Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

开始日期2024-10-16

申办/合作机构

西京医院第四军医大学

NCT06501807

/ Not yet recruitingN/AIIT

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

开始日期2024-09-02

申办/合作机构-

100 项与美泊利珠单抗相关的临床结果

登录后查看更多信息

100 项与美泊利珠单抗相关的转化医学

登录后查看更多信息

100 项与美泊利珠单抗相关的专利（医药）

登录后查看更多信息

1,515

项与美泊利珠单抗相关的文献（医药）

2025-12-01·Current Cardiology Reports

Eosinophilic Myocarditis: A Concise Review

Review

作者: Kahwash, Rami ; Trovato, Vincenzo ; Asada, Ashlee M

Abstract:

Purpose of Review:

Eosinophilic myocarditis (EM) is a rare and heterogeneous form of inflammatory heart disease that can present with a wide range of severity. Current literature is limited to case reports or small case series that outline the evaluation process, disease course, and the nonstandardized treatments trialed. This review aims to concisely summarize the current literature on EM including an update on maintenance therapy for refractory or recurrent disease.

Recent Findings:

In the last several years, several observational studies have reported the clinical benefit of mepolizumab and benralizumab in refractory EM.

Summary:

EM is a complex and heterogenous cause of inflammatory heart disease with a wide range of etiologies and presentations. Treatment of this disease has not been standardized as there are no large scale trials quantifying benefit of any specific therapy regimen. Targeted biologics show promise in observational studies; therefore, prospective studies are needed to quantify this benefit in EM.

2025-12-01·CURRENT ALLERGY AND ASTHMA REPORTS

Olfactory Dysfunction in Chronic Rhinosinusitis with Nasal Polyps: Effect of Treatment with Emphasis on Biological Therapy

Review

作者: Reitsma, Sietze ; Fokkens, Wytske Johanna ; Otten, Josje Janna

PURPOSE OF REVIEW:

Olfactory dysfunction significantly impacts quality of life that affects a majority of the patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The aim of this review is to explore the impact of various treatment regimens on olfactory dysfunction in patients diagnosed with CRSwNP.

RECENT FINDINGS:

Accurate assessment of olfactory dysfunction remains challenging and should incorporate both psychophysical tests and patient-reported outcomes. Patients with CRSwNP appear capable of reliably evaluating their olfactory function. Standard treatment such as intranasal corticosteroids and surgery have limited capability of restoring the sense of smell. Oral corticosteroids have a far greater potency, albeit short-lived and at the cost of adverse events and side effects. Recent studies on registered biological agents- specifically dupilumab, mepolizumab, and omalizumab- indicate their effectiveness in restoring olfactory function in severe CRSwNP. According to meta-analyses and indirect comparisons, dupilumab shows superiority; however, direct comparative studies are necessary.

2025-05-01·The journal of allergy and clinical immunology. Global

Elevated mepolizumab levels in patients with severe asthma responsive to 1 year’s mepolizumab treatment

Article

作者: Sasano, Hitoshi ; Nishimaki, Takayasu ; Ohuchi, Mayu ; Harada, Norihiro ; Takahashi, Kazuhisa ; Matsuno, Kei ; Harada, Sonoko ; Sandhu, Yuuki ; Ito, Jun ; Yagishita, Shigehiro ; Nagaoka, Tetsutaro ; Takeshige, Tomohito ; Tanabe, Yuki ; Hamada, Akinobu ; Atsuta, Ryo

Background:

Asthma involves variable airflow limitation and persistent airway inflammation. Eosinophilic asthma, characterized by cytokine-mediated type 2 inflammation, is generally treated with inhaled corticosteroids. However, patients with severe asthma may require biologics, such as mepolizumab, which targets IL-5 and can manage uncontrolled eosinophilic asthma.

Objective:

We investigated the relationship between serum mepolizumab concentrations and treatment response in patients with severe asthma.

Methods:

Patients with mepolizumab-treated severe asthma were enrolled onto this prospective cohort study. Baseline assessments were conducted and repeated at 3, 6, and 12 months. Those with response were categorized on the basis of improvements in asthma control test score, lung function, and asthma exacerbations. We quantified the serum concentration of mepolizumab at 3, 6, and 12 months after treatment by liquid chromatography coupled with tandem mass spectrometry.

Results:

Twenty-five adult patients aged 20 years and older with severe asthma were included in the analysis. Serum mepolizumab concentrations significantly increased at 6 and 12 months compared with those at 3 months, particularly in those with disease that responded to therapy. Furthermore, the relative change in mepolizumab concentration was significantly higher in those with response than in those with no response. Body size parameters were negatively correlated with mepolizumab concentration. In those with response, there were inverse correlations between mepolizumab concentration and baseline body size parameters.

