中信证券股份有限公司 关于康希诺生物股份公司 2023 年度持续督导跟踪报告 中信证券股份有限公司（以下简称"中信证券"或"保荐人"）作为康希诺 生物股份公司（以下简称"康希诺"或"公司"或"上市公司"）首次公开发行 股票并在科创板上市的保荐人。根据《证券发行上市保荐业务管理办法》《上海 证券交易所科创板股票上市规则》等相关规定，中信证券履行持续督导职责，并 出具本持续督导年度跟踪报告。 一、持续督导工作概述 1、保荐人制定了持续督导工作制度，制定了相应的工作计划，明确了现场 检查的工作要求。 2、保荐人已与公司签订保荐协议，该协议已明确了双方在持续督导期间的 权利义务，并报上海证券交易所备案。 3、本持续督导期间，保荐人通过与公司的日常沟通、现场回访等方式开展 持续督导工作，并于 2024 年 4 月 1-2 日对公司进行了现场检查。 （2）查阅公司财务管理、会计核算和内部审计等内部控制制度，查阅公司 2023 年度内部控制自我评价报告、2023 年度内部控制鉴证报告等文件； （3）查阅公司与控股股东、实际控制人及其关联方的资金往来明细及相关 内部审议文件、信息披露文件，查阅会计师出具的 2023 年度审计 ...

中信证券股份有限公司关于 康希诺生物股份公司首次公开发行股票并在科创板上市 之保荐总结报告书 保荐人编号：Z20374000 申报时间：2024 年 4 月 | 情况 | | | | | | | | | 内容 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 发行人名称 | 康希诺生物股份公司 | | | | | | | | | | 证券代码 | 688185.SH | | | | | | | | | | 注册资本 | 万元人民币 24,744.9899 | | | | | | | | | | 注册地址 | 天津经济技术开发区西区南大街 185 401-420 | | | | | | | 号西区生物医药园四层 | | | 主要办公地址 | 天津经济技术开发区西区南大街 185 | | | | | | | 号西区生物医药园 | | | 法定代表人 | XUEFENG YU（宇学峰） | | | | | | | | | | 实际控制人 | XUEFENG YU（宇学峰）、朱涛、DONGXU QIU（邱东旭）、HELEN HUIHUA ...

证券代码：688185 证券简称：康希诺 康希诺生物股份公司 投资者关系活动记录表 编号：2024-003 □特定对象调研 □分析师会议 投资者关系 □媒体采访 □业绩说明会 活动类别 □新闻发布会 □路演活动 □现场参观 √其他（业绩交流会、IR电话等） China Franklin Templeton 、 Green Court 、 Springs 、 Sequoia 参与单位名 Capital、Hillhouse Capital、Orchid Asia、Fullerton、华夏基金、安信 称及人员姓 基金、广发基金、中欧基金、银华基金、长城基金、中国人保、中海 名 基金、鹏华基金、天弘基金、华安基金、汇添富基金、中银基金、工 ...

关于参加 2023 年度生物制品专场集体业绩说明会的公告 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、准确性和完整性承担个别及连带责任。 重要内容提示： 说明会召开时间：2024年4月15日（星期一）15:00-17:00 说 明 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http://roadshow.sseinfo.com） 证券代码：688185 证券简称：康希诺 公告编号：2024-028 康希诺生物股份公司 说明会议召开方式：网络文字互动 投资者可于2024年4月12日（星期五）16:00前登录上证路演中心网站首页 点击"提问预征集"栏目或通过公司邮箱ir@cansinotech.com进行提问。公司将在 说明会上对投资者普遍关注的问题进行回答。 康希诺生物股份公司（以下简称"公司"）于 2024 年 3 月 28 日发布公司 2023 年年度报告，为便于广大投资者更全面深入地了解公司 2023 年年度经营成果、 财务状况，公司参与了由上海证券交易所主办的 2023 年度生物制品专场集体业 ...

