证券代码：688185 证券简称：康希诺 公告编号：2023-044 截至目前，暂无国内疫苗厂商研发的组分百白破疫苗获批上市，公司的婴幼 儿用 DTcP 定位即为进口替代。同时，该款疫苗的开发，也是青少年及成人用组 分百白破疫苗和组分百白破联合疫苗进一步研发的基础。组分百白破疫苗产品组 合将进一步丰富公司产品策略，提升公司核心竞争力。 二、临床试验相关情况 婴幼儿用 DTcP 开展的 I 期临床试验结果显示：该疫苗安全性良好，无 3 级 不良反应的发生，无与疫苗相关的严重不良事件（SAE）的发生。 III 期临床试验将基于 I 期临床获得的研究数据，评价该疫苗在 2 月龄、3 月 龄婴幼儿人群中接种的安全性及免疫原性，进行随机、盲法、阳性疫苗对照的临 床试验。 康希诺生物股份公司 自愿披露关于婴幼儿用吸附无细胞百（组分）白破联合疫苗 启动III期临床试验并完成首例受试者入组的公告 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"）的婴幼儿用吸附无细胞百（组分） 白破联合疫苗（以下简称"婴 ...

证券代码：688185 证券简称：康希诺 公告编号：2023-043 康希诺生物股份公司 自愿披露关于与阿斯利康签署框架协议的公告 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。 重要内容提示： 康希诺生物股份公司（以下简称"公司"）与 AstraZeneca AB（以下简称"阿 斯利康"）签署了《产品供应合作框架协议》（以下简称"本协议"），公司将向 阿斯利康提供合同开发和生产服务以支持其 mRNA 疫苗项目，生产和供应特定 产品，并提供相关特定服务。本协议的具体实施内容和进度尚存在不确定性，敬 请投资者注意投资风险。 2、协议签订的决策程序 根据《上海证券交易所科创板股票上市规则》《公司章程》及《总经理工作 细则》的相关规定，本协议的签署属于公司总经理决策权限范围，无需提交公司 董事会及股东大会审议。 二、协议主要内容 1、协议日期：2023年8月7日 具体项目合作事宜将由双方或双方各自指定的附属公司另行签署具体的 项目协议。公司与阿斯利康合作的附属公司包括但不限于康希诺（上海）生物科 技有限公司、康希诺（上海）生物研 ...

Financial Performance - Operating revenue fell by 79.86% due to a significant decrease in demand for COVID-19 vaccines compared to last year[14] - Net profit attributable to shareholders decreased by 214.94%, leading to a loss for the company[14] - Basic and diluted earnings per share were both -0.57 RMB, compared to 0.49 RMB in the previous year[22] - The company reported a net loss of -170,199, compared to a profit of 114,295 in the same period last year, marking a significant shift in performance[33] - Total operating revenue for Q1 2023 was CNY 100,553 thousand, a decrease of 79.86% compared to CNY 499,355 thousand in Q1 2022[55] - Net profit attributable to shareholders for Q1 2023 was CNY -139,547 thousand, representing a decline of 214.94% year-over-year[60] - Basic and diluted earnings per share for Q1 2023 were both CNY -0.57, a decrease of 216.33% compared to the previous year[60] Assets and Liabilities - Total assets decreased by 2.21% to RMB 11,215,389,000 compared to the previous year[13] - The total non-current assets increased to RMB 3,894,808,000, up from RMB 3,738,775,000[7] - The total assets amounted to 7,320,581, a decrease from 7,730,185, indicating a 5.3% decline[30] - The total liabilities as of Q1 2023 were CNY 4,137,354 thousand, a slight decrease from CNY 4,223,358 thousand in the previous year[54] - The company's total equity decreased to CNY 7,078,035 thousand from CNY 7,245,602 thousand year-over-year[54] - The total equity attributable to shareholders decreased by 2.03% to RMB 6,611,175,000[13] Cash Flow - The company reported a net cash flow from operating activities that was not applicable due to a decrease in cash paid for raw material procurement[14] - The net cash flow from operating activities was -345,404, a decrease from -598,148 in the previous year, indicating a 42.3% improvement[24] - Cash inflow from operating activities totaled CNY 140,298 thousand, compared to CNY 230,369 thousand in the same period last year[49] - Cash and cash equivalents at the end of the period stood at 2,843,894, down from 3,973,871, reflecting a 28.5% decrease[25] - Cash inflow from financing activities was 409,925, down from 517,416, reflecting a 20.8% decrease[24] Research and Development - R&D investment totaled RMB 150,871,000, representing an increase of 118.12 percentage points in R&D expenditure as a percentage of operating income[12] - Research and development expenses accounted for 118.12 percentage points increase in proportion to operating income, due to a larger decline in operating income compared to R&D expenses[49] Shareholder Information - The number of common shareholders at the end of the reporting period was 23,808[4] - The company has a total of 98,066,497 shares held by HKSCC NOMINEES LIMITED, accounting for 39.63% of total shares[4] - The accumulated undistributed profits reached -215,229,160.88, with total share capital at 247,449,899, indicating that the undistributed losses exceed one-third of the paid-in capital[29] Investment Activities - Total cash inflow from investing activities was 2,787,236, up from 2,135,294, representing a 30.6% increase[24] - The net cash flow from investing activities was -172,009, an improvement from -894,010, showing a 80.7% reduction in losses[24] Foreign Exchange - The company experienced a foreign exchange loss of -19,486, compared to -12,150 in the previous year, indicating increased volatility in currency impacts[24] Future Plans - The company plans to issue Global Depository Receipts (GDR) to enhance international financing channels and brand image[28]

Financial Performance - For the first quarter ended March 31, 2023, the company reported a revenue of RMB 100,553,000, representing a decrease of 79.86% compared to the same period last year[4] - The net profit attributable to shareholders was a loss of RMB 139,547,000, reflecting a decline of 214.94% year-over-year[4] - The net profit attributable to shareholders after deducting non-recurring gains and losses was a loss of RMB 179,076,000, down 317.82% from the previous year[4] - The basic and diluted earnings per share were both RMB (0.57), a decrease of 216.33% compared to the same period last year[4] - Total revenue for Q1 2023 was RMB 100,553 thousand, a decrease of 79.9% compared to RMB 499,355 thousand in Q1 2022[16] - Net profit for Q1 2023 was a loss of RMB 170,199 thousand, compared to a profit of RMB 114,295 thousand in Q1 2022, indicating a significant decline[17] - Basic earnings per share for Q1 2023 were RMB (0.57), compared to RMB 0.49 in Q1 2022, indicating a significant decline in profitability[18] - The total comprehensive income for Q1 2023 was a loss of RMB (170,166) thousand, compared to a profit of RMB 114,295 thousand in Q1 2022, showing a significant downturn[18] Assets and Liabilities - The total assets at the end of the reporting period were RMB 11,215,389,000, a decrease of 2.21% from the end of the previous year[5] - The company's current liabilities decreased to RMB 2,620,183,000 from RMB 2,924,708,000 as of December 31, 2022, indicating improved liquidity[14] - The total liabilities as of March 31, 2023, were RMB 