Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control

基于MIRACLE III期试验的批准表明，哮喘急性发作的显着减少和哮喘症状控制的改善具有临床意义

AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older with severe eosinophilic asthma (SEA).1

阿斯利康的Fasenra（贝那利珠单抗）已在中国获得国家医疗产品协会（NMPA）的批准，用于12岁及以上严重嗜酸性粒细胞性哮喘（SEA）患者的维持治疗

The approval is based on results from the MIRACLE Phase III trial, which was conducted in China, South Korea and the Philippines.2 In the trial, Fasenra achieved a statistically significant and clinically meaningful 74% reduction (0.49 in the Fasenra group compared to 1.88 in the placebo group, rate ratio 0.26, p<0.0001) in the annualised asthma exacerbation rate (AAER) when added to standard of care in patients with SEA.2 Fasenra met all primary and key secondary endpoints in the trial, demonstrating improvements in lung function and asthma symptom control.2.

该批准是基于在中国，韩国和菲律宾进行的MIRACLE III期试验的结果。在该试验中，当加入SEA患者的护理标准时，Fasenra实现了统计学显着和临床意义上的74%降低（Fasenra组为0.49，安慰剂组为1.88，比率为0.26，p＜0.0001）。Fasenra符合试验中所有主要和关键次要终点，表明肺功能和哮喘症状控制有所改善。

It is estimated that approximately 3 million people in China have SEA.3-6 Despite the significant prevalence in China, treatment options are limited, and severe asthma is often misdiagnosed and undertreated.3 The burden of SEA for patients is significant with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.7-10 Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma, have twice the risk of asthma-related hospitalisations.11-13 There is also a significant socio-economic burden, with these patients accounting for approximately 50% of asthma-related costs.14.

据估计，中国约有300万人患有SEA.3-6。尽管中国患病率很高，但治疗选择有限，严重哮喘常被误诊和治疗不足[3]。SEA对患者的负担很重，患者经常出现恶化，肺功能显着受限，生活质量下降[7-10]。严重哮喘患者的死亡风险增加，与持续性哮喘患者相比，哮喘相关住院风险增加了一倍[11-13]。社会经济负担也很重，这些患者约占哮喘相关费用的50%。

Dr. Nanshan Zhong, Academician of the Chinese Academy of Engineering, and International Coordinating Investigator of the trial said: “Many patients in China with severe eosinophilic asthma have uncontrolled disease and experience frequent exacerbations, symptom worsening and reduced lung function despite the use of inhaled therapies.

中国工程院院士、该试验国际协调研究员钟南山博士表示：“尽管使用了吸入疗法，但中国许多严重嗜酸性粒细胞性哮喘患者的疾病不受控制，经常恶化，症状恶化，肺功能下降。

There are several ongoing studies to address these unmet needs in China. The recent MIRACLE trial showed that benralizumab, which has a unique mechanism of action, can help patients achieve early and sustained control of their asthma symptoms. There’s now potential for many more patients in China to benefit from treatment.”.

有几项正在进行的研究旨在解决中国这些未满足的需求。最近的MIRACLE试验表明，贝那利珠单抗具有独特的作用机制，可以帮助患者早期持续控制哮喘症状。现在，中国有可能有更多的患者从治疗中受益。”。

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: “Today's approval is an important step forward in the treatment of severe asthma in China, which affects millions of patients. Those living with severe asthma will soon have access to Fasenra, which rapidly targets eosinophils, resulting in a significant reduction of asthma exacerbations and clinically meaningful symptom relief for patients.”.

阿斯利康生物制药事业部执行副总裁路德·多伯（Ruud Dobber）表示：“今天的批准是中国治疗严重哮喘的重要一步，严重哮喘会影响数百万患者。患有严重哮喘的患者将很快可以使用Fasenra，Fasenra可迅速靶向嗜酸性粒细胞，从而显着减少哮喘恶化，缓解患者的临床症状。”。

The safety and tolerability profile for benralizumab in the MIRACLE trial was consistent with the known safety profile of the medicine.2

MIRACLE试验中贝那利珠单抗的安全性和耐受性与已知的药物安全性一致。2

Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries, including the US, Japan, EU and now China.15-18 It is also approved in children and adolescents ages 6 and above in the US and Japan.

Fasenra目前在80多个国家被批准作为SEA的附加维持治疗，包括美国、日本、欧盟和现在的中国。15-18它也被批准用于美国和日本6岁及以上的儿童和青少年。

Notes

注意事项

Severe Asthma

严重哮喘

Asthma is a major chronic respiratory disease that affects an estimated 300 million people worldwide.2 Up to 10% of people with asthma have severe asthma that is uncontrolled.2 Eosinophilic inflammation drives the eosinophilic phenotype of asthma, which is seen in more than 80% of patients with severe asthma.2 Patients may be uncontrolled despite high dosages of standard of care asthma controller medicines, experiencing frequent exacerbations and significant limitations on lung function and health-related quality of life as a result.7-10,19.