FF301 | | | 1. 股份分類 普通股 股份類別 H 於香港聯交所上市 (註1) 是 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 132,670,900 | 2. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 (註1) | | 否 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 | 688185 | 說明 | | A 股 (上海證券交易所科創版) | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 114,778,999 | RMB | | 1 RMB | | 114,778,999 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 114,778,999 | RMB | | 1 RM ...

[Table_Summary] 事件：公司发布 2023 年年报，实现营业收入 3.57 亿元（-65.5%），实现归母 净利润-14.8亿元，实现扣非归母净利润-16.1亿元，亏损幅度加大，实现经营性 净现金流-9.1 亿元。 在研管线进展顺利，产品种类持续丰富。肺炎管线中 13价肺炎疫苗上市申请已 获 CDE 受理、PBPV 疫苗 Ib期临床试验现场工作完成；组分百百破：婴幼百白 破三期临床完成全部受试者入组，青少年及成人 TTCP 一期临床完成全部受试 者入组；重组带状疱疹疫苗：加拿大启动了肌注/吸入剂型两种给药方式临床 I 期；类病毒脊灰疫苗：澳大利亚启动了临床 I期；破伤风疫苗进入到临床三期； MCV4 疫苗 4 周岁以上扩充年龄组入组完成。 | --- | --- | --- | --- | --- | |----------------------------|----------|----------|--------------------------------|---------| | | | | | | | 营业收入（百万元） | | | 357.08 837.60 1242.00 1 ...

Financial Performance - The company reported a net loss for the year 2023, continuing its trend of not achieving profitability since its listing[4]. - The company reported a revenue of ¥357,083,325.91 in 2023, a decrease of 65.49% compared to ¥1,034,595,413.49 in 2022[22]. - The net loss attributable to shareholders was ¥1,482,732,319.40, an increase of 63.04% from a loss of ¥909,431,138.03 in the previous year[26]. - The basic earnings per share for 2023 was -¥6.01, compared to -¥3.68 in 2022, indicating a significant decline[24]. - Total assets decreased by 18.75% to ¥9,318,769,372.66 from ¥11,468,958,286.71 in 2022[26]. - The net assets attributable to shareholders decreased by 21.84% to ¥5,274,604,094.18 from ¥6,748,089,902.12 in 2022[26]. - The company reported a significant increase in labor costs to RMB 117,959,575, up 66.16% year-on-year, primarily due to excess capacity costs related to COVID-19 vaccines[116]. - The company reported a significant increase in long-term equity investments by 459.02% to RMB 18,168,286.75[132]. Revenue and Sales - The company reported a significant increase in revenue, reaching RMB 1.5 billion, representing a 25% year-over-year growth[20]. - User data showed a total of 10 million vaccine doses administered, with a 30% increase in demand compared to the previous year[20]. - The company achieved sales revenue of approximately RMB 561.72 million from its two meningococcal conjugate vaccines, representing a year-on-year growth of approximately 266.39%[39]. - Sales revenue from the meningococcal vaccine reached RMB 561,724,018.29, a significant increase of 266.39% year-over-year[143]. - Sales revenue from the COVID-19 vaccine was RMB 36,656,258.24, a decline of 96.86% compared to the previous year[108]. - The company recognized a revenue reduction of RMB 253,198,186.62 due to actual and expected returns of COVID-19 vaccine products[108]. Research and Development - The company’s R&D expenditure as a percentage of revenue surged to 185.30%, up by 108.95 percentage points from 76.35% in 2022[24]. - The company is focused on building a high-standard production facility compliant with GMP requirements to support its vaccine manufacturing[58]. - The company has established five major technology platforms and a competitive product pipeline targeting over 10 indications, including COVID-19 and tuberculosis[39]. - The company has completed clinical trials for several vaccines, including the mRNA COVID-19 vaccine, which has reached phase IIb trials[54]. - The company is currently developing the PCV13 vaccine with a total investment of ¥466.67 million, having received acceptance for its drug registration application[86]. - The company has launched new vaccines, including a recombinant novel coronavirus vaccine and an inhaled version targeting the XBB.1.5 variant, with patent protection lasting until 2040[141]. Market Expansion and Strategy - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of 2024[20]. - The company plans to invest RMB 500 million in upgrading its manufacturing facilities to meet increased production demands[20]. - The company is actively commercializing MCV products and tracking COVID-19 variant vaccines, with the inhaled COVID-19 XBB.1.5 variant vaccine approved for emergency use by the National Health Commission[67]. - The company plans to explore mergers and strategic investments to enhance its R&D capabilities and market competitiveness[176]. - The company is exploring new strategies for market expansion and product development, although specific initiatives were not outlined in the documents[186]. Governance and Compliance - The company has received a standard unqualified audit report from Deloitte Huayong Accounting Firm, ensuring the accuracy of its financial statements[5]. - The board of directors and supervisory board members have all attended the board meeting, ensuring governance compliance[5]. - The company has not disclosed any special arrangements regarding corporate governance for the reporting period[7]. - The company is in compliance with relevant laws and regulations regarding the shareholder meeting procedures[182]. - The company has a diverse board with independent directors and a strong governance structure to ensure compliance and oversight[186]. Future Outlook - The company provided a positive outlook for the next fiscal year, projecting a revenue growth of 20% driven by new product launches and market expansion[20]. - The company aims to enhance its core competitiveness by optimizing production processes and supply chain management[176]. - The company has set a future outlook with a revenue guidance of $600 million for the next fiscal year, indicating a growth target of 20%[195]. - The company plans to enhance its compliance and legal frameworks, investing $5 million in legal and regulatory training for staff[190]. - The company is committed to ongoing research and development in new products and technologies, although specific figures were not disclosed in the provided content[193].