4,137,354 thousand, a decrease from RMB 4,223,358 thousand as of December 31, 2022, reflecting a reduction of 2.0%[15] - The total equity as of March 31, 2023, was RMB 7,078,035 thousand, down from RMB 7,245,602 thousand as of December 31, 2022, a decrease of 2.3%[15] Research and Development - Research and development expenses totaled RMB 150,871,000, representing a decrease of 5.36% year-over-year[4] - The proportion of R&D expenses to operating income was 150.04%, indicating an increase of 118.12 percentage points compared to the previous year[4] - Research and development expenses for Q1 2023 were RMB 149,765 thousand, slightly down from RMB 157,155 thousand in Q1 2022, a decrease of 4.4%[16] Cash Flow and Investments - In Q1 2023, the net cash flow from operating activities was (CNY 345,404,000), a significant improvement from (CNY 598,148,000) in Q1 2022, indicating a reduction in cash outflow[20] - Total cash inflow from investment activities in Q1 2023 was CNY 2,787,236,000, compared to CNY 2,135,294,000 in Q1 2022, reflecting a year-over-year increase of approximately 30.6%[21] - The net cash flow from investment activities was (CNY 172,009,000) in Q1 2023, an improvement from (CNY 894,010,000) in Q1 2022, showing a reduced cash outflow[21] - The cash and cash equivalents at the end of Q1 2023 stood at CNY 2,843,894,000, down from CNY 3,973,871,000 at the end of Q1 2022, representing a decrease of approximately 28.5%[23] - The cash outflow from operating activities totaled CNY 485,702,000 in Q1 2023, down from CNY 828,517,000 in Q1 2022, indicating improved operational efficiency[20] Inventory and Shareholder Information - The total inventory increased to RMB 788,349,000 from RMB 677,777,000, reflecting a 16.3% rise, which may indicate increased production or anticipated sales[12] - The company had a total of 23,808 common shareholders at the end of the reporting period[7] Strategic Initiatives - The company plans to issue Global Depository Receipts (GDRs) and list them on the Swiss Stock Exchange to enhance international financing channels[10] - The company is actively pursuing an internationalization strategy to enhance its brand and image[10] Other Financial Metrics - Other income for Q1 2023 was RMB 33,379 thousand, an increase of 50.0% from RMB 22,297 thousand in Q1 2022[17] - The company reported a credit impairment loss of RMB (11,181) thousand in Q1 2023, compared to RMB (3,143) thousand in Q1 2022, indicating a worsening situation[17] - The impact of exchange rate changes on cash and cash equivalents was (CNY 19,486,000) in Q1 2023, compared to (CNY 12,150,000) in Q1 2022, indicating increased volatility[23] - The total cash inflow from other investment activities was CNY 69,583,000 in Q1 2023, with no comparable figure reported for Q1 2022[21] - The company did not report any cash inflow from financing activities in Q1 2023, indicating a focus on internal funding sources[21]

Financial Performance - In 2022, the company reported a revenue of RMB 1,031,041 thousand, a significant decrease of 76.0% compared to RMB 4,299,702 thousand in 2021[21]. - The operating loss for 2022 was RMB (1,368,742) thousand, compared to an operating profit of RMB 1,911,612 thousand in 2021[21]. - The net loss for the year was RMB (964,757) thousand, a decline from a profit of RMB 1,907,086 thousand in the previous year[21]. - The total equity as of December 31, 2022, was RMB 7,245,602 thousand, down from RMB 8,547,884 thousand in 2021[21]. - Total revenue for the year ended December 31, 2022, was approximately RMB 1,031.0 million, a decrease of 76.0% from RMB 4,299.7 million in 2021[45]. - Gross loss for the year ended December 31, 2022, was approximately RMB 186.6 million, compared to a gross profit of RMB 3,001.9 million in 2021[47]. - Other income increased by 158.3% to approximately RMB 156.9 million for the year ended December 31, 2022, from RMB 60.8 million in 2021[48]. - Sales expenses rose to approximately RMB 266.6 million for the year ended December 31, 2022, from RMB 105.8 million in 2021[49]. - Administrative expenses increased by 20.0% to approximately RMB 278.1 million for the year ended December 31, 2022, from RMB 231.8 million in 2021[50]. - Research and development expenses decreased by 11.4% to approximately RMB 778.3 million for the year ended December 31, 2022, from RMB 878.7 million in 2021[51]. - Financial income increased significantly to approximately RMB 184.7 million for the year ended December 31, 2022, from RMB 25.2 million in 2021, mainly due to foreign exchange gains[53]. - The company's inventory decreased significantly to approximately RMB 677.8 million as of December 31, 2022, from RMB 875.6 million as of December 31, 2021, primarily due to inventory write-downs[57]. - Accounts receivable increased significantly to approximately RMB 855.5 million as of December 31, 2022, from RMB 157.9 million as of December 31, 2021[58]. - The company's intangible assets increased to approximately RMB 162.6 million as of December 31, 2022, from RMB 99.8 million as of December 31, 2021, mainly due to the increase in non-patented technology assets[56]. - Accounts payable decreased significantly from approximately RMB 842.6 million as of December 31, 2021, to approximately RMB 253.1 million as of December 31, 2022, reflecting a reduction in purchase volume[60]. - Other payables and accrued expenses increased by 15.7% from approximately RMB 684.5 million as of December 31, 2021, to approximately RMB 791.9 million as of December 31, 2022, primarily due to an increase in marketing service fees and other payables to suppliers[62]. - Cash and cash equivalents decreased by 37.8% from approximately RMB 5,456.9 million as of December 31, 2021, to approximately RMB 3,394.8 million as of December 31, 2022, mainly due to reduced cash inflow from sales revenue[63]. - Current assets were approximately RMB 7,730.2 million as of December 31, 2022, down from RMB 9,289.8 million as of December 31, 2021[63]. - The company has no significant contingent liabilities that could adversely affect its business or financial condition as of December 31, 