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国产突破!智飞生物MVA猴痘减毒活疫苗获NMPA受理,有望填补国内防控空白
Jin Rong Jie· 2025-12-17 10:11
Core Viewpoint - The announcement by Zhifei Biological regarding the acceptance of the clinical trial application for its modified Ankara strain monkeypox vaccine marks a significant milestone in the development of domestic monkeypox vaccines, contributing to the country's infectious disease prevention and control system [1][5]. Group 1: Vaccine Development Progress - Zhifei Biological's subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., has developed a modified live vaccine for monkeypox, which has received acceptance for clinical trial application from the National Medical Products Administration [1]. - The acceptance allows for the initiation of clinical trials within 60 days if no negative feedback is received from the drug review center, indicating a critical phase in the vaccine's development [1]. Group 2: Epidemiological Context - Monkeypox, caused by the monkeypox virus, presents distinct epidemiological characteristics, with symptoms including fever, severe headache, and lymphadenopathy, which are crucial for diagnosis [2]. - The transmission of monkeypox primarily occurs through close skin contact, particularly sexual contact, and can also spread via contaminated objects and respiratory droplets [2]. - Epidemiological data shows a significant incidence among young males, with over 90% of reported cases being male, highlighting the need for targeted prevention strategies [2]. Group 3: Public Health Implications - Special populations, such as children, pregnant women, and immunocompromised individuals, face higher risks of severe complications from monkeypox, necessitating differentiated public health strategies [3]. - Vaccination is emphasized as a cost-effective means of preventing infectious diseases, aiming to establish herd immunity and control the spread of monkeypox [3]. Group 4: Technological Innovation - The vaccine utilizes advanced live attenuated vaccine technology, employing the modified Ankara strain, which has biological properties that prevent effective replication in human cells, enhancing safety [4]. - The vaccine is intended for individuals aged 6 years and older, balancing safety requirements with public health needs [4]. - Currently, there are no approved monkeypox vaccines in the domestic market, and Zhifei Biological's progress is expected to fill this critical gap [4]. Group 5: Strategic Importance for the Company - The acceptance of the clinical trial application represents a key breakthrough for Zhifei Biological in its vaccine development matrix, reflecting its focus on innovative technology and core research efforts [5]. - Successful progression through clinical trials and eventual approval would diversify Zhifei Biological's vaccine portfolio and strengthen its market position in the infectious disease prevention sector [5].
智飞生物(300122.SZ):改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗临床试验申请获得受理
智通财经网· 2025-12-17 08:51
Core Viewpoint - The company, Zhifei Biological, has received a clinical trial application acceptance notice for its modified Ankara vaccine for monkeypox, marking a significant breakthrough in its vaccine development efforts [1] Group 1: Clinical Trial Acceptance - Zhifei Longkema, a wholly-owned subsidiary of Zhifei Biological, has developed a modified Ankara vaccine for monkeypox, which has been accepted for clinical trial by the National Medical Products Administration [1] - The acceptance number for the clinical trial application is CXSL2501083, allowing the company to proceed with trials if no negative feedback is received within 60 days [1] Group 2: Vaccine Technology and Safety - The vaccine utilizes a live attenuated vaccine technology route, employing the modified Ankara strain, which cannot effectively replicate in human cells, ensuring high safety [1] - This development is seen as a key achievement in the company's focus on innovative technology and enhancing core capabilities [1] Group 3: Strategic Implications - The acceptance of the clinical trial application is expected to enhance the company's long-term stable development and improve China's independent innovation capabilities in major infectious disease prevention [1] - Successful progress in this project will diversify the company's vaccine offerings, improve its product portfolio, and strengthen its market position [1]
智飞生物:改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗临床试验申请获得受理
Zhi Tong Cai Jing· 2025-12-17 08:49
Core Viewpoint - The company has received a clinical trial application acceptance notice for its modified Ankara vaccinia virus (MVA) monkeypox live attenuated vaccine, marking a significant breakthrough in its vaccine development efforts [1] Group 1: Clinical Trial Development - The clinical trial application for the modified MVA monkeypox vaccine was accepted by the National Medical Products Administration, allowing the company to proceed with trials if no objections are raised within 60 days [1] - The vaccine utilizes a modified Ankara strain that cannot effectively replicate in human cells, ensuring high safety levels and preventing secondary transmission [1] Group 2: Strategic Implications - This acceptance signifies a key breakthrough in the company's focus on innovative technologies and core competencies in addressing emerging infectious diseases [1] - Successful progress in this project is expected to enhance the company's vaccine portfolio, improve product layout, and strengthen its market position [1]
智飞生物(300122) - 关于改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗临床试验申请获得受理的公告
2025-12-17 08:32
证券代码:300122 证券简称:智飞生物 公告编号:2025-75 重庆智飞生物制品股份有限公司 关于改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗 临床试验申请获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司(以下简称"公司")于近日获悉,由全资子 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")研发的改良型 安卡拉痘苗病毒(MVA)猴痘减毒活疫苗获得国家药品监督管理局药物临床试 验申请受理通知书(受理号:CXSL2501083)。自受理之日起 60 日内,未收到 药审中心否定或质疑意见的,智飞龙科马可以按照提交的方案开展临床试验。 一、研发项目简介 1 截至本公告披露日,经查询国家药品监督管理局官网,国内暂无猴痘疫苗获 批上市使用。 公司的改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗采用减毒活疫苗技 术路线,利用改良型安卡拉痘苗病毒 Ankara 株进行疫苗生产,Ankara 株无法在 人体细胞中有效复制,不会在身体中扩散或造成继发传播,安全性较高。该疫苗 临床试验申请获得受理,标志着公司在新发突发传 ...
