GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients, limited to those who are inadequately controlled with standard treatment..

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，日本厚生劳动省（MHLW）已批准Nucala（mepolizumab），一种靶向白细胞介素-5（IL-5）的单克隆抗体，用于治疗成人慢性鼻-鼻窦炎伴鼻息肉（CRSwNP），仅限于那些标准治疗控制不足的患者。。

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, at GSK said: “The chronic and debilitating impact that chronic rhinosinusitis with nasal polyps can have on those affected is often underestimated. This additional indication for Nucala in Japan could provide patients with an alternative treatment option to surgery or systemic steroids.”.

葛兰素史克呼吸/免疫学研发全球负责人高级副总裁Kaivan Khavandi表示：“慢性鼻-鼻窦炎伴鼻息肉对患者的慢性和衰弱影响常常被低估。日本Nucala的这一额外适应症可能为患者提供手术或全身类固醇的替代治疗选择。”。

CRSwNP is a chronic condition that affects 1% to 4% of the general population, of whom 40% have uncontrolled disease.1,2 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pressure, sleep disturbance and nasal discharge, which can significantly affect their emotional and physical well-being.3 In Japan, an estimated 2 million people suffer from chronic rhinosinusitis, of which about 200,000 are subject to surgery due to nasal polyps.4.

CRSwNP是一种慢性病，影响1%至4%的普通人群，其中40%患有不受控制的疾病[1,2]。CRSwNP患者会出现鼻塞，嗅觉丧失，面部压力，睡眠障碍和鼻涕等症状，这可能会显着影响他们的情绪和身体健康[3]。在日本，估计有200万人患有慢性鼻-鼻窦炎，其中约20万人因鼻息肉而接受手术。

CRSwNP is caused by chronic inflammation of the nasal lining that can cause soft tissue growth, known as nasal polyps, that develop in the sinuses and nasal cavity.3 Over 80% of patients with CRSwNP have type 2 inflammation, which is associated with more severe disease and nasal polyp recurrence.5-8 IL-5 is a key cytokine driving this type 2 inflammation and is present at high levels in nasal polyp tissue.3,5-8 Although surgery can be effective at removing polyps, the underlying type 2 inflammation means they have a tendency to regrow.7,8.

CRSwNP是由鼻腔衬里的慢性炎症引起的，可导致鼻窦和鼻腔中形成的软组织生长，称为鼻息肉[3]。超过80%的CRSwNP患者患有2型炎症，这与更严重的疾病和鼻息肉复发有关[5-8]。IL-5是驱动这种2型炎症的关键细胞因子，在鼻息肉组织中存在高水平[3,5-8]。虽然手术可以有效去除息肉，但潜在的2型炎症意味着它们有再生的趋势[7,8]。

The approval is based on results of the phase III MERIT trial, which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab vs.

该批准基于III期MARIT试验的结果，该试验研究了mepolizumab在52周内对日本，中国和俄罗斯CRSwNP控制不佳的患者群体的疗效和安全性，并得到了全球III期SYNAPSE研究的数据支持，该研究探讨了mepolizumab与。

placebo in more than 400 patients with CRSwNP.3,9.

400多名CRSwNP患者服用安慰剂3,9。

Mepolizumab is approved in Japan as a treatment for bronchial asthma in children aged 6 years or older and in adults with refractory asthma whose symptoms are inadequately controlled with standard treatment, and also for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) inadequately responding to the standard treatment..

Mepolizumab在日本被批准用于治疗6岁或以上儿童和难治性哮喘患者的支气管哮喘，这些患者的症状没有得到标准治疗的充分控制，也用于治疗对标准治疗反应不足的嗜酸性肉芽肿伴多血管炎（EGPA）的成年患者。。

About the MERIT trial9

关于MERIT trial9

The phase III MERIT trial the co-primary endpoints were change from baseline in nasal obstruction visual analogue scale (VAS) score during weeks 49 to 52 compared with placebo and change in endoscopic nasal polyp score at week 52 compared with placebo.1 Treatment with mepolizumab significantly improved nasal obstruction VAS score (mean treatment difference: -1.43 [95% CI: -2.37, -0.50]; p=0.003) and was associated with a numerical reduction in nasal polyp score at Week 52 (-0.43 [-0.89, 0.03]; p=0.067).

III期MERIT试验的共同主要终点是与安慰剂相比，在第49周至第52周期间，鼻阻塞视觉模拟评分（VAS）评分从基线发生变化，而在第52周时，内镜下鼻息肉评分与安慰剂相比发生变化。1美泊利珠单抗治疗显着改善了鼻阻塞VAS评分（平均治疗差异：-1.43[95%CI:-2.37，-0.50]；p=0.003），并且与第52周鼻息肉评分的数字降低相关（-0.43[-0.89，0.03]；p=0.067）。

Improvements in patient quality of life, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22) were demonstrated with mepolizumab versus placebo. Safety and tolerability data were consistent with the known profile of mepolizumab.3,5 A similar proportion of patients experienced on-treatment adverse events in the mepolizumab (68/84 [81%]) and placebo (65/85 [76%]) groups.

mepolizumab与安慰剂相比，通过22项鼻窦结局试验（SNOT-22）测量，患者生活质量得到改善。安全性和耐受性数据与mepolizumab的已知特征一致[3,5]。在mepolizumab（68/84（81%））和安慰剂（65/85（76%）组中，相似比例的患者经历了治疗不良事件。

In total, seven patients had treatment-related AEs (five in the placebo group and two in the mepolizumab group); none of these were SAEs..

总共有7名患者患有与治疗相关的AE（安慰剂组5名，mepolizumab组2名）；这些都不是SAE。。

About Nucala (mepolizumab)

关于Nucala（mepolizumab）

First approved in 2015 for severe asthma with an eosinophilic phenotype in the US, mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation.10,11 IL-5 is central to the development, maturation and activation of eosinophils, a type of white blood cell implicated in the pathogenesis of asthma and CRSwNP.3 Evidence indicates that IL-5 has an impact on other cell types beyond eosinophils that contribute to inflammation in airways disease.12-16 Mepolizumab binds directly to and inhibits IL-5 molecules.10,11 Mepolizumab has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.10,11 .

2015年首次在美国批准用于嗜酸性粒细胞表型的严重哮喘，mepolizumab是一种单克隆抗体，可靶向并结合白细胞介素-5（IL-5），白细胞介素-5是2型炎症中的关键信使蛋白（细胞因子）。10,11 IL-5是嗜酸性粒细胞（一种与哮喘和CRSwNP发病机制有关的白细胞）的发育，成熟和活化的核心。有证据表明，IL-5对嗜酸性粒细胞以外的其他细胞类型有影响，这些细胞会导致气道疾病的炎症。12-16 mepolizumab直接结合并抑制IL-5分子。10,11 mepolizumab已经开发用于治疗一系列与2型炎症相关的IL-5介导的疾病[10,11]。

GSK in respiratory

呼吸系统中的GSK

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.

葛兰素史克公司继续在数十年开创性工作的基础上，为数亿呼吸系统疾病患者提供更具雄心的治疗目标，制定下一代护理标准，并重新定义呼吸医学的未来。凭借业界领先的呼吸产品组合和疫苗、靶向生物制剂和吸入药物管道，我们专注于改善患有各种类型哮喘和COPD以及不太了解的难治性慢性咳嗽或罕见疾病（如系统性硬化症伴间质性肺病）的患者的预后和生活。

GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression..

葛兰素史克利用最新的科学技术，旨在改变潜在的疾病功能障碍，预防疾病进展。。

About GSK

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.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。