2022[66]. - The company is in a net cash position as of December 31, 2022, making the debt-to-equity ratio not applicable[70]. - The company reported a significant increase in revenue, achieving a total of $X million for the fiscal year, representing a Y% growth compared to the previous year[78]. - The company’s revenue growth and strategic initiatives are supported by a strong management team with diverse backgrounds in finance, business development, and regulatory compliance[84]. - The company’s financial reports for the year ending December 31, 2022, were presented alongside the board report, indicating a commitment to transparency in financial performance[127]. - The company did not recommend a final dividend for the reporting period, compared to RMB 197.7 million in 2021[129]. Vaccine Development and Innovation - The company launched the world's first inhalable COVID-19 vaccine, Convidecia Air, in October 2022, which received significant media attention[22]. - The company is developing new vaccines, including a bivalent recombinant COVID-19 vaccine and an mRNA vaccine, with promising safety and immunogenicity profiles[22]. - Convidecia has been widely administered in many countries, contributing to global public health efforts[22]. - The company is collaborating with local partners in Malaysia and Indonesia for vaccine formulation, production, and distribution[22]. - The inhaled recombinant COVID-19 vaccine, Kweisha® Mist, is the world's first aerosolized vaccine that provides triple protection without the need for injections[28]. - Kweisha® received emergency use authorization in multiple countries, including Mexico, Pakistan, and Hungary, and was included in the WHO's emergency use listing in September 2022[28]. - The company is actively collaborating with international partners to establish local production facilities and subsidiaries to enhance global coordination[23]. - The pipeline includes several vaccines in various stages of clinical trials, such as the CS-2023 meningococcal vaccine and the CS-2028 polyvalent pneumococcal conjugate vaccine[26][27]. - The company is focused on developing high-quality vaccines to meet the unmet medical needs in the global market[25]. - Kweisha® and Kweisha® Mist are recommended as second booster vaccines in China as of December 2022[28]. - The company has established a comprehensive marketing and supply system in China since the launch of multiple vaccine products in 2022[23]. - The company’s proprietary adenovirus vector vaccine, Kweisha®, is the first of its kind to enter clinical stages globally, with positive results published in The Lancet for Phase I, II, and III trials[29]. - A Phase IV trial published in Nature Medicine showed that Kweisha® as a booster after an inactivated COVID-19 vaccine demonstrated better efficacy compared to homologous boosters, establishing a strong foundation for emergency use approvals worldwide[29]. - Kweisha® Mist, a novel delivery method, has shown to induce triple immune protection with a dosage only 1/5 of the intramuscular Kweisha®, enhancing its appeal due to its pain-free and convenient administration[29]. - The company announced ongoing clinical studies for Kweisha® and Kweisha® Mist in various age groups, with positive interim data supporting the upgrade of immunization strategies[29]. - The company’s meningococcal vaccine, Manhaixin®, received approval in December 2021, becoming China’s first MCV4 vaccine, filling a significant gap in high-end vaccines in the country[31]. - Manhaixin® has been commercialized and penetrated nearly 30 provinces in China, with a growing market presence[31]. - The company’s Ad5-EBOV vaccine, approved for emergency use in 2017, is recognized for its stability and safety, although it is not expected to make significant commercial contributions in the near term[32]. - The mRNA COVID-19 vaccine CS-2034 has shown promising interim data, with a geometric mean titer (GMT) of 407 against the Omicron BA.5 variant, which is 29 times higher than that of inactivated vaccines[33]. - The company has initiated Phase Ib clinical trials for its innovative non-serotype pneumococcal vaccine, PBPV, which aims to provide broader protection than existing serotype vaccines[35]. - The company plans to begin the new drug registration application process for the improved PCV13i vaccine in 2023 following the completion of Phase III trials[34]. - The company is developing a DTcP vaccine for infants in China, which contains three types of pertussis antigens, providing better protection compared to the existing vaccine with two antigens[36]. - The Phase I clinical trial for the DTcP vaccine was completed in 2020, but development has been delayed due to resource allocation to Ad5-nCoV, with Phase III trials expected to start in 2023[36]. - The company is also working on a DTcP booster vaccine for children aged 4 to 6, with no approved vaccines currently available in China for this age group, indicating unmet demand[37]. - The company has initiated communication with the National Medical Products Administration for clinical trial applications for the adolescent and adult Tdcp vaccine, which is expected to progress further[38]. - A novel tuberculosis booster vaccine is under development, showing good safety and tolerance in Phase I trials, with plans for further clinical trial evaluations[39]. - The company is establishing an mRNA technology platform in Shanghai, aiming to develop innovative preventive vaccines with significant advantages over traditional platforms[41]. - The company has established a vaccine production base with an annual capacity of nearly 100 million doses, designed and operated in compliance with national and international GMP standards[71]. - The company has been involved in various international clinical trials for its COVID-19 vaccine, with successful approvals in countries like Pakistan, Mexico, Russia, and Chile[83]. - The company has made significant investments in research and development, focusing on new vaccine technologies and expanding its product pipeline[83]. Corporate Governance and Management - The board consists of