The Health Sciences Authority (HSA) has approved Sanofi and AstraZeneca's BEYFORTUS (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season..

新加坡卫生科学局（HSA）已批准赛诺菲和阿斯利康的BEYFORTUS（尼塞韦单抗），用于预防新生儿和在第一个呼吸道合胞病毒（RSV）季节出生或进入的婴儿，以及通过第二个RSV季节仍然容易感染严重RSV疾病的24个月以下儿童的RSV下呼吸道疾病。

Globally, around 2 in 3 babies will catch RSV before their first birthday[4] and it remains the most common cause of lower respiratory tract disease, including bronchiolitis and pneumonia, in infants[5]. RSV is also a leading cause of hospitalisation among infants in Singapore, with most cases occurring in otherwise healthy, full-term babies.

全球范围内，大约每3名婴儿中就有2名会在他们一岁生日前感染RSV [4]，并且它仍然是婴幼儿下呼吸道疾病（包括细支气管炎和肺炎）最常见的原因[5]。RSV也是新加坡婴儿住院的主要原因之一，大多数病例发生在其他方面健康、足月出生的婴儿中。

Each year, approximately 1,804 children under 29 months are hospitalised due to RSV-related illness[6-10]..

每年，大约有1,804名29个月以下的儿童因与RSV相关的疾病住院[6-10]。

A panel of leading paediatricians in Singapore recently published an expert consensus, underscoring the urgent need for RSV protection in all infants. They concur that nirsevimab is key to alleviating the RSV burden on the healthcare system and recommend that immunisation be considered for all infants under the National Immunisation Programme in Singapore.[11].

新加坡一群领先的儿科医生最近发表了一份专家共识，强调了所有婴儿都需要预防RSV的迫切性。他们一致认为，nirsevimab是减轻医疗系统RSV负担的关键，并建议在新加坡国家免疫计划下考虑为所有婴儿进行免疫接种。[11]

Zainab Sadat, Head of Vaccines, Sanofi Southeast Asia & India

赛诺菲东南亚及印度疫苗主管扎伊纳卜·萨达特

'Today, Singapore joins other countries worldwide where an innovative immunisation solution is now available to protect all infants against RSV. The approval of BEYFORTUS marks a critical step towards giving parents the ability to protect their babies during their first year of life, when they are most vulnerable to severe RSV disease.

“今天，新加坡加入了全球其他国家的行列，拥有了保护所有婴儿免受呼吸道合胞病毒（RSV）侵害的创新免疫解决方案。BEYFORTUS的获批标志着在赋予父母保护其宝宝在出生后第一年内免受严重RSV疾病侵害的能力方面迈出了关键一步。

We are committed to working with stakeholders across the RSV care continuum to ensure seamless implementation and broad availability of this innovative preventive solution — because every baby needs protection. Our goal is simple: to help parents protect their babies, and give them peace of mind.' .

我们致力于与RSV护理连续体的各利益相关者合作，确保这一创新预防解决方案的无缝实施和广泛可用性——因为每个婴儿都需要保护。我们的目标很简单：帮助父母保护他们的孩子，并让他们安心。

The approval was based on results from the extensive BEYFORTUS clinical development programme spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of BEYFORTUS demonstrated high and consistent efficacy against RSV disease sustained for at least five months.

该批准基于广泛的BEYFORTUS临床开发计划的结果，涵盖三项关键的晚期临床试验。在所有临床终点中，单剂量的BEYFORTUS显示出对RSV疾病至少持续五个月的高效且一致的疗效。

BEYFORTUS was well tolerated with a favourable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between BEYFORTUS and placebo and the majority of adverse events were mild or moderate in severity..

BEYFORTUS 耐受性良好，在所有临床试验中表现出一致且良好的安全性。BEYFORTUS 和安慰剂的不良事件总体发生率相当，且大多数不良事件的严重程度为轻度或中度。

In temperate countries, the single administration of BEYFORTUS was developed to correspond with the beginning of the RSV season for babies born prior to the season or at birth for those born during the RSV season. In clinical trials, BEYFORTUS helped prevent RSV disease requiring medical care in all infant populations studied, including those born healthy, at term or preterm, or with specific health conditions that make them vulnerable to severe RSV disease.

在温带国家，BEYFORTUS 的单次给药方案是为对应RSV季节开始时出生的婴儿或在RSV季节期间出生的婴儿设计的。在临床试验中，BEYFORTUS 有助于预防所有研究中的婴儿群体因RSV疾病需要医疗护理的情况，包括足月出生、早产或具有使其易患严重RSV疾病的特定健康状况的婴儿。

RSV disease requiring medical care included physician office, urgent care, emergency room visits and hospitalisations..

