尼塞韦单抗

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 呼吸道合胞病毒进入高发期 “预防针”尼塞韦单抗适合所有宝宝接种吗?
 Yang Guang Wang· 2025-10-25 06:14
央广网北京10月25日消息(总台中国之声记者谭瑱)据中央广播电视总台中国之声《新闻纵横》报 道,秋冬季是呼吸道疾病高发季节,近期,不少婴幼儿"中招"呼吸道合胞病毒,出现上呼吸道感染症 状,部分患儿还进展为支气管炎、肺炎等。目前针对呼吸道合胞病毒尚无特效药,不过有一种能起预防 作用的抗体——尼塞韦单抗,它能有效阻止病毒对呼吸道的侵袭。 广东药科大学附属第一医院儿科主任孟翠萍介绍,临床上目前尚无针对呼吸道合胞病毒的特效抗病 毒药物。她告诉记者:"没有什么特效药物,我们只是对症治疗。如果有气喘、憋气这些症状,我们就 会缓解气道痉挛,进行雾化,给一些止喘止咳的口服药物。如果患者出现低氧血症的话,我们就会给患 者吸氧,主要还是针对症状来治疗。" 为了预防呼吸道合胞病毒感染,上周,山东济南的成女士带着刚满10个月的宝宝,前往社区卫生服 务中心,为孩子完成了尼塞韦单抗的接种。成女士说,在网上有不少关于尼塞韦单抗"预防针"的讨论, 因为接种价格需要两三千元,也会有家长犹豫是否为孩子接种。 成女士说:"因为我最近在各个网络平台上刷到特别多这种帖子,看得我还挺焦虑的。他们基本上 最后的结论都是说打一下比较好。所以我就图个放心,就 ...
 呼吸道合胞病毒进入流行期,国内多家企业布局相关药物研发
 Xin Jing Bao· 2025-10-14 10:13
 Core Insights - The respiratory syncytial virus (RSV) is currently in an epidemic phase in China, with a significant number of children being hospitalized, including cases in the ICU [1] - There is no specific treatment for RSV in infants, making prevention crucial, and several companies are developing RSV-related drugs [1][2] - The global market for passive immunization agents for RSV prevention in infants is projected to grow at a compound annual growth rate (CAGR) of 78.4% from 2024 to 2028, reaching 2.99 billion yuan [2]   Drug Development Landscape - Three monoclonal antibodies (mAbs) for RSV have been approved globally: Palivizumab, Nirsevimab, and Clonabivimab, with Nirsevimab being the first long-acting mAb approved in China [3] - Six additional mAbs are in clinical trials, with TNM-001 from Zhuhai Tenomab Pharmaceutical progressing to Phase III trials [3]   Vaccine Development - There are 188 RSV vaccines in development globally, with three approved: GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mRESVIA, none of which are available in China yet [4] - Several Chinese companies, including Chengdu Huarenkang and Beijing Kexing Zhongwei, are actively developing RSV vaccines, with some in Phase III clinical trials [4]   Innovative Drug Research - Currently, there are no approved specific treatments for RSV, but notable progress is being made in small molecule drug development [6] - Aikobaf's Qiruisuo is the first targeted RSV fusion protein inhibitor to complete Phase III trials and is recognized as a breakthrough therapy in China [6] - Shionogi's oral antiviral S-337395 is in Phase II trials and has shown promising results in reducing viral load [6]   Future Outlook - The ongoing development of vaccines, monoclonal antibodies, and therapeutic drugs is expected to lead to more effective prevention and treatment options for RSV [7]
 国内外药企竞相布局合胞病毒疫苗
 Bei Jing Shang Bao· 2025-10-13 15:39
据了解,WHO已将RSV预防产品列为全球最优先开发产品之一。 根据弗若斯特沙利文报告,预计2024—2028年中国0—1岁婴幼儿呼吸道合胞病毒预防被动免疫制剂市场 规模将以复合年增长率78.4%增长至29.9亿元,并进一步以复合年增长率23.68%增长至2032年的69.9亿 元。 在RSV感染后治疗方面,目前对RSV感染后的治疗则普遍以干扰素、广谱抗病毒药物及皮质类激素为 主,疗效及安全性欠佳,全球范围内未有针对RSV的特异性药物。 据了解,在当前针对RSV的免疫防控体系中,主要干预策略包括妊娠女性疫苗和长效单克隆抗体两种路 径。目前全球共有三款RSV预防药物获批上市,分别为MedImmune的帕利珠单抗、默沙东的克莱罗韦 单抗,以及阿斯利康与赛诺菲联合开发的尼塞韦单抗。 具体来看,由于帕利珠单抗衰期短,在RSV流行季内需每月注射,价格昂贵且适用人群少,不适宜广泛 使用,目前尚未在中国上市;尼塞韦单抗分别于2022年、2023年获得欧盟EMA与美国FDA批准,用于 预防早产儿和幼龄婴儿的RSV感染,并于2023年12月在国内上市,用于即将进入或出生在第一个RSV感 染季的新生儿和婴儿预防RSV引起的下呼吸道 ...
