Zelicapavir

Continuing Phase 3 Enabling Activities, Including Discussions with U.S. Food & Drug Administration (FDA) Following Positive Phase 2b RSVHR Results for Zelicapavir, an N-Protein Inhibitor in Development to Treat Respiratory Syncytial Virus (RSV) Expanding Immunology Pipeline with New Discovery Program Focused on MRGPRX2 Inhibition Addressing High Unmet Need in Chronic Spontaneous Urticaria (CSU); On Track to Select a Development Candidate in 2H 2026 Advancing EDP-978, an Oral, Once-Daily KIT Inhibitor Clinical Candidate; On Track to File an Investigational New Drug Application (IND) in 1Q 2026 and Report Phase 1 Data in 4Q 2026 Progressing EPS-3903, an Oral, Once-Daily STAT6 Inhibitor Development Candidate; On Track to File an IND in 2H 2026 Strong Financial Position Supported by Continuing Retained Royalties with Cash Runway Expected to Fund Operations into Fiscal 2029 Company to Present 2026 Outlook at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14 at 3:00 PM PT WATERTOWN, Mass.--(BUSINESS WIRE)--Jan. 8, 2026-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases today announced updates on its research and development programs and highlighted upcoming key milestones for 2026. “Building on the progress we achieved in our RSV and immunology portfolios this past year, we enter 2026 with strong momentum as we continue to expand our pipeline and deliver on key milestones,” said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “We are eager to advance our RSV portfolio with the progression of both zelicapavir and EDP-323. We look forward to continuing our discussions with the FDA to align on an adult Phase 3 study design and solidify next steps for zelicapavir’s registration path. With positive data from both zelicapavir and EDP-323 in hand, we continue to have the leading portfolio of RSV therapeutics, offering broad optionality and the potential for first- and best-in-disease treatments.” Dr. Luly continues, “Today, we are pleased to announce our third immunology program, focused on developing oral MRGPRX2 inhibitors for type 2 immune driven diseases, with an initial focus on CSU and other mast cell driven diseases, with other future expansion opportunities. MRGPRX2 signaling is a critical driver of inflammation, and inhibitors have the potential for strong efficacy with best-in-disease safety. This program represents a meaningful addition to our growing immunology portfolio, and we look forward to nominating a development candidate in the second half of 2026. In parallel, we are advancing EDP-978, our oral, once-daily KIT inhibitor clinical candidate with the goal of filing an IND in the first quarter and reporting Phase 1 data in the fourth quarter of this year. We are also progressing EPS-3903, our oral, once-daily STAT6 development candidate with plans to file an IND in the second half of 2026 and advance into the clinic shortly thereafter. With programs in KIT, STAT6 and MRGPRX2 inhibition, we are leveraging our proven expertise in small molecule drug discovery and development to build a leading immunology portfolio focused on type 2 immune driven diseases where there is a clear unmet need for convenient, safe and efficacious oral treatments. Finally, our strong cash position, with runway into fiscal 2029, provides us the resources to continue to build value by delivering highly differentiated therapeutics through innovative small molecule drug discovery.” Pipeline Updates Virology Enanta’s virology pipeline includes the leading portfolio in development for RSV treatment, consisting of zelicapavir and EDP-323, both of which received Fast Track designation from the FDA. Enanta most recently evaluated zelicapavir, an oral, once-daily RSV N-protein inhibitor, in RSVHR, a Phase 2b study in a high-risk adult outpatient population, including the elderly and/or those with asthma, chronic obstructive pulmonary disease, or congestive heart failure. In September 2025, the Company announced positive data from the study. A clinically meaningful improvement in time to complete resolution of all 13 RSV symptoms was observed for zelicapavir compared to placebo, with a benefit of 6.7 days for patients with congestive heart failure, chronic obstructive pulmonary disease or age 75 or older, termed the HR3 population. Zelicapavir also showed an improvement in time to complete resolution on the 29-parameter total RiiQ™ symptom scale of 7.2 days for