需要医疗护理的RSV疾病包括医生门诊、紧急护理、急诊室就诊和住院治疗。

About RSV

关于RSV

RSV is a highly contagious virus that can lead to serious respiratory illness for infants.[5] It is a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in otherwise healthy infants born at term[6-10]. Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday[4].

RSV是一种高度传染性的病毒，可导致婴儿严重呼吸道疾病。它是所有婴儿住院的主要原因，大多数因RSV住院的婴儿是足月出生的健康婴儿。三分之二的婴儿在出生后的第一年内感染RSV，几乎所有儿童在两岁生日前都会感染。

Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years[12]. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017[13]. .

2019年在全球范围内，急性下呼吸道感染病例约为3300万例，导致超过300万例住院治疗，并估计有26,300名5岁以下儿童在医院内死亡[12]。2017年，全球与RSV相关的直接医疗费用（包括住院、门诊和随访护理）估计为48.2亿欧元[13]。

About BEYFORTUS

关于BEYFORTUS

BEYFORTUS (nirsevimab) is the first immunisation designed for all newborns and infants for protection against RSV disease through their first RSV season, including for those born healthy at term or preterm, or with specific health conditions. It is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. .

BEYFORTUS（尼塞韦单抗）是首个为所有新生儿和婴儿设计的免疫接种，可保护他们在第一个RSV流行季免受RSV疾病侵害，包括足月或早产的健康婴儿，以及有特定健康状况的婴儿。该药物还适用于在第二个RSV流行季仍然容易罹患严重RSV疾病的24个月以下儿童。

As a long-acting antibody provided directly to newborns and infants as a single dose, BEYFORTUS offers rapid protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system. BEYFORTUS administration can be timed to coincide with the RSV season..

作为一种直接提供给新生儿和婴儿的长效抗体，BEYFORTUS单剂即可提供快速保护，帮助预防由呼吸道合胞病毒（RSV）引起的下呼吸道疾病，且无需激活免疫系统。BEYFORTUS的施用时间可以与RSV流行季节同步。

BEYFORTUS has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. Special designations to facilitate expedited development of BEYFORTUS were granted by several regulatory agencies, including Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation and Fast Track Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and BEYFORTUS has been named 'a medicine for prioritized development' under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development..

BEYFORTUS 已获准在欧盟、美国、中国、日本及世界许多其他国家使用。多个监管机构给予了特殊指定以促进 BEYFORTUS 的加速开发，包括中国国家药品监督管理局药品审评中心的突破性疗法认定和优先审评资格；美国食品和药物管理局的突破性疗法认定和快速通道资格；欧洲药品管理局（EMA）的PRIority MEdicines（PRIME）计划准入及 EMA 加速评估；英国药品和健康产品管理局的有前景创新药物资格；此外，根据日本医学研究开发机构的儿科新药开发促进药物筛选项目，BEYFORTUS 被列为“优先开发药物”。

About the clinical trials

关于临床试验

The Phase 2b trial[14] was a randomised, placebo-controlled trial designed to measure the efficacy of BEYFORTUS against medically attended lower respiratory tract disease (LRTD) caused by RSV through 150 days post-dose in healthy preterm infants of 29 to less than 35 weeks' gestation (n=1,453). Infants were randomised (2:1) to receive a single 50 mg intramuscular injection of BEYFORTUS (n=969) or placebo (n=484) regardless of weight at the RSV season start.

2b期试验[14]是一项随机、安慰剂对照试验，旨在评估BEYFORTUS在妊娠29至不足35周的健康早产儿（n=1,453）中，通过接种后150天内对由RSV引起的需医疗干预的下呼吸道疾病（LRTD）的疗效。婴儿按2:1的比例随机分配，接受单次50毫克肌肉注射的BEYFORTUS（n=969）或安慰剂（n=484），无论其在RSV季节开始时的体重如何。

The primary endpoint was met, significantly reducing the incidence of medically attended RSV LRTD by 70.1% (95% CI: 52.3, 81.2; P<0.001) compared to placebo. In a prespecified secondary endpoint, BEYFORTUS reduced medically attended RSV LRTD with hospitalisation by 78.4% (95% CI 51.9, 90.3) versus placebo..

