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康希诺(688185) - 2024 Q4 - 年度财报
2025-03-25 12:55
Financial Performance - The company reported a net loss for the period, continuing its trend of not achieving profitability since its listing [3]. - The company reported a revenue of RMB 1.2 billion for the fiscal year 2024, representing a 15% increase compared to the previous year [14]. - The company achieved operating revenue of RMB 846,338,072.24 in 2024, a year-on-year increase of 137.01% [25]. - The net loss attributable to shareholders of the listed company was RMB 378,884,001.37, a decrease in loss of 74.45% compared to the previous year [25]. - The total assets at the end of 2024 were RMB 7,958,132,235.38, a decrease of 14.60% year-on-year [25]. - The basic earnings per share for 2024 was -RMB 1.53, compared to -RMB 6.01 in 2023 [24]. - The gross margin for the current fiscal year is reported at 60%, maintaining a stable level compared to last year [22]. - The total net profit from non-recurring items for 2024 was RMB 62,366,451.62, compared to RMB 128,356,172.58 in 2023 [31]. Research and Development - The company continues to focus on research and development of new products and technologies, although specific financial metrics are not provided in the current report [3]. - The R&D department is focusing on the development of a new mRNA vaccine, with an expected completion date for clinical trials in Q3 2024 [17]. - The company has allocated RMB 300 million for research and development in the upcoming year, a 30% increase from the previous budget [20]. - Research and development expenses accounted for 60.35% of operating revenue, a decrease of 124.95 percentage points from the previous year [24]. - The company has established five major technology platforms for vaccine research and development, enhancing its competitive product portfolio [72]. - The company has received 7 new patents during the reporting period, bringing the total number of granted patents to 57 [78]. - The company is focusing on the development of high-quality vaccine products to replace imports in developed markets, with specific products like MCV2 and MCV4 showing promising safety and immunogenicity [165]. Market Expansion and Strategy - The company plans to expand its market presence in Southeast Asia, targeting a 25% increase in market share by the end of 2025 [18]. - The company projects a revenue growth of 10% for the next fiscal year, driven by new product launches and market expansion strategies [16]. - The company is advancing its internationalization efforts, targeting Southeast Asia, the Middle East, North Africa, and South America for the commercialization of its quadrivalent meningococcal conjugate vaccine MCV4, which received registration in Indonesia in December 2024 [40]. - The company is exploring new strategies for market expansion and product development to enhance its competitive position in the vaccine industry [138]. - The company is actively expanding its product pipeline with various vaccines in different clinical stages, including those for meningitis and tuberculosis [45]. Corporate Governance - The board of directors confirmed the absence of any profit distribution plan or capital reserve transfer to increase share capital for the reporting period [5]. - The company has not disclosed any special arrangements regarding corporate governance [5]. - The company has established a governance structure that complies with regulatory requirements, ensuring effective operation and accountability [173]. - The company has proposed a profit distribution plan for the year 2023, which is currently under review [175]. - The company has not reported any changes in the governance structure of its red-chip architecture during the reporting period [176]. Risk Factors and Financial Management - The company has identified significant risk factors that may adversely affect its operations, as detailed in the management discussion section [3]. - The company is exposed to financial risks, including currency exchange risks related to overseas operations and potential asset impairment risks [96]. - The company has implemented strict risk control measures for derivative trading, ensuring that the scale and direction of trades match the hedged foreign exchange assets [157]. - The company is committed to improving operational efficiency through resource focus and cost control measures [170]. Product Development and Clinical Trials - The company is conducting Phase I clinical trials for a recombinant shingles vaccine in Canada, utilizing adenovirus vector technology to stimulate both cellular and humoral immunity, with production adhering to international quality standards [39]. - The company has completed Phase I clinical trials for PBPV (pneumococcal vaccine) with positive preliminary results [45]. - The company is advancing multiple vaccine projects, including a recombinant polio vaccine currently in clinical trials in Indonesia [84]. - The company has received acceptance for the drug registration application of PCV13, a 13-valent pneumococcal conjugate vaccine, indicating progress in its R&D pipeline [139]. Sales and Marketing - The company has established partnerships with three major healthcare organizations to enhance distribution channels and improve vaccine accessibility [23]. - The sales revenue from the two meningococcal conjugate vaccines reached approximately 793.79 million RMB, representing a year-on-year growth of 41.31% [35]. - The company is enhancing its corporate governance framework to align with best practices in the industry [181]. - The company is expanding its market presence in Asia, aiming to increase market share by 15% over the next two years [185]. Operational Efficiency - The company has optimized resource allocation, leading to a decrease in management and research expenses, and improved operational efficiency [26]. - The company reported a significant reduction in lease liabilities by 92.76% to ¥12,675,754.57 due to the exclusion of a subsidiary from consolidation [128]. - The company is committed to advancing the commercialization of existing products while maintaining significant investment in R&D for future pipeline products [93]. - The company has seen a trend of decreasing procurement amounts from the top five suppliers since 2023, indicating a diversification in supplier relationships [119]. Shareholder Engagement - The company held its first extraordinary shareholders' meeting of 2024 on February 21, where the third board of directors and the third supervisory board were elected [180]. - The company has proposed to revise its shareholder dividend return plan for the next three years (2023-2025) [1]. - The company has not reported any dissenting votes on the proposals presented at the shareholders' meeting, indicating strong shareholder support [175].
