyinhai: 7.58% deviation, closing price 21.00 yuan, with a daily increase of 9.66% and turnover rate of 6.43% [1] Additional Stocks with Deviation Rates - Other stocks with notable performance include: - Guangyun Technology: 7.45% deviation, closing price 14.13 yuan, with a daily increase of 9.20% and turnover rate of 4.78% [1] - Yaowang Technology: 5.93% deviation, closing price 7.12 yuan, with a daily increase of 7.88% and turnover rate of 13.64% [1] - Nuotai Biotech: 5.91% deviation, closing price 55.37 yuan, with a daily increase of 10.36% and turnover rate of 5.58% [1] Summary of Other Stocks - Additional stocks with lower deviation rates that have just crossed the six-month moving average include: - Guangdong Hongtu: just above the six-month line [1] - Xinhe Shares: just above the six-month line [1] - Songjing Shares: just above the six-month line [1]

证券代码：688185 证券简称：康希诺 公告编号：2025-016 康希诺生物股份公司 2024年年度股东大会决议公告 本公司董事会及全体董事保证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。 重要内容提示： 本次会议是否有被否决议案：无 一、 会议召开和出席情况 （一） 股东大会召开的时间：2025 年 6 月 4 日 （二） 股东大会召开的地点：天津市河东区卫国道 126 号天津东凯悦酒店二层 悦宾厅 1 （三） 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况： | 1、出席会议的股东和代理人人数 | 275 | | --- | --- | | 其中：A 股股东人数 | 274 | | H 股股东人数 | 1 | | 2、出席会议的股东所持有的表决权数量 | 89,499,039 | | 股股东所持有表决权数量 其中：A | 46,684,269 | | 股股东所持有表决权数量 H | 42,814,770 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 36.23 | | 例（%） ...

中国北京市朝阳区建国路 77 号华贸中心 3 号写字楼 34 层 邮政编码 100025 电话: （8610）58091000 传真: （8610）58091100 2024 年年度股东大会的 法律意见书 致：康希诺生物股份公司 根据《中华人民共和国证券法》《中华人民共和国公司法》以及中国证券监 督管理委员会颁布的《上市公司股东大会规则》（以下简称"《股东大会规则》"） 的规定，北京市竞天公诚律师事务所（以下简称"本所"）指派律师现场出席了 康希诺生物股份公司（以下简称"公司"）2024 年年度股东大会（以下简称"本 次股东大会"），并就本次股东大会的相关事宜出具本法律意见书。 本所及经办律师依据《中华人民共和国证券法》《律师事务所从事证券法律 业务管理办法》和《律师事务所证券法律业务执业规则（试行）》等规定及本法 律意见书出具日以前已经发生或者存在的事实，严格履行了法定职责，遵循了勤 勉尽责和诚实信用原则，进行了充分的核查验证，保证本法律意见书所认定的事 实真实、准确、完整，所发表的意见合法、准确，不存在虚假记载、误导性陈述 或者重大遗漏，并承担相应法律责任。 本所同意，公司可以将本法律意见书作为本次股东大 ...