智飞生物:促进公司稳健发展
Zheng Quan Ri Bao Wang· 2025-12-12 12:46
Core Viewpoint - The company emphasizes its commitment to legal compliance in information disclosure and is focused on optimizing its business strategy to enhance product launch and market promotion efforts [1] Group 1 - The company is actively working on accelerating the launch of self-developed products [1] - The company is enhancing its market promotion strategies to support stable growth [1] - The company is adhering to legal regulations in its information disclosure practices [1]
股市面面观丨2025,“茅”股的失意之年?
Xin Hua Cai Jing· 2025-12-11 02:35
Group 1: Guizhou Moutai Performance - Guizhou Moutai's stock price has been declining, dropping below 1400 CNY per share on December 10, but managed to close at this key level [1] - The decline in Moutai's stock is attributed to the falling prices of Moutai liquor, with the wholesale reference price for 2025 53-degree 500ml Moutai dropping to 1500 CNY per bottle, a decrease of 15 CNY from the previous day, marking a historical low [1] - Year-to-date, Guizhou Moutai's stock has fallen by 6.26%, underperforming the CSI 300 index by nearly 23 percentage points [1] Group 2: Other "Mao" Stocks Performance - The top three "Mao" stocks with the largest declines this year are Zhifei Biological, Mindray Medical, and Aimeike, with respective stock price drops of 24.64%, 20.92%, and 19.3% [2] - A total of 18 "Mao" stocks have declined this year, with 9 of them experiencing drops exceeding 10% [1][4] Group 3: Zhifei Biological Analysis - Zhifei Biological's significant decline is closely related to a substantial drop in performance, reporting a loss of 1.206 billion CNY in the third quarter, resulting in a negative price-to-earnings ratio [4] - The company faces increased competition and pricing pressure in the HPV vaccine market, with a gross margin dropping to 23.77% and a net margin of -15.99% [4] - The company is attempting to diversify away from reliance on HPV vaccines, with 34 self-developed projects in various stages of clinical trials [5] Group 4: Mindray Medical and Aimeike Performance - Mindray Medical's net profit fell by 28.83% year-on-year in the first three quarters, marking the first negative growth in net profit since its listing [6] - Aimeike reported a 31.05% decline in net profit and a 21.49% drop in revenue, both representing the first instances of simultaneous negative growth since its listing [6][7] - Analysts suggest that both companies may see a turnaround in 2026, with Mindray's domestic business expected to achieve positive revenue growth [7][8] Group 5: Market Sentiment and Future Outlook - Despite the overall poor performance of "Mao" stocks in 2025, some technology stocks have significantly outperformed the CSI 300 index, indicating potential new "Mao" stocks emerging from innovative sectors [9] - Notable investors express optimism about Guizhou Moutai, suggesting it remains a better investment than keeping cash in the bank [9]
低至5.5元/支,疫苗价格“跳水”背后
Tai Mei Ti A P P· 2025-12-10 10:15
Core Viewpoint - The HPV vaccine market has shifted dramatically from scarcity and high prices to aggressive price competition, leading to significant revenue declines for many companies in the vaccine industry [3][4][11]. Price Competition and Market Changes - The price of the bivalent HPV vaccine has dropped from 245 yuan to 27.5 yuan, a nearly 90% decrease, while the nine-valent HPV vaccine is being offered in "buy one, get one free" promotions [3]. - The flu vaccine market has also seen price reductions, with the trivalent vaccine dropping to 5.5 yuan and the quadrivalent vaccine decreasing from 128 yuan to 88 yuan [3]. - In the first three quarters of 2025, only 5 out of 14 domestic vaccine companies reported revenue growth, while 10 companies, including industry leader Zhifei Biological, experienced significant profit declines [2][3]. Structural Issues in the Industry - The industry's performance decline is attributed to structural problems rather than cyclical fluctuations, with price wars compressing profit margins and leading to a situation where revenue growth does not translate into profit [4][5]. - The lack of innovation and reliance on technology replication has resulted in oversupply and a lack of differentiation among products, making price competition inevitable [6][9]. Innovation as a Key to Recovery - Companies that focus on innovation, such as CanSino with its quadrivalent meningococcal vaccine, have shown resilience, achieving revenue growth and profitability despite the overall market downturn [6][7]. - The market is willing to pay a premium for differentiated products that offer better protection and safety, indicating that true innovation is essential for avoiding price competition [7]. Challenges to Original Innovation - The high costs and long timelines associated with developing new vaccines, along with regulatory uncertainties, deter companies from pursuing original innovation [9]. - The current regulatory framework is more suited to traditional technologies, creating barriers for new vaccine platforms [9]. Industry Response and Future Directions - The China Vaccine Industry Association has initiated a campaign to oppose "involutionary" competition and promote high-quality development in the vaccine sector [10]. - Companies are encouraged to focus on unmet clinical needs and explore international markets to alleviate domestic competition pressures [10]. - There is a need for improved public awareness and vaccination services to enhance demand and increase vaccination rates, particularly for flu vaccines [10]. Conclusion - The price competition in the vaccine industry is a result of homogeneous competition and represents a transitional phase for industry upgrade [11]. - Successful examples of innovative companies and emerging industry consensus indicate a potential path forward, emphasizing the importance of clinical value over price competition [11].
