Workflow
流感病毒裂解疫苗
icon
Search documents
智飞生物四价流感病毒裂解疫苗、流感病毒裂解疫苗3岁以下人群扩龄申请未获批准
Xin Lang Cai Jing· 2026-01-28 14:12
此前,智飞生物于 2024 年 9 月至 2024 年 10 月分别向国家药品监督管理局提交这两款儿童型流感疫苗 的注册上市申请并获得受理。(智通财经 李科文) 1月28日,智飞生物公告,公司全资子公司智飞龙科马于近日收到国家药品监督管理局核准签发的 《药 品注册申请终止通知书》 , 同意智飞龙科马撤回儿童型四价流感病毒裂解疫苗(6 月龄-35 月龄人群) 和流感病毒裂解疫苗(6 月龄-35 月龄人群)的注册申请。 ...
智飞生物撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗注册申请
Bei Jing Shang Bao· 2026-01-28 10:39
北京商报讯(记者 丁宁)1月28日晚间,智飞生物(300122)发布公告称,公司全资子公司安徽智飞龙 科马生物制药有限公司(以下简称"智飞龙科马")于近日收到国家药品监督管理局核准签发的《药品注 册申请终止通知书》,同意智飞龙科马撤回儿童型四价流感病毒裂解疫苗和流感病毒裂解疫苗的注册申 请。 智飞生物表示,鉴于流感病毒的变异性特征及儿童群体免疫系统的特殊性,为更全面科学地评价疫苗临 床使用效果,结合公司研发策略与市场对高品质儿童疫苗的需求,经审慎评估,公司决定撤回上述药品 注册申请。公司将稳步推进补充研究,持续完善临床证据链,继续推进上市申报工作。 ...
复星医药拟分拆疫苗子公司复星安特金至港交所主板上市
Xin Lang Cai Jing· 2026-01-22 18:09
中访网数据 上海复星医药(集团)股份有限公司于2026年1月22日召开董事会,审议通过了分拆其控股 子公司复星安特金(成都)生物制药股份有限公司至香港联合交易所有限公司主板上市的相关议案。根 据预案,复星安特金本次拟发行H股,初始发行规模不超过发行后总股本的25%(超额配售权行使 前),并可授予不超过初始发行规模15%的超额配售权。董事会认为,本次分拆符合《上市公司分拆规 则(试行)》等法律法规的要求,有利于公司聚焦主业、增强独立性,并释放疫苗业务板块的估值潜 力。分拆完成后,复星医药预计仍将保持对复星安特金的控制权。相关议案尚需提交公司股东大会、A 股及H股类别股东大会审议批准。复星安特金作为复星医药旗下的疫苗业务平台,主要围绕多项技术平 台从事疫苗的研发、生产与销售,目前已上市产品包括人用狂犬病疫苗、流感病毒裂解疫苗等。 MACD金叉信号形成,这些股涨势不错! ...
智飞生物2025年短期业绩承压 期待创新管线与国际化增长新空间
Core Viewpoint - The company, Zhifei Biological, is facing significant financial losses in 2025, with projected losses between 10.698 billion to 13.726 billion yuan, representing a year-on-year decline of 630% to 780% due to the deep adjustment period in the vaccine industry [1][2] Industry Adjustment and Financial Challenges - The vaccine industry is undergoing a deep adjustment due to decreased public vaccination willingness, increased vaccine hesitancy, and policy changes [2] - Zhifei Biological's losses are attributed to underperformance in product sales, inventory impairment due to market demand changes, and credit loss provisions for accounts receivable [2] Strategic Responses and Innovations - The company is actively optimizing its operational strategies by adjusting procurement plans, enhancing product promotion strategies, accelerating the launch of self-developed products, and restructuring debt [2][3] - Zhifei Biological is focusing on research and development, with 34 projects in the pipeline, including 24 in clinical trials, which are expected to improve revenue structure upon approval [4] Market Opportunities and Product Expansion - The inclusion of the HPV vaccine in the national immunization program is expected to enhance public awareness and open up market opportunities for related vaccine products [3] - The company has successfully expanded the indications for its HPV vaccines and shingles vaccine, targeting high-risk populations and potentially increasing revenue streams [5] Internationalization and Clinical Trials - Zhifei Biological is pursuing an internationalization strategy with a focus on clinical trials, including a dual-valent vaccine for dysentery in Bangladesh and a 26-valent pneumococcal vaccine in Australia [6] - The company is also engaging in partnerships for therapeutic products, which will likely increase its overseas revenue share [6] Future Outlook and Commitment - Despite the current losses, the company expresses commitment to improving operations and aims to launch more self-developed products while optimizing commercial collaborations [7] - Industry experts believe that with the upcoming product launches and market expansion, Zhifei Biological is positioned to reshape its growth trajectory and enhance its core competitiveness in the biopharmaceutical sector [7]
秋霜不改丹青志!智飞生物以创新开新局 锚定“预防+治疗”主航线
Quan Jing Wang· 2026-01-14 02:22
Core Insights - The vaccine industry is entering a deep transformation period characterized by stock competition and structural adjustments, where differentiated innovation is crucial for companies to navigate through cycles [1] - Zhifei Biological, a leader in the domestic biological vaccine sector, is facing challenges due to a decline in industry overall prosperity by 2025, driven by reduced public vaccination willingness and intensified market competition [1] - The company anticipates a temporary net profit loss for the year, reflecting the industry's deep reshuffling [1] Company Strategies - In response to performance pressures, Zhifei Biological is taking proactive measures, including recognizing inventory and accounts receivable impairments to accurately reflect its financial status, thereby laying a solid foundation for future development [1] - The company has secured over 10 billion yuan in loans from financial institutions, guaranteed by its actual controller, to optimize operational capacity and restructure existing debts, reinforcing its financial stability [1] - Zhifei Biological is adjusting procurement plans with partners in its traditional vaccine agency line to alleviate upstream supply pressures while enhancing marketing strategies to accelerate inventory turnover [1] Research and Development - The company has over 40 products in its research pipeline, with several, including the diploid rabies vaccine and 15-valent pneumonia conjugate vaccine, currently under review for market approval, indicating significant market potential [2] - Zhifei Biological's self-developed products, such as the quadrivalent influenza virus split vaccine and the 26-valent pneumonia conjugate vaccine, have achieved notable breakthroughs, showcasing its technological leadership [2] - The company is committed to a differentiated competitive strategy focused on technological innovation and product iteration, which is expected to help it navigate the industry's adjustment cycle effectively [2]