 进口单抗最高超3000一针!呼吸道合胞病毒进入高发期,国内外药企竞相布局
 Bei Jing Shang Bao· 2025-10-13 12:13
面对这一公共卫生挑战,国内外制药企业正在RSV预防与治疗领域积极布局。截至目前,全球已有三款RSV预防药物获 批上市,其中,已在国内获批的仅有尼塞韦单抗一款。该单抗系阿斯利康与赛诺菲联合开发,价格不菲,适用于5kg以上 儿童的剂型价格超过3000元。此外,国内当前也有多家药企布局RSV相关药物研发,包括珠海泰诺麦博制药股份有限公 司(以下简称"泰诺麦博")的TNM001、智翔金泰的GR2102注射液等。 近日,呼吸道合胞病毒(RSV)感染来势汹汹,相关患者数量增多。"呼吸道合胞病毒流行期提前"相关话题更是登上微博热 搜。据悉,呼吸道合胞病毒在婴幼儿和老年人群体中更容易引发较严重的症状,是世界范围内引起5岁以下儿童呼吸道感 染最常见的病原体之一。临床上目前尚无针对该病毒的特效抗病毒药物,治疗以对症退热等手段为主。 尽管目前RSV药物选择仍较有限、用药成本较高,但随着国内外药企的加紧布局与多款在研药物的推进,未来RSV的预 防与治疗格局有望进一步优化,为相关患者提供更可及、更有效的健康保障。 | 通用名 | 商品名 | 生产 | 靶点 | 类别 | 获批时间 | 销售额 | | --- | --- | --- | ...
 爱科百发坎坷上市路:五年四度冲击资本市场 管线多为授权引进核心竞争力如何体现?
 Xin Lang Zheng Quan· 2025-10-11 08:05
炒股就看金麒麟分析师研报,权威,专业,及时,全面,助您挖掘潜力主题机会! 从2021年首次递表至今已逾四年,在此期间,资本市场环境、行业监管政策、投资者偏好均已发生显著 变化。公司错失了可能的融资窗口,而研发支出却在持续累积,进一步加剧了资金压力。 近日,上海爱科百发生物医药技术股份有限公司(下称"爱科百发")再次向港交所递交招股书,这已是 该公司自2021年以来第四次冲击资本市场、第二次叩响港交所大门。在此期间,公司曾先后尝试港股与 科创板上市,却均以主动撤回告终。上市屡屡受挫的背后,是公司高度依赖授权引进的研发模式、商业 化潜力存疑以及持续承压的现金流状况。 五年四度冲击资本市场 资金储备已捉襟见肘 爱科百发的资本化道路并不顺利,2021年6月,公司首次向港交所递交上市申请,并在同年10月获得证 监会关于核准发行境外上市外资股的批复。然而,就在市场期待其挂牌交易之际,公司却主动终止了上 市进程。 随后,公司迅速转向内地资本市场。2023年4月,爱科百发申请科创板上市获得受理,但在历经多轮问 询后,公司及保荐人于2024年1月撤回了发行上市申请。如今,公司再度调转方向,重新回归港股市 场。 财务数据显示,爱 ...
