GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications.

GSK plc（LSE/NYSE：GSK）今天宣布，美国食品和药物管理局（FDA）已接受对其生物制品许可申请进行审查，该申请涉及depemokimab在两种适应症中的使用。

The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)..

提议的适应症为：作为12岁及以上具有2型炎症（以嗜酸性粒细胞表型为特征）的成人和儿童哮喘患者的附加维持治疗，这些患者使用中至高剂量吸入性糖皮质激素（ICS）加另一种哮喘控制药物；以及作为对伴有鼻息肉的慢性鼻窦炎（CRSwNP）控制不佳的成年患者的附加维持治疗。

The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025.

《处方药使用者费用法案》（PDUFA）的日期是2025年12月16日。

Global Head, Respiratory, Immunology & Inflammation R&D, GSK

全球呼吸、免疫与炎症研发主管，GSK

“Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems. Our SWIFT and ANCHOR trials support depemokimab’s potential to suppress interleukin-5 (IL-5), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year.”.

“同时提交两种适应症的监管文件，彰显了我们对depemokimab在减轻哮喘和CRSwNP对患者及卫生系统负担方面的信心。我们的SWIFT和ANCHOR试验支持depemokimab抑制白细胞介素-5（IL-5）的潜力，IL-5是已知的2型炎症驱动因素，通过每年仅两次的剂量即可为患者提供对其疾病关键驱动因素的持续抑制。”

Depemokimab, a monoclonal antibody that targets IL-5, is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions.

Depemokimab是一种靶向IL-5的单克隆抗体，是首个在III期试验中评估并被接受用于这些条件的监管审查的超长效生物制剂。

Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results from the SWIFT and ANCHOR trials.

根据SWIFT和ANCHOR试验的结果，Depemokimab的延长半衰期、高结合亲和力和效力支持六个月（26周）的给药方案。

In patients with asthma with type 2 inflammation and patients with CRSwNP, these trials met their primary endpoints, showing that depemokimab could offer sustained inhibition of a key driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year..

在患有2型炎症的哮喘患者和慢性鼻窦炎伴鼻息肉患者中，这些试验达到了主要终点，显示depemokimab能够持续抑制其疾病的关键驱动因素，并通过每年仅两次注射的给药方案帮助实现关键临床结果。

As demonstrated in studies of other diseases, longer intervals between doses have been shown to overcome barriers to optimal care, such as patient adherence.

正如在其他疾病的研究中所证明的那样，延长剂量间隔可以克服最佳治疗的障碍，例如患者的依从性。

IL-5 is a key cytokine (protein) in type 2 inflammation.

IL-5是2型炎症中的关键细胞因子（蛋白质）。

Type 2 inflammation is typically identified by blood eosinophil count and is

2型炎症通常通过血液嗜酸性粒细胞计数来识别，并且是

an underlying driver in many diseases.

许多疾病的一个根本驱动因素。

This type of inflammation is present in the majority of patients with difficult to treat asthma and can lead to exacerbations and hospitalisation.

这种炎症类型存在于大多数难以治疗的哮喘患者中，可能导致病情加重和住院。

Type 2 inflammation is also present in up to 85% of people with CRSwNP and is associated with more severe disease and symptoms.

2型炎症也存在于高达85%的CRSwNP患者中，并与更严重的疾病和症状相关。

In the United States, more than 26 million people are currently affected by asthma, 40% of whom report having had at least one asthma attack in the previous year which contributes to significant burden this condition exerts on healthcare resources and the lives of patients.

在美国，目前有超过 2600 万人患有哮喘，其中 40% 的人报告称在上一年至少出现过一次哮喘发作，这对医疗资源和患者的生活造成了巨大的负担。

Each year asthma leads to an estimated 100,000 hospitalisations and nearly 1 million emergency department visits and we

每年哮喘导致约 10 万人住院，近 100 万急诊就诊，我们

are determined to help reduce the burden that respiratory diseases like asthma and CRSwNP exert on patients and healthcare systems.

决心帮助减轻哮喘和CRSwNP等呼吸系统疾病给患者和医疗系统带来的负担。

In the United States, 2.1% of the population are affected by chronic rhinosinusitis, up to 30% of whom have nasal polyps.

在美国，2.1%的人口受到慢性鼻窦炎的影响，其中多达30%的人患有鼻息肉。

People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.