the HR3 population compared to placebo. The study met key secondary endpoints, including a reduction in hospitalization and antiviral effects. Zelicapavir has been dosed in more than 700 people to date and continues to be well-tolerated with a favorable safety profile. Enanta is continuing Phase 3 enabling activities, including aligning with the FDA on an adult Phase 3 trial design and overall registration path. In parallel, the Company is exploring potential business development opportunities related to its RSV program. Enanta’s second RSV candidate, EDP-323, is an oral, once-daily RSV L-protein inhibitor, which can be used alone or in combination with other agents, such as zelicapavir, to potentially broaden the treatment window or addressable patient populations. In October, the Company presented data on a post-exposure prophylaxis analysis performed in subjects who were not infected by Day 5 after RSV exposure in the EDP-323 human challenge study. The data showed the potential for EDP-323 to be effective in preventing RSV infection when initiated up to five days after RSV exposure, building on the previously reported EDP-323 challenge study treatment data. Enanta most recently evaluated zelicapavir, an oral, once-daily RSV N-protein inhibitor, in RSVHR, a Phase 2b study in a high-risk adult outpatient population, including the elderly and/or those with asthma, chronic obstructive pulmonary disease, or congestive heart failure. In September 2025, the Company announced positive data from the study. A clinically meaningful improvement in time to complete resolution of all 13 RSV symptoms was observed for zelicapavir compared to placebo, with a benefit of 6.7 days for patients with congestive heart failure, chronic obstructive pulmonary disease or age 75 or older, termed the HR3 population. Zelicapavir also showed an improvement in time to complete resolution on the 29-parameter total RiiQ™ symptom scale of 7.2 days for the HR3 population compared to placebo. The study met key secondary endpoints, including a reduction in hospitalization and antiviral effects. Zelicapavir has been dosed in more than 700 people to date and continues to be well-tolerated with a favorable safety profile. Enanta is continuing Phase 3 enabling activities, including aligning with the FDA on an adult Phase 3 trial design and overall registration path. In parallel, the Company is exploring potential business development opportunities related to its RSV program. Enanta’s second RSV candidate, EDP-323, is an oral, once-daily RSV L-protein inhibitor, which can be used alone or in combination with other agents, such as zelicapavir, to potentially broaden the treatment window or addressable patient populations. In October, the Company presented data on a post-exposure prophylaxis analysis performed in subjects who were not infected by Day 5 after RSV exposure in the EDP-323 human challenge study. The data showed the potential for EDP-323 to be effective in preventing RSV infection when initiated up to five days after RSV exposure, building on the previously reported EDP-323 challenge study treatment data. Enanta is continuing Phase 3 enabling activities, including aligning with the FDA on an adult Phase 3 trial design and overall registration path. In parallel, the Company is exploring potential business development opportunities related to its RSV program. Immunology Enanta’s immunology pipeline is focused on designing and developing highly potent and selective oral inhibitors for the treatment of inflammatory diseases, by targeting key drivers of the type 2 immune response. Enanta today announced its third immunology program targeting MRGPRX2, a non-canonical G-Protein-Coupled-Receptor (GPCR) expressed predominantly on mast cells. Inhibiting MRGPRX2 may have potential to address multiple chronic inflammatory diseases including urticaria, asthma, prurigo nodularis and others. Currently, Enanta is advancing novel, potent and selective oral inhibitors of MRGPRX2. The Company’s prototype MRGPRX2 inhibitors exhibit potent inhibition in vitro and in vivo. Specifically, they demonstrate MRGPRX2 inhibition with nanomolar potency (EC50 of 1-2nM) in cellular assays and prevent skin mast cell activation in humanized MRGPRX2 mouse models. Further, the Company’s MRGPRX2 prototype inhibitors show potent activity across multiple MRGPRX2 agonists. These prototypes are highly selective for MRGPRX2 