哮喘是一种主要的慢性呼吸系统疾病，影响全世界约3亿人[2]。高达10%的哮喘患者患有严重的哮喘，无法控制[2]。嗜酸性粒细胞炎症驱动哮喘的嗜酸性粒细胞表型，超过80%的严重哮喘患者[2]。尽管使用了高剂量的标准治疗哮喘控制药物，但患者可能无法控制，因此经常恶化，肺功能和健康相关生活质量受到显着限制[7-10,19]。

MIRACLE

奇迹

MIRACLE was a randomised, double-blind, parallel group, placebo-controlled Phase III trial in China, South Korea, and Philippines evaluating the efficacy and safety of Fasenra in 695 patients aged 12 to 75 years of age with a history of uncontrolled asthma who received medium or high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.2.

MIRACLE是一项在中国，韩国和菲律宾进行的随机，双盲，平行组，安慰剂对照的III期临床试验，评估了Fasenra对695名年龄在12至75岁之间，有不受控制哮喘病史的患者的疗效和安全性。接受中剂量或高剂量吸入皮质类固醇加长效β2受体激动剂（ICS-LABA），有或没有口服皮质类固醇和其他哮喘控制者。

The primary endpoint was a reduction in the AAER over 48 weeks in patients with severe eosinophilic asthma and baseline blood eosinophil count (bEOS) ≥300/μL on 30mg Fasenra subcutaneous eight-week dosing compared to placebo. All patients were randomised to either placebo or Fasenra (1:1 ratio). Fasenra achieved a statistically significant and clinically meaningful 74% reduction (0.49 in the Fasenra group compared to 1.88 in the placebo group, rate ratio 0.26, p<0.0001).2.

主要终点是严重嗜酸性粒细胞哮喘患者48周内AAER降低，与安慰剂相比，30mg Fasenra皮下给药8周后基线血嗜酸性粒细胞计数（bEOS）≥300/μL。所有患者被随机分配到安慰剂或Fasenra（1:1比例）。Fasenra降低了74%，具有统计学意义和临床意义（Fasenra组为0.49，安慰剂组为1.88，比率为0.26，p＜0.0001）。

Patients were stratified by country/region, age group (adult or adolescent), and peripheral blood eosinophil count at time of visit 1 (<300 or ≥300 cells/μL). Key secondary efficacy endpoints were change from baseline at Week 48 in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) and total asthma symptom score (TASS) in patients with baseline bEOS ≥300/μL.

患者在第1次就诊时按国家/地区，年龄组（成人或青少年）和外周血嗜酸性粒细胞计数（<300或≥300个细胞/μL）进行分层。关键的次要疗效终点是基线bEOS≥300/μL患者的支气管扩张剂（BD）1秒用力呼气量（FEV1）和总哮喘症状评分（TASS）从第48周的基线变化。

Other secondary efficacy endpoints included change from baseline in morning and evening peak expiratory flow (PEF), Asthma Control Questionnaire 6 (ACQ-6), St. George’s Respiratory Questionnaire (SGRQ), AAER associated with an emergency room (ER)/urgent care (UC) visit or hospitalisation, time to first asthma exacerbation and proportion of patients with ≥1 asthma exacerbation, and blood eosinophil levels.2.

其他次要疗效终点包括早晚呼气峰流量（PEF），哮喘控制问卷6（ACQ-6），圣乔治呼吸问卷（SGRQ），与急诊室（ER）/紧急护理相关的AAER（UC）就诊或住院，首次哮喘恶化的时间和≥1次哮喘恶化患者的比例，以及血液嗜酸性粒细胞水平。

Fasenra

法森拉

Fasenra (benralizumab) is currently approved in more than 80 countries, including the US, EU, Japan and now China.15-18 Fasenra has been prescribed to over 130,000 patients globally.20

Fasenra（benralizumab）目前已在80多个国家获得批准，包括美国，欧盟，日本和现在的中国.15-18 Fasenra已被全球超过130000名患者处方.20

Fasenra is in development for other diseases, including chronic obstructive pulmonary disease (COPD), chronic rhinosinuitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome.21-24

Fasenra正在开发其他疾病，包括慢性阻塞性肺病（COPD），慢性鼻息肉伴鼻息肉（CRSwNP），嗜酸性肉芽肿伴多血管炎（EGPA）和嗜酸性粒细胞增多综合征

Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

Fasenra由阿斯利康开发，由日本协和麒麟株式会社的全资子公司BioWa，Inc.授权。

AstraZeneca in Respiratory & Immunology

阿斯利康呼吸与免疫学

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

呼吸与免疫学是阿斯利康生物制药的一部分，是该公司的关键疾病领域和增长驱动力。

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets.

阿斯利康是呼吸系统护理领域的公认领导者，拥有50年的历史，并且在免疫介导疾病方面的药物组合不断增加。。

Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases..

我们的目标是提供改变生命的药物，帮助消除COPD作为主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康（LSE/STO/Nasdaq:AZN）是一家全球科学领先的生物制药公司，专注于肿瘤学，罕见病和生物制药（包括心血管，肾脏和代谢以及呼吸和免疫学）处方药的发现，开发和商业化。

Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

阿斯利康的创新药物总部位于英国剑桥，在125多个国家销售，全球数百万患者使用。请访问astrazeneca.com并在社交媒体@astrazeneca上关注该公司。

Contacts

联系人

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

有关如何联系投资者关系团队的详细信息，请单击此处。有关媒体联系人，请单击此处。

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