A Randomized, Double-blind, Two-stage, Placebo-controlled Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of Ziresovir (AK0529) in Adult Patients at High Risk for Respiratory Syncytial Virus (RSV) Infection.

Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.

开始日期2026-03-03

申办/合作机构

上海爱科百发生物医药技术股份有限公司

NCT06591845

/ Completed临床1期

A Single-Center, Randomized, Partially Double-Blind, Placebo- and Active-Controlled, Four-period Crossover, Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects

This is a single-center, randomized, partially double-blind, placebo and active-controlled, 4-period crossover design thorough QT/QTc (TQT) clinical study to evaluate the effects of ziresovir on cardiac repolarization in healthy subjects.

开始日期2024-09-25

申办/合作机构

上海爱科百发生物医药技术股份有限公司

NCT06775405

/ Recruiting临床3期

A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants with Respiratory Syncytial Virus Infection

Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.

开始日期2024-02-29

申办/合作机构

上海爱科百发生物医药技术股份有限公司

100 项与齐瑞索韦相关的临床结果

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100 项与齐瑞索韦相关的转化医学

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100 项与齐瑞索韦相关的专利（医药）

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项与齐瑞索韦相关的文献（医药）

2026-06-01·LIFE SCIENCES

Broad-spectrum coronavirus inhibition by RSV fusion inhibitors targeting six-helix bundle formation

Article

作者: Chen, Weiyi ; Go, Yun Young ; Shin, Jin Soo ; Yeh, Jung-Yong ; Chen, Zhenhai ; Zhou, Bin ; Ji, Min Chae ; Jung, Eunhye

Waning vaccine-derived immunity and the emergence of new SARS-CoV-2 subvariants continue to challenge global public health, emphasizing the need for novel inhibitors against SARS-CoV-2 infection. Molecular inhibitors targeting virus entry are promising candidates as they can disrupt viral replication at the earliest stage. In this study, we utilized a fluorescence-based SARS-CoV-2 pseudovirus screening platform to identify entry inhibitors from a repurposed library of bioactive compounds. Ziresovir and TMC353121, both small molecules known as respiratory syncytial virus (RSV) fusion inhibitors, were identified as hits that inhibited SARS-CoV-2 pseudovirus entry. In vitro and in silico analyses, together with site-directed mutagenesis, demonstrated that these molecules interfere with the formation of the six-helix bundle (6HB) in the SARS-CoV-2 spike (S) protein, thereby inhibiting membrane fusion. Additionally, both compounds exhibited inhibitory effects against SARS-CoV pseudovirus, wild-type SARS-CoV-2, and several other coronaviruses. These findings identify Ziresovir and TMC353121 as mechanistically validated scaffolds that target conserved fusion mechanisms across different viral families. While further optimization is required to enhance their potency against infectious SARS-CoV-2, this study provides a strategic foundation and chemical templates for the development of broad-spectrum fusion inhibitors to combat current and future coronavirus threats.

2026-02-01·RESPIRATORY MEDICINE

Respiratory syncytial virus in high-risk adults: A critical appraisal of therapeutic options and unmet needs

Review

作者: Ranellou, Kyriaki ; Panagiotopoulos, Antonios-Periklis ; Anastassopoulou, Cleo ; Mariolis, Ilias ; Tsakris, Athanasios

Respiratory syncytial virus (RSV) has traditionally been viewed as a causative agent of pediatric illness, yet accumulating evidence shows substantial morbidity and mortality among adults, particularly older individuals, those with cardiopulmonary comorbidities, and the immunocompromised. Although recent vaccine approvals for older adults represent major progress in prevention, effective therapeutic options for established infection remain limited. Herein we provide a critical analysis of existing and emerging antiviral and monoclonal antibody (mAb) therapies for the management of RSV infection in adults, highlighting current options and compounds in clinical development. At present, ribavirin remains the only antiviral recommended for treatment in adults, and no mAb has received regulatory authorization for prophylaxis or therapy in this population. Several development programs for direct-acting antivirals have been discontinued for reasons unrelated to safety or efficacy in adults, contributing to an ongoing treatment gap. Nevertheless, newer drug candidates, including ziresovir, EDP-938, and S-337395, have shown encouraging antiviral activity and acceptable safety in adult studies. By examining both the scientific evidence and the structural factors shaping the current landscape, we emphasize the need for sustained adult-focused clinical development to complement preventive vaccination. Addressing this therapeutic gap will be essential to reduce the burden of RSV disease in high-risk adult populations, particularly as the global population ages.

