格隆汇1月26日｜A股市场疫苗股集体走强，其中，华兰疫苗、金迪克20CM涨停，智飞生物涨超15%， 康乐卫士涨超13%，康希诺涨超12%，沃森生物涨超10%，康泰生物涨超7%，万泰生物涨近6%。 | 代码 | 名杯 | | 涨幅% ↓ | 总市值 | 年初至今涨幅% | | --- | --- | --- | --- | --- | --- | | 301207 | 华兰疫苗 | 1 | 20.00 | 140亿 | 25.28 | | 688670 | 金油克 | 李 | 19.98 | 31.14亿 | 24.96 | | 300122 | 智飞生物 | 1 | 15.39 | 477亿 | 5.67 | | 920575 | 康乐卫士 | 长 | 13.05 | 31.63亿 | 36.15 | | 688185 | 康布诺 | 1 | 12.38 | 192亿 | 23.63 | | 300142 | 沃森生物 | 1 | 10.78 | 230亿 | 32.24 | | 300601 | 康泰生物 | | 7.83 | 192亿 | 16.59 | | 603392 | 万泰生物 | 兼 | 5.9 ...

1月26日，A股市场疫苗股集体走强，其中，华兰疫苗、金迪克20CM涨停，智飞生物涨超15%，康乐卫 士涨超13%，康希诺涨超12%，沃森生物涨超10%，康泰生物涨超7%，万泰生物涨近6%。 | 代码 | 名称 | | 涨幅% ↓ | 总市值 | 年初至今涨幅% | | --- | --- | --- | --- | --- | --- | | 301207 | 中学疫苗 | 1 | 20.00 | 140亿 | 25.28 | | 688670 | 金油克 | 安 | 19.98 | 31.14亿 | 24.96 | | 300122 | 智飞生物 | 1 | 15.39 | 477亿 | 5.67 | | 920575 | 康乐卫士 | 兼 | 13.05 | 31.63亿 | 36.15 | | 688185 | 康希诺 | 4 | 12.38 | 192亿 | 23.63 | | 300142 | 沃森生物 | 1 | 10.78 | 230亿 | 32.24 | | 300601 | 康泰生物 | | 7.83 | 192亿 | 16.59 | | 603392 | 万泰生物 | 兼 | 5.98 | ...

近日，康乐卫士公告称，因临床试验经费支付逾期，山西、江苏两省疾控中心暂停其三价及九价HPV疫 苗女性适应症的III期临床试验。这家曾自称"北交所人用疫苗第一股"的企业，账面货币资金仅剩百万 元，却承载着10款在研疫苗的庞大管线。资金断裂，不仅拖累了关键疫苗的上市进程，也折射出创新疫 苗企业在商业化前夜的普遍困境。 一、资金见底，临床试验被迫按下暂停键 康乐卫士的财务数据已拉响警报。2025年前三季度，公司营收仅127.63万元，净亏损却高达2.29亿元， 销售净利率为惊人的-18000%，相当于每获得1元收入，就要承担180元的亏损。公司自2020年以来累计 亏损超17亿元，账面资金早已难以支撑研发和试验的巨额开支。 资金危机早已蔓延至日常运营。公司此前已出现银行贷款违约、多个银行账户被冻结的情况，涉及劳动 争议、建设工程合同等诉讼仲裁金额超过3000万元。此次临床试验经费拖欠，直接导致核心产品III期试 验停滞，尤其是九价HPV疫苗正处于收集次要终点病例的关键阶段。若长期无法恢复，不仅将延误上市 时间，更可能使其在国产九价疫苗竞争中掉队。 二、管线沉重，三价、九价疫苗命运各异 康乐卫士研发管线看似丰富，涵盖 ...

也就是说，这两款疫苗都处在报产的关键阶段。 康乐卫士称将积极筹资，尽快支付逾期经费，恢复临床试验正常开展，努力保障受试者的合法权益。而相关方也将保留在公司无法及时支付逾期经费的前提 下，终止项目的权利。 1月19日，智通财经联系康乐卫士方面并发送采访邮件至董秘邮箱，询问公司具体的筹资计划、三价和九价HPV疫苗的商业化策略等问题，截至发稿暂未获 得回复。 智通财经注意到，这并非康乐卫士两款核心HPV疫苗首次受财务压力影响。半个月前，2025年12月，康乐卫士亦在公告中提及，受限于资金状况，三价及九 价HPV疫苗相关临床研究及资料补充等工作进度放缓。此外，公司已有部分员工因无法按时发放薪资及缴纳社保等原因离职，对公司日常经营管理、主要业 务开展造成了不利影响。 智通财经记者 | 陈杨 智通财经编辑 | 谢欣 三价HPV疫苗市场有限，九价HPV疫苗试验暂停，这就是昔日"北交所人用疫苗第一股"康乐卫士现在面临的尴尬境地。 日前，康乐卫士发布公告称，收到山西省疾控中心和江苏省疾控中心的相关函件，两者将暂停公司三价HPV疫苗和九价HPV疫苗（女性适应证）的Ⅲ期临床 试验。原因是康乐卫士临床试验经费支付逾期，现场研究经费短 ...