versus other GPCRs. Finally, these prototypes show favorable in vitro and in vivo ADME properties supporting once daily dosing. Enanta continues to evaluate multiple compounds in preclinical studies and expects to select a development candidate in the second half of 2026. Enanta recently selected EDP-978, a novel, potent and selective oral KIT inhibitor, as its clinical candidate for the treatment of chronic spontaneous urticaria and potentially other mast cell driven diseases. EDP-978 demonstrates nanomolar potency in both binding and cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also exhibits favorable in vitro and in vivo ADME properties preclinically. The Company is on track to submit an IND in the first quarter, with topline Phase 1 data expected in the fourth quarter of 2026. In November, Enanta nominated EPS-3903, a novel, potent and selective oral STAT6 inhibitor, as its lead development candidate for the treatment of atopic dermatitis and other diseases currently treated by dupilumab. Preclinical data show EPS-3903 exhibits nanomolar activity in binding and cellular assays and high selectivity for STAT6. Importantly, EPS-3903 shows rapid, continuous and complete (>90%) inhibition of phosphorylated STAT6 (pSTAT6) after oral dosing in mice. Further, EPS-3903 demonstrates efficacy comparable to dupilumab in multiple disease models. Specifically, in a house dust mite asthma model, treatment with EPS-3903 results in complete (>90%) inhibition of lung pSTAT6 and decreased inflammation comparable to dupilumab, including clinically relevant biomarkers of eosinophils and TARC in the lung and serum IgE. Additionally, in an MC903 atopic dermatitis mouse model, EPS-3903 demonstrates efficacy comparable to dupilumab, with complete (>90%) inhibition of pSTAT6 in the skin and spleen, as well as a robust decrease in serum IgE. EPS-3903 has favorable in vitro and in vivo ADME properties with once-daily dosing potential. The Company is currently performing scale-up and IND enabling activities and targeting an IND filing in the second half of 2026. Enanta today announced its third immunology program targeting MRGPRX2, a non-canonical G-Protein-Coupled-Receptor (GPCR) expressed predominantly on mast cells. Inhibiting MRGPRX2 may have potential to address multiple chronic inflammatory diseases including urticaria, asthma, prurigo nodularis and others. Currently, Enanta is advancing novel, potent and selective oral inhibitors of MRGPRX2. The Company’s prototype MRGPRX2 inhibitors exhibit potent inhibition in vitro and in vivo. Specifically, they demonstrate MRGPRX2 inhibition with nanomolar potency (EC50 of 1-2nM) in cellular assays and prevent skin mast cell activation in humanized MRGPRX2 mouse models. Further, the Company’s MRGPRX2 prototype inhibitors show potent activity across multiple MRGPRX2 agonists. These prototypes are highly selective for MRGPRX2 versus other GPCRs. Finally, these prototypes show favorable in vitro and in vivo ADME properties supporting once daily dosing. Enanta continues to evaluate multiple compounds in preclinical studies and expects to select a development candidate in the second half of 2026. Enanta recently selected EDP-978, a novel, potent and selective oral KIT inhibitor, as its clinical candidate for the treatment of chronic spontaneous urticaria and potentially other mast cell driven diseases. EDP-978 demonstrates nanomolar potency in both binding and cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also exhibits favorable in vitro and in vivo ADME properties preclinically. The Company is on track to submit an IND in the first quarter, with topline Phase 1 data expected in the fourth quarter of 2026. In November, Enanta nominated EPS-3903, a novel, potent and selective oral STAT6 inhibitor, as its lead development candidate for the treatment of atopic dermatitis and other diseases currently treated by dupilumab. Preclinical data show EPS-3903 exhibits nanomolar activity in binding and cellular assays and high selectivity for STAT6. Importantly, EPS-3903 shows rapid, continuous and complete (>90%) inhibition of phosphorylated STAT6 (pSTAT6) after oral dosing in mice. Further, EPS-3903 demonstrates efficacy comparable to dupilumab in multiple disease models. Specifically, in a house dust mite asthma model, treatment with EPS-3903 results in complete (>90%) inhibition of lung pSTAT6 and decreased inflammation comparable to