智飞生物上榜2025重庆民营企业科技创新指数100强
Huan Qiu Wang· 2025-12-26 09:41
Core Insights - The Chongqing Private Economy Innovation and Development Conference successfully held on December 26, where the "2025 Chongqing Private Enterprises Technology Innovation Index Top 100 List" was officially released, with Zhifei Biological ranking 3rd in the index and 4th in the R&D investment list [1][3]. Group 1: Company Achievements - Zhifei Biological has consistently adhered to an innovation strategy focused on independent research and development, increasing R&D investment, and enhancing pipeline layout, with a cumulative R&D investment exceeding 6 billion yuan over the past three years [3]. - The company has made significant progress in multiple self-developed projects this year, entering a period of intensive innovation achievements [3]. Group 2: Product Development - In the prevention field, Zhifei Biological has launched several vaccines, including a quadrivalent influenza virus split vaccine and a rabies vaccine, with various other products in different stages of approval and clinical trials [5]. - The company has a total of 34 self-developed projects in the prevention field, with 24 projects currently in the application, clinical trial, or approval stages [5]. - In the treatment field, Zhifei Biological has 8 self-developed projects, with 7 in clinical trials or registration application stages, including liraglutide injection and insulin products [5]. Group 3: Innovation and Future Plans - Zhifei Biological has successfully incubated over ten technology enterprises through its Zhihui Investment platform, with more than fifty projects in development, leading the industry in the progress of several first-class new drugs [6]. - The company aims to launch one to two first-class innovative drugs annually from its incubated enterprises over the next decade, significantly advancing the high-end development of Chongqing's biopharmaceutical industry [6]. - The recognition in the Chongqing Private Enterprises Technology Innovation Index is an authoritative acknowledgment of Zhifei Biological's R&D investment, technical accumulation, and innovation achievements, with plans to strengthen its innovation position and contribute to high-quality development in the biopharmaceutical industry [6].
复星医药想在“疫苗降价潮”中分拆疫苗子公司上市
Xin Lang Cai Jing· 2025-10-29 10:12
Core Viewpoint - Fosun Pharma plans to spin off its subsidiary Fosun Antigen for a listing on the Hong Kong Stock Exchange, aiming to enhance its financing channels and market competitiveness in the vaccine sector [1] Group 1: Company Overview - Fosun Antigen is a vaccine business platform under Fosun Pharma, currently holding a limited product line including human rabies vaccine and influenza virus split vaccine [6][7] - As of October 29, 2023, Fosun Pharma's A-share closed at 28.91 CNY per share, with a total market capitalization of 77.202 billion CNY [1] Group 2: Market Context - The vaccine industry has faced challenges, with a general trend of price reductions observed over the past two years, impacting profitability [3][4] - The procurement price for the bivalent HPV vaccine is set at 27.5 CNY per dose, which is relatively high compared to government procurement prices for other vaccines [3] Group 3: Financial Performance - Fosun Antigen's projected revenue and net profit for 2024 are 97.42 million CNY and -123 million CNY, respectively, indicating ongoing losses despite some improvement in operations [5][6] - Other vaccine companies have reported significant declines in net profits, with companies like Kangtai Biologics and Watson Bio experiencing over 90% and 60% declines, respectively [4] Group 4: Competitive Landscape - Fosun Antigen lacks a strong competitive edge in the four-valent influenza vaccine market, where other companies have established advantages [6][7] - The company’s market share in the human rabies vaccine sector is limited, ranking third with an 8.86% market share [7] Group 5: Future Prospects - The approval of the freeze-dried human rabies vaccine in March 2024 may help Fosun Antigen expand its market presence [7] - The spin-off is seen as a strategy to achieve faster operational decisions and potentially attract innovation premiums in the Hong Kong market [8]
今年流感高发时间提前!疫苗种类众多,如何选择?