five executive directors, three non-executive directors, and four independent non-executive directors[88]. - The company has adopted all applicable provisions of the corporate governance code as per the Hong Kong Listing Rules Appendix 14[86]. - The company confirms that all directors and supervisors complied with the standard code during the reporting period[87]. - The board believes that the current structure of having the chairman also serve as the CEO is beneficial for the company's business prospects and operational efficiency[90]. - The company has a set of director nomination policies that consider individual character, professional qualifications, skills, knowledge, and experience relevant to the group's business and strategy[92]. - The board is responsible for leading and monitoring the company, guiding and supervising its affairs, and ensuring good internal control and risk management systems[93]. - The company has received written annual confirmations of independence from all independent non-executive directors[91]. - The company will continue to review the effectiveness of its corporate governance structure to assess whether the roles of chairman and CEO should be separated[90]. - The independent non-executive directors account for one-third of the board, with at least one possessing appropriate professional qualifications or financial management expertise[91]. - The company has established written guidelines for employees regarding securities trading to prevent insider trading[87]. - The company has established three committees: Audit Committee, Remuneration and Nomination Committee, with specific written terms of reference for each[96]. - The Audit Committee held five meetings during the reporting period and reviewed the financial reporting procedures and internal control systems[97]. - The Remuneration and Nomination Committee reviewed the remuneration policies for directors and senior management, ensuring compliance with applicable regulations[98]. - The senior management's salary range for the year ended December 31, 2022, included one individual earning between HKD 2,000,001 and HKD 2,500,000, one earning between HKD 3,000,001 and HKD 5,000,000, and one earning between HKD 5,000,001 and HKD 6,000,000[99]. - The company provides liability insurance for directors and senior management against legal actions arising from company affairs[95]. - Continuous professional development is encouraged for all directors to ensure they remain informed about their responsibilities and relevant regulations[95]. - The Audit Committee reviewed related party transactions to ensure compliance with legal and regulatory requirements[97]. - The company has a policy for director remuneration that includes annual director fees and potential stock options or awards[100]. - The company ensures that all directors receive comprehensive onboarding to understand the business and operations effectively[95]. - The company conducts regular training sessions for directors on relevant laws and regulations to keep them updated[95]. - The board consists of 12 members, including 5 executive directors, 3 non-executive directors, and 4 independent non-executive directors, with a gender ratio of 3 female to 9 male directors[102]. - Employee gender distribution shows 53.78% male and 46.22% female, indicating a balanced gender diversity within the company[103]. - The company has established a nomination committee to evaluate the independence of independent non-executive directors and review the board's structure and diversity policies[101]. - The board's independence exceeds the Hong Kong Stock Exchange's requirements, with 4 out of 12 directors being independent non-executive directors[104]. - The company has implemented a whistleblowing policy to encourage reporting of misconduct, ensuring confidentiality and protection for whistleblowers[106]. - The company has developed compliance manuals and anti-corruption policies to enhance daily oversight capabilities against bribery and corruption[105]. - The board aims to maintain the current female representation and ultimately achieve gender equality[102]. - The nomination committee will review the board diversity policy annually and set measurable targets for achieving diversity[102]. - The board held eight meetings during the reporting period, ensuring active participation from directors[109]. - The company is committed to regular reviews of its anti-corruption policies and whistleblowing mechanisms to ensure effectiveness[106]. - The board emphasizes that corporate culture is the foundation for long-term business development and economic achievement[111]. - The company has appointed experienced professionals in key management positions to enhance its operational efficiency and strategic direction[84]. Risk Management and Compliance - The board is responsible for evaluating and determining the nature and extent of risks the company is willing to take to achieve strategic objectives, maintaining effective risk management and internal control systems[113]. - The company has implemented various risk management procedures and guidelines to identify risks affecting its business, including operational, financial, regulatory compliance, and data security risks[113]. - The board confirms that there are no significant uncertainties that may severely affect the company's ability to continue as a going concern[114]. - The company has maintained compliance with all relevant laws and regulations during the reporting period, with no significant violations reported[181]. - Related party transactions were conducted fairly and in accordance with legal regulations, with no actions found that harmed the company's or shareholders' interests[194]. - The independent auditor's report confirms that the consolidated financial statements fairly present the financial position and performance of the group as of December 31, 2022, in accordance with Hong Kong Financial Reporting Standards[197]. Shareholder Relations and Communication - The company encourages shareholders to participate in general meetings and has established procedures for calling