dupilumab, including clinically relevant biomarkers of eosinophils and TARC in the lung and serum IgE. Additionally, in an MC903 atopic dermatitis mouse model, EPS-3903 demonstrates efficacy comparable to dupilumab, with complete (>90%) inhibition of pSTAT6 in the skin and spleen, as well as a robust decrease in serum IgE. EPS-3903 has favorable in vitro and in vivo ADME properties with once-daily dosing potential. The Company is currently performing scale-up and IND enabling activities and targeting an IND filing in the second half of 2026. Corporate In August 2025, Enanta filed a patent infringement action in the Unified Patent Court (UPC) of the European Union against Pfizer Inc. and certain of its subsidiaries. The suit seeks a determination of liability for infringement of European Patent No. EP 4 051 265 (the “’265 Patent”) in connection with Pfizer’s manufacture, use, and sale of Paxlovid™ (nirmatrelvir tablets; ritonavir tablets) in the 18 EU member states participating in the UPC. Under UPC procedures, a hearing on the infringement action is expected to occur within the UPC’s published 12-month target, with a decision rendered within weeks thereafter. Enanta expects to provide an update on the UPC litigation in the second half of 2026. The Company expects the following milestones across its pipeline in 2026: Virology Respiratory Syncytial Virus Align with FDA on adult Phase 3 design and registration path in 2Q 2026 Prepare for a Phase 3 study of zelicapavir in high-risk adults in 2H 2026 Explore business development opportunities for RSV assets Respiratory Syncytial Virus Align with FDA on adult Phase 3 design and registration path in 2Q 2026 Prepare for a Phase 3 study of zelicapavir in high-risk adults in 2H 2026 Explore business development opportunities for RSV assets Align with FDA on adult Phase 3 design and registration path in 2Q 2026 Prepare for a Phase 3 study of zelicapavir in high-risk adults in 2H 2026 Explore business development opportunities for RSV assets Immunology KIT Program File IND for EDP-978 in 1Q 2026 Report Phase 1 data for EDP-978 in 4Q 2026 STAT6 Program File an IND for EPS-3903 in 2H 2026 MRGPRX2 Program Nominate development candidate in 2H 2026 KIT Program File IND for EDP-978 in 1Q 2026 Report Phase 1 data for EDP-978 in 4Q 2026 STAT6 Program File an IND for EPS-3903 in 2H 2026 MRGPRX2 Program Nominate development candidate in 2H 2026 File IND for EDP-978 in 1Q 2026 Report Phase 1 data for EDP-978 in 4Q 2026 File an IND for EPS-3903 in 2H 2026 Nominate development candidate in 2H 2026 Webcast Information Enanta will provide further details on these updates at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 3:00 p.m. PT. A live webcast of the presentation will be accessible by visiting the “Events and Presentations” section on the “Investors” page of Enanta’s website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT, STAT6 and MRGPRX2 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information. Forward Looking Statements This press release contains forward-looking statements, including statements with respect to the timeline and prospects for advancement of Enanta’s clinical programs in RSV and its preclinical immunology programs, including its programs targeting KIT, STAT6 and MRGPRX2 inhibition. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to vaccines and competitive treatments for RSV; the discovery and development risks of Enanta’s programs in virology and immunology; Enanta’s limited clinical development experience; Enanta’s ability to partner its RSV or other programs; Enanta’s need to attract and retain senior management and key research and development personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year-ended September 30, 2025, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260108666055/en/ Media and Investors Contact: Jennifer Viera 617-744-3848 jviera@enanta.com Source: Enanta Pharmaceuticals, Inc.