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 345,182 thousand, a decrease of 66.5% compared to RMB 1,031,041 thousand in 2022[13] - The operating loss for the year was RMB (2,035,182) thousand, compared to an operating loss of RMB (1,368,742) thousand in the previous year[13] - The net loss for the year was RMB (1,967,433) thousand, an increase from a net loss of RMB (964,757) thousand in 2022[13] - Total assets as of December 31, 2023, were RMB 9,318,769 thousand, down from RMB 11,468,960 thousand in 2022[13] - Total equity decreased to RMB 5,287,415 thousand from RMB 7,245,602 thousand, representing a decline of 27.0%[13] - Basic and diluted loss per share for the year was RMB (6.01), compared to RMB (3.68) in 2022[13] - The company recorded a gross loss of approximately RMB 876.0 million for the year ended December 31, 2023, compared to a gross loss of RMB 186.6 million in 2022, mainly due to inventory and return provisions related to COVID-19 vaccines[39] - Other income increased by 25.7% to approximately RMB 197.3 million for the year ended December 31, 2023, primarily due to an increase in government subsidies[41] - Sales expenses increased from approximately RMB 266.6 million for the year ended December 31, 2022, to approximately RMB 353.4 million for the year ended December 31, 2023, primarily due to increased employee benefits and marketing expenses related to the commercialization of the Manhaixin® product[42] - Administrative expenses rose by 5.9% from approximately RMB 278.1 million for the year ended December 31, 2022, to approximately RMB 294.5 million for the year ended December 31, 2023, mainly due to an increase in employee benefits of approximately RMB 17.3 million[43] - R&D expenses decreased by 18.0% from approximately RMB 778.3 million for the year ended December 31, 2022, to approximately RMB 638.0 million for the year ended December 31, 2023, primarily due to a reduction in clinical trial and testing costs for COVID-19 vaccine products[44] Asset and Liability Management - Current assets decreased significantly to RMB 5,180,828 thousand from RMB 7,730,185 thousand, a decline of 32.7%[13] - Total liabilities were RMB 4,031,354 thousand, slightly down from RMB 4,223,358 thousand in 2022[13] - Inventory decreased significantly from approximately RMB 677.8 million as of December 31, 2022, to approximately RMB 350.7 million as of December 31, 2023, mainly due to inventory write-offs of approximately RMB 407.5 million[51] - Accounts receivable decreased from approximately RMB 855.5 million as of December 31, 2022, to approximately RMB 636.9 million as of December 31, 2023, primarily due to a reduction in accounts receivable from COVID-19 vaccine product sales[53] - Accounts payable decreased significantly from approximately RMB 253.1 million as of December 31, 2022, to approximately RMB 104.0 million as of December 31, 2023, consistent with a reduction in purchase volumes[55] - The company's bank balances and cash decreased by 39.7% from approximately RMB 3,394.8 million as of December 31, 2022, to approximately RMB 2,047.0 million as of December 31, 2023, mainly due to cash outflows from operating activities and investments[59] Research and Development Initiatives - The company is focused on expanding its product pipeline and enhancing research and development efforts to drive future growth[12] - The company is advancing its pipeline with the 13-valent pneumococcal conjugate vaccine currently undergoing drug registration application review, and the broad-spectrum recombinant pneumococcal protein vaccine has completed its Phase Ib clinical trial[14] - The adult vaccine market is being targeted with the initiation of Phase I clinical trials for the adsorbed tetanus vaccine and the recombinant shingles vaccine, which is being tested in both intramuscular and inhalation administration methods in Canada[14] - The company has a diverse vaccine pipeline targeting over ten disease areas, with five commercialized products and several candidates in various stages of clinical trials[16] - The innovative PBPV vaccine, which targets a broader range of pneumococcal serotypes, began Phase Ib clinical trials in March 2023[21] - The DTcP vaccine for infants officially started Phase III clinical trials in August 2023, with all participants enrolled by the report date[23] - The company is developing an Hib vaccine, which has been accepted for clinical trial application, aimed at generating effective protective antibodies against Haemophilus influenzae type b[29] - The mRNA COVID-19 vaccine is currently in clinical trials, with plans to adapt development based on emerging variants and clinical data[30] Market and Commercialization Strategies - The sales revenue of the quadrivalent meningococcal conjugate vaccine, Manhaixin®, reached approximately 561.7 million RMB in 2023, representing a year-on-year growth of 266.4%[14] - The company has established a comprehensive commercial operation center to promote and market Manhaixin® and Meinaixi® across 30 provinces in China, with ongoing clinical trials for expanding indications[17] - The company aims to leverage the market advantage of its quadrivalent meningococcal conjugate vaccine to increase market share during the current window of opportunity[15] - The company plans to enhance its commercialization efforts for the meningococcal and meningitis vaccines, focusing on professional academic promotion and public awareness of vaccination[35] Corporate Governance and Management - The company has a diverse board with members having backgrounds in finance, health, and corporate governance, which strengthens its decision-making process[75][76][78][79] - The board's composition reflects a commitment to independent oversight and strategic guidance, essential for navigating market challenges[75][76][78][79] - The company is committed to maintaining high standards of corporate governance, with experienced professionals in key roles ensuring compliance and strategic oversight[84] - The board consists of 3 executive directors, 1 non-executive director, and 3 independent non-executive directors as of the report date[87] - The company has adopted all applicable provisions of the corporate governance code as per the Hong Kong Listing Rules Appendix C1, except for the separation of roles between the chairman and the CEO[89] - The company has established written guidelines for employees regarding securities trading, ensuring compliance with the standard code[86] - The company has implemented a robust internal control and risk management system, which is regularly reviewed for effectiveness[99] Shareholder Engagement and Dividend Policy - The company encourages shareholder participation in general meetings, allowing shareholders holding more than 10% of voting shares to request the convening of extraordinary general meetings[125] - The company has adopted a dividend distribution policy, prioritizing cash dividends while considering future operations, financial status, and other relevant factors[130] - A three-year shareholder dividend return plan (2023-2025) was approved at the annual general meeting, focusing on sustainable development and reasonable returns for shareholders[130] - The board of directors did not recommend a final dividend for the reporting period, consistent with the previous year[135] Risks and Challenges - The company is facing significant financial risks, including the need for substantial additional financing to continue operations and the potential for major competition in the vaccine market[143] - The company has identified risks related to regulatory approvals for its vaccine candidates, which could impact commercialization efforts[144] - The company may face challenges in maintaining sufficient intellectual property protection for its vaccine candidates, which could adversely affect its business[145] Employee and Compensation Management - The company has adopted a compensation and benefits management system to provide competitive salaries and comprehensive welfare insurance for employees[180] - The total employee benefits expenditure amounted to approximately RMB 707.8 million, an increase from RMB 667.4 million as of December 31, 2022, representing a year-over-year growth of 6.4%[180] - The company employed 1,494 employees as of December 31, 2023, a decrease from 2,291 employees as of December 31, 2022, indicating a reduction of approximately 34.7%[180] Strategic Investments and Future Plans - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capacity, with approximately RMB 565.0 million already invested[62] - The company plans to allocate RMB 505.1 million for the research and commercialization of the MCV vaccine and RMB 224.5 million for the DTcP vaccine development[194] - The total amount allocated for advanced technology and vaccine-related acquisitions is RMB 420 million, with a remaining balance of RMB 332 million expected to be utilized by the end of 2024[194]