2025-12-02·Expert Opinion on Drug Discovery

Synthetic oxetanes in drug discovery: where are we in 2025?

Review

作者: Bull, James A. ; Ishikura, Hikaru

INTRODUCTION:

Oxetanes are increasingly prevalent motifs in medicinal chemistry. While oxetanes feature famously in the taxol family, it was not until the recent approval of rilzabrutinib that they have been validated in a fully synthetic drug. These four-membered oxygen-containing rings are valued for their ability to modulate key physicochemical properties such as polarity, lipophilicity, and metabolic stability. Their incorporation can improve aqueous solubility, reduce metabolic liability, reduce basicity of adjacent amines, and redirect metabolic clearance away from cytochrome P450 enzymes.

AREAS COVERED:

This review examines the role of the oxetane in nine clinical candidates, one very recently approved, two recently discontinued clinical candidates, two tool compounds, and three lead compounds disclosed in 2024. Recent advances indexed in SciFinder-n (2017-2024) in the process-scale and laboratory-scale synthetic routes are discussed, highlighting ongoing innovation required to access these motifs efficiently and sustainably.

EXPERT OPINION:

The regulatory approval of rilzabrutinib and likely approval of ziresovir provide confidence in using oxetanes as important elements in drug design. While oxetanes have so far been incorporated primarily as pendant groups to optimize physicochemical properties, their use as scaffolding and binding elements presents an exciting opportunity. Enhanced synthetic accessibility to oxetane derivatives will expedite their inclusion in drug discovery campaigns.

