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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受理
Bei Jing Shang Bao· 2025-12-17 11:52
Core Viewpoint - The company Zhifei Biological Products (智飞生物) announced that its subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd. (智飞龙科马), has received a clinical trial application acceptance notice from the National Medical Products Administration for its modified Ankara strain monkeypox live attenuated vaccine [1] Group 1 - The modified Ankara strain monkeypox live attenuated vaccine is developed to prevent monkeypox disease caused by the monkeypox virus [1] - The vaccine is intended for use in individuals aged 6 years and older [1] - The company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center after the acceptance of the application [1]
12月17日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-17 10:21
Group 1 - CICC is planning to absorb and merge Dongxing Securities and Xinda Securities through a share swap, with trading resuming on December 18, 2025 [1] - Victory Energy's major shareholder plans to transfer 29.99% of its shares to Qiteng Robotics, with no plans for asset restructuring in the next 12 months [2] - China Metallurgical Group intends to repurchase A-shares worth 1 to 2 billion yuan at a price not exceeding 4.9 yuan per share [3] Group 2 - Boten Co. plans to acquire part of the Yifeng Yunding Fund for 1 yuan, with a commitment to fulfill a 20 million yuan capital contribution [4] - Tongyou Technology has initiated a 50 million yuan accounts receivable factoring business [5] - Gaode Infrared has received approval to issue debt financing tools totaling up to 3 billion yuan [6] Group 3 - Zhengyu Industrial's application for a private placement of A-shares has been approved by the Shanghai Stock Exchange [7] - China CRRC signed contracts totaling approximately 53.31 billion yuan, accounting for 21.6% of its projected 2024 revenue [9] - High Energy Environment's director increased his stake by purchasing 56,100 shares [10] Group 4 - Shantou Technology received approval from the CSRC for a convertible bond issuance [11] - Puyang Co. plans to use up to 900 million yuan of idle funds for entrusted wealth management [12] - Huibai New Materials has been awarded a government subsidy of 3.8 million yuan, with the first installment of 2.12 million yuan already received [13] Group 5 - Jiayuan Technology's shareholders plan to transfer 2.51% of the company's shares through a pricing inquiry [14] - Lingpai Technology's subsidiary terminated a 125 million yuan procurement contract due to market changes [15] - Juguang Technology intends to use up to 200 million yuan of idle funds for cash management [16] Group 6 - Zhongwen Media's subsidiary terminated a 200 million yuan private equity fund subscription due to market changes [17] - Zhifei Biological's modified vaccine for monkeypox has received clinical trial acceptance [19] - GeKowei's subsidiary received a government subsidy of 60 million yuan, accounting for 32.12% of the company's audited net profit [20] Group 7 - Wantai Biological's application for a clinical trial of a respiratory syncytial virus vaccine has been accepted [21] - Haitai Technology plans to increase capital in its Thai joint venture from 500,000 to 3 million Thai baht [22] - Shanghai Airport signed contracts for the transfer of duty-free store operating rights [23] Group 8 - Del Shares received approval to issue shares for the acquisition of 100% of Aizhuo Intelligent [24] - Novozymes' products have obtained EU CE IVDR certification [25] - Shibai Testing's chairman's assistant plans to increase shareholding by 8 to 12 million yuan [26] Group 9 - Huitian New Materials plans to invest approximately 97.68 million yuan in a lithium battery anode glue project [27] - Pudong Construction's subsidiaries won contracts totaling 1.649 billion yuan [29] - Acolyte's subsidiary has entered trial production for a special high-temperature resistant resin project [30] Group 10 - Pingzhi Information's subsidiary signed a 38.25 million yuan computing power service contract [31] - Tianma Technology is required to pay 5.3625 million yuan in taxes and penalties [32] - Yahon Pharmaceutical's clinical trial application for GLX002 has been approved [34]
智飞生物自主研发MVA猴痘疫苗临床试验申请获受理 瞄准6岁以上人群防护
Jin Rong Jie· 2025-12-17 10:11
Core Viewpoint - The announcement by Zhifei Biological regarding the acceptance of its clinical trial application for a modified Ankara strain monkeypox vaccine marks a significant milestone in the development of domestic monkeypox vaccines in China [1][2]. Group 1: Vaccine Development - Zhifei Biological's subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has developed a modified live vaccine for monkeypox, which has been accepted for clinical trial application by the National Medical Products Administration [1]. - The monkeypox vaccine is intended for individuals aged 6 years and older and utilizes a modified live vaccine technology based on the Ankara strain, which is noted for its high safety profile as it does not replicate effectively in human cells [2]. Group 2: Public Health Implications - Monkeypox, caused by the monkeypox virus, poses a significant public health risk, particularly for vulnerable populations such as children, pregnant women, and immunocompromised individuals, who may experience severe complications [2]. - The development and administration of a monkeypox vaccine are critical measures to reduce disease incidence and alleviate public health burdens, especially since no monkeypox vaccine has been approved for use in China as of the announcement date [2]. Group 3: Strategic Importance - The acceptance of the clinical trial application is seen as a key breakthrough for Zhifei Biological in building its portfolio of vaccines for emerging infectious diseases, reflecting the company's focus on innovative technologies and core research efforts [3]. - This progress is expected to enhance the company's long-term sustainable development and contribute to the improvement of China's independent innovation capabilities in major infectious disease prevention [3].
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
智通财经APP讯,智飞生物(300122.SZ)发布公告,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(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。 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染病疫苗矩阵实现关键性突 破,是公司聚焦创新技术、增强核心攻关的成果。这一突破性进展不仅赋能公司长期稳健发展,也将推 动我国重大传染病防控自主创新能力的提升。若本项目进展顺利,将进一步丰富公司疫苗品种,完善公 司产品布局,强化公司的市场地位。 ...
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
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染病疫苗矩阵实现关键性突 破,是公司聚焦创新技术、增强核心攻关的成果。这一突破性进展不仅赋能公司长期稳健发展,也将推 动我国重大传染病防控自主创新能力的提升。若本项目进展顺利,将进一步丰富公司疫苗品种,完善公 司产品布局,强化公司的市场地位。 智飞生物(300122)(300122.SZ)发布公告,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(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。 ...
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
证券日报网讯 12月12日,智飞生物(300122)在互动平台回答投资者提问时表示,公司严格按照法律 法规履行信息披露义务。公司正持续优化经营策略,加速推进自研产品上市,强化市场宣传推广,促进 公司稳健发展。 ...
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].