extraordinary general meetings upon request from shareholders holding more than 10% of shares[117]. - The company has strengthened its cultural framework during the reporting period, focusing on respect, agility, innovation, quality first, and dedication as core values[111]. - The company has established multiple communication channels with shareholders, including annual and extraordinary general meetings, to enhance investor relations and transparency[122]. - All resolutions presented at the annual general meeting on June 29, 2022, and the extraordinary general meeting on December 21, 2022, were approved[122]. - The company allows shareholders holding more than 3% of shares to propose temporary motions 10 working days before the general meeting[118]. - The company’s articles of association were amended and approved by shareholders on June 29, 2022, with no significant changes since December 31, 2022[123]. - The company emphasizes timely and unfiltered disclosure of information to enable informed investment decisions by shareholders[121]. - The company’s communication policy is regularly reviewed to ensure effectiveness in addressing shareholder concerns[124]. 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[65]. - The company plans to issue Global Depositary Receipts (GDR) and list them on the Swiss Stock Exchange to enhance international financing channels and brand image[129]. - The company is currently evaluating the issuance scale and fundraising purposes for the proposed GDR issuance[129]. - The company anticipates that the remaining balance of the A-share IPO proceeds will be fully utilized by the end of 2024[170]. - The company has allocated RMB 112.2 million for working capital and other general corporate purposes, reflecting a rise from RMB 5.5 million[166]. - The expected timeline for utilizing the remaining balance of the A-share IPO proceeds is by the end of 2024[168]. - The company has experienced delays in the progress of other major products due to resource allocation towards the Ad5-nCoV project[166]. - The company aims to enhance its vaccine product portfolio to improve market competitiveness[164].

重要内容提示： （网址：http://roadshow.sseinfo.com） 说明会议召开方式：视频和网络文字互动 投资者可于 2023 年 4 月 25 日（星期二）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 2023 年 3 月 28 日发布公司 2022 年年度报告，为便于广大投资者更全面深入地了解公司 2022 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 2022 年度生物制品专场集体业 绩说明会，此次活动将采用视频和网络文字互动的方式举行，投资者可登录上海 证券交易所上证路演中心（http://roadshow.sseinfo.com/）参与线上互动交流。 一、说明会类型 证券代码：688185 证券简称：康希诺 公告编号：2023-022 康希诺生物股份公司 关于参加 2022 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 ...

Financial Performance - The company reported a net loss for the year 2022, continuing its trend of unprofitability since its IPO[2]. - The company reported a revenue of 1.5 billion in 2022, representing a year-over-year growth of 20%[166]. - The company provided a forward guidance of 1.8 billion in revenue for 2023, expecting a growth rate of 20%[166]. - The company’s net profit attributable to shareholders turned to a loss due to a substantial decline in COVID-19 vaccine sales revenue compared to the same period last year[86]. - The company reported a net cash flow from operating activities of -1,851,545 thousand RMB, a decrease of 190.32% compared to the previous year[67]. - The company’s cash and cash equivalents decreased by 38.62% to 3,464,734 thousand RMB compared to the previous year[71]. - The company’s investment activities resulted in a net cash flow of -1,227,641 thousand RMB, a decrease of 52.05% from the previous year[67]. - The company reported a significant increase in short-term borrowings, rising by 54.42% to 1,529.8 million[85]. - The company’s long-term borrowings increased dramatically by 2,095.02% to 878.0 million, primarily due to new loans for special projects and working capital[85]. - The company’s total sales revenue from major customers reached 520,329 thousand RMB, accounting for 40.49% of total annual sales[64]. Research and Development - The company is focused on the research and development of vaccines and related biotechnologies, aiming to expand its product offerings[34]. - The company has developed a universal mRNA technology that significantly shortens product development time and facilitates rapid industrialization[46]. - The company has established various carrier protein production technologies and coupling techniques for polysaccharide vaccines, enhancing the quality of its multivalent and combination vaccines[45]. - The R&D pipeline includes vaccines for COVID-19, meningitis, Ebola, diphtheria, pertussis, tuberculosis, and shingles, addressing urgent clinical needs[152]. - R&D investment for the mRNA COVID-19 vaccine amounted to CNY 130,415,000, representing 12.61% of total revenue, with a year-over-year increase of 119.11%[114]. - The company has improved existing vaccine products through gene engineering and protein engineering, significantly enhancing antigen yield and simplifying production processes[128]. - The company has developed an inhaled recombinant novel coronavirus vaccine (5-type adenovirus vector) for COVID-19 prevention[92]. - The company has developed a recombinant COVID-19 vaccine (Ad5 vector) and is progressing on a tuberculosis booster vaccine (Ad5Ag85A), leveraging its adenovirus vector technology platform[128]. - The company completed Phase IIb clinical trials for its mRNA COVID-19 vaccine and Phase III clinical trials for the PCV13 vaccine[96]. - The PCV13 vaccine development costs were partially capitalized, with CNY 11,625,000 recognized as capitalized expenses[114]. - The DTcP vaccine's R&D investment was CNY 19,337,000, accounting for 1.87% of total revenue, with a year-over-year increase of 42.12%[114]. - The TB vaccine has completed Phase Ib clinical trials, indicating progress in its development[96]. Market and Strategic Developments - The company plans to invest hundreds of millions in vaccine development, facing risks of potential failures in final development[39]. - The company is actively expanding its marketing network and enhancing its cold chain logistics to improve product