Key Points Summary of 康希诺生物 Conference Call Company Overview - 康希诺生物 (CanSino Biologics) is a biotechnology company focused on vaccine development and commercialization, particularly in the fields of infectious diseases. Financial Performance - In 2024, 康希诺's revenue exceeded 846 million yuan, representing a year-on-year growth of 137% [3] - Vaccine business revenue surpassed 800 million yuan, growing over 40% compared to the previous year [3] - The company's annual loss significantly narrowed by over 74%, with a net loss close to 80% after excluding one-time investment losses [3] - The three expense ratios (R&D, sales, and management) decreased significantly year-on-year, indicating effective cost control measures [3] Product Development and Market Position - 康希诺's four-valent meningococcal conjugate vaccine (MCV four) is the only product of its kind in the market, with increasing penetration and registration in Indonesia, marking a significant step in international commercialization [3][4] - The company anticipates the launch of the thirteen-valent pneumococcal conjugate vaccine (PCV13) in 2025, with preparations underway for market-related activities [5] - Other products entering the market include infant DTP (diphtheria, tetanus, pertussis) vaccine, adsorbed tetanus vaccine, and the expansion application for the MCV four vaccine [5] Marketing and Sales Strategy - 康希诺 employs an academic marketing strategy, utilizing a professional team to focus on promotion and implementing a dual-mode approach to drive sales [6] - The company has conducted market segmentation analysis on nearly 10,000 PUCs (Potential User Customers) to develop regional marketing strategies [6] - Plans to expand international business focus on Southeast Asia, the Middle East, North Africa, and South America, with a strong emphasis on clinical registration and commercialization of products like MCV four [7] Future Growth Plans - 康希诺 aims to expand its market share in the 4-6 years, 7-17 years, and 18-59 years age groups, with a focus on newborns for PCV13 and DTP vaccines [8] - The company has a comprehensive product portfolio for bacterial vaccines targeting infants aged 0-6 years and plans to enhance its offerings for older age groups [8] R&D Pipeline and Innovations - The PCV13 vaccine has passed site inspections and is expected to complete production batches by the second quarter of 2025 [9] - The DTP vaccine is prioritized for review due to its excellent phase III clinical data and is expected to be approved by mid-2026 [11] - The company is also developing innovative combination vaccines, including a five-component vaccine, which is currently in the early clinical trial phase [16][19] Challenges and Solutions - The development of meningococcal vaccines faces technical challenges, including immune interference from multiple antigens, which 康希诺 addresses by using different carriers to enhance success rates [20] - The company maintains a low inventory level for its meningococcal vaccine, unaffected by industry-wide destocking trends, and expects further optimization in 2025 [21] Financial Health and Investment Plans - As of December 2024, 康希诺 has approximately 3.5 billion yuan in total funds, indicating a healthy financial status to support R&D and strategic development [22] - The company plans to control capital expenditures and focus on necessary projects, ensuring efficient resource allocation [22] mRNA Technology and Future Directions - 康希诺 is exploring mRNA technology for flu vaccines and has partnered with the Malaysian Institute of Medical Research for multi-valent flu vaccine development [23] - The company has successfully transitioned from the impact of COVID-19 and aims to maximize product value through various collaborations, targeting better performance in 2025 [24]