点击蓝字 关注我们 引用本文：国家呼吸医学中心, 中华医学会呼吸病学分会, 中华医学会儿科学分会呼吸学组, 等. 呼吸道合胞病毒感染防治医防协同专家共识[J]. 中华医学杂志,2026, 106: 网络预发表. DOI: 10.3760/cma.j.cn112137-20251107-02908. 通信作者：杨子峰，广州医科大学附属第一医院广州呼吸健康研究院，广州510120，Email：jeffyah@163.com；刘恩梅，重庆医科大学，重庆 400016，Email：emliu186@126.com；钟南山，广州医科大学附属第一医院呼吸内科，广州 510120，Email：nanshan@vip.163.com *本文内容已经过同行评议，作为优先出版方式在线发表，可作为有效引用数据。由于优先发表的内容尚未完成规范的编校流程，《中华医学杂志》不保证其数据与印刷版内容的一致性。 摘要 呼吸道合胞病毒（RSV）是引起人下呼吸道感染最常见的病毒性病原体，在婴幼儿和老年人群体中造成的疾病负担尤为沉重，是一个重要的全球公共卫生问题。我国RSV感染防控亟需建立“预防-诊疗-管理”一体化的医防协同体系，实现“以治病为中心”向“以健康为中心”的防控模式转变。为更好地指导和规范我国RSV防治措施，特联合多学科专家成立工作组，整合现有循证医学证据并结合国内外实践经验，制订了《呼吸道合胞病毒感染防治医防协同专家共识》。本共识立足于中国RSV感染防控的战略需求，以创新性的医防协同机制和决策推荐，为各级医疗机构、疾病预防控制机构和基层相关专业人员提供参考，以期全面提升我国RSV感染的防治水平。 关键词：呼吸道合胞病毒；医防协同；预防；治疗；专家共识 呼吸道合胞病毒（RSV）是引起急性呼吸道感染（ARTI）的主要病原体之一，各年龄段的人群都普遍易感，但在婴幼儿、特殊健康状态儿童和老年人群中，病情往往更为严重。全球疾病负担研究显示，RSV是5岁以下儿童急性下呼吸道感染（ALRTI）的首要病毒病原体，其中1岁以下婴儿的发病率和死亡率尤为突出 ［ 1 , 2 ］ 。中国近年来流行病学相关研究结果显示，RSV感染呈现年龄分布差异，5岁以下儿童是主要易感人群，而老年人群发生重症和出现并发症的比率则更高 ［ 3 , 4 ］ 。RSV感染给家庭和社会造成了沉重的负担，已成为全球公共卫生领域的重大挑战。 近年来，随着RSV免疫相关基础研究的突破性进展和研发技术的提高，新型预防性生物制剂如长效单克隆抗体、RSV重组蛋白疫苗和mRNA疫苗相继问世，推动了全球RSV防控策略从被动治疗向主动预防的转变。通过提升RSV监测与预警的能力、完善重点人群防护策略、加强公众健康知识教育，以及加速创新防治技术的发展，将有望降低RSV感染率及相关疾病负担。我国实施健康优先的发展战略，RSV感染作为威胁公共健康的一种传染病，推动医防协同和社会共治的发展已成为RSV防控策略的重要组成部分。基于此，为进一步创新我国RSV防控的医防协同机制，推进医疗机构和公共卫生机构深度协作，由我国多学科领域权威专家共同制定本共识，以期规范我国RSV感染的防控策略，全面提升RSV整体防治水平。 一、共识制订方法学 1.共识注册与计划书：本共识已在国际实践指南注册平台（ http：//www.guidelines-registry.cn）完成前瞻性注册，并提交研究计划书，确保制定流程的透明性和规范性。共识注册编号：PREPARE-2025CN730。 2.共识制定工作组：由感染病学、呼吸病学、儿科学、检验医学、疫苗学、流行病学及公共卫生等多学科专家组成核心工作组，涵盖临床医学、预防医学和卫生政策领域。专家组基于循证证据与既往实践经验，共同确定共识的核心议题与推荐意见。 3.证据检索与整合：证据组对每一个章节主题分别构建检索策略，通过系统性检索万方数据库、中国知网、PubMed、Embase、Cochrane Library、Web of Science数据库中RSV感染预防、诊疗及医防协同策略的相关中英文文献（包括指南、系统评价、临床研究及公共卫生实践报告），检索时间为各平台建库始至2025年11月。中英文检索词主要包括“呼吸道合胞病毒”“肺炎”“毛细支气管炎”“预防”“治疗”“医防协同”“RSV””“Respiratory syncytial virus”“Pneumonia”“Bronchiolitis”“Prevention”“Treatment”“Collaboration of medical and preventive care”等。证据筛选注重时效性与权威性，优先采纳高质量研究及国内外最新指南共识。 4.共识意见形成：本共识的推荐意见制定以现有证据为基础，综合考虑我国适用人群的偏好与价值观、干预措施的利弊权衡、资源利用等因素，并结合多学科专家组的实践经验，采用改良德尔菲法制定。通过6次专家会议讨论和2轮投票，对争议性问题进行充分论证，最终达成共识（同意推荐度≥85%视为达成共识）。对于证据不足但具有实践价值的创新性医防协同策略，由专家组基于临床与公共卫生需求综合研判后提出建议。本共识共形成15条推荐意见，涵盖了RSV病原学概述、RSV感染的流行病学与疾病负担、免疫预防、医防协同防控策略、重点人群预防及未来展望等方面。 5.同行评审与发布：共识文本撰写成文后由外审专家组进行审阅，工作组针对反馈意见进行修改，最终形成共识终稿。 二、RSV感染概述 （一）病原学概述 RSV是一种单股负链RNA病毒，属于肺炎病毒科正肺病毒属。病毒颗粒呈球形或丝状，结构包括附着蛋白（G）、融合蛋白（F）和小疏水蛋白（SH）等，在病毒侵入宿主细胞过程中起关键作用。F蛋白通过与胰岛素样生长因子1受体及核蛋白的多受体互作，触发膜融合级联反应 ［ 5 , 6 ］ 。G蛋白通过硫酸乙酰肝素蛋白聚糖介导初始附着，同时可能抑制宿主免疫应答，基于干扰素（IFN）信号通路，削弱宿主的抗病毒防御能力，导致不完全免疫和持续性感染 ［ 7 , 8 ］ 。SH蛋白是离子同道蛋白，主要调节膜的通透性、感染性和阻止宿主细胞凋亡，在细胞表面表达量低。RSV根据G蛋白基因序列差异可分为A和B两种亚型。 RSV通过与宿主人呼吸道上皮细胞表面受体结合，进入细胞内复制，可导致上皮细胞坏死、气道炎症、支气管上皮脱落和黏液分泌物增加阻塞等一系列病理变化；这些病理改变导致气道狭窄和通气受限，进而引发毛细支气管炎和肺炎，严重者导致低氧血症和呼吸衰竭。除呼吸系统以外，RSV还可侵犯其他脏器，造成中枢神经系统、心血管系统、消化系统等受累 ［ 9 , 10 ］ 。此外，婴幼儿早年感染RSV后还可能会引起气道高反应性，在儿童期出现反复喘息，甚至哮喘的风险增加 ［ 11 ］ 。 （二）RSV感染的流行病学与疾病负担 RSV流行高峰期的基本再生数（R0）均值约为4.5，即单个感染者在整个传染期内平均能够传染约4.5人，显著高于流感病毒、鼻病毒和腺病毒 ［ 12 ］ 。RSV的传播通过多途径实现，主要包括直接或间接接触传播（感染者与易感者间物理接触）、飞沫传播（5~10 μm颗粒短距离沉降）以及气溶胶传播（<5 μm颗粒可长时悬浮于空气中） ［ 13 , 14 ］ 。感染者在症状出现前后均具有传染性。RSV感染传播易发于以下三类场景：（1）家庭内传播，因成员共同生活，密切接触等促进短距离传播；（2）医疗机构内传播，污染物暴露与近距离飞沫接触构成主要风险；（3）易感人群密集的密闭场所，如母婴护理机构、养老院等 ［ 15 , 16 ］ 。此外，低湿度条件可增加病毒在气溶胶中的传播风险，而通风不足则加剧传播效率 ［ 17 , 18 ］ 。 RSV的流行具有季节性规律和地域差异。从全球角度看，温带地区RSV流行季主要在深秋和冬季，在亚热带地区的持续时间则更长，而在一些靠近赤道的地区则可出现近乎全年流行的趋势 ［ 19 ］ 。我国北方地区主要以冬、春季流行为主，从每年10—11月起至次年4月 ［ 20-22 ］ ；而在北回归线附近的部分南方地区（热带或亚热带气候），如广东、福建、广西、云南、海南、台湾、香港、澳门等，RSV的季节性特征不明显，呈现全年流行的特点 ［ 20 ， 23 , 24 ］ 。在新型冠状病毒感染（COVID-19）大流行期间，中国RSV流行季节性发生改变，表现为传统冬季高峰消失和反季节流行，随时间推移已逐步恢复疫情前模式 ［ 25 , 26 ］ 。 RSV感染所致的疾病负担在儿童和老年人群体中较为严重。2019年全球5岁以下儿童中，约发生了3 300万次RSV相关ALRTI，其中360万次感染需要住院治疗，101 400例死亡归因于RSV感染 ［ 1 ］ 。2009—2019年中国疾病预防控制中心开展的一项研究，纳入了我国31个省份主动监测ARI患者数据，发现RSV是5岁以下儿童ARI患者首位检出病毒病原体，占25.7%；在5岁以下儿童肺炎患者中，RSV同样位居病原首位，占28.1%；在超过60岁的老年患者中，RSV检出比例达7.4% ［ 2 ］ 。另一项于2009—2023年期间，在我国16个省份开展的基于ARI患者监测报告显示，RSV检出率为10.83%，其中87.95%为5岁以下儿童，此外6月龄以下婴儿RSV检出率最高，占25.69%，60岁以上老年人RSV感染率为2.69% ［ 3 ］ 。2015—2023年在北京开展的研究显示，RSV感染老年患者中，住院比例高达78.68%，其中24.87%出现并发症，机械通气使用率为13.32%，说明老年人RSV感染病情更严重、预后较差 ［ 4 ］ 。 有先天性疾病、基础疾病的患者RSV感染风险增加，且感染后临床症状可能更加严重。在婴幼儿群体，6月龄以下婴儿、早产出生儿、患有先天性心肺疾病、唐氏综合征以及神经肌肉疾病的婴幼儿RSV感染风险高，临床症状更加严重 ［ 27 ］ 。对于成年人，感染RSV的风险因素包括：高龄、既往患有慢性阻塞性肺疾病（COPD）、慢性心力衰竭、慢性肾病、卒中病史、缺血性心脏病、糖尿病以及肥胖等，具有上述风险因素可能导致患者在感染RSV后发生COPD急性加重和急性心血管事件的风险增加，还可能加重肺功能和心脏功能的损伤，引发晚期心血管事件等长期不良预后 ［ 28 ］ 。在基础疾病患者中，免疫功能低下人群由于免疫系统受损，感染RSV的风险显著增加，且感染后更容易发展为下呼吸道感染（LRTI），住院率和死亡率显著高于普通人群 ［ 29 ］ 。在免疫抑制人群中（如血液系统肿瘤、移植患者），RSV可导致高住院率、ICU转入率及病死率 ［ 30-32 ］ 。而对于合并慢性心肺疾病的患者来说，RSV往往在患者肺部中持续存在 ［ 33 ］ ，是导致慢性基础疾病急性加重的常见诱因，进而造成严重临床结局甚至死亡 ［ 34 , 35 ］ 。因此，针对有基础疾病人群，建立多层防控体系和早期干预尤为重要，从而降低这一高危人群的致病率和致死率，策略包括推广疫苗和单克隆抗体接种、早期快速分子检测，以及治疗层面实施个体化管理方案（包括抗病毒药物联合免疫调节治疗）。 除流行病学负担外，RSV感染还会带来沉重的卫生经济负担。根据荟萃分析估计，2017年全球用于管理5岁以下儿童RSV感染的直接医疗费用约为48.2亿欧元，其中约55%为住院费用 ［ 36 ］ 。目前我国尚缺乏基于真实世界人群的RSV所致经济负担研究。基于流行病学模型估计，在中国每年0~1岁婴儿因RSV-ALRTI造成的经济负担可高达70亿元人民币，0~1岁RSV-ALRTI住院儿童（包含PICU和机械通气）总医疗费用高达27.4亿元人民币 ［ 37 , 38 ］ 。未来应鼓励开展相关研究，调查RSV在人群中的直接和间接经济负担，为未来免疫防控政策的实施提供基础数据。 