康希诺(688185) - 康希诺H股公告
2025-03-12 09:45
CanSino Biologics Inc. 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。 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2025年3月25日(星 期 二)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12月31日 止 年 度 的 全 年 業 績 及 其 發 佈,以 及 考 慮 建 議 派 發 年 度 股 息(如 有)。 承董事會命 康希諾生物股份公司 Xuefeng YU 董事長 香港,2025年3月12日 於本通告日期,本公司董事會包括執行董事Xuefeng YU博士、Shou Bai CHAO博 士 及王靖女士;非執行董事李志成先生;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。 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) 董事會會議通告 ...
康希诺(688185):MCV4商业化进展顺利,带动公司营收快速增长
Xiangcai Securities· 2025-03-11 09:24
证券研究报告 2025 年 03 月 07 日 湘财证券研究所 公司研究 康希诺(688185.SH) MCV4 商业化进展顺利,带动公司营收快速增长 相关研究: 1. 《以创新为核心,由Biotech转 型为Biopharma》 20241216 近十二个月公司表现 % 1 个月 3 个月 12 个月 相对收益 1 -10 6 绝对收益 3 -10 18 -40% -30% -20% -10% 0% 10% 20% 30% 40% 50% 康希诺 沪深300 注:相对收益与沪深 300 相比 分析师:许雯 证书编号:S0500517110001 Tel:021-50293534 Email:xw3315@xcsc.com 地址:上海市浦东新区银城路88号 中国人寿金融中心10楼 公司发布2024年度业绩快报。2024年实现营收8.46亿元,同比增长137.01%; 实现归母净利润-3.79 亿元,亏损幅度显著收窄(去年同期-14.83 亿元);EPS 为-1.53 元/股(去年同期-6.01 元/股)。 核心要点: ❑ 受益于 MCV4 商业化的快速推进,公司营收实现快速增长 公司目前已上市产品共五款,其中 ...
康希诺:MCV4商业化进展顺利,带动公司营收快速增长-20250311
Xiangcai Securities· 2025-03-11 08:40
证券研究报告 2025 年 03 月 07 日 湘财证券研究所 公司研究 康希诺(688185.SH) MCV4 商业化进展顺利,带动公司营收快速增长 相关研究: 1. 《以创新为核心,由Biotech转 型为Biopharma》 20241216 近十二个月公司表现 % 1 个月 3 个月 12 个月 相对收益 1 -10 6 绝对收益 3 -10 18 -40% -30% -20% -10% 0% 10% 20% 30% 40% 50% 康希诺 沪深300 注:相对收益与沪深 300 相比 分析师:许雯 证书编号:S0500517110001 Tel:021-50293534 Email:xw3315@xcsc.com 地址:上海市浦东新区银城路88号 中国人寿金融中心10楼 公司发布2024年度业绩快报。2024年实现营收8.46亿元,同比增长137.01%; 实现归母净利润-3.79 亿元,亏损幅度显著收窄(去年同期-14.83 亿元);EPS 为-1.53 元/股(去年同期-6.01 元/股)。 核心要点: 公司的研发管线及产品布局体现出其较强的研发创新能力。强产品力、成 功的商业化模式、丰富的在研 ...
康希诺(688185) - 康希诺H股公告
2025-03-04 09:30
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年2月28日 狀態: 新提交 致:香港交易及結算所有限公司 呈交日期: 2025年3月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06185 | 說明 | H 股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 2. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 ( ...
