十五价HPV疫苗

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康乐卫士(833575) - 投资者关系活动记录表
2025-05-16 11:20
Group 1: Investor Relations Activity - The investor relations activity was an earnings briefing held online on May 15, 2025, from 15:00 to 16:30 [3] - Key participants included the Chairman, Chief Scientific Officer, Chief Capital Officer, Chief Financial Officer, and the Board Secretary [3] Group 2: HPV Vaccine Development - The three-valent HPV vaccine was included in the priority review list by the National Medical Products Administration (NMPA) in March 2025, with the application accepted in April 2025 [4][5] - The review period for the three-valent HPV vaccine is shortened from 200 working days to 130 working days due to priority review [4] - The nine-valent HPV vaccine for female indications is currently undergoing phase III clinical trials, with the 42 and 48-month visits ongoing [6] - The nine-valent HPV vaccine for male indications is also in phase III trials, with 18 and 24-month visits currently being conducted [6][10] Group 3: Regulatory and Market Strategy - The company is actively communicating with the NMPA to ensure compliance and expedite the review process for the nine-valent HPV vaccine [8] - The nine-valent HPV vaccine (female indication) is expected to submit its Biologics License Application (BLA) soon, with the timeline being a few months behind the three-valent vaccine [7] - The company has adjusted its strategy in Indonesia from building a manufacturing base to collaborating with local partners for registration and market access [13][14] Group 4: Financial and Funding Strategies - The company plans to address funding shortages through various financing channels, including equity and debt financing, while maintaining high R&D investment [16] - A loan of up to 477 million yuan is being organized by a banking syndicate, with approval completed by the lead bank [19] - The company aims to enhance cash flow management and reduce operational costs to improve financial stability [18][20]
研发费用增加、运营资金承压,康乐卫士去年仍亏损
Bei Ke Cai Jing· 2025-04-30 08:49
Core Viewpoint - 康乐卫士 is currently in a loss-making state with no products commercialized, reporting a revenue of 885,600 yuan in 2024, a decrease of 50.24% year-on-year, and a net profit of -357 million yuan, down 18.51% year-on-year [1] Group 1: Financial Performance - In 2024, 康乐卫士 reported a revenue of 885,600 yuan, a decline of 50.24% compared to the previous year [1] - The net profit attributable to the parent company was -357 million yuan, representing a year-on-year decrease of 18.51% [1] - The operating cash flow was -125 million yuan, indicating a reliance on external financing for working capital [3] Group 2: Research and Development - 康乐卫士 has a total of 9 vaccine candidates in development, including 8 recombinant protein candidates and 1 mRNA candidate [2] - Key products such as the trivalent HPV vaccine and the nine-valent HPV vaccines for both female and male indications have entered Phase III clinical trials [2] - The trivalent HPV vaccine's market approval application has been accepted by the National Medical Products Administration (NMPA) and is included in the priority review process [2] Group 3: Operational Strategy - 康乐卫士 is transitioning towards becoming a commercial pharmaceutical company and has established a production base in Kunming that meets GMP standards, with an annual production capacity of 10 million doses of the trivalent HPV vaccine and 30 million doses of the nine-valent HPV vaccine [2] - The company has introduced a systematic response plan to address the risk of insufficient working capital, which includes accelerating HPV vaccine development and commercialization, optimizing asset utilization, actively seeking financing, and enhancing internal management to reduce costs and increase efficiency [3] Group 4: Recent Developments - In the first quarter of 2024, 康乐卫士 reported a 90.51% decline in revenue, while the net profit attributable to the parent company increased by 18.12% year-on-year [4]
康乐卫士:向不特定合格投资者公开发行股票并在北京证券交易所上市招股说明书
2023-02-28 14:02
证券简称: 康乐卫士 证券代码: 833575 北京市北京经济技术开发区荣昌东街 7 号 A2 幢 201、202 北京康乐卫士生物技术股份有限公司 BEIJING HEALTH GUARD BIOTECHNOLOGY INC. 北京康乐卫士生物技术股份有限公司招股说明书 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证券交易所主要 服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风险高等特点,投资者面临较 大的市场风险。投资者应充分了解北京证券交易所市场的投资风险及本公司所披露的风险因素,审 慎作出投资决定。 保荐机构(主承销商) 广东省深圳市福田区中心三路 8 号卓越时代广场(二期)北座 联席主承销商 北京市西城区车公庄大街 4 号 2 幢 1 层 A2112 室 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表明其对注册申 请文件及所披露信息的真实性、准确性、完整性作出保证,也不表明其对发行人的盈利能力、 投资价值或者对投资者的收益作出实质性判断或者保证。任何与之相反的声明均属虚假不实 陈述。 根据《证券法》的规定,股票依法发行后,发行人经营与收益的变化 ...
