21% reduction in annualised rate of moderate/severe exacerbations in a wide COPD population

在广泛的COPD患者群体中，中度/重度急性加重的年化率降低了21%

31% reduction in annualised rate of moderate/severe exacerbations in the sub-group of patients with chronic bronchitis only in post-hoc analysis

仅在慢性支气管炎患者的亚组中，中/重度急性加重的年化率在事后分析中减少了31%。

35% reduction in annualised rate of exacerbations leading to emergency department visit and/or hospitalisation secondary endpoint*

年化急性加重导致急诊就诊和/或住院的次要终点指标减少了35%*

GSK plc (LSE/NYSE: GSK) today announced positive results for

葛兰素史克公司（伦敦证券交易所/纽约证券交易所：GSK）今天宣布了积极的结果

Nucala

美泊利单抗

(mepolizumab) in the treatment of chronic obstructive pulmonary disease (COPD), with the full results from the MATINEE phase III trial published in the

（美泊利单抗）用于治疗慢性阻塞性肺疾病（COPD），其MATINEE III期试验的全部结果已发布在

New England Journal of Medicine

新英格兰医学杂志

. The trial evaluated mepolizumab, a monoclonal antibody targeting interleukin-5 (IL-5), in a wide spectrum of patients with COPD, including the most severe and difficult to treat as categorised in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.

该试验评估了美泊利单抗（一种靶向白细胞介素-5（IL-5）的单克隆抗体）在广泛慢性阻塞性肺疾病（COPD）患者中的效果，包括根据《全球慢性阻塞性肺疾病倡议》（GOLD）指南分类的最严重且最难治疗的患者。

1

1

Patients recruited had evidence of type 2 inflammation, characterised by blood eosinophil count, and included those with chronic bronchitis, emphysema-only or both.

招募的患者有2型炎症的证据，其特征为血液嗜酸性粒细胞计数，并包括那些患有慢性支气管炎、仅肺气肿或两者皆有的患者。

2

2

The monthly administration of mepolizumab demonstrated improvement across all exacerbation endpoints, which were maintained over the 2-year (up to 104 weeks) study period.

每月使用美泊利单抗治疗在所有恶化终点指标上均显示出改善，并在为期2年的（最长104周）研究期间保持了这种改善。

2

2

In the full population studied, mepolizumab showed a clinically meaningful and statistically significant 21% reduction in the annualised rate of moderate/severe exacerbations versus placebo, meeting the primary endpoint for MATINEE (rate ratio [95% confidence interval (CI)]: 0.79 [0.66, 0.94]; P=0.011) (AER mepolizumab = 0.80 exacerbations per year versus placebo = 1.01) n= 804; mepolizumab = 403, placebo = 401)..

在所研究的全人群中，与安慰剂相比，美泊利单抗显示出临床意义重大且统计学显著的21%的中/重度急性加重年化率降低，达到了MATINEE的主要终点（比率 [95%置信区间 (CI)]：0.79 [0.66, 0.94]；P=0.011）（美泊利单抗的年化率为每年0.80次急性加重，而安慰剂为1.01次）n=804；美泊利单抗组=403，安慰剂组=401）。

2

2

In addition, mepolizumab also showed a 31% reduction in the annualised rate of moderate/severe exacerbations versus placebo in a post-hoc analysis of patients with clinician assessed chronic bronchitis only (rate ratio [95% CI]: 0.69 [0.51, 0.93] n=338: mepolizumab = 170, placebo = 168).

此外，在对仅由临床医生评估为慢性支气管炎患者的后设分析中，与安慰剂相比，美泊利单抗显示出年度中/重度恶化率降低了31%（比率 [95% CI]: 0.69 [0.51, 0.93]，n=338：美泊利单抗 = 170，安慰剂 = 168）。

2

2

A 35% reduction in the annualised rate of exacerbations leading to emergency department visits and/or hospitalisation was shown with mepolizumab versus placebo, a secondary endpoint of the MATINEE study (rate ratio [95% CI]: 0.65 [0.43, 0.96] nominally significant after adjustment for multiplicity) (AER mepolizumab = 0.13 exacerbations per year versus placebo = 0.20)).

与安慰剂相比，美泊利单抗在导致急诊就诊和/或住院的年化急性加重率上显示出35%的降低，这是MATINEE研究的次要终点（率比[95%置信区间]：0.65 [0.43, 0.96]，在调整多重性后名义上显著）（美泊利单抗的年化急性加重率为0.13次/年，而安慰剂为0.20次/年）。

Mepolizumab is the only biologic with data that shows a reduction in emergency department visits and/or hospitalisation in a phase III trial. Reducing hospitalisations is a key goal of COPD management..

美泊利单抗是唯一一种在III期试验中显示出减少急诊就诊和/或住院次数的生物制剂。减少住院次数是慢性阻塞性肺疾病管理的关键目标。

3

3

COPD-related hospitalisations are a major healthcare challenge and projected to become the number one cause of medical admissions.