康希诺(688185) - 2024 Q4 - 年度业绩
2025-02-27 08:40
Financial Performance - Total revenue for 2024 reached ¥846,338,072.24, a year-on-year increase of 137.01%[4] - Net loss attributable to shareholders decreased to ¥378,884,001.37, a reduction of 74.45% compared to the previous year[6] - The company reported a significant reduction in operating losses by 80.62% and total losses by 80.74%[9] - The basic earnings per share improved to -¥1.53, compared to -¥6.01 in the previous year[4] Assets and Liabilities - Total assets at the end of the reporting period were ¥7,958,132,235.38, a decrease of 14.60% year-on-year[4] Research and Development - Research and development expenses decreased significantly, contributing to improved operational efficiency[7] - The company focused on commercializing the ACYW135 meningococcal polysaccharide conjugate vaccine, which is the only four-valent meningococcal vaccine in the Chinese market[6] Operational Efficiency - The company optimized resource allocation and implemented cost-reduction measures, leading to a notable decrease in asset impairment losses[7] - The sales channel for the meningococcal vaccine was continuously developed, resulting in increased market penetration and sales volume[9] Risk Management - The company emphasizes the importance of monitoring investment risks as the financial data is preliminary and unaudited[10]
康希诺(688185) - 关于吸附无细胞百(组分)白破b型流感嗜血杆菌(结合)-ACYW135群脑膜炎球菌(结合)联合疫苗获得药物临床试验批准通知书的公告
2025-02-24 11:30
证券代码:688185 证券简称:康希诺 公告编号:2025-004 康希诺生物股份公司 关于吸附无细胞百(组分)白破b型流感嗜血杆菌(结合) -ACYW135群脑膜炎球菌(结合)联合疫苗获得 药物临床试验批准通知书的公告 申请事项:境内生产药品注册临床试验 申请人:康希诺生物股份公司 一、通知书基本情况 产品名称:吸附无细胞百(组分)白破 b 型流感嗜血杆菌(结合)-ACYW135 群脑膜炎球菌(结合)联合疫苗 注册分类:预防用生物制品 1.4 类 通知书编号:2025LP00435 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,DTcP-Hib-MCV4 联合疫苗符合药品注册的有关要求, 建议批准开展临床试验。 二、产品相关情况 随着中国上市疫苗品种的不断增加,越来越多剂次疫苗使用,给家长、孩子 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 核准签发的关于吸附无细胞百(组分)白破b型流感嗜血杆菌(结合)- ...
康希诺(688185) - 自愿披露关于婴幼儿用吸附无细胞百(组分)白破联合疫苗正式纳入优先审评品种的公告
2025-02-07 08:45
证券代码:688185 证券简称:康希诺 公告编号:2025-003 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 正式纳入优先审评品种的公告 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。 公司的婴幼儿用DTcP本次被纳入优先审评品种对公司近期业绩不会产生重 大影响,其审评审批进度及取得药品注册批件的时间具有一定的不确定性,待获 批上市销售,将对公司经营业绩产生积极的影响。 一、产品基本情况 目前国内在售的共纯化百白破疫苗的制造过程使用百日咳抗原共纯化的工 艺,公司的婴幼儿用 DTcP 为组分百白破疫苗,每种百日咳抗原进行单独纯化, 以确定的比例配制,从而可以确保产品质量的批间一致性,使产品的质量更加稳 定。 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 分百白破疫苗和以组分百白破为基础的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。 公司的婴幼 ...
康希诺(688185) - 康希诺H股公告
2025-02-06 11:16
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年1月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 康希諾生物股份公司 呈交日期: 2025年2月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06185 | 說明 | H 股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 2. 股份分類 | 普通股 | 股份類別 | ...
康希诺(688185) - 自愿披露关于吸附破伤风疫苗药品注册申请获得受理的公告
2025-02-06 11:16
证券代码:688185 证券简称:康希诺 公告编号:2025-002 康希诺生物股份公司 自愿披露关于吸附破伤风疫苗药品注册申请 获得受理的公告 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")研发的吸附破伤风疫苗境内生产 药品注册上市许可申请(以下简称"药品注册申请")于近日获得国家药品监督 管理局出具的《受理通知书》,受理号:CXSS2500022。现将相关情况公告如下: 一、产品基本情况 破伤风是由破伤风杆菌感染机体导致的一种急性感染性疾病,破伤风杆菌产 生的一种外毒素即破伤风痉挛毒素,是破伤风的致病因子,可引起全身骨骼肌强 直性收缩和阵发性痉挛。重症破伤风患者可并发喉痉挛、窒息、肺部感染和器官 功能衰竭,病死率高达 30%-50%,在无医疗干预的情况下病死率接近 100%,是 一种极为严重的潜在致命性疾病。 公司研发的吸附破伤风疫苗采用无动物源培养基进行发酵,更加安全,已确 定产业化规模工艺,工艺稳定。该款疫苗主要用于非新生儿破伤风预防,将进一 步丰富公司产品管线,提升公司核心 ...