GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

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批准Nucala (美泊利单抗)，一种针对白细胞介素 5 (IL-5) 的单克隆抗体，作为鼻内皮质类固醇的辅助疗法，用于治疗 CRSwNP 成人患者，对于这些患者，全身皮质类固醇治疗和/或手术治疗无法充分控制病情。

Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D at GSK said: “We are delighted that Nucala has been approved in China as a treatment for CRSwNP, a chronic condition for which new and effective treatments are needed. Patients now have a non-surgical option available to them and an alternative to repeated exposure to oral corticosteroids.”

GSK 高级副总裁、呼吸/免疫学研发全球主管 Kaivan Khavandi 表示： “我们很高兴Nucala在中国获批用于治疗 CRSwNP，这是一种需要新且有效治疗方法的慢性疾病。患者现在有了非手术治疗选择，可以替代反复服用口服皮质类固醇。”

It is estimated that about 107 million people in China suffer from chronic sinusitis, about 1/3 of whom have chronic sinusitis with nasal polyps.1-4 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

据估计，中国约有 1.07 亿人患有慢性鼻窦炎，其中约 1/3 患有伴有鼻息肉的慢性鼻窦炎。1-4 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，这些症状会严重影响他们的情绪和身体健康。

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.5,6 Up to 80% of patients with CRSwNP have type 2 inflammation, which is associated with more severe disease and nasal polyp recurrence and can be detected by blood eosinophil count, a biomarker measured by a simple blood test.6-9 IL-5 is a key cytokine driving this type 2 inflammation and is present at high levels in nasal polyp tissue.4-8 Although surgery can be effective at removing polyps, the underlying type 2 inflammation means they have a tendency to regrow.

CRSwNP 是由鼻黏膜慢性炎症引起的，可导致鼻窦和鼻腔中形成软组织生长，即鼻息肉。5,6高达80% 的 CRSwNP 患者患有 2 型炎症，这种炎症与更严重的疾病和鼻息肉复发有关，可通过血液嗜酸性粒细胞计数检测出来，这是一种通过简单血液测试测量的生物标志物。6-9 IL-5 是驱动这种 2 型炎症的关键细胞因子，在鼻息肉组织中含量很高。4-8虽然手术可以有效切除息肉，但潜在的 2 型炎症意味着它们有再生的趋势。

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 versus placebo in a population of Japanese, Chinese and Russian patients with inadequately controlled CRSwNP, and is supported by data from the global phase III SYNAPSE study, which explored the effect of mepolizumab versus placebo in more than 400 patients with CRSwNP

此次批准以 III 期 MERIT 试验的结果为基础，该试验在日本、中国和俄罗斯控制不佳的慢性鼻窦炎 (CRSwNP) 患者群体中研究了美泊利单抗与安慰剂相比在 52 周内的疗效和安全性，并得到了全球 III 期 SYNAPSE 研究数据的支持，该研究在 400 多名慢性鼻窦炎 (CRSwNP) 患者中探讨了美泊利单抗与安慰剂相比的效果。

Mepolizumab is already approved in China as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe eosinophilic asthma as well as for adults with eosinophilic granulomatosis with polyangiitis.

美泊利单抗已在中国获批作为辅助维持治疗，用于治疗患有重度嗜酸性哮喘的成人和12岁及以上的青少年患者以及患有嗜酸性肉芽肿性多血管炎的成人患者。