推荐意见1：RSV具有高度传染性，其流行季节受到地理位置和环境气候因素的影响。鉴于我国地域辽阔、气候多样，应进一步加强RSV流行病学研究工作，以掌握其流行动态，为防控策略的制定提供科学依据。 推荐意见2：RSV感染在婴幼儿、老年人以及免疫功能低下患者中的疾病负担较重，建议将这三类高风险人群作为RSV防控工作的重点关注对象。 三、RSV免疫预防 RSV感染给全球带来的巨大疾病负担，然而尚无被证实安全有效的药物获批用于针对病原体的治疗，因此预防RSV感染已被WHO列为全球首要任务之一。人群在RSV自然感染后无法获得持久免疫力，仍会反复感染，因此特异性免疫预防至关重要。 RSV免疫预防措施包括主动免疫和被动免疫。主动免疫方面，由于此前儿童RSV疫苗在临床试验阶段中发现，接种疫苗的儿童在随后自然感染RSV时出现了疫苗相关增强型呼吸道疾病（VAERD）的现象 ［ 39-41 ］ ，因此多年来研发进展缓慢，至今尚无用于儿童的RSV疫苗获批。2023年至今，国外已获批多款用于孕妇和老年人群体的RSV疫苗，国内尚未引进。在被动免疫方面，RSV单克隆抗体的成功研发填补了婴幼儿RSV预防需求的空白。 （一）单克隆抗体的种类 RSV的F蛋白是中和抗体的主要靶点，其介导病毒与宿主细胞膜的融合过程。F蛋白存在两种构象：亚稳态的融合前形式（pre-F）和稳定的融合后形式（post-F）。pre-F构象在融合过程中转变为post-F，这一过程伴随显著的构象变化，而大多数高效中和抗体靶向pre-F特有的表位，因此pre-F成为疫苗和抗体开发的核心靶点 ［ 42 , 43 ］ 。目前，RSV F蛋白已鉴定出6个主要抗原表位（SiteⅠ~Ⅴ以及Ø），其免疫原性和保守性差异显著。Site Ø与SiteⅤ位于pre-F构象，是中和活性最强的表位 ［ 44- 46 ］ 。Site Ⅳ在于pre-F和post-F两种构象中，既往研究发现靶向此表位的抗体活性较强，且较为保守 ［ 47 , 48 ］ 。Site Ⅲ存在于pre-F，部分靶向该位点的抗体如MPE8及RSV-199等可交叉中和RSV与人类偏肺病毒（hMPV） ［ 49 , 50 ］ ，具有广谱潜力，但其活性有别；而靶向Site I/Ⅱ的抗体显示出的效力有限 ［ 51 ］ 。不同种类RSV单克隆抗体的研发历程体现了抗体工程技术的重要演进。 1.第一代人源化鼠源抗体：帕利珠单抗（Palivizumab），作为1998年首个获美国食品药品监督管理局（FDA）批准的预防用RSV单抗，其人源化程度达95%，靶向F蛋白Site Ⅱ表位 ［ 52 ］ 。该抗体需每月肌肉注射给药1次，仅获批用于高风险早产儿群体。其临床局限性主要体现在：给药方案繁琐（5次/流行季）、目标人群受限（仅适用于胎龄<35周早产儿）、中和广度不足（对部分临床分离株效力降低） ［ 53 ］ 。 2.第二代全人源抗体：尼塞韦单抗（Nirsevimab）作为2023年7月FDA获批的首个婴幼儿长效预防用全人源单抗，源自人记忆B细胞抗体D25，特异性靶向RSV pre-F蛋白中和活性最强且高度保守的SiteØ表位 ［ 54 ］ 。经Fc-YTE修饰后，其半衰期显著延长至71.4（11.4）d ［ 55 ］ 。该抗体抑制病毒进入细胞过程中必要的膜融合步骤，中和病毒并阻断细胞间融合。基于其在婴儿群体中卓越的安全性和有效性证据，2023年12月国家药品监督管理局批准其在中国上市。 Clesrovimab于2025年6月获得FDA批准国外上市，其前体RB1抗体靶向F蛋白保守表位SiteⅣ表位。药代动力学研究显示，经Fc-YTE改造后其血清半衰期约为44.9 d ［ 56 ］ 。临床试验数据证实其安全性和保护效益良好，目前国内尚未引进。 （二）国内外单克隆抗体的应用现状 最早用于预防RSV感染的帕利珠单抗，在国外多个国家已有超过二十年的使用经验，被推荐用于1岁以内胎龄小于35周的早产出生儿、合并慢性肺疾病的早产儿以及患有显著血流动力学异常的先天性心脏病婴儿的RSV预防。在高危儿中，帕利珠单抗可降低RSV感染住院率和重症发生率 ［ 57 ］ 。该单抗因临床应用存在局限性，给药频率高，成本较高，目前我国尚未引进。 新一代长效单克隆抗体尼塞韦单抗半衰期长，单次注射可提供至少6个月的保护效力 ［ 58 ］ ，能够覆盖常规RSV流行季，已经在全球多个国家获批并且使用。一项针对1 453名年龄<1岁的健康早产出生儿（29~34周）的随机对照试验（RCT）表明，在首次面对RSV流行季节时，与安慰剂相比，尼塞韦单抗能使RSV相关需医疗干预的LRTI发生率降低70.1%（95% CI：52.3%~81.2%， P<0.001），住院率降低78.4%（95% CI：51.9%~90.3%， P<0.001） ［ 59 ］ 。另一项针对1 490名年龄<1岁的健康晚期早产儿（胎龄≥35周）及足月儿的RCT显示，在首次面对RSV流行季节时，单剂尼塞韦单抗能使RSV相关需医疗干预的LRTI发生率降低74.5%（95% CI：49.6~87.1， P<0.000 1），同时观察到患儿住院率减少62.1%（95% CI：8.6%~86.6%， P=0.07） ［ 55 ］ 。一项对925例患有先天性心脏病、慢性肺部疾病或早产儿（胎龄≤35周）的RCT表明，尼塞韦单抗的安全性与帕利珠单抗相似，RSV相关需医疗干预的LRTI发生率在尼塞韦单抗组0.6%优于帕利珠单抗组的1.0% ［ 60 ］ 。目前尼塞韦单抗已在全球数十个国家获批应用，来自美国、法国、西班牙、卢森堡和意大利等国家大量的真实世界研究证实，尼塞韦单抗在全婴儿人群的保护有效性在70%~90%，且安全性高 ［ 61-68］ 。一项纳入27项真实世界研究、约14万例婴幼儿的系统综述和荟萃分析结果显示，尼塞韦单抗能使RSV相关住院风险下降83%，入住ICU风险下降81%，以及RSV相关LRTI风险下降75% ［ 69 ］ 。进一步的成本效益分析表明，尼塞韦单抗可减少30%~50%的RSV相关住院费用 ［ 70 , 71 ］ 。 另一RSV长效单抗Clesrovimab，在2025年6月9日获FDA批准用于预防新生儿及进入首个RSV流行季的婴儿RSV相关LRTI，目前在我国尚未上市和应用。在一项针对1岁以内健康早产和足月出生儿的Ⅱb/Ⅲ期研究中，单剂Clesrovimab能使RSV相关LRTI的就医风险下降60.4%（95% CI：44.1~71.9， P<0.001），RSV感染相关住院的风险下降84.2%（95% CI：66.6~92.6， P<0.001） ［ 56-72］ 。 近年来在RSV免疫预防领域，单克隆抗体从鼠源化向人源化的制备演变、从短效制剂向长效制剂的研发突破，以及从高危儿向全婴儿人群的保护扩面，为婴幼儿RSV预防提供了新方案。 （三）单克隆抗体的可及性途径 在全球多个国家和地区，预防用RSV单克隆抗体已被正式纳入当地的免疫规划程序 ［ 73-76 ］ 。自我国引入RSV单克隆抗体以来，鉴于其作为创新生物制品并不属于传统疫苗范畴，其可及性与使用路径仍在持续探索与实践中不断完善。与国外不同的是，我国儿科临床、儿童保健和儿童预防接种都存在一定程度的医防分离，为保障广泛新生儿和婴儿群体的RSV预防可及性，亟需各地在医防融合、医防协同的模式下探索和优化实践路径。 在我国，RSV预防性单抗的可及性主要通过以下两种途径实现：第一种途径是在各级综合医院、专科医院和社区卫生服务中心的临床科室，由儿科医生或全科医生开具RSV预防性单抗处方，对符合条件的新生儿和婴儿进行注射；第二种途径是在北京、天津、上海、湖北、内蒙古等地，在当地卫生健康委员会及疾控体系的监管下，整合区域临床医疗与公共卫生预防资源，开展RSV预防性单抗的试点管理工作。纳入试点的医院机构和社区卫生服务中心可在儿童保健科、新生儿科、儿科、产科和预防接种门诊，由具备处方权和预防接种资质的医务人员提供RSV预防性单抗注射使用服务。在以上场景中，家长对于RSV的科普宣教和预防使用更易于接受，同时也很大程度上减少就诊环节，避免了流行期的交叉感染，还可参照各地相关政策进行不良反应的后续处置和管理，保障了预防服务的质量和安全性。 RSV预防性单抗在我国试点管理探索的过程中，从政策争取到落地推进，从调研讨论到重难点突破，从单抗使用服务到随访评估，医防协同的理念始终贯穿于政策指导与执行的全过程。在2024—2025年RSV流行季期间各试点地区的实践工作表明，RSV预防性单抗在国内的预防使用路径具备良好的可及性、安全性和便捷性。 推荐意见3：建议我国各级医疗机构根据当地实际情况，开展跨学科协作，为新生儿和婴儿群体提供规范、便利的RSV预防性单抗注射服务。在已将RSV预防性单抗纳入试点管理的地区，预防接种工作需严格按照当地管理方案的规定执行。 四、医防协同防控策略 近年来，我国“医防协同、医防融合”的改革政策为强大医疗卫生与公共卫生体系指明了方向。当前，立足RSV防控实践需求，需构建“预警监测-精准干预-防治协同”三位一体的创新防控体系，为提升公共卫生应急能力和医疗服务水平提供有力的支撑。 （一）诊断与治疗 1.病原学诊断：由于RSV感染缺乏特异性的临床表现和影像学特征，因此实验室病原学检测结果是确诊的主要依据。RSV病原检测方法主要包含以下4种类型： （1）核酸检测：主要是基于PCR技术的核酸扩增、具有高灵敏度和高特异度，且用时相对较低，是目前实验室诊断RSV感染的主流方法。实时荧光定量RT-PCR还可对病毒载量进行定量分析，以及病毒RSV-A和RSV-B亚型鉴定。此外，近年来出现的如宏基因组测序（mNGS）、靶向测序（tNGS）等二代测序技术，凭借其相比传统检测技术的高靶向性、高灵敏度和多样化应用，同样具有重要应用价值。 （2）抗原检测：主要有免疫荧光检测、免疫层析检测等。免疫荧光检测（直接/间接）需要RSV的单克隆抗体和荧光显微镜，对平台要求较高，但具有较高的灵敏度和特异度。免疫层析检测（如快速抗原检测）操作简单快捷，用时短，但灵敏度相对核酸检测较低，易出现假阴性结果。 （3）血清学检测：主要是检测RSV特异性IgM、IgG检测，但无法有效区分急性期感染和既往感染，也无法区分是否母体来源的抗体，因此单份血清抗体阳性不能单独作为现症RSV感染的实验室指标。该方法主要适用于疾病控制中心、海关等机构的RSV血清流行病学研究，疫苗效果评估等，也可作为回顾性诊断的参考。 （4）病毒培养：特异性高，但用时长，操作复杂，因此不推荐作为临床常规检测方法，目前主要用于科研目的或特殊情况下（如新型病毒株的鉴定）。 