Core Viewpoint - The company, Kang Le Wei Shi, has announced the suspension of clinical trials for its three-valent and nine-valent HPV vaccines due to overdue funding and financial pressures, which have been a recurring issue for the company [1][4]. Group 1: Clinical Trial Suspension - The clinical trials for the three-valent and nine-valent HPV vaccines have been paused by the Shanxi and Jiangsu Provincial Centers for Disease Control due to overdue clinical trial funding [1]. - The three-valent HPV vaccine's phase III clinical trial is expected to reach its pathological endpoint (CIN2+) by August 2024, and the suspension is not anticipated to significantly impact the accumulated qualified cases or the upcoming Biologics License Application (BLA) [2]. - The nine-valent HPV vaccine (female indication) has completed the primary endpoint case collection but may face challenges in secondary endpoint case collection and BLA submission if the trial does not resume soon [3]. Group 2: Financial Challenges - The company has faced significant financial pressure, previously announcing issues with repaying bank loans and having multiple bank accounts frozen due to liquidity problems [4]. - As of December 31, 2024, the company's cash balance was 77.77 million yuan, with total current assets of 117 million yuan, and by September 30, 2025, cash had decreased to 6.32 million yuan, a 91.88% year-on-year decline [5]. - The company has yet to commercialize its core products, with revenue primarily from research testing reagents, reporting revenues of 885,600 yuan in 2024 and a net loss of 357 million yuan [5].

Core Viewpoint - 康乐卫士 is facing significant financial difficulties, leading to the suspension of its Phase III clinical trials for the three-valent and nine-valent HPV vaccines due to a lack of funding [1][2][4][5][6][20]. Financial Performance - For the first three quarters of 2025, 康乐卫士 reported total revenue of 1.2763 million yuan and a net loss of 22.9 million yuan, worsening from a loss of 14.7 million yuan in the first half of the year [1][20]. - The company's net profit margin is extremely low at -18,000%, indicating a loss of 180 yuan for every 1 yuan of revenue [1][20]. - Cumulative losses since 2020 exceed 1.7 billion yuan, impacting operational capabilities [20]. Clinical Trial Suspension - The suspension of the Phase III trials for the three-valent and nine-valent HPV vaccines is due to overdue clinical trial funding, which has led to a halt in necessary gynecological visits [5][6][19]. - The three-valent HPV vaccine has reached the required pathological endpoint for its Phase III trial, and its application for marketing approval was accepted in April 2025, suggesting limited impact on its approval timeline [6][19]. - The nine-valent HPV vaccine is in a critical data collection phase, and prolonged suspension could adversely affect its market entry [6][19]. Industry Context - The HPV vaccine market in China is experiencing intense competition, transitioning from a growth phase to a more selective competition phase [21]. - Domestic vaccines face challenges from imported products, with the market for two-valent vaccines being particularly pressured due to lower public trust in their efficacy [21][22]. - The market is characterized by high inventory levels and a significant gap in research and development progress compared to international competitors [22][23]. Broader Industry Challenges - The industry is witnessing a price war, with significant price drops for two-valent HPV vaccines, from 329 yuan to 27.5 yuan, reflecting a more competitive landscape [23][27]. - Many companies are experiencing cash flow issues due to long R&D cycles and high costs, leading to a reliance on external funding [24][26]. - The global vaccine market is projected to grow, with the Chinese market expected to reach approximately 300 billion yuan by 2035, but domestic companies hold a small share of this market [27].

Core Viewpoint - The company, 康乐卫士, is facing significant financial difficulties, leading to the suspension of its Phase III clinical trials for its HPV vaccines due to a lack of funding, which highlights the vulnerability of innovative vaccine companies in late-stage clinical trials [2][4][6]. Financial Performance - For the first three quarters of 2025, 康乐卫士 reported total revenue of 1.2763 million yuan and a net loss of 22.9 million yuan, which is an increase from a 14.7 million yuan loss in the first half of the year, indicating a deteriorating financial situation [2][4]. - The company's sales net profit margin is at -18,000%, meaning it incurs 180 yuan in losses for every 1 yuan of revenue, significantly below the industry average [2]. Clinical Trial Status - The Phase III clinical trials for the three-valent and nine-valent HPV vaccines have been suspended due to overdue clinical trial funding, with the company having only 1 million yuan in cash remaining [2][4]. - The three-valent HPV vaccine has reached the required pathological endpoint for clinical trials, and its market application is under review, suggesting limited short-term impact from the suspension [6]. - In contrast, the nine-valent HPV vaccine is in a critical data collection phase, and prolonged suspension could adversely affect its market application and competitive position [6]. Industry Context - The HPV vaccine market in China is experiencing intense competition, transitioning from a growth phase to a more selective competition phase, with domestic vaccines facing challenges from imported products [8][9]. - The market is characterized by a structural imbalance, with high-end products in short supply and low-end products facing oversupply, leading to a competitive disadvantage for domestic vaccines [8][9]. - The price war in the industry has intensified, with significant price drops for vaccines, such as the two-valent HPV vaccine's bid price falling from 329 yuan to 27.5 yuan, indicating a challenging market environment [10]. Future Strategies - To survive in the competitive landscape, vaccine companies are exploring various strategies, including enhancing product quality, increasing R&D investment, and expanding international collaborations [11][12]. - Companies are encouraged to develop higher-tier vaccines and create technological barriers to remain competitive, rather than relying solely on price reductions [12][14]. - Addressing funding issues is critical for companies like 康乐卫士 to resume clinical trials and ensure survival in the current market [12].

