证券代码：688185 证券简称：康希诺 公告编号：2024-033 康希诺生物股份公司 关于 2023 年年度报告的信息披露监管问询函的回复公告 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 2024 年 4 月 12 日收到上海证 券交易所科创板公司管理部向公司发送的《关于康希诺生物股份公司 2023 年年 度报告的信息披露监管问询函》（上证科创公函【2024】0056 号，以下简称 "《问询函》"），公司及相关中介机构就《问询函》关注的问题逐项进行认真 核查，现就《问询函》相关问题回复如下： 一、 关于经营业绩 1、关于主营业务。年报显示，2023 年公司实现营业收入 3.57 亿元，同比 减少 65.49%，归母净亏损 14.83 亿元，同比增亏 63.04%，主营业务毛利率为 26.50%，较上年减少 33.17 个百分点。其中，流脑疫苗产品销售收入 5.62 亿元， 同比增长 266.39%，新冠疫苗产品销售收入 0.37 亿元，同比下降 96.86%；同 时，公司根 ...

中信证券股份有限公司 关于 康希诺生物股份公司 2023 年年度报告的 信息披露监管问询函回复的 核查意见 保荐人（主承销商） 深圳市福田区中心三路 8 号卓越时代广场（二期）北座 1 上海证券交易所： 根据贵所于 2024 年 4 月 12 日出具的《关于康希诺生物股份公司 2023 年年 度报告的信息披露监管问询函》（上证科创公函【2024】0056 号，以下简称"问询 函"）的有关要求，中信证券股份有限公司（以下简称"中信证券"）作为康希诺 生物股份公司（以下简称"公司"或"康希诺"）首次公开发行股票并在科创板 上市的保荐机构及持续督导机构，与发行人对问询函所列问题认真进行了逐项落 实，现将有关问题的核查情况说明如下： 2 目 录 | 一、关于经营业绩 5 | | --- | | 问题 1 关于主营业务 5 | | （一）分产品列示营业收入构成、营业成本构成及毛利率情况，并结合新冠 | | 疫苗产品退货、产能冗余等情况，量化分析各产品毛利率变化的具体原因 5 | | （二）结合市场需求变化、退货政策调整（如适用）等，说明公司本期调整 | | 预计退货率的主要依据，本期销售退货估计的关键假设、主要参数及确 ...

Deloitte. 德勤华永会计师事务所(特殊普通合伙)关于 康希诺生物股份公司 2023年年度报告的信息披露监管问询函中相关问题的回复 德师报(函)字(24)第 Q01108 号 康希诺生物股份公司: 德勤华永会计师事务所(特殊普通合伙)接受委托,对康希诺生物股份公司 (以下简称:"康希诺"或"公司")2023年年度财务报表执行了审计工作,并于 2024年3月27日出具了德师报(审)字(24)第 P03044 号无保留意见审计报告。 我们于 2024年4月12日收到了康希诺转来的上海证券交易所出具的《关于 康希诺生物股份公司 2023年年度报告的信息披露监管问询函》(上证科创公函 【2024】0056 号)(以下简称"问询函")。按照问询函的相关要求和公司的相关说 明,基于我们已执行的审计工作,我们对问询函中需由会计师进行说明的相关 问题回复如下。 WorldClass 智启非凡 一、关于经营业绩 1.关于主营业务。年报显示,2023年公司实现营业收入 3.57 亿元,同比减 少 65.49%, 归母净亏损 14.83 亿元,同比增亏 63.04%, 主营业务毛利率为 26.50%,较上年减少 33.17个 ...