不同年龄段、不同采样部位的RSV脱落情况有所不同。RSV脱落的持续时间为成人患者（10 d左右）<儿童（2周）<婴幼儿、免疫抑制患儿（数周、月余），如条件允许建议在发病4天内采集标本 ［ 77 , 78 ］ 。支气管、细支气管和肺泡的上皮细胞是RSV感染的主要靶细胞，从诊断灵敏度出发，下呼吸道标本优于上呼吸道标本，支气管肺泡灌洗液、呼吸道抽取深部痰液优于鼻咽拭子标本 ［ 79 , 80 ］ 。基于下呼吸道标本样本收集难度较大，一般多采用鼻咽拭子样本进行检测。 在选择RSV检验方法时，需综合考虑检测目的、样本类型、实验室条件、检测时效性以及成本效益等因素。对于快速诊断和临床决策，推荐优先采用病毒核酸检测（如RT-PCR技术）或快速抗原检测；对于大规模筛查和流行病学调查，可结合使用抗原检测（如免疫荧光法）和血清学检测；而病毒分离培养则主要用于科研领域，目前较少作为临床常规检测方法。 推荐意见4：临床实践中病原学诊断建议优先使用RSV核酸检测或快速抗原检测，但检测的准确性会受采样时间和部位的影响。在大规模筛查和流行病学调查中可结合使用抗原检测和血清学检测。 2.RSV感染治疗：由于当前尚无针对RSV感染的特效抗病毒药物，因此临床上根据感染者的个体情况酌情给予以氧疗、补液等对症支持治疗为主。医疗机构人员应尽早进行病原诊断和实施治疗方案，及时识别具有RSV重症感染风险因素的人群，密切观察病情变化和并发症情况 ［ 81-83 ］ 。 推荐意见5：建议医疗机构人员对感染RSV的患者尽早实施个体化对症治疗，重点识别、密切监测重症风险人群的病情变化。 3.感染防控：在医疗机构，接触RSV感染患儿的医护人员应使用个人防护用品，接触前后注意手部、医疗物品消毒。尽可能将RSV感染的患儿安置在单人病房或与其他RSV感染的患儿集中隔离治疗。在公共场所防控RSV感染时，须综合考虑病毒的传播途径、高危人群特征及季节性流行规律，采取多层次的措施。在RSV流行季节，在母婴护理机构、托幼机构和商场等公共场所高频接触的表面，如门把手和电梯按钮，应定期使用含氯或酒精类消毒剂进行清洁消毒。人群密集场所佩戴口罩能够有效降低飞沫传播风险，同时，规范的手卫生（如使用含酒精的洗手液或肥皂洗手）和正确的咳嗽礼仪（用纸巾或肘部遮挡咳嗽）也有助于防止病毒通过接触传播。 推荐意见6：建议医疗机构将早期病原诊断与非药物干预措施（NPI）相结合，促进院内诊防控一体化流程。同时，在RSV流行时期于公共场所倡导推行NPI，以有效控制RSV的传播。 （二）智能化监测与预警升级 国家疾病预防控制局于2023年10月依托覆盖全国31个省份的立体化监测网络，在200余家哨点医院推行“多病原同监测，一样本多检测”的呼吸道多病原监测策略，现已将RSV纳入门急诊流感样病例及住院病例的常规病原筛查。哨点医院与基层医疗机构通过国家疾控平台实时共享RSV病例数据，中国疾病预防控制中心部署的医疗机构前置软件可自动抓取医疗系统数据，提高RSV感染报告水平。建立多点触发监测网络、加强社区层面（如母婴护理机构、幼儿园、养老院等）的主动监测、人工智能技术的深度应用将进一步整合临床症状与实验室检测、病原流行特征、环境气象及人口流动数据，实现在流行高峰到来前数周预警，为RSV感染病例的早期识别和诊断、加强防控宣传、及时调配医疗资源（如医疗机构床位扩容、药物储备、加强门诊接诊；疾控部门增加预防人手和疫苗储备等相应措施）赢得关键窗口期。 推荐意见7：建议通过医防协同机制打破数据壁垒，实现多源数据的整合与共享，对多病原监测体系进行智慧化升级，从而实现对RSV流行更早期、更精准的预警，为防控决策提供有力支持。 （三）医防协同与科普教育 当前公众对RSV感染的认知不足，需要通过系统性健康科普填补公众知识盲区，实现“预防前移”的公共卫生目标。 建议由卫生健康部门主导，将RSV科普纳入公共卫生健康教育年度计划，联合疾控中心、医疗机构、街道办等制定统一宣教方案。在RSV流行季前启动专项科普行动，通过官方平台发布基于本地监测数据的流行预警、权威指南或指引。标准化核心健康宣传内容，包括强调无症状感染者的传播风险，传播途径以飞沫/接触传播为主，规范洗手、佩戴口罩、环境消毒流程，高危人群避免流行期到人群聚集场所等预防措施。联动医疗机构与疾控，社区卫生服务中心，综合性医院门急诊、儿科、呼吸科、老年科等重点科室设置RSV科普专栏，发放宣传手册，内容各有侧重。强化“临床-公卫”快速反馈机制，及时将RSV病例数据转化为风险预警科普内容。组织教育机构与社会组织参与，在托幼机构、老年大学开展RSV感染预防课程；联合妇联、街道办/村委会等针对孕产妇、婴幼儿家长、老年人群开展定向宣教。 分层分类精准科普内容，高危人群重点宣传，如面向婴幼儿家长宣传RSV单克隆抗体的预防获益、强调RSV感染的症状、体征，提醒及早就医。面向老年人群及慢病患者，侧重宣传RSV感染的症状特点，居家RSV快速检测技术，预防合并症及并发症。充分利用新媒体，多渠道传播RSV感染防治相关知识，帮助公众做好预防感染，早期识别感染并及时就医，降低重症风险。 推荐意见8：建议通过医防协同机制，开展具有证据多元、覆盖广泛和触达精准的RSV防控科普教育。 （四）基层医疗机构医防融合落地 基层医疗机构的公共卫生医师处方权试点工作是创新医防融合的重要举措，我国广大基层公共卫生医师群体长期面临“有专业无抓手”的困境，虽承担着疾病防控、健康管理与疾病随访等核心职能，却因缺乏处方权而难以给予进一步的用药建议，导致预防与治疗环节割裂。通过赋予基层公共卫生医师RSV预防健康处方权，可以进一步提升公共卫生医师的预防处置能力，满足群众卫生健康服务需求 ［ 84 , 85 ］ 。 另一方面，基层医疗机构应与上级医疗单位通过医联体、双向转诊等机制为RSV预防宣传、处方转诊和预约接种提供便捷通道。在诊疗方面，由基层医疗机构首诊识别出的RSV轻症患者（如无基础病的婴幼儿和老年人）可在基层医疗机构完成对症治疗，而出现呼吸急促、血氧饱和度下降的重症患者，通过电子转诊平台即可快速对接上级医院相关科室。上级医院治疗好转出院的患者，可在基层单位完成恢复期复诊和长期随访。 通过这些创新模式，将有助于实现临床和公卫相结合的双重成效，促进医疗资源合理应用，减少后续RSV感染带来的医疗负担。 推荐意见9：建议积极推进公共卫生医师健康处方的试点，基于医联体的双向转诊机制，优化RSV预防重点人群在基层和上级医院之间的协同防治路径，实现全周期管理。 五、重点人群的预防策略 （一）婴幼儿 1.单克隆抗体注射：尼塞韦单抗对于预防婴儿RSV感染具有良好的安全性和有效性，能够降低婴儿ALRTI的就医率、住院率以及重症感染风险，保护时间至少6个月。2025年WHO在其发布的“关于免疫注射保护婴儿免受RSV感染的立场文件”中明确阐述，在RSV流行季节明确的地区，建议在流行季到来前或流行期间为婴儿注射尼塞韦单抗；在RSV常年流行或季节性特征不显著的地区，建议推行全年免疫预防策略，婴儿出生后尽早注射尼塞韦单抗 ［ 19 ］ 。 根据国家药品监督管理局批准，我国注射尼塞韦单抗的目标人群为即将进入或出生在第一个 RSV流行季的新生儿和婴儿。对于体重<5 kg的婴儿，推荐剂量为单次肌肉注射50 mg；体重≥5 kg的婴儿，推荐剂量为单次肌肉注射100 mg。尼塞韦单抗是一种针对RSV的特异性被动免疫制剂，预期不会对常规疫苗接种所产生的主动免疫应答造成干扰。临床试验也表明尼塞韦单抗与常规儿童疫苗联合使用时，其安全性和反应原性特征与儿童疫苗单独使用时相当，因此可以与儿童疫苗同时注射 ［ 86 ］ 。 2.孕妇主动免疫：2023年8月FDA批准首个用于孕妇的RSV预防疫苗RSVpreF，在孕晚期（32~36周）接种产生的抗体可通过胎盘进入胎儿体内，提供新生儿出生后的保护，该措施可使婴儿出生后90 d内将RSV相关需医疗干预的严重LRTI风险降低81.8%，在出生后180 d内的风险降低69.4% ［ 87 ］ 。我国尚未引进孕母RSV预防疫苗RSVpreF。 3.非药物干预：母乳（尤其是初乳）提供IgA、乳铁蛋白、溶菌酶及多种细胞因子，这些成分可增强婴儿的黏膜免疫力，在上皮表面形成保护屏障，减少病毒黏附。研究表明，母乳喂养时间不足（<2个月）或非母乳喂养婴儿，发生严重RSV-ALRI和住院的风险显著增加，而母乳喂养（包括纯母乳喂养和部分母乳喂养）4~6个月可降低住院率、住院时长和ICU入住率 ［ 88-90 ］ 。针对婴幼儿还需强化日常卫生细节，如减少前往人群密集场所，家长接触婴儿前需严格洗手，加强室内环境卫生和定期通风换气，尤其需避免二手烟暴露。 推荐意见10：建议我国1岁以下的健康足月儿、早产儿以及特殊健康状态（先天性疾病、基础疾病）的婴儿在首个RSV流行季来临之前以及在流行季出生时注射尼塞韦单抗，以预防RSV引发的LRTI。对于我国RSV常年流行或季节性特征不显著的地区，婴儿出生后（不考虑出生季节）应尽早注射尼塞韦单抗，以提供及时的保护。尼塞韦单抗可以与其他常规儿童疫苗联合使用。 推荐意见11：提倡母乳喂养，可有效降低婴儿RSV感染的发病率，减轻疾病严重程度，并显著改善预后。同时家长及看护人需重视日常卫生管理细节，以降低感染风险。 （二）老年人 现有RSV研究多集中于儿童，对老年人群的疾病负担评估相对不足。RSV是60岁及以上成人呼吸道感染（RTI）的常见病原体，在有症状的RTI病例中占4.7%~7.8%，且其发病率随年龄增长及基础疾病增多而升高 ［ 91 ］ 。老年人因免疫功能下降，常出现支气管炎、肺炎及肺部基础疾病急性加重等，更易出现并发症并进展为重症 ［ 92 ］ 。老年人RSV感染后ICU入住率和死亡率可分别高达15%和12%，且两者随年龄增长而攀升，容易并发心肺基础疾病恶化等长期后遗症 ［ 28 ］ 。因此，RSV感染对老年人群造成了巨大的疾病负担和经济负担，需重视并做到早发现、早治疗，减少重症感染的发生。研究显示，在我国贵阳2016—2020年对5 131例≥60岁呼吸道感染住院患者的RT-PCR检测显示，RSV阳性率为2%（104例），ICU入住率7%（7例），死亡率6%（6例） ［ 93 ］ 。上海2013—2023年3 341例老年患者阳性率为2.27%（76例） ［ 94 ］ 。目前，尚缺乏针对老年人群的RSV系统监测数据以及特效药物。因此，防控策略应主要围绕系统监测、风险管理和疫苗接种等几个方面展开。 建立中国老年人RSV感染监测系统，需重点关注≥60岁合并慢性心肺疾病、免疫功能低下者，尤其是护理院等集体居住老人。