Core Viewpoint - The clinical trials for the three-valent and nine-valent HPV vaccines developed by Kang Le Wei Shi have been suspended due to overdue funding for clinical trial expenses, highlighting the company's financial difficulties and potential impact on its vaccine development timeline [1][2][4]. Group 1: Clinical Trial Status - The three-valent HPV vaccine and nine-valent HPV vaccine clinical trials have been paused due to overdue payments for clinical trial expenses, leading to a shortage of funds for ongoing research [2][4]. - The three-valent HPV vaccine is expected to submit its Biologics License Application (BLA) in 2025, while the nine-valent HPV vaccine for female indications is anticipated to submit its BLA in 2026 [4]. - The three-valent HPV vaccine has reached its clinical endpoint for case collection, and the nine-valent HPV vaccine has completed the collection of its primary endpoint cases, but prolonged suspension may affect secondary endpoint case collection [4][3]. Group 2: Financial Situation - Since 2020, the company has accumulated losses exceeding 1.7 billion yuan, with its revenue primarily coming from the sale of a small number of research reagents and technical services [1][7]. - As of September 30, 2025, the company's cash balance was 6.3154 million yuan, a decrease of 91.88% year-on-year, with total current assets of 26.3091 million yuan, down approximately 77% from the previous year [8]. - The company's current liabilities reached 1 billion yuan, resulting in a current ratio of 0.026 and a debt-to-asset ratio of 78.36% [8]. Group 3: Market Competition - The domestic HPV vaccine market is highly competitive, with six vaccines already on the market and over ten more in the application or clinical research stages [9]. - Kang Le Wei Shi's HPV vaccines will face intense competition from both international pharmaceutical giants and domestic companies if they obtain drug registration certificates [9].

Market Overview - The biopharmaceutical sector experienced a decline of 1.05% on January 16, with Olin Bio leading the drop [1] - The Shanghai Composite Index closed at 4101.91, down 0.26%, while the Shenzhen Component Index closed at 14281.08, down 0.18% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Wanzhe Co., Ltd. (000534) with a closing price of 22.85, up 3.02% and a trading volume of 251,300 shares, totaling 589 million yuan [1] - Wendi Pharmaceutical (688488) closed at 21.60, up 2.96% with a trading volume of 289,600 shares, totaling 597 million yuan [1] - Sanofi Biopharmaceuticals (688336) closed at 58.88, up 2.56% with a trading volume of 47,400 shares, totaling 279 million yuan [1] - Major decliners included: - Olin Bio (6158888) closed at 24.75, down 15.21% with a trading volume of 189,400 shares, totaling 515 million yuan [2] - Kanglao Health (920575) closed at 9.81, down 5.40% with a trading volume of 139,800 shares, totaling 139 million yuan [2] - Dongbao Bio (300239) closed at 6.19, down 3.88% with a trading volume of 214,700 shares, totaling 135 million yuan [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 681 million yuan from institutional investors, while retail investors contributed a net inflow of 337 million yuan [2] - The capital flow for specific stocks showed: - Aidi Pharmaceutical (688488) had a net inflow of 37.04 million yuan from institutional investors, but a net outflow of 44.62 million yuan from retail investors [3] - Wanzhe Co., Ltd. (000534) had a net inflow of 29.97 million yuan from institutional investors, with a net outflow of 39.12 million yuan from retail investors [3] - Te Bao Bio (688278) had a net inflow of 4.89 million yuan from institutional investors, but a net outflow of 5.01 million yuan from retail investors [3]

格隆汇1月16日｜康乐卫士公告，近日，北京康乐卫士生物技术股份有限公司收到山西省疾病预防控制 中心发送的《关于暂停重组三价和重组九价人乳头瘤病毒疫苗Ⅲ期临床试验的函》及江苏省疾病预防控 制中心发送的《关于暂停重组九价人乳头瘤病毒疫苗Ⅲ期临床试验的函》。根据函件内容，由于公司临 床试验经费支付逾期，现场研究经费短缺，无法继续开展后续妇科访视工作。因此，山西省疾病预防控 制中心暂停公司重组三价人乳头瘤病毒疫苗和重组九价人乳头瘤病毒疫苗Ⅲ期临床试验，江苏省疾病预 防控制中心暂停公司九价HPV疫苗Ⅲ期临床试验。 ...