Conclusions:

The study observed a yearlong increase in mepolizumab concentrations, particularly in those with response, indicating a potential mepolizumab surplus. Correlations between mepolizumab concentrations and baseline characteristics suggested differing mepolizumab requirements between those with response and those with no response. Further research is needed to validate these findings and optimize treatment strategies for patients with severe asthma.

242

项与美泊利珠单抗相关的新闻（医药）

2025-03-27

·药学进展

行业动态 |阿斯利康凡舒卓® 正式在华上市，用于重度嗜酸粒细胞性哮喘（SEA）的维持治疗

“ 点击蓝字关注我们阿斯利康凡舒卓® 正式在华上市，用于重度嗜酸粒细胞性哮喘（SEA）的维持治疗 PPS （2025年3月24日，中国上海）今日，阿斯利康宣布重度嗜酸粒细胞性哮喘（SEA）创新靶向生物制剂凡舒卓® （通用名:本瑞利珠单抗注射液）在中国正式商业上市，用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗1。本瑞利珠单抗是精准靶向嗜酸性粒细胞（EOS）的抗IL-5R创新生物制剂。一项汇总分析研究，在基线 bEOS≥300/μL 的患者中，与安慰剂组相比，本瑞利珠单抗治疗3天后即可快速改善哮喘症状2。PONENTE 及SHAMAL研究显示，与基线相比，超90%的重度哮喘患者减少口服糖皮质激素（OCS）及吸入激素（ICS-福莫特罗）使用3,4，长期治疗安全性良好5。 2024年8月，本瑞利珠单抗已基于III期临床试验MIRACLE研究的积极结果在中国获批。这项研究于中国、韩国以及菲律宾开展6。研究显示，MIRACLE研究达到所有主要研究终点和关键次要研究终点，接受标准治疗的重度嗜酸粒细胞性哮喘患者（基线血液EOS≥300/μL），在使用本瑞利珠单抗治疗后，与安慰剂组相比，其年急性发作率（AAER）显著降低达74%（本瑞利珠单抗治疗组AAER 0.49，安慰剂组1.88，风险比0.26，p<0.0001)6，本瑞利珠单抗有助于改善肺功能和哮喘症状6。中国约有300万重度嗜酸粒细胞性哮喘患者7-10，且重度哮喘被误诊和未充分治疗的情况仍然经常出现7。由于频繁的急性发作、肺功能严重受限以及生活质量的下降，患者面临沉重的疾病负担11-14。EOS是重度哮喘2型炎症的关键效应细胞15，既是重要的生物标志物也是治疗的关键靶标16。本瑞利珠单抗直接作用于嗜酸粒细胞表面的IL-5R，不仅阻碍IL-5与嗜酸粒细胞结合，还可通过抗体依赖的细胞毒作用直接快速地清除嗜酸粒细胞，并高效抑制相关的炎症循环，降低重度哮喘急性发作、改善肺功能、降低激素用量。同时，维持期每年仅需6针17，在方便使用的同时为患者带来临床获益。 MIRACLE研究的国际协调研究者、中国工程院院士钟南山院士表示：“哮喘是一种慢性气道炎症性疾病，ICS-LABA足剂量足疗程是基石；随着生物靶向治疗时代的到来，重度哮喘患者正确的诊断分型是关键。EOS型是重度哮喘患者最常见的表型，其中，MIRACLE试验结果显示，对于我国重度嗜酸粒细胞性哮喘患者，抗IL-5受体单抗可以快速并持久控制哮喘症状，显著降低年急性发作率。研究也显示，其在中、高剂量ICS/LABA控制不佳的哮喘人群中应用疗效显著。” 阿斯利康中国总经理，中国生物制药业务总经理林骁表示：“以哮喘为代表的呼吸慢病在中国面临患病人群数量庞大、公众知晓率低、治疗诊断率低等挑战，患者存在巨大未被满足的治疗需求。阿斯利康在慢病领域积淀深厚，尤其是在慢性呼吸疾病领域深耕超五十年，拥有丰富的产品管线及广阔的布局。