208

项与齐瑞索韦相关的新闻（医药）

2026-09-04

·薛定谔的Vaccine

两款国产单抗同日获批、百亿市场打开：RSV疫苗的'国产窗口期'还剩多久？

2026年9月3日，国家药品监督管理局同日批准两款国产RSV单抗——泰诺麦博的"新多妥"（芮特韦拜单抗）和先声药业代理的"英沐乐"（库莱韦拜单抗），用于新生儿和婴儿预防下呼吸道感染。这是中国RSV被动免疫制剂市场的一场集中爆发。而当我们把视线从单抗转向疫苗，会看到另一番光景：全球至今没有一款针对婴幼儿的RSV疫苗获批；国内管线最快仍在临床II期，距离上市至少3-5年。单抗和疫苗之间（主动免疫VS被动免疫），看起来只差一个字，背后却是两个时代的研发纵深。 01 9月3日的两个"第一" 9月3日有两颗"炸弹"。第一颗，泰诺麦博（688806.SH）的"新多妥"。这是珠海科创板上市公司自主研发的1类儿童专用创新药，走优先审评通道获批。关键III期数据：给药后150天内，对需就医的RSV下呼吸道感染保护效力71.3%，对导致住院的RSV-LRTI保护效力71.7%，对重症RSV-LRTI的保护效力跃升至93.9%（就医）和90.1%（住院）。公司宣称，这是全球首款拥有长达九个月临床保护数据的RSV单抗——单次注射覆盖一个完整流行季。第二颗，瑞阳生物（山东）的"英沐乐"，由先声药业（2096.HK）于2026年8月20日获得大中华区独家权益。其III期数据更亮眼：150天对需医学干预的RSV-LRTI保护效力85.32%，对RSV相关住院的保护效力83.27%。它靶向F蛋白II号表位，通过Fc段改造延长半衰期。两款产品同日获批，背后是国家药监局对儿童专用创新药开辟的优先审评通道——RSV预防药物被WHO列为全球最优先开发产品之一，监管资源在向这一赛道倾斜。加上更早的赛诺菲/阿斯利康尼塞韦单抗（2024.1在华获批，商品名"乐唯初"）和默沙东克莱罗韦单抗（国内NDA已受理），国内RSV单抗已经从"外资独占"快速演变为"四强逐鹿"格局。 02 全球RSV产品全景：疫苗三足鼎立，单抗四强并立 1. 疫苗端：三款全球产品，全部是国外原研销售业绩说明商业化速度：2024年Arexvy 7.88亿美元、Abrysvo 7.55亿美元、尼塞韦单抗19.60亿美元——三大RSV产品已站稳重磅炸弹（blockbuster）阵营。可以看出：单抗的赛道在快速从"外资垄断"过渡到"国产替代+创新"——四款主流产品中已有三款在国内上市，国产化进度走在疫苗前面。全球RSV防治正在形成"三大技术路径并行"的格局：单克隆抗体（被动免疫）+ 疫苗（主动免疫）+ 小分子抗病毒药物（治疗）。而其中，婴幼儿RSV疫苗至今仍是全球空白——这是本文的核心命题。 03 为什么疫苗比单抗慢这背后是横亘在RSV疫苗研发面前的科学鸿沟。 1. 1960年代的"原罪"：FI-RSV疫苗阴影 1957年，Robert Chanock首次从严重下呼吸道感染患儿体内分离出RSV。此后近60年，RSV疫苗研发是疫苗史上最漫长的长征之一。 1960年代，研究者用福尔马林灭活的RSV病毒（FI-RSV）加铝佐剂，制备了第一代RSV疫苗。初期安全性良好，但当这些儿童在第一个RSV流行季再次遭遇自然感染时，灾难发生了：接种过FI-RSV疫苗的儿童，再次感染RSV后，80%需要住院治疗，2名儿童死亡。这一事件直接冻结了全球RSV疫苗研发数十年。它引发的是"抗体依赖性增强疾病（ERD, Enhanced Respiratory Disease）"——接种不仅没保护，反而放大了疾病的严重程度。直到2009年，阿根廷科学家Fernando Polack团队在Nature Medicine揭示了机制：福尔马林灭活过程使F蛋白几乎全部转变为"post-fusion"构象，诱导出的抗体虽然数量众多，却无法有效中和真正的病毒颗粒。