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 824,884,000, an increase from RMB 345,182,000 in 2023[10] - Operating loss for the year was RMB (403,390,000), improved from a loss of RMB (2,035,182,000) in 2023[10] - Basic and diluted loss per share for 2024 was RMB (1.53), improved from RMB (6.01) in 2023[10] - The company achieved revenue of approximately RMB 824.9 million during the reporting period, representing a 139.0% increase compared to 2023[62] - Revenue from the cerebrospinal meningitis vaccine product reached RMB 793.8 million, up from RMB 561.7 million in 2023, indicating significant sales growth[63] - The company reported a gross profit of approximately RMB 580.5 million, recovering from a gross loss of RMB 876.0 million in 2023[66] - Other income decreased by 44.5% to approximately RMB 109.5 million, primarily due to a reduction in government subsidies and lower investment returns[67] Assets and Liabilities - Total assets decreased to RMB 7,958,132,000 from RMB 9,318,769,000 in 2023, representing a decline of approximately 14.6%[10] - Total liabilities decreased to RMB 3,048,260,000 from RMB 4,031,354,000 in 2023, a reduction of about 24.4%[10] - Total equity decreased to RMB 4,909,872,000 from RMB 5,287,415,000 in 2023, a decline of approximately 7.1%[10] - Current assets decreased to RMB 4,282,491,000 from RMB 5,180,828,000 in 2023, a reduction of about 17.3%[10] - Non-current assets decreased to RMB 3,675,641,000 from RMB 4,137,941,000 in 2023, a decline of approximately 11.2%[10] Research and Development - The company is focusing on new product development and market expansion strategies to enhance future performance[10] - The product registration application for the innovative 13-valent pneumococcal conjugate vaccine is expected to be submitted in 2024, with the aim of addressing unmet domestic market needs[13] - The recombinant pneumonia protein vaccine has shown promising preliminary results in Phase I clinical trials, covering at least 98% of pneumococcal serotypes[14] - The company is advancing its pipeline of innovative vaccines, including mRNA-based vaccines for influenza and other diseases[22] - The company has received positive results from the Phase I clinical trial of the PBPV vaccine, demonstrating good safety and significant antibody responses in adults and the elderly[35] - The company is developing an innovative tuberculosis booster vaccine, with positive results from Phase I trials indicating good safety and immune response[44] Market Strategy and Expansion - The company aims to establish long-term strategic partnerships based on its diverse product pipeline and is preparing for pre-qualification by the World Health Organization[17] - The product line strategically targets the large and underserved global market, including innovative vaccines and those aimed at replacing existing mainstream vaccines in China[20] - The company aims to expand its international market presence, particularly in Southeast Asia, the Middle East, and Latin America, through strategic acquisitions and partnerships[61] - The company is committed to providing innovative, high-quality, and accessible vaccines to meet global healthcare needs[20] Corporate Governance - The board consists of three executive directors, one non-executive director, and three independent non-executive directors[125] - The company has adopted the corporate governance code as per the Hong Kong Listing Rules Appendix C1, ensuring high standards of corporate governance[123] - The board believes that the current structure, where the chairman also serves as the CEO, benefits the company's operational efficiency[131] - The company will continue to review the effectiveness of its corporate governance structure[132] - The independent non-executive directors are considered independent throughout the reporting period[134] Clinical Trials and Approvals - The company has initiated Phase II/III clinical trials for the Tdcp vaccine for adolescents and adults, addressing a current market gap in China[40] - The company has received clinical trial approval for the DTcP-Hib-MCV4 combined vaccine and aims to meet market demand for combined vaccines[52] - The Phase I clinical trial for the recombinant shingles vaccine officially commenced in Canada in November 2023, with the first subject enrolled[47] - The company has received regulatory approval for its innovative recombinant vaccine products, demonstrating its commitment to research and development[119] Financial Management - Financial income decreased from approximately RMB 563 million for the year ended December 31, 2023, to approximately RMB 222 million for the year ended December 31, 2024, primarily due to a reduction in financial income of approximately RMB 362 million[73] - Income tax expense for the year ended December 31, 2024, was approximately RMB 25 million, a decrease from approximately RMB 115 million in 2023, due to the write-off of deferred tax assets[74] - Cash and cash equivalents decreased by 24.0% from approximately RMB 20,470 million as of December 31, 2023, to approximately RMB 15,565 million as of December 31, 2024, mainly due to cash outflows from operating activities and loan repayments[90] Management and Team - The company has established a strong operational team, significantly contributing to the rapid development and production of COVID-19 vaccines[105] - The management team has extensive experience in the biotechnology industry, contributing to strategic business development[120] - The company has attracted senior professionals from the vaccine industry, enhancing its expertise and capabilities in vaccine development[104] Legal and Compliance - The group faced a lawsuit from Belcher Farmaceutica Ltda. claiming damages of approximately RMB 197 million, but management believes the claim is unlikely to succeed[96] - The company has established written guidelines for employees regarding securities trading to prevent insider trading[124] - The company has implemented anti-corruption policies to enhance daily supervision and prevent unethical business practices[174] Employee Diversity and Inclusion - The company aims to maintain the current female representation on the board, with a long-term goal of achieving gender equality[169] - Among all employees, male employees account for 48.6% and female employees account for 51.4%, indicating a balanced gender diversity within the group[170] - The company will continue to maintain employee gender diversity and has measures in place to enhance gender diversity further[170]