与慢性阻塞性肺疾病相关的住院治疗是一个主要的医疗挑战，并预计将成为医疗住院的首要原因。

4

4

If hospitalised due to COPD, one in ten patients will die during the stay, up to one in four over the next year and half will lose their lives within five years.

如果因慢性阻塞性肺病住院，十分之一的患者会在住院期间死亡，接下来的一年半内，四分之一的患者将失去生命，五年内会有一半患者去世。

5,6

5,6

Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology & Inflammation R&D, GSK said:

凯万·哈凡迪，高级副总裁，全球呼吸、免疫与炎症研发主管，GSK表示：

“Today’s MATINEE results show that mepolizumab can help prevent exacerbations, including those leading to emergency department visits and/or hospitalisation. These exacerbations are devastating for patients, known to cause irreversible lung damage, worsening of symptoms and increased mortality. For decades, we have and will continue to push the boundaries of innovation to prevent disease progression and make a meaningful impact on the lives of people affected by COPD.”.

“今天的MATINEE结果表明，美泊利单抗可以帮助预防病情恶化，包括那些导致急诊就诊和/或住院的情况。这些病情恶化对患者来说是毁灭性的，可能导致不可逆的肺损伤、症状加重以及死亡率增加。几十年来，我们一直在并将继续推动创新的边界，以防止疾病进展，并对受慢性阻塞性肺病影响的人们的生活产生有意义的影响。”

Frank Sciurba, Professor of Pulmonary, Allergy and Critical Care Medicine, and lead author of the MATINEE trial said:

肺部、过敏和重症监护医学教授，MATINEE试验的首席作者弗兰克·希乌尔巴表示：

“Every physician will know the feeling of seeing a patient hospitalised due to an exacerbation that could have possibly been prevented. The MATINEE trial uncovers new possibilities in the treatment landscape for COPD patients with type 2 inflammation, as we strive to target drivers of disease and improve the lives of patients suffering with COPD.”.

“每位医生都了解看到患者因可能预防的病情恶化而住院时的那种感受。MATINEE 试验揭示了针对具有 2 型炎症的 COPD 患者治疗领域的新可能性，我们致力于针对疾病驱动因素并改善 COPD 患者的生活。”

High response rates were observed in Patient Reported Outcomes (PROs) in the mepolizumab group, however there was no difference observed for St George’s Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT) and the Evaluating Respiratory Symptoms (E-RS) in the full study population versus placebo..

在美泊利单抗组中，患者报告结果（PROs）的反应率较高，但在整个研究人群中，圣乔治呼吸问卷（SGRQ）、慢性阻塞性肺病评估测试（CAT）和呼吸症状评估（E-RS）与安慰剂相比未观察到差异。

2

2

The incidence of adverse events were similar between mepolizumab and placebo (mepolizumab vs placebo: 74% vs 77%), with the most frequent being exacerbation or worsening of COPD (mepolizumab vs placebo: 12% vs 15%) and COVID-19 infection (12% vs 12%).

美泊珠单抗和安慰剂的不良事件发生率相似（美泊珠单抗 vs 安慰剂：74% vs 77%），其中最常见的为慢性阻塞性肺病（COPD）加重或恶化（美泊珠单抗 vs 安慰剂：12% vs 15%）以及新冠肺炎感染（12% vs 12%）。

2

2

Nucala

美泊利单抗

is not approved for the treatment of COPD in any country. Regulatory submissions are under review in several countries, including the US, China and the EU. The US FDA has provided a PDUFA date of May 7, 2025.

未获任何国家批准用于治疗慢性阻塞性肺疾病（COPD）。包括美国、中国和欧盟在内的多个国家正在审查监管提交。美国食品药品监督管理局（FDA）提供的PDUFA日期为2025年5月7日。

*Nominally significant after adjustment for multiplicity

*经多重性调整后名义上显著

About MATINEE

关于MATINEE

MATINEE is a phase III, randomised (1:1), double-blind, parallel-group trial assessing the efficacy and safety of mepolizumab 100 mg as add-on therapy, administered subcutaneously every 4 weeks for 52–104 weeks, versus placebo in addition to optimal inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroid)..

MATINEE 是一项 III 期、随机（1:1）、双盲、平行组试验，评估每4周一次皮下注射100 mg美泊利单抗作为附加治疗，持续52至104周，与安慰剂联合最佳吸入三联疗法（双长效支气管扩张剂加吸入性糖皮质激素）相比的疗效和安全性。

2

2

Positive results were achieved in a wide population of patients with COPD. The efficacy and safety of mepolizumab was assessed in patients with COPD with evidence of type 2 inflammation, characterised by a blood eosinophil count (≥300 cells/µL). Patients could participate with a range of clinical presentations of COPD including chronic bronchitis, emphysema only or a combination of both.