患有CRSwNP的人会出现鼻塞、嗅觉丧失、面部疼痛、睡眠障碍、感染和流鼻涕等症状，这些症状可能严重影响他们的情绪和身体健康。

Such symptoms mean the

这样的症状意味着

impact of CRSwNP on overall quality of life has been reported to be comparable with other chronic diseases such as COPD, asthma, and diabetes.

CRSwNP对整体生活质量的影响据报道与其他慢性疾病如COPD、哮喘和糖尿病相当。

Depemokimab is currently not approved for use in any country.

Depemokimab目前尚未在任何国家获得批准使用。

About the depemokimab development programme

关于depemokimab开发计划

The phase III asthma programme consists of SWIFT-1 and SWIFT-2 in asthma with type 2 inflammation, with an open label extension study (AGILE).

III期哮喘项目包括SWIFT-1和SWIFT-2，针对具有2型炎症的哮喘，并附有一个开放标签扩展研究（AGILE）。

An additional study (NIMBLE) is underway to assess the efficacy and safety of depemokimab when participants with asthma with type 2 inflammation are switched from mepolizumab or benralizumab.

一项额外的研究（NIMBLE）正在进行中，以评估当2型炎症哮喘患者从美泊利单抗或贝那利珠单抗转换为depemokimab时，该药物的疗效和安全性。

The phase III programme in CRSwNP includes two studies, ANCHOR-1 and ANCHOR-2.

针对CRSwNP的III期项目包括两项研究，ANCHOR-1和ANCHOR-2。

Depemokimab is currently being evaluated in phase III trials for the treatment of other IL-5

Depemokimab目前正在进行III期临床试验，用于治疗其他IL-5相关疾病。

mediated diseases, including OCEAN for eosinophilic granulomatosis with polyangiitis (EGPA)

介导的疾病，包括用于嗜酸性肉芽肿性多血管炎 (EGPA) 的 OCEAN

and DESTINY for hypereosinophilic syndrome (HES).

和 DESTINY 用于高嗜酸性粒细胞综合征 (HES)。

About SWIFT-1 and SWIFT-2

关于SWIFT-1和SWIFT-2

SWIFT-1 and SWIFT-2 were replicate 52-week, randomised (2:1), double-blind, placebo-controlled, parallel-group, multi-centre Phase III clinical trials.

SWIFT-1 和 SWIFT-2 是为期 52 周的重复、随机（2:1）、双盲、安慰剂对照、平行组、多中心 III 期临床试验。

The trials assessed the efficacy and safety of depemokimab as adjunctive therapy in 382 and 380 participants with severe asthma with

试验评估了 depemokimab 作为辅助疗法在 382 名和 380 名重度哮喘参与者中的疗效和安全性，具有

type 2 inflammation characterised by blood eosinophil count, including

以血液嗜酸性粒细胞计数为特征的2型炎症，包括

adult and adolescent patients, who were randomised to receive depemokimab or a placebo respectively, in addition to their standard of care treatment with medium to high-dose inhaled corticosteroids plus at least one additional controller.

成人和青少年患者，他们被随机分配接受depemokimab或安慰剂，同时继续使用中高剂量吸入性糖皮质激素及至少一种其他控制药物的标准治疗。

Number of subjects included in the Full Analysis of SWIFT-1: depemokimab = 250, placebo = 132 and in SWIFT-2: depemokimab = 252, placebo = 128.

SWIFT-1 全分析中包含的受试者数量：depemokimab = 250，安慰剂 = 132；SWIFT-2：depemokimab = 252，安慰剂 = 128。

have been reported and published in the

已被报告并发布在

New England Journal of Medicin

新英格兰医学杂志

About ANCHOR-1 and ANCHOR-2

关于ANCHOR-1和ANCHOR-2

ANCHOR-1 and ANCHOR-2 were replicate phase III clinical trials

ANCHOR-1 和 ANCHOR-2 是重复的 III 期临床试验

with the same primary and secondary endpoints

具有相同的主要和次要终点

assessing the safety and efficacy of depemokimab as add-on therapy in adult patients with CRSwNP.

评估depemokimab作为成人CRSwNP患者的附加治疗的安全性和有效性。

Both were 52-week, randomised (1:1), double-blind, parallel group, placebo- controlled, multi-centre trials.

两项试验均为 52 周、随机（1:1）、双盲、平行分组、安慰剂对照、多中心试验。

Number of subjects included in the Full Analysis Set of ANCHOR-1: depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab = 129, placebo = 128.