主要终点已达成，与安慰剂相比，显著降低了70.1%的医疗就诊RSV下呼吸道疾病（LRTD）发生率（95%置信区间：52.3%，81.2%；P<0.001）。在预先设定的次要终点中，BEYFORTUS相较于安慰剂，将伴有住院的医疗就诊RSV下呼吸道疾病（LRTD）减少了78.4%（95%置信区间：51.9%，90.3%）。

The BEYFORTUS dosing regimen was determined based on further exploration of the Phase 2b data and was used in subsequent trials as a single 50 mg dose for infants who weigh less than 5 kg, or a single 100 mg dose for those who weigh 5 kg or greater. A post-hoc analysis of the Phase 2b study that applied the recommended 50 mg dose in a subgroup of infants weighing less than 5 kg showed the efficacy of BEYFORTUS against medically attended RSV LRTD and medically attended RSV LRTD with hospitalisation was 86.2% (95% CI 68.0, 94.0) and 86.5% (95% CI 53.5, 96.1), respectively..

BEYFORTUS的剂量方案是基于对2b期数据的进一步探索确定的，在后续试验中，体重低于5公斤的婴儿使用单次50毫克剂量，体重5公斤或以上的婴儿使用单次100毫克剂量。一项对2b期研究的事后分析应用了推荐的50毫克剂量于体重低于5公斤的婴儿亚组，结果显示BEYFORTUS对因RSV下呼吸道疾病（LRTD）就医和因RSV下呼吸道疾病住院的疗效分别为86.2%（95%置信区间68.0, 94.0）和86.5%（95%置信区间53.5, 96.1）。

The Phase 3 MELODY trial[15] was a randomised, double-blind, placebo-controlled trial conducted across 21 countries designed to determine the safety and efficacy of BEYFORTUS against medically attended LRTD caused by RSV in healthy term and late preterm infants (35 weeks gestational age or greater) entering their first RSV season, including efficacy against severe disease such as hospitalisation, through 150 days after dosing.

MELODY 三期试验[15] 是一项随机、双盲、安慰剂对照的试验，覆盖了 21 个国家，旨在评估 BEYFORTUS 在健康足月儿和晚期早产儿（胎龄 35 周或以上）中对抗由 RSV 引发的需医疗干预的下呼吸道疾病 (LRTD) 的安全性和有效性。这些婴儿正处于其首个 RSV 流感季节，试验还评估了对包括住院在内的重症的有效性，持续至给药后 150 天。

The primary endpoint was met, reducing the incidence of medically attended RSV LRTD by 74.5% (95% CI 49.6, 87.1; P<0.001) compared to placebo. The efficacy of BEYFORTUS against the secondary endpoint of hospitalisation was 62.1% (-8.6, 86.8). A pre-specified pooled analysis of the Phase 3 MELODY trial showed the efficacy of BEYFORTUS against medically attended RSV LRTD and medically attended RSV LRTD with hospitalisation was 79.5% (95% CI 65.9, 87.7; P<0.0001) and 77.3% (95% CI 50.3, 89.7; P<0.001), respectively..

主要终点得以达成，与安慰剂相比，BEYFORTUS将医学观察的RSV下呼吸道疾病（RSV LRTD）的发病率降低了74.5%（95%置信区间[CI] 49.6, 87.1；P<0.001）。针对次要终点住院率，BEYFORTUS的有效性为62.1%（95% CI -8.6, 86.8）。对3期MELODY试验的预设汇总分析显示，BEYFORTUS对医学观察的RSV LRTD以及伴有住院的医学观察RSV LRTD的有效性分别为79.5%（95% CI 65.9, 87.7；P<0.0001）和77.3%（95% CI 50.3, 89.7；P<0.001）。

MEDLEY was a Phase 2/3[16], randomised, double-blind, palivizumab-controlled trial with the primary objective of assessing safety and tolerability for BEYFORTUS in preterm infants of less than 35 weeks' gestational age and infants with congenital heart disease (CHD) and/or chronic lung disease (CLD) of prematurity eligible to receive palivizumab.

MEDLEY 是一项 2/3 期[16]、随机、双盲、以帕利珠单抗为对照的试验，其主要目的是评估 BEYFORTUS 在胎龄不足 35 周的早产儿以及患有先天性心脏病 (CHD) 和/或早产所致慢性肺病 (CLD) 且符合接受帕利珠单抗条件的婴儿中的安全性和耐受性。

Between July 2019 and May 2021, a total of 925 infants at higher risk for severe RSV disease entering their first RSV season were randomised to receive BEYFORTUS or palivizumab. Safety was assessed by monitoring the occurrence of treatment emergent adverse events (TEAEs) and treatment emergent severe adverse events (TESAEs) through 360 days post-dose.