解密主力资金出逃股 连续5日净流出553股
Core Insights - A total of 553 stocks in the Shanghai and Shenzhen markets have experienced net outflows of main funds for five consecutive days or more as of December 10 [1] - ST Jinglan has the longest streak of net outflows, with 23 days, followed by Aier Eye Hospital with 22 days [1] - The largest total net outflow amount is from Changcheng Military Industry, which has seen a cumulative outflow of 2.123 billion yuan over 12 days [1] Summary by Category Stocks with Longest Net Outflow Duration - ST Jinglan: 23 days of net outflow [1] - Aier Eye Hospital: 22 days of net outflow [1] - Sairisi: 7 days of net outflow [1] Stocks with Largest Net Outflow Amount - Changcheng Military Industry: 2.123 billion yuan over 12 days [1] - Aier Eye Hospital: 1.706 billion yuan over 22 days [1] - Sairisi: 1.370 billion yuan over 7 days [1] Stocks with Highest Net Outflow Proportion - *ST Zhengping: 26.44% decline over the last 5 days [1] - Aier Eye Hospital: 14.30% decline over 22 days [1] - Sairisi: 11.26% decline over 7 days [1] Additional Notable Stocks - Keda Xunfei: 1.209 billion yuan net outflow over 12 days with a 2.75% decline [1] - Dongfang Precision: 1.171 billion yuan net outflow over 7 days with a 10.92% decline [1] - Huaying Technology: 939 million yuan net outflow over 5 days with a 7.32% decline [1]
【江北嘴发布】智飞生物又获发明专利证书
Core Viewpoint - Zhifei Biological has recently obtained a patent for a stable adenoviral vector freeze-dried preparation and its application, which will enhance the company's intellectual property protection and core competitiveness [1] Group 1: Patent Acquisition - Zhifei Biological and its subsidiaries have received the invention patent certificate for "a stable adenoviral vector freeze-dried preparation and its application" [1] - The patent was issued by the National Intellectual Property Administration of the People's Republic of China, with application number ZL202311377259.3 and certificate number 8546593 [1] - The patent application date was October 24, 2023, and the authorization announcement date is December 5, 2025 [1] Group 2: Implications of the Patent - The patent acquisition is a result of the company's independent research and development efforts [1] - This patent will be applied in relevant research and development projects, promoting technological innovation [1] - The achievement of this patent is expected to enhance the company's core competitiveness by leveraging its independent intellectual property advantages [1]
智飞生物(300122) - 关于取得发明专利证书的公告
2025-12-08 09:38
证券代码:300122 证券简称:智飞生物 公告编号:2025-74 重庆智飞生物制品股份有限公司 关于取得发明专利证书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 | 发明专利名称 | 专利号 | 专利证书号 | 专利类型 | 专利申请日 | 授权公告日 | 专利权人 | | --- | --- | --- | --- | --- | --- | --- | | 一种稳定腺病毒 载体冻干制剂及 | ZL202311377259.3 | 第 8546593 号 | 发明专利 | 2023 年 10 月 | 2025 年 12 月 | 智飞生物 智飞绿竹 | | | | | | 24 日 | 05 日 | | | 其应用 | | | | | | 智飞龙科马 | 上述发明专利在公司自主研发过程中取得,未来将应用于相关研发项目。该 专利证书的取得不会对公司近期生产经营产生重大影响,但有利于进一步完善公 司知识产权保护体系,充分发挥自主知识产权优势,促进技术创新,提升公司的 核心竞争力。 特此公告 重庆智飞生物制品股份有限公司董事会 2025 年 12 月 ...