《香港联合交易所有限公司证券上市规则》等相关规定，康希诺生物股份公司（以 下简称"康希诺"或"公司"）于2025年3月25日召开第三届董事会第六次会议， 审议通过《关于提请股东大会授权董事会以简易程序向特定对象发行股票的议 案》，同意公司董事会提请股东大会授权董事会决定公司向特定对象发行融资总 额不超过人民币3亿元且不超过最近一年末净资产20%的股票，授权期限为自公 司2024年年度股东大会审议通过之日起至公司2025年年度股东大会召开之日止。 康希诺: 关于提请股东大会授权董事会以简易程序 向特定对象发行股票的公告 证券代码：688185 证券简称：康希诺 公告编号：2025-009 康希诺生物股份公司 关于提请股东大会授权董事会以简易程序 向特定对象发行股票的公告 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、本次授权事项概述 根据《上市公司证券发行注册管理办法》《上海证券交易所上市公司证券发 行上市审核规则》《上海证券交易所上市公司证券发行与承销业务实施细则》及 本议案尚需提交公司2024年年度股东大会审议通过 ...

康希诺: 2024年度环境、社会及管治（ESG）报告暨可持续发 展报告 关于本报告 本期环境、社会及管治（ESG）暨可持续发展报告本着客观、规范、透明和全面的原则，详细披露了康希诺生物在经营与发 展、环境、劳工与社区、价值链等领域内的 ESG 与可持续发 展的社会责任实践和绩效。 编制依据 汇报原则 本报告依照香港联合交易所有限公司《香港联合交易所有限公司证券上市规则》附录 C2《环 重要性： 为编制本报告，本公司开展议题重要性评估程序，以确定本报告的披露内容及各 境、社会及管治报告守则》及上海证券交易所《上海证券交易所上市公司环境信息披露指 议题内容的 详实程度。2024 年度重大性议题分析结果已呈列在"利益相关方沟通"小节中。 引》要求，参考上海证券交易所《上市公司自律监管指引 第 14 号——可持续发展报告（试 量化：本报告在环境、社会范畴均披露定量数据以展现 我们在各关键 ESG 绩效指标中的 行）》，并参照全球可持续发展标准委员会 (GSSB) 发布的《GRI 可持续发展报告标准》 （GRI 表现。 Standards）要求编写。 报告范围 平衡：本报告客观披露正面及负面信息，确保内容平 衡。 一致 ...

目 录 委托单位： 审计单位： 康希诺: 控股股东、实际控制人及其他关联方资金占 用情况的专项说明 关于康希诺生物股份公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 联系电话： 限公司 总计 3,232.44 49,783.70 64.42 38,172.30 14,908.26 注：该金额已全额计提预期信用损失。 | | | 占用方 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 与上市 | 上市公司 | 2024 年期 | | | 2024 年度 | 2024 | | 年期 | | | | | | | | | | 非经营性资金占 | | 资金占用方 | | | | 占用累计发 | 占用资 | | | 金 | | | 占用形 | | | | | | | | | 公司的 | 核算的会 | 初占用资金 | | | 偿还累计 | | | 发 | 末占用资金 | | 占用性质 | | | | | | | 用 | 名称 | | | | 生金额(不 | 的利 | | | | 息 | | | 成原因 ...

二、完善公司治理，确保规范运作 曼海欣®目前作为中国唯一的四价流脑结合疫苗，随着公众对疫苗的了解加深， 对安全性更佳、保护性更全面的疫苗的需求上升，公司将持续进行专业化学术推 广工作，以带动终端选择以及产品的市场占有率。同时，2024 年 11 月，公司提交 了 MCV4 的适用人群年龄扩大至 3 月龄至 6 周岁儿童的补充申请，获批后可覆盖 国家免疫规划的脑膜炎疫苗全程免疫程序。公司也正在积极拓展该产品在其他国 家和地区的准入工作，以期进一步扩大公司优质产品在海外区域的影响力，受惠 更广阔的人群。 对于下一款商业化产品 PCV13i，现阶段已完成临床现场检查及生产现场检查 相关工作，将继续与药监保持积极沟通，保障审评审批工作的顺利进行，同时， 公司已对该产品进行了详细的竞争优势和市场定位分析，目前正积极推动商业化 前期准备工作，旨在产品获批后能够迅速推向市场，快速形成终端需求。 公司基于搭建的五大技术平台形成了技术优势，同时结合市场需求，形成当 前丰富且有竞争力的产品管线，且针对不同的疾病领域形成覆盖更广年龄的产品 组合。公司将继续聚焦重点产品管线的推进，同时拓展成人疫苗、多价多联疫苗 等产品的开发，深化研 ...