在2019年7月至2021年5月期间，共有925名在首个RSV季节中面临较高重症RSV风险的婴儿被随机分配接受BEYFORTUS或帕利珠单抗治疗。通过监测给药后360天内治疗相关不良事件（TEAEs）和治疗相关严重不良事件（TESAEs）的发生情况来评估安全性。

Serum levels of BEYFORTUS following dosing (on day 151) in this trial were comparable with those observed in the Phase 3 MELODY trial, indicating similar protection in this population to that in healthy term and late preterm infants is likely..

在这个试验中，BEYFORTUS的血清水平（在第151天给药后）与3期MELODY试验中观察到的水平相当，表明该人群的保护作用可能与健康足月和晚期早产儿相似。

BEYFORTUS was well tolerated with a favourable safety profile that was similar to palivizumab in the MEDLEY Phase 2/3 trial and consistent with the safety profile in healthy term and preterm infants compared to placebo across the MELODY and Phase 2b trials. The overall rates of adverse events were comparable between BEYFORTUS and placebo and the majority of adverse events were mild or moderate in severity..

BEYFORTUS在MEDLEY的2/3期试验中显示出与帕利珠单抗相似的良好耐受性和良好的安全性，在MELODY和2b期试验中，其安全性与健康足月儿和早产儿中的安慰剂相比也是一致的。BEYFORTUS和安慰剂之间的总体不良事件发生率相当，且大多数不良事件的严重程度为轻度或中度。

The results of MELODY, Phase 2/3 MEDLEY and the Phase 2b trials illustrate that BEYFORTUS helped prevent RSV disease requiring medical care in all infant populations studied, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to severe RSV disease.

MELODY、2/3期MEDLEY和2b期试验的结果表明，BEYFORTUS有助于预防所有研究中的婴儿群体因RSV疾病需要就医的情况，包括足月或早产出生的健康婴儿，或具有特定健康状况使他们容易罹患严重RSV疾病的婴儿。

RSV disease requiring medical care included physician office, urgent care, emergency room visits and hospitalisations.[11].

需要医疗护理的RSV疾病包括医生门诊、紧急护理、急诊室就诊和住院。[11]。

These trials form the basis of regulatory submissions that began in 2022.

这些试验构成了 2022 年开始的监管提交的基础。

Another study, the Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) trial[2], [3], was a large European interventional clinical trial in 250 sites and including over 8,000 infants aiming to determine the efficacy and safety of a single intramuscular (IM) dose of BEYFORTUS (<5 kg 50 mg; ≥5 kg 100 mg), compared to no intervention (standard of care), for the prevention of hospitalisations due to RSV-related LRTD in infants under 12 months of age who are not eligible to receive palivizumab..

另一项研究，即住院RSV单克隆抗体预防（HARMONIE）试验[2]，[3]，是一项大型欧洲干预性临床试验，在250个地点进行，包括超过8000名婴儿，旨在确定单次肌肉注射（IM）BEYFORTUS（<5公斤 50毫克；≥5公斤 100毫克）与无干预（标准护理）相比，在预防因RSV相关下呼吸道疾病（LRTD）导致的住院方面的有效性和安全性，针对的是12个月以下且不符合接受帕利珠单抗条件的婴儿。

The data from HARMONIE show that BEYFORTUS reduced the incidence of hospitalisations due to RSV-related LRTD by 82.7% (95% CI: 67.8-91.5; p<0.0001) through 180 days after administration compared to no intervention, exceeding the typical length of the five-month RSV season. The high efficacy of 83.2% previously reported in the primary analysis was sustained over the longer follow-up period with no evidence of waning protection in infants born before or during the RSV season.

来自HARMONIE的数据表明，与未进行干预相比，BEYFORTUS在给药后180天内将因RSV相关下呼吸道疾病导致的住院率降低了82.7%（95%置信区间：67.8%-91.5%；p<0.0001），超过了通常为期五个月的RSV季节。先前在初步分析中报告的83.2%的高疗效在更长的随访期内得以维持，在RSV季节前或期间出生的婴儿中没有出现保护减弱的迹象。

BEYFORTUS maintained a favorable safety profile, consistent with clinical study results. [2], [3].

BEYFORTUS保持了良好的安全性，与临床研究结果一致。[2]，[3]。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more.

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并实现令人瞩目的增长。我们凭借对免疫系统的深刻理解，开发药物和疫苗，治疗和保护全球数百万人，并通过创新的研发管线，有望惠及更多人。

Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time..

我们的团队以一个目标为指导：我们追逐科学的奇迹以改善人们的生活；这激励我们通过应对当今最紧迫的医疗、环境和社会挑战，推动进步，为我们的员工和所服务的社区带来积极影响。