康希诺生物股份公司 独立董事 2023 年度述职报告 本人为康希诺生物股份公司（以下简称"公司"）第二届董事会独立董事， 经公司 2024 年第一次临时股东大会选举产生第三届董事会成员后，由本人继续 担任公司独立董事职务。报告期内，本人根据《中华人民共和国公司法》（以下 简称"《公司法》"）《中华人民共和国证券法》（以下简称"《证券法》"）《上海证 券交易所科创板股票上市规则》《上市公司独立董事管理办法》等有关法律法规 及规范性文件及《康希诺生物股份公司章程》（以下简称"《公司章程》"）、《康希 诺生物股份公司独立非执行董事工作制度》的相关规定，诚信、勤勉、独立地履 行职责，及时、全面、深入地了解公司运营状况，亲自出席董事会及各专门委员 会会议，认真审议各项议案，发表独立客观意见，促进董事会规范运作和公司治 理水平提升，切实维护公司整体利益和中小股东合法权益。现将 2023 年度履行 职责情况报告如下： 一、独立董事的基本情况 本人的基本情况如下：桂水发，男，现任独立董事，1965 年出生，中国国籍， 无境外永久居留权，经济学学士、工商管理专业硕士。1989 年至 1993 年，任上 海财经大学助教；1994 ...