康希诺: 2024年度内部控制评价报告 公司代码：688185 公司简称：康希诺 康希诺生物股份公司 康希诺生物股份公司全体股东： 根据《企业内部控制基本规范》及其配套指引的规定和其他内部控制监管要求（以下简称企业内部 控制规范体系），结合本公司（以下简称公司）内部控制制度和评价办法，在内部控制日常监督和专项 监督的基础上，我们对公司2024年12月31日（内部控制评价报告基准日）的内部控制有效性进行了评 价。 一. 重要声明 按照企业内部控制规范体系的规定，建立健全和有效实施内部控制，评价其有效性，并如实披露内 部控制评价报告是公司董事会的责任。监事会对董事会建立和实施内部控制进行监督。经理层负责组织 领导企业内部控制的日常运行。公司董事会、监事会及董事、监事、高级管理人员保证本报告内容不存 在任何虚假记载、误导性陈述或重大遗漏，并对报告内容的真实性、准确性和完整性承担个别及连带法 律责任。 公司内部控制的目标是合理保证经营管理合法合规、资产安全、财务报告及相关信息真实完整，提 高经营效率和效果，促进实现发展战略。由于内部控制存在的固有局限性，故仅能为实现上述目标提供 合理保证。此外，由于情况的变化可能导致 ...

康希诺: 关于使用闲置自有资金进行现金管理的公 告 证券代码：688185 证券简称：康希诺 公告编号：2025-012 康希诺生物股份公司 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2025年3月25日召开第三届董事 会第六次会议和第三届监事会第六次会议，审议通过了《关于使用闲置自有资金 进行现金管理的议案》，同意在确保不影响公司主营业务正常开展，保证运营资 金需求和风险可控的前提下，公司及下属公司拟使用最高不超过人民币28亿元的 暂时闲置自有资金进行现金管理，用于购买安全性高、流动性好的中低风险投资 产品（包括但不限于银行、证券公司或信托公司等金融机构发行的理财产品、信 托产品等）。授权期限为本次董事会审议通过之日起12个月内，在前述额度及期 限范围内，公司可以循环滚动使用。董事会授权董事长在上述额度及决议有效期 内行使投资决策权、签署相关文件等事宜，具体事项由公司财务管理中心负责组 织实施。 一、拟使用自有资金进行现金管理的概况 （一）现金管理目的 在保证公司正常经营所需 ...

康希诺: 2024年度募集资金存放与实际使用情况专项报告 | 证券代码：688185 证券简称：康希诺 | 公告编号：2025-011 | | --- | --- | | 康希诺生物股份公司 | | 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"）董事会根据中国证券监督管理委 员会（以下简称"证监会"）《上市公司监管指引第 2 号—上市公司募集资金管 理和使用的监管要求》及《上海证券交易所科创板上市公司自律监管指引第 1 号 —规范运作》等有关规定，编制了截至 2024 年 12 月 31 日止公开发行 A 股股票 募集资金存放与实际使用情况的专项报告。现将截至 2024 年 12 月 31 日止募集 资金存放与实际使用情况专项说明如下： 一、募集资金基本情况 经中国证监会《关于同意康希诺生物股份公司首次公开发行股票注册的批复》 （证监发行字20201448 号文）核准，公司在上海证券交易所公开发行人民币普 通股（A 股）股票 24,800,000 股，每股发行价格为人民币 209.71 ...

康希诺: 关于续聘会计师事务所的公告 证券代码：688185 证券简称：康希诺 公告编号：2025-008 康希诺生物股份公司 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。 重要内容提示： ? 康希诺生物股份公司（以下简称"公司"）拟续聘德勤华永会计师事务 所（特殊普通合伙）（以下简称"德勤华永"）为2025年度境内审计机构及内部 控制审计机构，拟续聘德勤·关黄陈方会计师行（以下简称"德勤香港"）为2025 年度境外审计机构。 一、拟续聘会计师事务所的基本情况 公司拟续聘德勤华永为 2025 年度境内审计机构及内部控制审计机构，德勤 香港为 2025 年度境外审计机构。德勤华永和德勤香港的情况如下： （一）机构信息 （1）基本信息 德勤华永的前身是 1993 年 2 月成立的沪江德勤会计师事务所有限公司，于 批准转制成为特殊普通合伙企业。德勤华永注册地址为上海市黄浦区延安东路 德勤华永具有财政部批准的会计师事务所执业证书，并经财政部、中国证监 会批准，获准从事 H 股企业审计业务。德勤华永已根据财政部和中国证监会《会 计 ...