 现金状况吃紧的爱科百发再度冲击IPO
 Xin Lang Cai Jing· 2025-10-09 09:02
来源:智通财经 智通财经记者 | 黄华 智通财经编辑 | 谢欣 近日,创新药公司爱科百发再次向港交所递交了上市申请。近些年内,该公司多番冲击IPO,这已是其 五年内二度尝试港股上市。 据行业媒体药研网报道,爱科百发首次公开冲刺IPO的时间可追溯至2021年6月,当时目标是港股主 板,随后在2022年年初选择主动终止上市申请。 智通财经此前报道,2023年上半年,爱科百发放弃港交所IPO之后,正式向科创板递交了IPO招股书; 但在2024年初,爱科百发撤回了发行上市申请。 9月18日上午,就港股IPO动态一事,智通财经记者向爱科百发官网投资者关系邮箱发送了采访提纲, 截至发稿时尚未收到回复。同日上午,智通财经记者拨打了爱科百发官网联系电话,通话没有被接通。 若是从财务面看,爱科百发由于缺乏商业化产品,加之前几年的大研发投入,目前的现金状况较为糟 心,入不敷出态势严峻,这也可能促使企业再度启动IPO计划。 企业招股书显示,截至今年上半年末,爱科百发现金及现金等价物不足1亿元。但在同期,公司的研发 成本和行政开支分别是8613.8万元、1943.4万元。今年上半年,该公司继续亏损,期内亏损也过亿。 | | 截至12 ...
 科创板“第五套”重启首单解析:泰诺麦博核心药品刚上市遇竞品“打5折”?
 Hua Er Jie Jian Wen· 2025-08-02 05:12
 Core Viewpoint - The acceptance of Zhuhai Tainuo Maibo Pharmaceutical Co., Ltd.'s IPO application under the fifth set of standards for the Sci-Tech Innovation Board marks a significant milestone after a two-year hiatus for similar projects [1][9].   Financial Performance - Tainuo Maibo's revenue from 2022 to 2024 was 4.34 million yuan, 0 yuan, and 15.06 million yuan, respectively, while net losses during the same period were 429 million yuan, 446 million yuan, and 515 million yuan, totaling over 1.4 billion yuan [2]. - The company plans to raise 1.5 billion yuan through the IPO to fund new drug development, expand antibody production facilities, and supplement working capital [6].   Product Pipeline - Tainuo Maibo's core products include the recombinant anti-tetanus toxin monoclonal antibody, "Xintuituo" (new tetanus antibody), which has been approved for market, and TNM001, which is currently in Phase III clinical trials [3][15]. - "Xintuituo" is the first recombinant anti-tetanus toxin monoclonal antibody globally, aimed at reducing reliance on human blood-derived products for passive immunity [11][12].   Market Challenges - The competitive landscape for "Xintuituo" is challenging, with similar products priced below 200 yuan, leading to a price drop of over 50% compared to pre-collection prices [5][13]. - The terminal market price for "Xintuituo" is set at 798 yuan per injection, while competing products have significantly lower prices due to recent price reductions in the market [13].   Competitive Landscape - TNM001 targets respiratory syncytial virus (RSV) and is facing competition from established products like Synagis and Clesrovimab, which are already available in the market [15][17]. - The global market for RSV treatments is projected to reach $12.8 billion by 2030, indicating significant commercial potential for TNM001 [15].   Strategic Implications - The progress of Tainuo Maibo's core products exceeds the requirements for the fifth set of IPO standards, suggesting a more certain commercial outlook [18]. - The acceptance of Tainuo Maibo's IPO application may serve as a reference for other companies considering similar paths in the future [18].
 南方地区呼吸道合胞病毒持续流行,呼吸科专家建议将预防关口前移
 Bei Ke Cai Jing· 2025-07-14 01:24
 Core Viewpoint - The Respiratory Syncytial Virus (RSV) is the leading pathogen detected in hospitalized severe acute respiratory infection cases in China, indicating a persistent epidemic status and necessitating enhanced preventive measures [1][2].   Group 1: RSV Prevalence and Impact - RSV has consistently ranked among the top three pathogens in hospitalized severe acute respiratory infection cases from the 4th to the 27th week of 2025, maintaining a detection rate of around 10% [1][2]. - The virus poses a significant threat to infants, particularly those under one year old, as it is the primary cause of lower respiratory infections leading to hospitalization in this age group [1][2].   Group 2: Preventive Measures and Recommendations - Public health measures, including health education and immunization, should be integrated into medical services to reduce the risk of severe cases in infants [1]. - High-risk groups, such as premature infants and those with congenital conditions, are advised to receive the monoclonal antibody Nirsevimab, which is the first preventive measure for all infants against RSV [2].   Group 3: Monitoring and Data Utilization - Continuous monitoring of RSV through weekly reports is essential for understanding its prevalence and guiding preventive strategies [2]. - The protective effect of the monoclonal antibody lasts approximately 5-6 months, aligning with the RSV epidemic season, thus facilitating a connection between prevention and treatment [2].





