Beyfortus approved in Japan for the prevention of RSV disease in infants

First and only RSV preventive option for broad infant population authorised for use in Japan

澳门在线赌城娱乐和赛诺菲 Beyfortus (nirsevimab), 长效单克隆抗体, 在日本被批准用于预防由呼吸道合胞病毒(RSV)引起的所有新生儿下呼吸道疾病(LRTD), 婴儿和儿童进入他们的第一个呼吸道合胞病毒季节, 以及预防新生儿呼吸道合胞病毒感染, 有严重呼吸道合胞病毒感染风险的婴儿和儿童 进入他们的第一个或第二个RSV季节.¹ Beyfortus is anticipated to be available for the upcoming 2024/25 RSV season, 符合日本现有的指导方针.

Beyfortus is the first preventive option developed to protect a broad infant population against RSV LRTD, 包括保护那些足月健康出生的婴儿, or preterm, or with specific health conditions that make them vulnerable to severe disease. The approval by the Japanese Ministry of Health, Labour and Welfare is based on three Beyfortus 关键的后期临床试验. 在所有临床终点，单剂量 Beyfortus demonstrated consistent efficacy against RSV LRTD extending through five months, 典型RSV流行季节的持续时间.^2-5

More than 100,000 cases of RSV LRTD in infants are reported every year in Japan including healthy infants born at term.⁶

Dr. Hiroyuki Moriuchi, 儿科学教授兼系主任, 长崎大学生物医学研究生院, said: “This is an important milestone in the fight against RSV in infants. Almost all children are affected by RSV by the age of two and all infants, 包括那些健康出生和足月出生的人, can be at risk. 呼吸道合胞病毒对儿童造成重大负担, 他们的家庭和医疗系统可能导致婴儿严重感染的长期后果. Beyfortus 是否能在整个RSV季节保护婴儿，其批准对日本RSV疾病的预防和控制做出了重要贡献.”

Iskra Reic, 执行副总裁, 疫苗和免疫疗法, AstraZeneca, 说:“批准。 Beyfortus 这意味着首次有可能预防日本所有婴儿因呼吸道合胞病毒引起的严重呼吸道疾病，并减轻卫生保健系统的传染病负担. Beyfortus 这反映了澳门在线赌城娱乐对科学开发预防方案的承诺，以支持最脆弱的患者群体，澳门第一赌城在线娱乐期待着做出 Beyfortus 该片将于2024/25季在日本上映.” 

Beyfortus 已在欧盟、美国和中国获得批准.

Notes

Japan Beyfortus indication¹
以下几组新生儿, infants or children at risk of serious RSV infection 进入他们的第一个或第二个RSV季节, 应至少符合下列其中一项标准:

• 在第一个呼吸道合胞病毒季节的早期阶段

o  Infants born at 28 weeks’ gestation or earlier and less than 12 months of age

o  Infants born at 29 to 35 weeks' gestation and less than 6 months of age

• 在第一个和第二个RSV季节的早期阶段

o  Neonates, 在过去6个月内接受过一种慢性肺病治疗的婴儿或小于24个月的儿童

o  Neonates, infants or children less than 24 months of age with hemodynamically significant congenital heart disease

o   Neonates, infants or children less than 24 months of age with immunocompromised conditions

o   Neonates, infants or children less than 24 months of age with Down syndrome

全球关键性临床试验
IIb期(试验03)研究是随机的, 安慰剂对照试验旨在衡量的疗效 Beyfortus against medically attended (MA) Lower Respiratory Tract Infection (LRTI) through 150 days post-dose. 29至小于35周胎龄的健康早产儿随机(2:1)接受单次50mg的肌内注射 Beyfortus 或者安慰剂，不管体重如何.^1,4

The Beyfortus 给药方案是基于对IIb期数据的进一步探索确定的，并在随后的试验中作为50mg单剂量用于体重小于5kg的患者, 体重在5公斤或以上的人单次服用100毫克.^1,4

MELODY III期研究(Trial 04)是一项随机研究, double-blind, placebo-controlled trial conducted across 21 countries designed to determine efficacy of Beyfortus against medically attended LRTI through 150 days after dosing, versus placebo, 健康足月和晚期早产儿(胎龄35周或更大)进入第一个RSV季节.^1-3

The MEDLEY (Trial 05) was a Phase II/III, randomised, double-blind, Synagis (palivizumab)-controlled trial with the primary objective of assessing safety and tolerability for Beyfortus 在小于35周胎龄的早产儿和患有先天性心脏病(CHD)和/或早产儿慢性肺部疾病(CLD)的婴儿中接受治疗 Synagis. 2019年7月至2021年5月, 在每个接受治疗的早产儿和CLD/CHD队列中，共有925名进入第一个RSV季节的婴儿被随机分配(2:1) Beyfortus or Synagis. 来自CLD/CHD队列的262名24个月以下的儿童在第二个RSV季节继续进行试验. Safety was assessed by monitoring the occurrence of adverse events through 360 days post-dose.

MELODY的结果, MEDLEY Phase II/III and the Phase IIb trials demonstrate that a single dose of Beyfortus helps protect infants during their first RSV season against RSV disease. 这一广泛的婴儿人口包括健康的足月, 晚期早产儿和早产儿, as well as infants with specific health conditions that make them vulnerable to severe RSV disease.^1,5

These trials formed the basis of regulatory submissions which began in 2022.