第一财经· 2025-10-28 06:10
Core Viewpoint - The article highlights the rising trend of influenza cases in southern China, particularly in Guangdong Province, with a recommendation for increased vaccination and preventive measures as the flu season approaches [3][4]. Group 1: Current Situation of Influenza - Guangdong Province is currently experiencing an influenza outbreak, primarily caused by the H3N2 strain, with a noted risk of outbreaks in densely populated areas [3]. - Monitoring data from the China CDC indicates that while northern provinces show low levels of flu activity, southern provinces are seeing an increase [3]. - Clinical observations report a significant rise in flu patients, with symptoms including fever, sore throat, headache, body aches, and fatigue [3]. Group 2: Vaccination Recommendations - The chief expert from Guangdong's CDC recommends flu vaccination as the most effective preventive measure against influenza and its complications, urging all individuals aged six months and older to get vaccinated unless contraindicated [4]. - High-risk groups, including children under five, the elderly, and individuals with chronic diseases, should be prioritized for vaccination [4]. - Vaccination should ideally be completed before the flu season begins, as protective antibodies typically develop 2 to 4 weeks post-vaccination [4]. Group 3: Types of Influenza Vaccines - Influenza vaccines are categorized into trivalent and quadrivalent types, with quadrivalent vaccines providing coverage for an additional strain of B influenza [5]. - Vaccines are further divided into inactivated and live attenuated types, with inactivated vaccines containing "killed" viruses and live attenuated vaccines containing weakened viruses [5]. - The majority of inactivated vaccines on the market are split vaccines, which are produced by breaking down the virus, while subunit vaccines involve further purification of the antigens [5]. Group 4: Safety and Administration of Vaccines - Both split and subunit vaccines are considered safe and effective, with the main differences lying in production methods, costs, and age suitability [5]. - For live attenuated vaccines administered via nasal spray, specific populations are advised against vaccination, including those with compromised immune systems and certain medical histories [6][7].
今年流感高发时间提前!疫苗接种如何选择
Di Yi Cai Jing· 2025-10-28 05:54
Core Insights - The flu season is currently active in Guangdong Province, primarily driven by the H3N2 strain, with a noted increase in flu cases in outpatient departments [1][2] - The flu peak season in southern regions has arrived earlier this year, indicating a potential increase in flu intensity, necessitating early preventive measures [1][2] Vaccine Recommendations - Vaccination is the most effective method for preventing flu and its complications, recommended for all individuals aged six months and older, especially high-risk groups [2] - High-risk groups include children under five, the elderly, and individuals with chronic conditions such as cardiovascular diseases and diabetes [2] Vaccine Types and Administration - Various flu vaccines are approved in China, including trivalent inactivated vaccines, quadrivalent inactivated vaccines, and trivalent live attenuated vaccines [2][3] - The main difference between inactivated and live attenuated vaccines lies in their production methods and administration routes, with inactivated vaccines administered via intramuscular injection and live attenuated vaccines via nasal spray [2][3] Vaccine Safety and Efficacy - Both inactivated and live attenuated vaccines are considered safe and effective, with no significant differences in protective efficacy [3] - The majority of inactivated vaccines on the market are split vaccines, which are produced using a mature technology [3] Contraindications for Live Attenuated Vaccines - Specific populations are advised against receiving live attenuated vaccines, including immunocompromised individuals, children on aspirin therapy, and pregnant women [4][5]
流感抗病毒类药品销量攀升,这个流感季,你接种疫苗了吗?
Bei Ke Cai Jing· 2025-10-24 03:49
Group 1: Flu Vaccine Market Dynamics - The sales of antiviral flu medications in China have surged significantly, with specific products like 999 Cold Medicine and Pudilan increasing by 210% and 390% year-on-year, respectively [1] - The number of flu vaccine batches approved for distribution in China has reached 112, with quadrivalent vaccines making up over 53% of the total [8][9] - The price of flu vaccines has decreased significantly, with some quadrivalent vaccines priced below 100 yuan, and public market prices for trivalent vaccines dropping to single digits [10] Group 2: Public Health Concerns and Vaccination Rates - The flu season in the Northern Hemisphere typically starts in October, with Japan reporting a significant increase in flu cases, indicating a potential early flu season [3][4] - China's flu vaccination rate remains low, with only 3.9% of the population vaccinated during the 2022-2023 season, and a further decline to 3% expected for the upcoming seasons [9][11] - Public health experts emphasize the need for improved vaccination rates among high-risk groups, including the elderly and children, to establish herd immunity [12][13] Group 3: Strategies for Increasing Vaccination Uptake - Recommendations for increasing flu vaccination rates include policy guidance, public education, and collaboration across multiple sectors [12][14] - Initiatives such as setting up "green channels" for the elderly and mobile vaccination units are being implemented to facilitate access to flu vaccines [13] - The importance of public awareness campaigns, including endorsements from public figures, is highlighted as a means to improve public perception and uptake of flu vaccinations [14]