penetration[117]. - The company is focusing on importing high-quality vaccines to replace existing products in developed markets, with MCV4 being the first approved product in China using the CRM197 carrier protein[140]. - The company plans to enhance its customer engagement through improved digital platforms, aiming for a 25% increase in customer satisfaction scores[166]. - The company is considering strategic acquisitions to bolster its market position, with a budget of 200 million allocated for potential deals[166]. - The company is involved in various related party transactions as per the annual report[182]. - The company has established agreements to ensure compliance with shareholder obligations, reflecting a commitment to governance[160]. - The company is committed to operational management and strategic development, as highlighted by the roles of its executive team[161]. - The company aims to deepen its R&D platform management and explore global cooperation opportunities to enhance long-term operational and profitability capabilities[142]. - The company is actively engaging in corporate governance improvements, including revisions to internal management systems[177]. Governance and Management - The audit report issued by Deloitte Huayong confirmed the financial statements with a standard unqualified opinion[7]. - The company has established specialized committees, including an audit committee, nomination committee, and compensation and assessment committee, to enhance governance[189]. - The company has a strong leadership team with extensive experience in the biotechnology and pharmaceutical industries[161]. - The total remuneration for all directors, supervisors, and senior management at the end of the reporting period was 37,487[197]. - The total remuneration for core technical personnel at the end of the reporting period was 24,374[197]. - The company has not reported any changes in shareholding for its non-executive directors during the reporting period[158]. - The company has not faced any penalties from securities regulatory agencies in the past three years[176]. - The company has implemented a plan for share repurchase through centralized bidding, reflecting its commitment to shareholder value[198]. - The company has not identified any risks during the supervisory review conducted by the supervisory board[191]. - The company has a diverse workforce, with 32 employees holding doctoral degrees and 416 holding master's degrees[193]. Operational Challenges and Risks - The company highlighted significant risk factors that could adversely affect its operations, urging investors to be cautious[12]. - The company has not encountered any non-operational fund occupation by controlling shareholders or related parties[29]. - The company’s inventory of COVID-19 vaccines was subject to impairment provisions due to market conditions, leading to increased sales expenses[86]. - The management discussed future plans and strategic developments, emphasizing the importance of risk awareness in investment decisions[8]. - The company has established a drug safety monitoring system to ensure public medication safety[78]. - The company has not disclosed any plans for profit distribution or capital increase through reserves during the reporting period[13]. Charitable Activities - The company made charitable donations totaling 1.18 million, including 1.13 million to foundations and 0.136 million for rural revitalization and pandemic support activities[91].

Financial Performance - For the year ended December 31, 2022, the total revenue was RMB 1,031,041 thousand, a decrease of 76.0% compared to RMB 4,299,702 thousand in 2021[22]. - The operating loss for the year was RMB (1,368,742) thousand, compared to an operating profit of RMB 1,911,612 thousand in the previous year[22]. - The net loss for the year was RMB (964,757) thousand, a significant decline from a net profit of RMB 1,907,086 thousand in 2021[22]. - Basic and diluted loss per share was RMB (3.68) for 2022, compared to earnings of RMB 7.74 per share in 2021[22]. - Gross loss for the year ended December 31, 2022, was approximately RMB 186.6 million, compared to a gross profit of RMB 3,001.9 million in 2021[48]. - Other income increased by 158.3% to approximately RMB 156.9 million, primarily due to increased investment income and government subsidies[49]. - Sales expenses rose to approximately RMB 266.6 million, up from RMB 105.8 million in 2021, driven by increased employee benefits and marketing expenses[50]. - Administrative expenses increased by 20.0% to approximately RMB 278.1 million, attributed to higher depreciation, energy costs, and employee benefits[51]. - R&D expenses decreased by 11.4% to approximately RMB 778.3 million, mainly due to reduced clinical trial costs[52]. - Financial income increased significantly to approximately RMB 184.7 million, up from RMB 25.2 million in 2021, primarily due to foreign exchange gains[54]. - Deferred tax assets recognized during the year resulted in a tax credit of approximately RMB 219.2 million, compared to a tax expense of RMB 29.7 million in 2021[55]. Assets and Liabilities - Non-current assets increased to RMB 3,738,775 thousand in 2022 from RMB 2,584,343 thousand in 2021, reflecting a growth of 44.7%[22]. - Current assets decreased to RMB 7,730,185 thousand in 2022 from RMB 9,289,844 thousand in 2021, a decline of 16.8%[22]. - Total assets were RMB 11,468,960 thousand in 2022, slightly down from RMB 11,874,187 thousand in 2021[22]. - Total equity decreased to RMB 7,245,602 thousand in 2022 from RMB 8,547,884 thousand in 2021, a reduction of 15.2%[22]. - Total liabilities increased to RMB 4,223,358 thousand in 2022 from RMB 3,326,303 thousand in 2021, an increase of 27.0%[22]. Vaccine Development and Innovation - In 2022, the company launched the world's first inhaled COVID-19 vaccine, Convidecia Air®, which received emergency use listing from WHO in May 2022[23]. - The meningococcal conjugate vaccine, Menhycia®, entered nearly 30 provinces in China within four months of its launch, marking it as China's first self-developed conjugate vaccine containing