当儿童再次遭遇自然感染，这些"非中和性抗体"与病毒抗原形成免疫复合物，沉积在肺部组织，引发补体激活和Th2型炎症风暴——最终造成比未接种者更严重的下呼吸道损伤。这一阴影，至今笼罩着所有RSV疫苗的临床试验设计。图注：RSV F蛋白的融合前（pre-F，左）与融合后（post-F，右）构象对比。金色冠顶为关键中和表位Site Ø，仅在融合前构象短暂存在（示意，非真实结构） 2. F蛋白的"两副面孔"：疫苗设计的核心难题 RSV表面有三种跨膜蛋白，其中F蛋白（融合蛋白）是疫苗的首选靶点。它存在两种构象： pre-fusion（融合前）构象：病毒尚未感染细胞时的"待机"形态，暴露出最强的中和抗体表位——尤其是Site Ø，只存在于pre-F。 post-fusion（融合后）构象：病毒与细胞膜融合后的"折叠"形态，Site Ø消失。问题在于：Site Ø是RSV疫苗诱导保护性免疫的关键靶点，但它仅在pre-fusion构象短暂存在。F蛋白与细胞融合后会不可逆地转变为post-fusion构象。这意味着：1960年代的FI-RSV疫苗诱导出的是post-F抗体 → 无中和活性，且可能引发ERD；重组post-F蛋白疫苗同样只能诱导post-F抗体。真正的解决方案：必须用结构生物学手段，将F蛋白锁定在pre-fusion构象。这一突破来自美国NIH疫苗研究中心（VRC）的Barney Graham和Jason McLellan团队。他们用冷冻电镜和X射线晶体学技术解析了pre-F结构，筛选超过13000个鼠源抗体，找到了比当时标准疗法（palivizumab）效力高约50倍的中和抗体（D25），从而锁定pre-F的关键中和表位。随后研究者用"分子钉"技术（DS-Cav1等设计）将F蛋白锁定在pre-fusion构象。结果显示，稳定化的pre-F蛋白在恒河猴中诱导的中和抗体滴度是post-F的70-80倍。没有2010年代的结构生物学突破，就不会有今天的RSV疫苗三巨头。 3. 婴幼儿直接接种的三道关卡为什么婴幼儿直接接种就这么难？背后有三道独立的科学关卡：第一道，免疫系统不成熟。新生儿和婴幼儿的抗原呈递细胞（DC）和生发中心反应较弱，难以产生高滴度、高亲和力的抗体。第二道，母体抗体的干扰。 6个月以内的婴儿体内还残留来自母亲的抗RSV抗体。母体抗体可能掩盖疫苗抗原表位，抑制婴儿自身B细胞的激活——学界称"母体抗体干扰"或"原始抗原罪"。第三道，减毒活疫苗（LAIV）的"治疗窗"困境。 LAIV理论上最适合婴幼儿（模拟自然感染、激活黏膜免疫），但"太弱"则免疫原性不足，"太强"则可能让婴儿直接发病。婴幼儿个体免疫状态又差异巨大，找到适合所有婴儿的"治疗窗"几乎不可能。目前唯一可行的婴幼儿免疫路径有三条：①母体免疫（孕32-36周接种疫苗，抗体通过胎盘传给婴儿约6个月）——辉瑞Abrysvo已批准这条路；②被动免疫（直接注射长效单抗）——尼塞韦单抗、国产两款单抗走的都是这条路；③大龄儿童（>6月龄）直接接种——赛诺菲的SP0125鼻喷减毒活疫苗正在国内推进III期临床，是全球首个针对6-24月龄婴幼儿的RSV减毒活疫苗III期项目。另外两道独立关卡：对老年人，RSV疫苗面对的是免疫衰老（immunosenescence）——树突状细胞减少、T细胞共刺激信号减弱、记忆B细胞库"磨损"，这也是为什么GSK Arexvy要加入AS01佐剂强行撬开。对孕妇，安全性近乎苛刻——Abrysvo在孕妇中的III期临床曾因早产率问题受FDA密切关注，最终批准时附加了严格的风险沟通材料。结论：单抗快、疫苗慢，不是研发投入的问题，而是——科学层面要解决"构象+免疫+安全"三重难题；技术层面要面对减毒活疫苗治疗窗、母体免疫干扰、免疫衰老三道独立关卡；监管层面因1960年代FI-RSV阴影对婴幼儿RSV疫苗安全性近乎苛刻。全球婴幼儿RSV疫苗至今仍是空白，不是企业不努力，是科学本身的限制。 