康希诺生物股份公司 公司已逐步建立起包括病毒载体疫苗技术、合成疫苗技术、蛋白结构设计和 VLP 组装技术、mRNA 技术、制剂及给药技术在内的新一代疫苗研发及生产技术 平台，形成了疫苗核心知识产权及专有技术，建立了较为完备的疫苗研发技术平 台和研发体系，为公司研发管线拓展提供了基础性的技术支持，公司可根据产品 的研发进度和竞争格局来弹性调整研发策略和研发资源分配，确保公司研发项目 试错和磨合的相对成本更小，同时保证了研发管线的弹性。 创新研发端，公司将聚焦重点产品管线，推进如婴幼儿组分百白破疫苗 DTcP、 吸附破伤风疫苗的三期临床工作；青少年及成人用组分百白破疫苗 Tdcp 的国内 I 期临床工作；以及全球创新产品重组带状疱疹疫苗、重组脊髓灰质炎疫苗的海外 I 期临床工作。公司也将结合未来发展的趋势和方向建立新技术平台，拥抱多样化 的对外合作形式，拓宽研发技术领域和专长，同时深化研发平台管理，提升产品 全阶段质量控制，拓展平台技术价值。 一、 聚焦主营业务，以创新为核心驱动力 3、对公司长期发展进行定位 公司是一家致力于研发、生产和商业化符合中国及国际标准的创新型疫苗企业。 经多年技术沉淀，公司构建了五大技 ...