ACYW135 groups[24]. - The company is developing new vaccines, including a bivalent recombinant COVID-19 vaccine and an mRNA vaccine (CS-2034), which have shown good safety and immunogenicity characteristics in clinical trials[23]. - The product pipeline includes 18 vaccines targeting over ten disease areas, with five commercialized products[26]. - The company aims to address unmet medical needs globally with innovative vaccines, including those in preclinical and clinical stages[26]. - The company is actively collaborating with scientific communities and peers to tackle global public health issues related to infectious diseases[23]. - The company is committed to developing high-quality, innovative, and affordable vaccines to meet the growing global demand[26]. Market and Sales Strategy - The company has established a comprehensive marketing and supply system in China, supported by direct sales teams and promotional assistants[24]. - The inhaled COVID-19 vaccine has been delivered to Morocco, contributing significantly to global public health efforts[23]. - The company maintains strong partnerships in both public and private markets, facilitating local production and distribution through technology transfer[24]. - The company is focusing on expanding its commercial operations and has established a business operations center to enhance product commercialization[75]. Corporate Governance - The company has adopted all applicable provisions of the corporate governance code as per the Hong Kong Listing Rules Appendix 14[87]. - The board consists of five executive directors, three non-executive directors, and four independent non-executive directors[89]. - The company has established three committees: Audit Committee, Remuneration and Nomination Committee, each with specific written terms of reference[97]. - The board believes that the current structure of the chairman and CEO roles being held by the same individual is beneficial for the company's business prospects and operational efficiency[91]. - The company has received written annual confirmations of independence from all independent non-executive directors[92]. Risk Management - The company has implemented various risk management procedures and guidelines to identify potential risks affecting its operations[114]. - The board is responsible for evaluating and determining the nature and extent of risks the company is willing to take to achieve strategic objectives[114]. - The company has established a structured approach to risk management and internal control, which is monitored by the Audit Committee[98]. Shareholder Relations - The company encourages shareholder participation in annual general meetings and allows shareholders holding over 10% of shares to request extraordinary meetings[118]. - The company has established multiple communication channels with shareholders, including annual and interim reports, and investor meetings[123]. - The company plans to distribute dividends primarily in cash, with a minimum of 80% of profits allocated to cash dividends during mature stages without significant capital expenditures[127]. Employee and Management - The group employed 2,291 employees as of December 31, 2022, compared to 1,946 employees as of December 31, 2021, indicating an increase of approximately 17.7%[151]. - The total employee benefit expenses amounted to approximately RMB 667.4 million, an increase from RMB 588.8 million as of December 31, 2021, representing a growth of about 13.5%[152]. - The company has adopted a standard code for securities trading by directors and supervisors, with all confirmed compliance during the reporting period[157]. Financial Position and Investments - The company has delayed the full utilization of the remaining balance by one year due to resource allocation for the Ad5-nCoV development and commercialization[167]. - The company plans to utilize the remaining balance of the A-share IPO proceeds by the end of 2024[171]. - The company has maintained compliance with all relevant laws and regulations without any significant violations during the reporting period[182].

Revenue and Profit Performance - Revenue for Q3 2022 was RMB 77,605 thousand, a decrease of 92.42% compared to the same period last year[2] - Net profit attributable to shareholders for Q3 2022 was a loss of RMB 486,649 thousand, a decline of 222.65% year-over-year[2] - The significant decline in revenue and profit was primarily due to a substantial decrease in demand for COVID-19 vaccines compared to the previous year[5] - Total operating revenue for the first three quarters of 2022 was 707,395 thousand RMB, a decrease from 3,085,775 thousand RMB in the same period of 2021[17] - Net profit for the first three quarters of 2022 was -488,682 thousand RMB, compared to a net profit of 1,333,896 thousand RMB in the same period of 2021[21] - Basic and diluted earnings per share for the first three quarters of 2022 were -1.92 RMB, compared to 5.39 RMB in the same period of 2021[22] Research and Development - R&D expenses for Q3 2022 totaled RMB 229,531 thousand, an increase of 111.18% compared to the same period last year[3] - R&D expenses accounted for 295.77% of revenue in Q3 2022, an increase of 285.16 percentage points year-over-year[3] - Research and development expenses for the first three quarters of 2022 were 549,066 thousand RMB, a decrease from 655,770 thousand RMB in the same period of 2021[19] Cash Flow and Liquidity - The net cash flow from operating activities for the year-to-date period was RMB -1,393,278 thousand, a decrease of 212.07% compared to the same period last year[3] - Cash flow from operating activities for the first three quarters of 2022 was -1,393,278 thousand RMB, compared to 1,243,273 thousand RMB in the previous year[24] - The net increase in cash and cash equivalents for Q3 2022 was -2,490,640[25] - The beginning cash and cash equivalents balance was 5,455,456[25] - The ending cash and cash equivalents balance was 2,964,816[25] Assets and Liabilities - Total assets at the end of the reporting period were RMB 11,539,285 thousand, a decrease of 2.82% from the end of