对高危人群分层干预，流行季前优先接种RSV疫苗；开启医防协同预警，基层医疗机构结合慢病管理系统评估高危老人感染风险、动态预警重症感染；应用多病原核酸检测或NGS提升检测敏感性与混合感染检出率，及时诊断高危老人重症RSV肺炎。近年来，针对老年人的RSV疫苗研发进展显著，2023年两种60岁及以上成人重症RSV预防用蛋白亚单位疫苗在国外获批上市，同年6月获美国疾病预防控制中心推荐，第三种 mRNA 疫苗随后也在美国获批。这些疫苗安全性良好、保护作用中等到高效，预防RSV相关下呼吸道疾病有效率为67%~84%，可显著降低相关发病率和死亡率 ［ 95- 97 ］ 。此外，RSV可作为共感染病原体，流行季常与其他呼吸道病毒存在重叠，肺炎球菌常于病毒感染后引发细菌性肺炎，因此，针对老年人群实施多种呼吸道疫苗联合接种，有望构建更为全面的免疫屏障。机制上，多种疫苗联合接种可能通过激活先天免疫系统，增强机体对病原体的防御能力。多项研究已证实该策略具有良好的可行性，同时接种并不会对各疫苗的免疫原性或安全性产生显著影响 ［ 98 , 99 ］ 。 推荐意见12：加快构建和完善中国老年人群RSV感染的流行特征及疾病负担的本土数据库，以实现对老年人群RSV感染风险的科学、规范管理。 推荐意见13：建议将60岁及以上人群，尤其是合并慢性肺疾病、心血管疾病或免疫功能低下的高风险老年人，作为RSV预防的重点关注对象。在针对老年人群的RSV预防疫苗可及后，推荐该人群在RSV流行季前接种疫苗。 （三）免疫功能低下人群 免疫功能低下（包括原发性免疫缺陷、恶性肿瘤、器官或干细胞移植、自身免疫性疾病等）人群感染RSV的风险显著增加，感染后更容易发展为LRTI，住院率和死亡率显著高于普通人群，且病毒脱落时间延长至数周，增加传播风险 ［ 100-103 ］ 。 有研究显示，在针对≥18岁人群RSV疫苗可及的国家和地区，推荐中至重度免疫功能受损患者接种RSV疫苗可带来预防获益，尤其是造血细胞移植（HCT）和肺移植受者；年龄≥50岁者则建议使用含佐剂疫苗而非其他疫苗制剂，因为免疫功能受损患者的疫苗应答通常较差，而含佐剂疫苗的免疫原性更强 ［ 104 ］ 。此外，研究显示在2岁以下免疫功能低下儿童中注射尼塞韦单抗的血清浓度与健康婴儿中预防RSV LRTI的有效浓度一致，且试验期间未发生LRTI事件 ［ 105 ］ 。 推荐意见14：建议将免疫功能低下人群作为RSV预防的重点关注对象之一，加速开发和引进适用于该人群的RSV疫苗或预防性单抗，以降低其重症和死亡风险。 六、研发方向 当前全球范围内RSV防治的研发领域发展迅速，且呈现多元化的态势。另一方面，我国预防用RSV单抗的自主研发也在迅速开展。TNM001是我国首个自主研发的长效全人源RSV中和抗体，采用HitmAb ®平台制备，靶向pre-F蛋白SiteØ。临床前研究显示其中和活性优于帕利珠单抗30倍，优化后半衰期达65~70 d。Ⅱb期试验表明，该抗体可降低5个月流行期内RSV相关就医率和住院率，高危婴幼儿亚组获益尤为显著，安全性特征与安慰剂相当 ［ 106 ］ 。此外，我国还有RB0026和SIBP-A16两款单抗处于临床研究阶段 ［ 106 , 107 ］ 。其中RB0026已启动Ⅲ期临床研究，旨在评估在正在进入或处于其第一个RSV流行季的婴儿人群中，RB0026注射液与安慰剂相比，给药后150 d内（D1~D151）降低RSV引起需医学干预的LRTI（MALRTI）的有效性；SIBP-A16于2025年7月获批进入临床研究阶段，并于8月启动Ⅰ期临床研究。RSM01是一种专门为中低收入国家（LMIC）开发的单抗，目前处于Ⅰ期临床试验（NCT05118386），同样靶向SiteØ表位并经Fc-YTE改造，半衰期约65-70天，初步数据显示其在健康成人中耐受性良好 ［ 108 ］ 。 RSV单克隆抗体未来研发应着力于：（1）筛选并鉴定免疫逃逸高阈值的表位（该位点对病毒自身结构、功能非常重要，不能轻易发生突变）；（2）实现广谱，对偏肺病毒等有交叉保护；（3）建立全球病毒变异监测网络，以应对潜在的免疫逃逸挑战。 RSV疫苗研发方面多种技术平台并进：我国目前有多款采用不同技术路线和制剂形式的RSV疫苗进入到临床研究阶段。进度最快的重组蛋白RSV疫苗采用水针剂型与预充针设计，提升了接种便捷性，2025年10月已启动针对60岁及以上老年人群的Ⅲ期临床研究（CTR20253963）；采用二价以及无佐剂的制剂方案的RSV疫苗，旨在提升毒株覆盖性与安全性，也已启动Ⅰ期临床研究；此外还有多款采用mRNA路线的RSV疫苗，分别处于不同临床研究阶段，其编码F蛋白保守区的设计为更持久的免疫应答提供可能性 ［ 109 ］ 。 RSV治疗领域，国产小分子口服F蛋白抑制剂AK0529（Ziresovir）在Ⅲ期临床试验中达成双项突破：较安慰剂降低症状评分30%、削减病毒载量77%，有望成为全球首个抗RSV感染的小分子药物 ［ 110-112 ］ 。Zelicapavir是一种新型N蛋白抑制剂，在Ⅱ期临床试验中显示在RSV感染患儿中给药的第5天病毒载量减少了大约97% ［ 113 ］ 。 将医防协同机制贯通“需求识别-研发设计-评价验证-应用反馈”全链条，可显著提升我国RSV自主防治产品研发的效率、质量和战略价值。通过整合临床医疗与公共卫生体系资源，优化我国研发策略、加速临床试验推进、强化证据支撑、打通上市路径，是突破中国RSV防治产品研发瓶颈、加速实现自主可控的核心方向。 推荐意见15：通过深化医疗与预防协同机制，加速提升我国RSV预防和治疗领域自主产品的研发效率、质量和战略价值。 七、总结与展望 本共识旨在为我国RSV防控策略的制订和实施提供参考，希望通过构建高效、创新的医防协同机制，实现临床医疗与公共卫生资源的协调整合，优化RSV精准防控和重点人群保护措施，以降低我国RSV感染造成的疾病负担和医疗成本。同时，以RSV感染防治领域医防协同为范式，为我国其他的重大传染病防控提供可借鉴的经验和模式。 除当前正在研发中的抗RSV药物、疫苗和单克隆抗体的临床试验以外，针对已上市的RSV预防制剂在真实世界中有必要开展公共卫生价值的研究，包括评估预防长期获益、RSV共感染效应、卫生经济效益以及对宏观群体的影响等。 本共识制定专家组成员 指导委员会成员：钟南山（广州医科大学附属第一医院）；沈洪兵（国家疾病预防控制局）；饶子和（清华大学）；尚红［中国医科大学附属第一医院检验科 医疗辅助技术（医学检验）国家临床医学研究中心］；刘恩梅（重庆医科大学）；曹彬（中日友好医院呼吸中心 国家呼吸医学中心）；陆权（上海交通大学医学院附属儿童医院 呼吸科）；申昆玲（深圳市儿童医院呼吸科/首都医科大学附属北京儿童医院呼吸科） 执笔者 ： 孙丽红 （ 广州医科大学附属第一医院小儿呼吸专科 广州呼吸健康研究院）；杨子峰（广州医科大学附属第一医院 广州呼吸健康研究院）；蒋荣猛（首都医科大学附属北京地坛医院）；冯录召（中国医学科学院北京协和医学院群医学及公共卫生学院）；李群（中国疾病预防控制中心）；张燕（中国疾病预防控制中心 病毒病预防控制所）；官旭华（湖北省疾病预防控制中心）；叶枫（广州医科大学附属第一医院 广州呼吸健康研究院）；吴健（广东省人民医院老年呼吸二科/广东省老年医学研究所）；梁振宇（广州医科大学附属第一医院 广州呼吸健康研究院）；徐金富（同济大学附属同济医院）；邓小燕（广州医科大学金域检验学院）；王立富（广州医科大学金域检验学院）；李千瑞（四川大学华西医院）；张飞（深圳市南山区医疗集团总部）；张冬莹（广州医科大学附属第一医院 广州呼吸健康研究院）；占扬清（广州医科大学附属第一医院 广州呼吸健康研究院）；梁靖怡（广州医科大学附属第一医院 广州呼吸健康研究院）；王祥喜（中国科学院 生物物理研究所）；彭伟（广州实验室 病原体结构与临床应用创新研究院）；张玉林（中日友好医院呼吸中心 国家呼吸医学中心） 参与专家组成员 （ 按姓氏汉语拼音排序 ）： 曹彬 （ 中日友好医院呼吸中心 国家呼吸医学中心）；陈荣昌（广州医科大学附属第一医院 广州呼吸健康研究院）；邓小燕（广州医科大学 金域检验学院）；冯录召（中国医学科学院北京协和医学院 群医学及公共卫生学院）；高怡（广州医科大学附属第一医院 广州呼吸健康研究院）；顾兵（广东省人民医院 检验科）；官旭华（湖北省疾病预防控制中心）；郝创利（苏州大学附属儿童医院 呼吸科）；蒋荣猛（首都医科大学附属北京地坛医院）；康敏（广东省疾病预防控制中心 传染病预防控制所）；李千瑞（四川大学 华西医院）；李群（中国疾病预防控制中心）；李有（南京医科大学 公共卫生学院）；梁靖怡（广州医科大学附属第一医院 广州呼吸健康研究院）；刘恩梅（重庆医科大学）；刘瀚旻（四川大学华西第二医院）；陆路（复旦大学 基础医学院）；陆权（上海交通大学医学院附属儿童医院 呼吸科）；陆小霞（华中科技大学附属武汉儿童医院）；马俊才（中国科学院微生物研究所 微生物资源与大数据中心）；牛艳（中国疾病预防控制中心 卫生应急中心）；彭伟（广州实验室 病原体结构与临床应用创新研究院）；申昆玲（深圳市儿童医院呼吸科/首都医科大学附属北京儿童医院呼吸科）；孙丽红（广州医科大学附属第一医院小儿呼吸专科 广州呼吸健康研究院）；孙鑫（四川大学华西医院 中国循证医学中心）；王贵强（北京大学第一医院感染疾病科/北京大学国际医院感染疾病科）；王立富（广州医科大学 金域检验学院）；王祥喜（中国科学院 生物物理研究所）；吴健（广东省人民医院老年呼吸二科/广东省老年医学研究所）；吴林寰（中国科学院微生物研究所 信息中心）；徐金富（同济大学附属同济医院）；杨子峰（广州医科大学附属第一医院 广州呼吸健康研究院）；叶枫（广州医科大学附属第一医院 广州呼吸健康研究院）；余宏杰（复旦大学 公共卫生学院）；占扬清（广州医科大学附属第一医院 广州呼吸健康研究院）；张冬莹（广州医科大学附属第一医院 广州呼吸健康研究院）；张飞（深圳市南山区医疗集团总部）；张燕（中国疾病预防控制中心 病毒病预防控制所）；张玉林（中日友好医院呼吸中心 国家呼吸医学中心）；周飞（中日友好医院呼吸中心 国家呼吸医学中心） 秘书组成员（按姓氏汉语拼音排序）：关文达（广州医科大学附属第一医院 广州呼吸健康研究院）；梁振宇（广州医科大学附属第一医院 广州呼吸健康研究院） 利益冲突 所有作者声明不存在利益冲突 参考文献（下滑查看）： [1]Li Y ,Wang X ,Blau DM ,et al. 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