04 国内研发管线全景当前RSV赛道呈现"单抗领跑、疫苗追赶、小分子突围"的格局。 1. 单抗：国内从"零"到"四强并立" 除9月3日获批的泰诺麦博"新多妥"、瑞阳生物"英沐乐"外，智翔金泰GR2102、爱科百发AK0610 也在临床推进中。国内单抗管线已基本实现国产替代。 2. 疫苗：管线拥挤，进度分化几个关键判断：第一，技术路线分布最广。重组蛋白（迈科康、艾棣维欣、万泰、远大、智飞引进）+ mRNA（智飞/蓝鹊、深信、纳美信）+ 病毒载体（康希诺）——覆盖全球RSV疫苗研发的全部主流路径。第二，进度差距巨大。头部项目（迈科康III期、艾棣维欣II期、纳美信II期）和跟随项目（万泰、远大刚获批临床）相差至少3-5年。最快预计2028-2030年才能获批上市。第三，GSK Arexvy于2026年2月已向NMPA提交上市申请——这是国内首款进入NDA阶段的RSV疫苗。如果顺利获批，将率先填补国内60岁以上成人RSV疫苗的空白，但仍不覆盖婴幼儿。第四，mRNA路径——纳美信生物NR222。这家2021年成立于上海、专注"AI驱动+冻干工艺"的mRNA公司，2024年12月获CDE IND批件，2025年5月进入I期，2026年5月29日在广西桂林正式启动II期临床（针对60周岁及以上人群），6月完成全部375例受试者入组，是国内进度最快的mRNA RSV疫苗。 NR222的三个差异化看点：（1）冻干剂型——预期可在2-8℃稳定存储≥36个月，解决了mRNA疫苗"超低温冷链"的卡脖子问题，直接打开基层和县域市场的可及性；（2）AI辅助pre-F抗原优化——头对头非临床研究显示优于已上市重组蛋白疫苗；（3）国内首个获批临床的冻干剂型RSV mRNA疫苗，也是国内首个进入II期的mRNA RSV疫苗。对康华生物而言，纳美信是2026年4月通过分三期收购（首期1.2亿元持股27.27%，叠加表决权委托合计43.47%）整合的mRNA技术平台，定位为"上海研发中心+创新管线孵化"。一支RSV mRNA疫苗管线，对应着康华从"狂犬单品种依赖"向"多管线mRNA平台"的战略转身——也是国产RSV疫苗研发中，唯一具备"传统疫苗龙头+创新mRNA平台"双重基因的玩家。 3. 小分子：爱科百发齐瑞索韦最快爱科百发的齐瑞索韦（AK0529，从罗氏引进）是全球进度最快的RSV小分子候选药，2026年8月已向NMPA提交NDA，预计2026年获批，将成为全球首个RSV特效治疗药。但小分子路径有三大挑战：病毒依赖人体细胞复制难以找到高选择性靶点；儿科药物开发要求显著高于成人；RSV预防性单抗获批后，治疗药物市场空间会被预防市场压缩。 05 百亿级蓝海：RSV市场的三个真相 1. 流行病学真相：被严重低估的疾病 5岁以下儿童：2019年全球3300万RSV-LRTI病例，360万住院，10万死亡。中国5岁以下RSV相关住院率7-11/1000，每年62万-95万住院病例。两岁以下儿童感染率高达90%。 65岁以上老年人：2024年全球感染人数4650万，中国1220万。60岁以上RSV感染致死率5.8%，高于流感病毒。传播力惊人：RSV的R0值约4.5（与新冠Delta株R0≈5.08接近），远高于流感病毒（R0≈1.7），意味着传播能力是流感的2.5倍以上。 WHO已将RSV预防产品列为全球最优先开发产品之一。超过95%的RSV相关死亡发生在中低收入国家。 2. 市场空间真相全球RSV预防药物市场（不含疫苗）：2024年约27亿美元，预计2035年达53亿美元。全球RSV治疗药物市场：2024年仅3000万美元（缺乏特效疗法），预计2035年达86亿美元（CAGR 67.1%）。中国RSV疫苗市场：2024年潜在规模135-225亿元，2030年（考虑老龄化）160-267亿元（按中国流感疫苗3%-5%渗透率中性假设）。