Financial Performance - The company's operating revenue for the first quarter was RMB 114,282,281.78, representing a year-on-year increase of 13.65%[4] - The net profit attributable to shareholders of the listed company was a loss of RMB 170,095,866.61, with a loss of RMB 178,676,681.71 after deducting non-recurring gains and losses[4] - The net loss attributable to shareholders for Q1 2024 was ¥174,882,984.28, compared to a net loss of ¥170,199,047.09 in Q1 2023, showing a slight increase in losses[23] - The total comprehensive income attributable to the parent company for Q1 2024 was (174,560,182.55) CNY, compared to (170,165,760.27) CNY in Q1 2023, indicating a slight increase in losses[25] - Basic and diluted earnings per share for Q1 2024 were (0.69) CNY, up from (0.57) CNY in Q1 2023, reflecting improved performance[25] Cash Flow - The net cash flow from operating activities was a negative RMB 108,195,674.35, indicating a significant cash outflow[4] - The company reported a significant reduction in net cash outflow from operating activities, narrowing by 68.68% compared to the same period last year[8] - Cash flow from operating activities for Q1 2024 was (108,195,674.35) CNY, a significant improvement from (345,405,099.94) CNY in Q1 2023[27] - Cash inflow from investment activities in Q1 2024 was 2,636,256,442.11 CNY, slightly down from 2,787,235,704.28 CNY in Q1 2023[28] - Net cash flow from investment activities for Q1 2024 was 275,011,228.44 CNY, compared to (172,008,398.75) CNY in Q1 2023, indicating a positive turnaround[28] - Cash flow from financing activities in Q1 2024 was 147,374,678.75 CNY, a recovery from (10,474,806.49) CNY in Q1 2023[29] - The net increase in cash and cash equivalents for Q1 2024 was 328,808,252.94 CNY, compared to (547,374,059.15) CNY in Q1 2023, showing improved liquidity[30] - The ending balance of cash and cash equivalents for Q1 2024 was 2,374,907,374.57 CNY, down from 2,843,893,796.13 CNY in Q1 2023[30] Assets and Liabilities - Total assets at the end of the reporting period were RMB 8,568,692,147.63, down 8.05% from the end of the previous year[5] - Non-current assets totaled ¥3,544,849,827.74 as of March 31, 2024, down from ¥4,137,941,596.05 at the end of 2023, a decrease of approximately 14.3%[18] - Current liabilities decreased to ¥2,102,763,825.91 from ¥2,565,301,751.60, representing a reduction of about 18%[17] - Long-term borrowings increased to ¥1,148,909,685.31 from ¥1,065,659,776.95, reflecting an increase of approximately 7.8%[18] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 21,770[9] - The top shareholder, HKSCC NOMINEES LIMITED, holds 98,066,897 shares, representing 39.63% of the total shares[11] - Xuefeng Yu and Dongxu Qiu each hold 17,874,200 shares, accounting for 7.22% of the total shares[11] - The company has a total of 1,403,742 shares held by Sun Ge, representing 0.57% of the total shares[11] Research and Development - Research and development (R&D) expenses totaled RMB 124,328,450.39, which accounted for 108.79% of operating revenue, a decrease of 41.25 percentage points compared to the previous year[4][8] - Research and development expenses for Q1 2024 were ¥96,745,611.33, down from ¥149,765,069.58 in Q1 2023, indicating a decrease of about 35.4%[20] Legal Matters - The company is facing a lawsuit from Belcher Farmaceutica Ltda. seeking approximately BRL 167 million (about RMB 241 million) for alleged damages related to COVID-19 vaccine registration and commercialization in Brazil[14] - The company has engaged a professional legal team to address the lawsuit, believing it has a strong defense position[14] Other Financial Metrics - The weighted average return on net assets was -3.28%, a decrease of 1.19 percentage points year-on-year[4] - The company experienced an investment loss of RMB 70,511,874.94 due to the exclusion of Shanghai Pharmaceuticals CanSino Biologics from the consolidation scope[8] - The company will no longer consolidate Kangxino into its financial statements, as the agreement with Shanghai Biomedical Industry Equity Investment Fund will automatically terminate on February 2, 2024[13] - The company’s financial assets held for trading increased to RMB 1,431,702,017.93 from RMB 1,308,274,692.11, marking an increase of approximately 9.4%[15] - The company’s inventory as of March 31, 2024, was RMB 355,418,384.95, slightly up from RMB 352,847,638.45[15] - Other comprehensive income after tax for Q1 2024 was 322,801.73 CNY, a significant increase from 33,286.82 CNY in Q1 2023[24] Future Outlook - The company plans to implement new accounting standards starting January 1, 2024, which may impact future financial reporting[31]

2024 年第一季度报告 2024 年第一季度报告 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务信息 的真实、准确、完整。 (一)主要会计数据和财务指标 对公司将《公开发行证券的公司信息披露解释性公告第 1 号——非经常性损益》未列举的项目认 定为的非经常性损益项目且金额重大的，以及将《公开发行证券的公司信息披露解释性公告第 1 号——非经常性损益》中列举的非经常性损益项目界定为经常性损益的项目，应说明原因。 □适用 √不适用 3 / 12 (一)普通股股东总数和表决权恢复的优先股股东数量及前十名股东持股情况表 单位：股 注：HKSCC NOMINEES LIMITED（香港中央结算代理人有限公司）所持股份为其代理的在香港中央 结算代理人有限公司交易平台上交易的公司 H 股股东账户的股份总和，不包含公司控股股东持有 的 H 股股份数量。 2024 年第一季度报告 (一)审计意见类型 | --- | --- | --- | --- | |----------------|-------|------------------|------------------| | | | ...