Results

IIb期试验(试验03)
IIb期研究的主要终点得到满足, 减少医疗护理下呼吸道感染的发生率 caused by RSV by 70.1% (95% CI: 52.3, 81.2)与安慰剂相比. 事件发生率为2.治疗组6% vs . 9%.5% in placebo arm. Between November 2016 and December 2017, 1,453 infants were randomised (Beyfortus, n=969; placebo, n=484) at the RSV season start. Research was conducted by AstraZeneca in both hemispheres, at 164 sites in 23 countries. 数据发表于 NEJM in July 2020.^1,4

在预先指定的次要终点， Beyfortus reduced medically attended RSV LRTI with hospitalisation by 78.4% (95% CI 51.9, 90.3) versus placebo. 观察到的事件为0.治疗组8% vs 4%.1% in placebo arm.¹ A subgroup analysis by body weight indicated a lower efficacy in infants >5 kg vs <5kg. IIb期研究的事后分析结果显示，在体重小于5kg的婴儿亚组中使用推荐的50mg剂量的效果 Beyfortus against medically attended RSV LRTI and medically attended RSV LRTI with hospitalisation was 86.2% (95% CI 68.0, 94.0) and 86.5% (95% CI 53.5, 96.1) respectively.^1,7

MELODY III期试验(试验04)
MELODY III期试验的主要终点达到了, 减少医疗护理下呼吸道感染的发生率, 如细支气管炎或肺炎, 是由RSV引起的.5%(95%置信区间(CI).6, 87.1; P<0.001)与安慰剂相比.³ 事件发生率为1.治疗组为2%，安慰剂组为5%. The Beyfortus dosing regimen was determined based on further exploration of the Phase IIb data and was 50mg<5kg and 100 mg >=5kg. The efficacy of Beyfortus 而住院治疗的次要终点为62例.1% (95% CI: -8.6, 86.8). 观察到的事件为0.治疗组6% vs . 1%.6% in placebo arm. Between July 2019 and March 2020, 1,490 infants were randomised to receive either Beyfortus 或在RSV季节开始时服用安慰剂. MELODY初级队列的初步数据发表于 NEJM in March 2022.^1,5

MEDLEY II/III期试验(试验05)
Serum levels of Beyfortus 在本试验中给药后(第151天)与MELODY III期试验中观察到的结果相当, 这表明在这一人群中，与健康足月婴儿和晚期早产儿的保护作用相似. 在第一个RSV季节, the incidence of medically attended RSV LRTI through 150 days post dose was 0.6% (4/616) in the Beyfortus group and 1.0% (3/309) in the Synagis group. 在第二个RSV季节, there were no cases of medically attended RSV LRTI through Day 150 in children who received either Beyfortus or Synagis. 数据发表于 新英格兰医学杂志(NEJM) in March 2022.^1,5

的安全概况 Beyfortus was similar to Synagis 在MEDLEY II/III期试验中，与MELODY和IIb期试验中研究的健康足月和早产儿的安全性一致. While uncommon, the most reported adverse reactions were: rash 14 days post-dose (the majority of which were mild to moderate); non-serious injection site reactions within 7 days post-dose.^1,3,5

Beyfortus
Beyfortus (nirsevimab)是单剂量长效抗体, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca’s YTE technology. 它旨在保护在第一个RSV季节出生或进入第一个RSV季节的婴儿，以及24个月以下的儿童，他们在第二个RSV季节仍然容易患上严重的RSV疾病.  Beyfortus, 以单剂形式直接提供给新生儿和婴儿, offers rapid protection via an antibody to help prevent LRTD caused by RSV, 不需要激活免疫系统.

Beyfortus 可在呼吸道合胞病毒流行季节开始时给药，或在该季节出生的婴儿接种时给药.¹

Beyfortus 是否已被世界各地的几个主要监管机构授予监管指定，以促进加速发展. 其中包括国家药品监督管理局中国药品审评中心认定的突破性疗法和优先审评认定; 突破性的治疗  Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA 优先级的药品 (PRIME)) scheme; and 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 (AMED).

Sanofi Alliance
2017年3月，澳门在线赌城娱乐和赛诺菲 announced 开发和商业化nirsevimab的协议. 根据协议条款, 澳门在线赌城娱乐在研发和生产活动中处于领先地位, and Sanofi leads commercialisation activities and records revenue. The two companies share costs and profits in all territories except the US. 澳门在线赌城娱乐从该协议中获得的收入在公司财务报表中报告为联盟收入和合作收入.

Following a revision 到澳门在线赌城娱乐公司与尼希米单抗在美国的开发和商业化的利润分享安排, Sanofi and Sobi, 索比已经与赛诺菲建立了直接合作关系, replacing the previous participation agreement with AstraZeneca entered into in November 2018.

Beyfortus will be co-promoted by AstraZeneca and Sanofi in Japan.

AstraZeneca
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, science-led biopharmaceutical company that focuses on the discovery, development, 以及肿瘤学处方药的商业化, Rare Diseases, 和澳门第一赌城在线娱乐, 包括心血管, Renal & 新陈代谢和呼吸 & Immunology. 总部设在剑桥, UK, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. Please visit basilinfracon.com 并在社交媒体上关注公司 @AstraZeneca.

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