参考美国市场——2023-2024年首个流感季，60岁以上人群接种率11%，人均接种费用约360美元，两款疫苗首年合计销售超24亿美元——中国RSV疫苗的天花板远不止267亿元。按中国60岁以上人群接种率达11%测算，老年人接种人群约1190万，叠加新生儿单抗市场（约100亿元），总市场规模可超400亿元。 3. 渗透率真相美国RSV疫苗首年表现：2023-2024年首个流感季，60岁以上人群接种率11%，68%选择GSK Arexvy，两款疫苗首年合计销售超24亿美元——速度超过了带状疱疹疫苗（Shingrix）上市初期。RSV疫苗的"老年人接受度"已经被验证——剩下的，是婴幼儿适应症的科学突破。 06 未来竞争格局：四个范式转移范式1：从"被动免疫独大"到"主被动协同" 未来格局将是单抗+疫苗+小分子互补：6月龄以内——孕妇接种RSV疫苗（母传抗体）+ 长效单抗覆盖6个月；6-24月龄——鼻喷减毒活疫苗（赛诺菲SP0125国内III期进行中）；60岁以上——GSK/辉瑞/Moderna三巨头竞速，国产疫苗2028-2030年陆续加入。单抗和疫苗不是替代关系，而是互补关系——这是WHO推荐的RSV防控最佳实践。范式2：从"单品竞争"到"全家桶竞争" 未来RSV市场的赢家不会是单品爆款，而是覆盖婴幼儿/儿童/孕妇/老年人的全生命周期产品组合。谁能在婴幼儿疫苗、单抗、老年人疫苗、小分子治疗药等多个维度都有布局，谁就能占据生态位优势。范式3：从"高价外资"到"国产替代+可及性提升" 当前痛点：尼塞韦单抗在中国5kg以上婴幼儿单针超3000元。国产单抗获批后——定价将显著下探（参考其他生物制剂国产化后60-70%降价幅度）；倒逼进口产品降价或进入医保谈判；北京、上海、内蒙古等试点城市将进一步扩大；最终目标是进入免疫规划（参考乙肝、脊灰等疫苗路径）。范式4：从"0到1"到"1到N"——国产疫苗的窗口期国内RSV疫苗最快2028-2030年才有首批产品获批。GSK Arexvy（2026年NDA）可能率先在国内上市，抢得先发优势。但国产疫苗的机会在于"婴幼儿适应症"：外资三巨头的婴幼儿适应症至今未获批，全球婴幼儿RSV疫苗仍是空白——谁先在中国婴幼儿RSV疫苗上取得突破，谁就有望拿下这块全球稀缺的空白市场。 07 RSV疫苗还远吗？远，但不是那么远。远，是因为婴幼儿RSV疫苗面对的是结构生物学、免疫学、病毒学、监管科学四道关卡，每一道都是硬骨头。不那么远，是因为：结构生物学（pre-F锁定）已被GSK/辉瑞/Moderna突破；国内管线最快（迈科康III期、艾棣维欣II期、纳美信NR222冻干mRNA II期）距获批仅3-5年；母体免疫路径（辉瑞Abrysvo孕妇适应症）已被FDA批准，可借鉴；鼻喷减毒活疫苗（赛诺菲SP0125国内III期进行中）开辟大龄儿童路径；长效单抗已覆盖6月龄以下婴幼儿，暂时填补了疫苗空白。单抗解决当下——婴幼儿RSV预防"无药可用"的燃眉之急；疫苗解决未来——覆盖全生命周期的RSV主动免疫防线。 9月3日的两款国产单抗同日获批，是中国RSV免疫时代的起点。从被动免疫到主动免疫，从婴幼儿到老年人，从国产替代到全球创新——RSV赛道还有10年的故事要讲，是继HPV、流感、带状疱疹之后，又一个值得医药人长期追踪的中国疫苗大单品赛道。数据及文献国家药品监督管理局公开公告（2026.9.3）泰诺麦博、先声药业/瑞阳生物公告及港交所披露文件灼识咨询、弗若斯特沙利文、中航证券等行业研究报告 The Lancet、Lancet Infectious Diseases、Nature Medicine等学术文献 WHO、CDC、NACI等公共卫生机构指南药智网、Insight数据库等公开管线信息康华生物（300841）2026年4月《关于对外投资暨关联交易的公告》及5月《关于纳美信RSV疫苗启动II期临床的自愿性信息披露公告》