Financial Performance - Total revenue for 2023 was RMB 345,182 thousand, a significant decrease of 66.5% compared to RMB 1,031,041 thousand in 2022[13] - Operating loss for 2023 was RMB (2,035,182) thousand, worsening from a loss of RMB (1,368,742) thousand in the previous year[13] - Net loss for the year was RMB (1,967,433) thousand, compared to a net loss of RMB (964,757) thousand in 2022, indicating a 104.3% increase in losses[13] - Total assets decreased to RMB 9,318,769 thousand in 2023 from RMB 11,468,960 thousand in 2022, reflecting a decline of 18.8%[13] - Total equity fell to RMB 5,287,415 thousand in 2023, down from RMB 7,245,602 thousand in 2022, a decrease of 27.0%[13] - Basic and diluted loss per share for 2023 was RMB (6.01), compared to RMB (3.68) in 2022, indicating a worsening of 63.9%[13] - Revenue from the Chinese market was RMB 342.0 million in 2023, down from RMB 812.8 million in 2022, while overseas revenue was RMB 3.2 million, down from RMB 218.3 million[38] - The company reported 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] Assets and Liabilities - Non-current assets increased to RMB 4,137,941 thousand in 2023, up from RMB 3,738,775 thousand in 2022, representing an increase of 10.7%[13] - Current liabilities decreased to RMB 2,591,844 thousand in 2023 from RMB 2,942,065 thousand in 2022, a reduction of 11.9%[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 during the reporting period[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, aligning with a reduction in purchase volumes[55] Market and Product Development - The company is focusing on expanding its market presence and developing new products and technologies to drive future growth[12] - 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 is advancing its product pipeline, with the 13-valent pneumococcal conjugate vaccine undergoing drug registration application review, and the broad-spectrum recombinant pneumococcal protein vaccine having completed Phase Ib clinical trial site work[14] - The adult vaccine market is being targeted, with the tetanus vaccine entering Phase I clinical trials and the recombinant shingles vaccine undergoing Phase I clinical trials in Canada using both intramuscular and inhalation methods[14] - The company has established international collaborations, including a framework agreement with AstraZeneca AB for contract development and manufacturing services for its mRNA vaccine project[14] Research and Development - The company has developed a pipeline of vaccines covering over 10 infectious diseases under the leadership of CEO Xuefeng Yu, who has over 30 years of experience in biotechnology research and development[68] - The company is conducting clinical trials for several innovative vaccines, including PBPV, PCV13i, and a tuberculosis booster vaccine[71] - The company has established a world-class research and development technology platform for vaccine development[71] - The company aims to enhance its product strategy and core competitiveness through the development of the infant DTcP vaccine, which serves as a domestic alternative to imported vaccines[22] Governance and Management - The company has a diverse board with members holding significant experience in finance, health, and corporate governance, enhancing its strategic oversight capabilities[75][76][78][79] - 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 is committed to maintaining high standards of corporate governance and compliance through its experienced management and supervisory team[84] - The independent non-executive directors confirmed their independence according to the Hong Kong Listing Rules, ensuring compliance with governance standards[179] Shareholder Engagement and Dividends - The company encourages shareholder participation in general meetings, allowing shareholders holding more than 10% of voting shares to request the board to convene an extraordinary general meeting within 10 days of the request[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 to 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 faces significant financial risks, including the need for substantial additional financing to support operations and potential delays in product development due to capital acquisition challenges[143] - The company has identified risks related to the commercialization of vaccines, including competition in the vaccine market and potential regulatory approval challenges[144] - The group faces foreign exchange risk due to financial assets and liabilities denominated in currencies other than the functional currency, with a current effective contract notional amount of $60.6 million (equivalent to RMB 430.0 million) for hedging purposes[66] Employee and Compensation - 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 growth of about 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 34.8%[180] - The company has established a remuneration and assessment committee to review the remuneration policies based on operational performance and individual performance of directors and senior management[180] Future Plans and Investments - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capacity, having already invested approximately RMB 565.0 million[62] - The company plans to allocate RMB 505.1 million for the development and commercialization of the MCV vaccine and RMB 224.5 million for the DTcP vaccine research[194] - The company aims to enhance its R&D, production, testing, and storage capabilities through the strategic use of the IPO proceeds[197]