在广泛的COPD患者群体中取得了积极的结果。评估了美泊利单抗在伴有2型炎症证据的COPD患者中的疗效和安全性，这些患者的特点是血液嗜酸性粒细胞计数（≥300个细胞/µL）。患者可以有多种COPD临床表现参与研究，包括慢性支气管炎、仅肺气肿或两者兼有。

The condition of patients ranged in severity from moderate to very severe, or stages 2-4 as assessed by the medically recognised scale of Global Initiative for Chronic Obstructive Lung Disease (GOLD)..

患者的病情严重程度从中度到非常严重不等，或者根据医学公认的慢性阻塞性肺疾病全球倡议（GOLD）评估标准，处于2-4阶段。

2

2

The full analysis of MATINEE included 403 patients enrolled on the mepolizumab arm and 401 on placebo, all of whom had experienced exacerbations in the previous year despite receiving optimised inhaled maintenance therapy.

MATINEE 的完整分析包括 403 名接受美泊利单抗治疗的患者和 401 名接受安慰剂的患者，所有患者在前一年尽管接受了优化的吸入维持治疗，仍然经历了病情加重。

2

2

About chronic obstructive pulmonary disease (COPD) and type 2 inflammation

关于慢性阻塞性肺疾病（COPD）和2型炎症

COPD is a progressive and heterogeneous inflammatory lung disease that includes chronic bronchitis and/or emphysema.

慢性阻塞性肺疾病（COPD）是一种进行性和异质性的炎症性肺部疾病，包括慢性支气管炎和/或肺气肿。

3

3

It affects more than 390 million people globally and is the third leading cause of death.

它影响着全球超过3.9亿人，并且是第三大死亡原因。

7,8

7,8

Patients with COPD experience persistent respiratory symptoms such as breathlessness, cough, and sputum along with progressive airflow obstruction due to the chronic inflammation, that impact daily life.

慢性阻塞性肺病患者因慢性炎症导致持续的呼吸道症状，如呼吸困难、咳嗽和咳痰，以及进行性气流阻塞，影响日常生活。

3

3

Type 2 inflammation is present in a variety of immuno-inflammatory conditions and is a major contributor to symptoms and exacerbations in up to 40% of people with COPD.

2型炎症存在于多种免疫炎症性疾病中，并且是高达40%的COPD患者出现症状和病情加重的主要原因。

2,9

2,9

Despite inhaled triple therapy, many patients experience persistent symptoms and exacerbations.

尽管使用了吸入三联疗法，许多患者仍然出现持续症状和病情加重。

10

10

Exacerbations are acute episodes of worsening COPD symptoms, which can result in hospitalisation and irreversible lung damage.

急性加重是COPD症状恶化的急性发作，可能导致住院和不可逆的肺损伤。

3

3

Early intervention is important in preventing exacerbations and cumulative lung damage.

早期干预对于预防病情加重和肺部累积损伤非常重要。

3

3

About

关于

Nucala

美泊利单抗

Nucala

美泊利单抗

is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation.

是一种单克隆抗体，靶向并结合白细胞介素-5（IL-5），这是2型炎症中的关键信使蛋白（细胞因子）。

Nucala

美泊利单抗

has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation. It is currently approved for use in the US and Europe across four IL-5 mediated conditions.

已被开发用于治疗一系列与2型炎症相关的IL-5介导疾病。它目前在美国和欧洲已获批用于四种IL-5介导的病症。

Nucala

美泊利单抗

is currently not indicated for COPD in any country.

目前在任何国家都不适用于慢性阻塞性肺病 (COPD)。

For product and important safety information please consult the country relevant summary of product characteristics.

有关产品和重要安全信息，请查阅与国家相关的特性概要。

EU available at:

欧盟可用：

https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf.

https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf

The US prescribing information is available at:

美国处方信息可在此处获取：

NUCALA-PI-PIL-IFU-COMBINED.PDF

NUCALA-PI-PIL-IFU-合并.PDF

.

。

About GSK in respiratory

关于GSK在呼吸领域的介绍

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease.

葛兰素史克继续基于数十年的开创性工作，致力于实现更宏大的治疗目标，开发下一代护理标准，并为数亿呼吸系统疾病患者重新定义呼吸医学的未来。凭借行业领先的呼吸系统产品组合与疫苗、靶向生物制剂和吸入药物的研发管线，我们专注于改善各类哮喘和慢性阻塞性肺病（COPD）患者的治疗效果与生活质量，同时关注较难理解的难治性慢性咳嗽以及系统性硬化症伴随间质性肺病等罕见病症。

GSK is harnessing the latest science and technology with the aim of modifying the underlying disease dysfunction and preventing progression..

GSK 正在利用最新的科学和技术，旨在改善潜在的疾病功能障碍并防止其进展。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性声明的警示性声明

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025..

GSK提醒投资者，GSK所做的任何前瞻性声明或预测，包括本公告中所做的声明，均受风险和不确定性的影响，可能导致实际结果与预测结果存在重大差异。这些因素包括但不限于GSK 2024年Form 20-F年度报告中“风险因素”部分以及GSK 2025年第一季度业绩报告中描述的内容。

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