康乐卫士:招股说明书(注册稿)
2023-02-28 10:34
北京市北京经济技术开发区荣昌东街 7 号 A2 幢 201、202 北京康乐卫士生物技术股份有限公司 BEIJING HEALTH GUARD BIOTECHNOLOGY INC. 北京康乐卫士生物技术股份有限公司招股说明书(注册稿) 本公司的发行申请尚未经中国证监会注册。本招股说明书申报稿不具有据以发行股票的法律效 力,投资者应当以正式公告的招股说明书全文作为投资决定的依据。 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证券交易所主要 服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风险高等特点,投资者面临较 大的市场风险。投资者应充分了解北京证券交易所市场的投资风险及本公司所披露的风险因素,审 慎作出投资决定。 保荐机构(主承销商) 广东省深圳市福田区中心三路 8 号卓越时代广场(二期)北座 联席主承销商 北京市西城区车公庄大街 4 号 2 幢 1 层 A2112 室 证券简称: 康乐卫士 证券代码: 833575 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表明其对注册申 请文件及所披露信息的真实性、准确性、完整性作出保证,也不表明其对发行人的盈利能 ...
康乐卫士:招股说明书(注册稿)
2023-02-13 07:40
证券简称: 康乐卫士 证券代码: 833575 北京康乐卫士生物技术股份有限公司 BEIJING HEALTH GUARD BIOTECHNOLOGY INC. 北京市北京经济技术开发区荣昌东街 7 号 A2 幢 201、202 北京康乐卫士生物技术股份有限公司招股说明书(注册稿) 本公司的发行申请尚未经中国证监会注册。本招股说明书申报稿不具有据以发行股票的法律效 力,投资者应当以正式公告的招股说明书全文作为投资决定的依据。 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证券交易所主要 服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风险高等特点,投资者面临较 大的市场风险。投资者应充分了解北京证券交易所市场的投资风险及本公司所披露的风险因素,审 慎作出投资决定。 保荐机构(主承销商) 广东省深圳市福田区中心三路 8 号卓越时代广场(二期)北座 1-1-1 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表明其对注册申 请文件及所披露信息的真实性、准确性、完整性作出保证,也不表明其对发行人的盈利能力、 投资价值或者对投资者的收益作出实质性判断或者保证。任何与之相 ...
康乐卫士:招股说明书(注册稿)
2023-01-04 07:54
证券简称: 康乐卫士 证券代码: 833575 北京康乐卫士生物技术股份有限公司 BEIJING HEALTH GUARD BIOTECHNOLOGY INC. 北京市北京经济技术开发区荣昌东街 7 号 A2 幢 201、202 北京康乐卫士生物技术股份有限公司招股说明书(注册稿) 本公司的发行申请尚未经中国证监会注册。本招股说明书申报稿不具有据以发行股票的法律效 力,投资者应当以正式公告的招股说明书全文作为投资决定的依据。 本次股票发行后拟在北京证券交易所上市,该市场具有较高的投资风险。北京证券交易所主要 服务创新型中小企业,上市公司具有经营风险高、业绩不稳定、退市风险高等特点,投资者面临较 大的市场风险。投资者应充分了解北京证券交易所市场的投资风险及本公司所披露的风险因素,审 慎作出投资决定。 保荐机构(主承销商) 广东省深圳市福田区中心三路 8 号卓越时代广场(二期)北座 1-1-1 中国证监会和北京证券交易所对本次发行所作的任何决定或意见,均不表明其对注册申 请文件及所披露信息的真实性、准确性、完整性作出保证,也不表明其对发行人的盈利能力、 投资价值或者对投资者的收益作出实质性判断或者保证。任何与之相 ...