纳入 ANCHOR-1 全分析集的受试者数量：depemokimab = 143，安慰剂 = 128；在 ANCHOR-2 中：depemokimab = 129，安慰剂 = 128。

Both studies met their co-primary endpoints of change from baseline in total endoscopic nasal polyp score at 52 weeks and change from baseline in nasal obstruction verbal response scale (VRS) mean score from weeks 49 to 52. The overall incidence and severity of treatment-emergent adverse events across ANCHOR-1 and ANCHOR-2 were also similar in patients treated with either depemokimab or placebo.

两项研究均达到了其共同主要终点，即在第 52 周时总鼻内镜鼻息肉评分相对于基线的变化，以及从第 49 周到第 52 周鼻塞语言反应量表 (VRS) 平均评分相对于基线的变化。在 ANCHOR-1 和 ANCHOR-2 中，接受 depemokimab 或安慰剂治疗的患者中，治疗相关不良事件的总体发生率和严重程度也相似。

Full results of ANCHOR-1 and ANCHOR-2 were presented on Saturday 1 March at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress in San Diego and simultaneously published in

2025年3月1日星期六，在圣地亚哥举行的美国过敏、哮喘和免疫学学会（AAAAI）与世界过敏组织（WAO）联合大会上，ANCHOR-1和ANCHOR-2的完整结果被公布，并同时发表在

About asthma, CRSwNP and type 2 inflammation

关于哮喘、CRSwNP 和 2 型炎症

Asthma affects more than 260 million people globally, many of whom continue to experience symptoms and exacerbations despite treatment with high-dose inhaled corticosteroids plus a second controller (and/or systemic corticosteroids).

全球超过2.6亿人受到哮喘的影响，其中许多人在接受高剂量吸入性糖皮质激素加上第二种控制药物（和/或全身性糖皮质激素）治疗后仍然出现症状和病情加重。

Asthma presents a significant financial burden to patients as exacerbations place a resource burden on healthcare systems due to emergency department visits and hospitalisations.

哮喘给患者带来了显著的经济负担，因为病情加重会导致医疗系统资源紧张，包括急诊就诊和住院治疗。

CRSwNP is caused by inflammation of the nasal lining that can lead to soft tissue growths, known as nasal polyps.

CRSwNP是由鼻腔内膜炎症引起的，可能导致软组织增生，称为鼻息肉。

People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being.

患有CRSwNP的人会出现鼻塞、嗅觉丧失、面部疼痛、睡眠障碍、感染和流鼻涕等症状，这些症状可能会严重影响他们的情绪和身体健康。

There is evidence to show IL-5 has broad effects on other structural and immune and cell types beyond eosinophils, and how they contribute to inflammation, which can lead to lung remodelling and disease progression.

有证据表明，IL-5对嗜酸性粒细胞以外的其他结构细胞、免疫细胞和细胞类型具有广泛影响，并揭示它们如何导致炎症，从而引发肺部重塑和疾病进展。

Ongoing research is generating further evidence to understand the roles of these cells and their potential contribution to clinical outcomes in patients with respiratory diseases. Type 2 inflammation drives the underlying dysfunction of various immune-mediated conditions. IL-5 is a core cytokine (protein) in type 2 inflammation..

正在进行的研究正在生成进一步的证据，以了解这些细胞的作用及其对呼吸系统疾病患者临床结果的潜在贡献。2型炎症驱动了各种免疫介导疾病的潜在功能障碍。IL-5是2型炎症中的核心细胞因子（蛋白质）。

The presence of type 2 inflammation in asthma or CRSwNP can be detected by blood eosinophil count, which measures the level of a type of white blood cell.

哮喘或CRSwNP中2型炎症的存在可以通过血液嗜酸性粒细胞计数来检测，该计数测量一种白细胞的水平。

About GSK in respiratory

关于GSK在呼吸领域

GSK is redefining the future of respiratory medicine as it builds on decades of pioneering work to deliver more ambitious treatment goals and develop the next-generation standard of care, 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 diseases like refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease.

GSK在重新定义呼吸医学的未来，它建立在数十年的开创性工作基础之上，致力于实现更宏大的治疗目标，并为数亿呼吸系统疾病患者开发下一代护理标准。凭借行业领先的呼吸产品组合和疫苗、靶向生物制剂及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）患者的生活质量，同时也关注那些较少被理解的疾病，如难治性慢性咳嗽或较为罕见的疾病，如伴间质性肺病的系统性硬化症。

GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease 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疾病进展。

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。