GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

葛兰素史克公司 (LSE/NYSE: GSK) 今天宣布，中国国家药品监督管理局已经接受了Nucala (mepolizumab)的新药申请审查，Nucala 是一种针对白细胞介素 5 (IL-5) 的单克隆抗体，用于治疗嗜酸性表型的慢性阻塞性肺病 (COPD) 患者的辅助维持治疗。

IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases. 2-4 This type of inflammation is detected in up to 40% of patients with COPD and is a major cause of symptoms and exacerbations that can lead to hospitalisation and/or emergency room visits.

IL-5 是 2 型炎症中的关键细胞因子（蛋白质），是许多疾病的潜在驱动因素。2-4多达40 % 的 COPD 患者会出现这种类型的炎症，并且是导致住院和/或急诊室就诊的症状和恶化的主要原因。

COPD affects more than 390 million people globally, with research estimating that approximately 100 people in China live with COPD, which accounts for almost 25% of the global COPD cases.5,6 This puts a significant burden on healthcare resources and the lives of patients, with recurrent exacerbations accounting for a large proportion of the annual direct medical costs of COPD due to emergency department visits and inpatient care.5-7 This burden is expected to dramatically increase due to the rapidly aging population in China

全球有超过 3.9 亿人患有 COPD，研究估计中国约有 1 亿 COPD 患者，占全球 COPD 病例的近 25%。5,6这给医疗资源和患者的生活带来了沉重的负担，反复发作的病情占 COPD 每年直接医疗费用的很大一部分，包括急诊就诊和住院治疗。5-7由于中国人口老龄化迅速，预计这一负担将急剧增加。

Nucala’s application was supported by results from the positive Phase III MATINEE trial which showed a significant and clinically meaningful reduction in rate of moderate/severe exacerbations with Nucala compared to placebo. The trial recruited a wide spectrum of COPD patients including those with chronic bronchitis, emphysema-only or both.1 These data indicate that Nucala, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations.

Nucala 的申请得到了积极的 III 期 MATINEE 试验结果的支持，该结果显示，与安慰剂相比， Nucala显著降低了中度/重度恶化率，且具有临床意义。该试验招募了广泛的 COPD 患者，包括患有慢性支气管炎、仅患有肺气肿或两者兼有的患者。1这些数据表明，除了吸入维持疗法外， Nucala还为需要治疗以降低恶化风险的患者群体提供了具有临床意义的益处。

If approved, Nucala could be the first approved biologic with monthly dosing for patients with COPD.

如果获得批准，Nucala将成为首个获批针对 COPD 患者每月给药的生物制剂。

Nucala is currently approved for use in the China across three IL-5 mediated conditions. These include two respiratory indications as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Indications also include the use of Nucala for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Nucala目前已获准在中国用于治疗三种 IL-5 介导的疾病。其中包括两种呼吸系统适应症，作为成人和 12 岁及以上青少年严重嗜酸性哮喘的辅助维持治疗，以及作为鼻内皮质类固醇的辅助疗法，用于治疗患有慢性鼻窦炎和鼻息肉的成人患者，这些患者的全身皮质类固醇治疗和/或手术无法充分控制疾病。适应症还包括使用Nucala治疗嗜酸性肉芽肿性多血管炎 (EGPA) 成人患者。

Nucala is currently not approved for use in COPD in any country.

目前， Nucala尚未在任何国家获准用于治疗 COPD。