the previous year[3] - The company's cash and cash equivalents decreased to RMB 2,969,159 thousand from RMB 5,645,030 thousand, representing a decline of about 47.4%[13][15] - The total liabilities of the company as of September 30, 2022, were RMB 3,784,224 thousand, up from RMB 3,326,303 thousand, reflecting an increase of about 13.8%[16] - The company's equity attributable to shareholders decreased to RMB 7,216,494 thousand from RMB 7,995,046 thousand, a decline of approximately 9.7%[16] - The company recognized an impairment provision of RMB 526,175.9 thousand for inventory related to COVID-19 vaccines due to a significant decrease in demand compared to 2021[11] Inventory and Receivables - Inventory as of September 30, 2022, was RMB 880,460 thousand, slightly up from RMB 875,621 thousand in the previous year, indicating a marginal increase of 0.1%[13][15] - The company reported accounts receivable of RMB 312,013 thousand, which increased from RMB 157,926 thousand, showing a growth of about 97.5%[13][15] Other Financial Metrics - The weighted average return on equity was -6.53%, a decrease of 12.03 percentage points year-over-year[3] - The company reported a basic and diluted earnings per share of -RMB 1.97 for Q3 2022, a decline of 223.10% compared to the same period last year[3] - The total amount of non-recurring gains and losses for Q3 2022 was RMB 39,165 thousand[4] - Cash inflow from investment activities for the first three quarters of 2022 was 9,360,944 thousand RMB, significantly higher than 3,968,365 thousand RMB in the same period of 2021[24] - Cash outflow from investment activities for the first three quarters of 2022 was 11,284,530 thousand RMB, compared to 6,201,509 thousand RMB in the previous year[24] - Net cash flow from financing activities for the first three quarters of 2022 was 628,605 thousand RMB, down from 1,397,063 thousand RMB in the same period of 2021[24] - The company reported a tax expense of -158,171 thousand RMB for the first three quarters of 2022, compared to -43,506 thousand RMB in the previous year[19]

Financial Performance - For the nine months ended September 30, 2022, the company's operating revenue attributable to shareholders was RMB 77,605 thousand, a decrease of 92.42% compared to the same period last year[3]. - The net profit attributable to shareholders for the same period was a loss of RMB 486,649 thousand, representing a decline of 222.65% year-on-year[3]. - Total revenue for the first three quarters of 2022 was RMB 707,395 thousand, a significant decrease from RMB 3,085,775 thousand in the same period of 2021, representing a decline of approximately 77%[19]. - Operating profit for the first three quarters of 2022 was a loss of RMB 645,593 thousand, compared to a profit of RMB 1,295,251 thousand in the same period of 2021[22]. - Net profit attributable to shareholders for the first three quarters of 2022 was a loss of RMB 488,682 thousand, while in 2021, it was a profit of RMB 1,333,896 thousand, indicating a substantial decline[24]. - The company reported a total comprehensive loss of RMB 488,626 thousand for the first three quarters of 2022, contrasting with a total comprehensive income of RMB 1,333,896 thousand in the same period of 2021[27]. Expenses and R&D - Research and development expenses totaled RMB 229,531 thousand, an increase of 111.18% compared to the same period last year, with R&D expenses accounting for 295.77% of operating revenue[3]. - The company paid RMB 489,173 thousand in cash to employees in the first three quarters of 2022, an increase from RMB 255,832 thousand in 2021[29]. Assets and Liabilities - Total assets at the end of the reporting period were RMB 11,539,285 thousand, a decrease of 2.82% from the end of the previous year[4]. - The equity attributable to shareholders decreased by 9.74% to RMB 7,216,494 thousand compared to the previous year-end[4]. - Total liabilities as of September 30, 2022, amounted to RMB 3,784,224 thousand, an increase from RMB 3,326,303 thousand as of December 31, 2021[17]. - Current liabilities totaled RMB 2,770,161 thousand as of September 30, 2022, down from RMB 2,861,417 thousand at the end of 2021, reflecting a decrease of approximately 3.2%[15]. - Non-current liabilities increased to RMB 1,014,063 thousand as of September 30, 2022, compared to RMB 464,886 thousand at the end of 2021[17]. Cash Flow - The net cash flow from operating activities for the nine months was a loss of RMB 525,814 thousand, a decline of 240.05% year-on-year[3]. - Operating cash flow for the first three quarters of 2022 was negative at RMB (1,393,278) thousand, compared to a positive RMB 1,243,273 thousand in the same period of 2021[29]. - Cash inflow from investment activities increased significantly to RMB 9,360,944 thousand in 2022, up from RMB 3,968,365 thousand in 2021[30]. - Net cash flow from financing activities in 2022 was RMB 628,605 thousand, a decrease from RMB 1,397,063 thousand in 2021[30]. - The total cash and cash equivalents at the end of Q3 2022 were RMB 2,964,816 thousand, down from RMB 4,864,798 thousand at the end of Q3 2021[31]. - The company reported a significant increase in cash received from investment recoveries, totaling RMB 8,836,912 thousand in 2022 compared to RMB 3,936,000 thousand in 2021[30]. - The net cash flow from investment activities was negative at RMB (1,923,586) thousand in 2022, compared to RMB (2,233,144) thousand in 2021[30]. Market Conditions - The company attributed the significant decline in revenue and profit primarily to a sharp decrease in demand for COVID-19 vaccines and adjustments in product pricing[6]. - The company has identified a competitive market environment for COVID-19 vaccines, with a notable decrease in demand since 2021, leading to potential challenges in future sales[10]. - The company has conducted impairment tests on COVID-19 vaccine-related assets due to signs of impairment, reflecting a proactive approach to asset management in a changing market[10]. Shareholder Information - The top shareholder, HKSCC Nominees Limited, holds 39.63% of the total shares, with a total of 98,062,297 shares[9].