证券代码：688185 证券简称：康希诺 公告编号：2024-030 康希诺生物股份公司 产品名称：冻干 b 型流感嗜血杆菌结合疫苗 申请人：康希诺生物股份公司 关于冻干b型流感嗜血杆菌结合疫苗获得 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 核准签发的关于冻干b型流感嗜血杆菌结合疫苗（以下简称"Hib疫苗"）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 公司研发的Hib疫苗系以纯化的Hib荚膜多糖与破伤风类毒素蛋白共价结合 而成，采用冻干剂型，预期可在接种后诱导针对 Hib 的体液免疫，对接种者提供 保护作用。 三、风险提示 通知书编号：2024LP00962 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，经审査，Hib 疫苗符合药品注册的有关要求，同意开展预防由 b 型流感嗜血杆菌引起的侵袭性感染（包括脑膜炎、肺炎、败血症、蜂窝织炎、 关节炎、会厌炎等）的临床 ...

证券代码：688185 证券简称：康希诺 公告编号：2024-029 康希诺生物股份公司 自愿披露关于重组肺炎球菌蛋白疫苗 获得I期临床积极初步结果的公告 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"）的重组肺炎球菌蛋白疫苗（以下简 称"PBPV"）于已开展的 I 期（包括 Ia 期及 Ib 期）临床试验中获得了积极的初 步结果。现将相关情况公告如下： 一、 产品基本情况 PBPV 是全球创新的在研肺炎疫苗，与已上市的 23 价肺炎球菌多糖疫苗（以 下简称"PPV23"）和 13 价肺炎球菌多糖结合疫苗（以下简称"PCV13"）不同， 并非血清型特异型疫苗，其主要采用基于肺炎球菌表面蛋白 A（PspA，一种几 乎所有肺炎球菌表达的高度保守蛋白）的抗原，相较于目前上市的 PPV23、 PCV13，PBPV 具有更高血清覆盖率（至少 98%的肺炎球菌株覆盖率）。在高覆 盖率保护下，可以有效防止"血清型替代"的产生。同时本产品相较多糖疫苗和 结合疫苗，生产工艺更为简便，易于放大和质量控制。 ...

承董事會命 康希諾生物股份公司 Xuefeng YU 董事長 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通告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本通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。 （股份代號：6185） 董事會會議通告 康希諾生物股份公司（「本公司」）董事（「董事」）會（「董事會」）謹此宣佈，董事會 會議將於2024年4月29日（星期一）舉行，藉以（其中包括）考慮及批准本公司及其 附屬公司截至2024年3月31日止三個月的第一季度業績及其發佈。 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） 於本通告日期，董事會包括執行董事Xuefeng YU博士、Shou Bai CHAO博士及王 靖女士；非執行董事梁頴宇女士，以及獨立非執行董事桂水發先生、劉建忠先生 及張耀樑先生 。 香港，2024年4月17日 ...

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） （股份代號：6185） 須予披露的交易 購買結構性存款 購買結構性存款 董事會宣佈，於2024年4月11日，本公司與渤海銀行訂立渤海銀行結構性存款 協議V，據此，本公司同意向渤海銀行購買本金金額人民幣60百萬元的結構性 存款。 《上市規則》的涵義 根據《上市規則》第14.07條計算的有關渤海銀行結構性存款協議V項下的交易的 所有適用百分比率低於5%，因此於渤海銀行結構性存款協議V項下購買結構性 存款單獨來看並不構成《上市規則》第14章項下本公司的一項須予披露的交易。 由於渤海銀行結構性存款協議V與渤海銀行結構性存款協議I、III及IV（各份協 議於本公告日未到期）均是與同一家銀行訂立的協議且彼等協議項下的交易性質 類似，因此根據《上市規則》第14.22條的規定，渤海銀行結構性存款協議項下的 交易 ...