2026-08-28

·动脉网

艾科生物的RSV抗病毒药物Ziresovir获得FDA二期临床试验批准

上海阿科生物制药有限公司宣布，美国食品药品监督管理局（FDA）已批准泽瑞索韦（AK0529）开展针对重症呼吸道合胞病毒（RSV）感染婴儿（包括儿科重症监护室患者）的II期临床试验。RSV是全球婴儿下呼吸道感染的首要病因，每年导致数百万人住院和超过10万人死亡。重症患儿往往需要重症监护，然而目前全球范围内尚无获批的特异性抗病毒疗法，存在巨大的未满足临床需求。泽瑞索韦是首款完成III期临床试验并取得阳性结果的直接抗RSV病毒药物。在中国1至24个月龄患者中开展的研究显示，泽瑞索韦能显著降低病毒载量，加速呼吸道症状缓解，并在24个月的随访期内降低复发性喘息和哮喘的风险，且安全性良好。（摘要由动脉网AI生成）

2026-08-19

·PRNewswire

ArkBio Announces China IND Approval for its Antiviral Drug-Fc Conjugate (AFC) Candidate AK0406 for Influenza Prophylaxis

SHANGHAI, Aug. 12, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the Investigational New Drug (IND) application for AK0406 injection, the company's first long-acting antiviral drug‑Fc conjugate (AFC) candidate for influenza prophylaxis, has been approved by the National Medical Products Administration (NMPA) of China, making AK0406 the first influenza AFC drug to enter clinical development in China. AK0406 is a new generation, long-acting antiviral agent discovered and developed by ArkBio. By precisely conjugating a highly potent antiviral small molecule with an antibody Fc fragment, AK0406 is designed to provide sustained pre‑ and post‑exposure prophylaxis and potential therapeutic benefits, addressing the high unmet needs for influenza prevention during peak seasons. Preclinical data show that AK0406 exerts broad-spectrum, high-potency activity against both influenza A and B viruses, maintains immune effector function, and provides prolonged exposure. Compared with other AFC molecules, AK0406 is engineered to offer an optimized profile for both prophylaxis and treatment of influenza infection. On the global clinical development front, ArkBio received approval from the Australian Human Research Ethics Committee (HREC) in February 2026 to initiate a phase I clinical trial of AK0406. Enrollment and dosing of healthy adult volunteers in all cohorts have been completed in Australia, and the trial has now entered the follow-up phase. Influenza remains a critical global public health challenge. Current flu preventive measures centered on seasonal vaccines face significant limitations, including the inability to effectively address antigenic drift, uncertainty in annual strain prediction and matching, and substantially reduced protective efficacy among elderly and immunocompromised populations, leaving significant unmet clinical needs. ArkBio will maintain close interactions with the CDE to advance the clinical development of AK0406 in China, while continuing the follow-up work of the ongoing phase I study in Australia. By pursuing a parallel, dual‑track development pathway in China and globally, the company aims to accelerate the clinical program to deliver a safer, more effective, and convenient solution for influenza prevention worldwide. About ArkBio ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations. Key pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive pivotal phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase 2 results in idiopathic pulmonary fibrosis, is currently in phase 3 registrational trials; AK0901, approved and commercialized in China for ADHD treatment. The company also has multiple first-in-class or best-in-class innovative candidates in clinical or preclinical development. ArkBio has established strategic partnerships with multinational pharmaceutical companies including Roche and Genentech, leading academic institutions including The Scripps Research Institute and the Institute of Microbiology of the Chinese Academy of Sciences, Qilu Pharmaceutical, as well as other domestic and international biotech companies and CROs. For more information, please visit: Investor Inquiries: [email protected] SOURCE Shanghai Ark Biopharmaceutical Co., Ltd. 21% more press release views with Request a Demo

临床3期临床1期临床申请临床结果临床2期

100 项与齐瑞索韦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	齐瑞索韦	-	DB15145

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
呼吸道合胞体病毒感染	申请上市	中国	上海爱科百发生物医药技术股份有限公司	2022-12-08
呼吸道合胞病毒肺炎	临床申请批准	美国	上海爱科百发生物医药技术股份有限公司	2026-08-14

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04231968 (Pubmed \| NEWS) 人工标引	临床3期	呼吸道合胞体病毒感染	188	ziresovir	顧襯蓋鑰餘廠築醖積艱(糧顧鬱窪鹽廠網憲餘膚) = 顧窪範壓淵遞衊鑰窪鑰壓繭餘積獵壓餘夢糧艱 (齋艱簾鑰鏇壓壓顧鑰壓, -3.9 ~ -3.1) 更多	积极	2025-05-01
				Placebo	顧襯蓋鑰餘廠築醖積艱(糧顧鬱窪鹽廠網憲餘膚) = 壓願膚餘繭醖鑰齋選遞壓繭餘積獵壓餘夢糧艱 (齋艱簾鑰鏇壓壓顧鑰壓, -2.8 ~ -1.7) 更多
NCT04231968 (AIRFLO, Pubmed \| N Engl J Med)	临床3期	呼吸道合胞体病毒感染	244	Ziresovir	膚構獵繭齋齋網窪憲廠(範衊蓋膚襯夢艱鏇糧糧) = Resistance-associated mutations were identified in 15 participants (9%) in the ziresovir group 廠網餘壓範顧簾襯獵繭 (獵餘衊構遞蓋獵範膚夢 ) 更多	积极	2024-09-26
				Placebo
NCT04231968 (AIRFLO, Literature) 人工标引	临床3期	呼吸道合胞体病毒感染	302	Ziresovir	網齋製膚獵壓顧膚鏇衊(選顧壓夢夢憲顧顧艱蓋) = 憲憲衊餘鑰衊鏇夢鬱獵選鑰蓋衊範醖鏇夢餘蓋 (鹹淵糧廠願簾選憲鑰醖, −3.7 ~ −3.1) 更多	积极	2024-09-25
				Placebo	網齋製膚獵壓顧膚鏇衊(選顧壓夢夢憲顧顧艱蓋) = 鏇淵廠醖鬱選鬱鹽鏇窪選鑰蓋衊範醖鏇夢餘蓋 (鹹淵糧廠願簾選憲鑰醖, −3.1 ~ −2.2) 更多