AstraZeneca and Sanofi’s long-acting antibody Beyfortus has been approved in China for the prevention of respiratory syncytial virus (RSV) infections in newborns and infants, opening up a major new market for the would-be blockbuster.

阿斯利康（AstraZeneca）和赛诺菲（Sanofi）的长效抗体Beyfortus已在中国获得批准，用于预防新生儿和婴儿呼吸道合胞病毒（RSV）感染，为这一未来的大片开辟了一个重要的新市场。

Beyfortus (nirsevimab) has also been approved in the US and Canada, EU, and GB, and is under review in other countries including Japan as a one-dose preventative treatment to protect infants born during or entering their first RSV season from lower respiratory tract infection (LRTI) with the virus.

Beyfortus（nirsevimab）也已在美国和加拿大，欧盟和英国获得批准，并正在包括日本在内的其他国家进行审查，作为一种单剂量预防性治疗，以保护在RSV季节出生或进入第一个RSV季节的婴儿免受下呼吸道感染（LRTI）病毒。

It is the first RSV prevention option to be approved in China that can be used in a broad infant population, including protecting those infants born healthy at term, or preterm, or with specific health conditions that make them vulnerable to severe RSV disease and is expected to be available in the upcoming 2024-2025 RSV season..

这是中国第一个获得批准的RSV预防方案，可用于广泛的婴儿人群，包括保护那些足月或早产健康出生的婴儿，或具有使其易患严重RSV疾病的特定健康状况的婴儿，预计将在即将到来的2024-2025 RSV季节提供。。

Beyfortus’ nearest rival is Pfizer’s RSV vaccine Abrysvo, which has also been approved in some markets for the protection of newborns from RSV in the first six months of life when given to mothers during pregnancy. So far Abrysvo has not been authorised in China.

Beyfortus最接近的竞争对手是辉瑞公司的RSV疫苗Abrysvo，该疫苗也已在一些市场获得批准，用于在怀孕期间给予母亲的新生儿在出生后头六个月内免受RSV的侵害。到目前为止，Abrysvo尚未在中国获得授权。

It replaces an older preventative antibody Synagis (palivizumab) that has been available for many years but was never widely adopted because it requires multiple doses and was quite expensive.

它替代了一种较旧的预防性抗体Synagis（帕利珠单抗），该抗体已有多年的历史，但从未被广泛采用，因为它需要多剂量且价格昂贵。

The Chinese approval comes shortly after clinical data from the UK, France and Germany on Beyfortus was published in the New England Journal of Medicine (NEJM), showing that the antibody could cut RSV-related hospitalisations by 83%.

在英国、法国和德国关于Beyfortus的临床数据发表在《新英格兰医学杂志》（NEJM）上后不久，中国批准了该抗体，表明该抗体可以将RSV相关的住院率降低83%。

The HARMONIE study in more than 8,000 infants randomly assigned to either Beyfortus or standard care during the winter season in conditions that approximated “real-world” settings also showed that the antibody reduced severe RSV LRTIs by 76%, and was tolerated well with only a few minor side effects..

HARMONIE研究在接近“现实世界”的条件下，在冬季随机分配到Beyfortus或标准护理的8000多名婴儿中进行，研究还表明，该抗体可将严重的RSV LRTI降低76%，并且耐受性良好，只有少数轻微副作用。。

That has already led to calls in the UK to extend the seasonal RSV immunisation programme to all newborn infants, sparing them from severe RSV disease and taking some of the pressure off hospital services.

这已经导致英国呼吁将季节性RSV免疫接种计划扩展到所有新生儿，使他们免于严重的RSV疾病，并减轻医院服务的一些压力。

Commenting on the data, Prof Peter Openshaw, professor of experimental medicine at Imperial College London (ICL), said some countries including Spain and Luxembourg have already decided to use Beyfortus to prevent RSV disease in all infants without contraindications.

伦敦帝国理工学院（ICL）实验医学教授彼得·Openshaw教授在评论这些数据时表示，包括西班牙和卢森堡在内的一些国家已经决定使用Beyfortus来预防所有没有禁忌症的婴儿的RSV疾病。

“We are waiting to see what effect it has on the circulation of the virus in communities, on viral evolution (we are not certain if escape mutants will develop) and on the wider health of babies and young children (some studies suggest that delaying RSV infection beyond the critical first 6 months of life will lead to reduced rates of recurrent wheeze and asthma diagnosis),” he added..

“我们正在等待它对病毒在社区中的传播，病毒进化（我们不确定是否会产生逃逸突变体）以及对婴儿和幼儿的更广泛健康产生什么影响（一些研究表明，将RSV感染延迟到生命的关键前6个月将导致反复喘息和哮喘诊断率降低），”他补充道。。

AZ has taken the lead on the development and manufacturing of the new drug, with Sanofi responsible for commercialisation, and recording sales, with the two companies sharing profits. There are already signs of strong take-up in the market, with supplies of the drug prioritised for use in vulnerable newborns in the US as the 2023-2024 RSV season got underway..

AZ在新药的开发和制造方面处于领先地位，赛诺菲负责商业化和销售记录，两家公司分享利润。随着2023-2024年RSV季节的开始，该药物的供应已被优先用于美国脆弱的新生儿，市场已经出现了强劲的吸纳迹象。。