扎根中国三十多年来，阿斯利康始终坚持以患者为中心，致力于推动创新药物迭代，不断革新呼吸慢病治疗方案。希望本瑞利珠单抗在中国的上市应用，能够尽早让患者实现疾病控制，摆脱重度哮喘的束缚。同时，我们也将继续携手多方重塑慢病治疗格局，让中国呼吸慢病患者的健康需求不断得到满足。” 阿斯利康中国副总裁，呼吸和自体免疫生物制药、疫苗及免疫疗法事业部负责人陈曦表示：“非常高兴看到本瑞利珠单抗在中国成功上市，这是阿斯利康在呼吸领域的首款生物制剂，也标志着中国重度哮喘的治疗步入了精准靶向治疗时代。目前我们在中国上市的产品涵盖了哮喘轻中度到重度的完整产品组合和解决方案，满足了不同分型哮喘患者全病程管理的需求。未来，我们也将持续加速引入创新药物，为患者提供更加个性、精准化的治疗服务。” 关于重度哮喘中国约有300万重度嗜酸粒细胞性哮喘患者7-10。该疾病在中国发病率高，且重度哮喘被误诊和未充分治疗的情况仍然经常出现7。由于频繁的急性发作、肺功能严重受限以及生活质量的下降，患者面临沉重的疾病负担11-14。同时，重度哮喘患者死亡风险更高，且哮喘相关住院风险是持续性哮喘患者的2倍18-20。此外，重度哮喘相关医疗费用约占哮喘患者医疗总成本的50%，为社会带来沉重的经济负担21。关于MIRACLE研究 MIRACLE研究是在中国、韩国和菲律宾进行的一项随机、双盲、平行组、安慰剂对照的III期临床研究，评估本瑞利珠单抗在亚太人群中的疗效和安全性。共有695例年龄介于12岁至75岁之间的未得到有效控制的哮喘患者纳入研究。所有患者均接受中高剂量吸入性糖皮质激素加长效β2-受体激动剂（ICS-LABA）治疗。在此基础上，部分患者同时接受口服糖皮质激素(OCS)及其他哮喘控制药物的辅助治疗，而另一部分患者则未接受上述额外治疗6。研究的主要终点是与安慰剂组相比，使用30毫克本瑞利珠单抗（30mg Q8W, 前三剂Q4W）的重度嗜酸粒细胞哮喘患者（基线血液EOS≥300/μL）在48 周内的哮喘年急性发作率（AAER）的下降。所有患者按照1:1的比例被随机分配到安慰剂组或本瑞利珠单抗治疗组。结果显示，与安慰剂组相比，本瑞利珠单抗组患者的年急性发作率（AAER）显著降低了74% (本瑞利珠单抗治疗组0.49，安慰剂组1.88，风险比0.26，95%CI 0.19, 0.36，p<0.0001) 6。在研究中，患者按国家/地区、年龄组（成人或青少年）和第1次访视时基线外周血嗜酸粒细胞计数（<300或≥300 cells/μL）进行了分层。研究的关键次要疗效终点为第48周时支气管扩张剂前（pre-BD）1秒用力呼气容积（pre-BD FEV1）和总哮喘症状评分（TASS）相对于基线的变化。其他次要疗效终点包括早晚呼气峰值流量（PEF）、哮喘控制问卷6（ACQ-6）、圣乔治呼吸问卷（SGRQ）、与急诊（ER）/紧急照护（UC）就诊或住院相关的AAER、首次出现哮喘急性发作的时间和出现过≥1次哮喘急性发作的患者比例以及血液嗜酸粒细胞水平较基线的变化6。关于本瑞利珠单抗本瑞利珠单抗重度嗜酸粒细胞性哮喘（SEA）适应症目前已在美国、欧盟、日本、中国等80多个国家和地区获批22-25。嗜酸性肉芽肿病伴多血管炎（EGPA）适应症也已经在美国、欧盟和日本等全球35多个国家和地区获批26。该药惠及的全球患者人数已超过14万27。阿斯利康也在对本瑞利珠单抗的其它适应症进行开发，包括慢性阻塞性肺疾病（COPD）和嗜酸粒细胞增多综合征28-30。本瑞利珠单抗由阿斯利康开发，并获得日本协和麒麟株式会社的全资子公司百讴瓦股份有限公司的授权许可而引进。关于阿斯利康呼吸及免疫治疗领域呼吸与免疫是阿斯利康生物制药业务的重要组成部分，是公司聚焦的关键疾病领域和业务增长的主要驱动力。阿斯利康是呼吸领域的领先企业，深耕呼吸领域50多年，在免疫疾病领域也拥有日益丰富的产品线。公司致力于通过对吸入制剂、生物制剂和针对全新靶点的新疗法的管线开发和产品组合，来满足慢性且具有衰竭性特征的疾病领域的巨大未满足需求。阿斯利康的目标是提供改变患者生命的药物，帮助消除慢性阻塞性肺病这一主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。声明：该文涉及尚未在中国获批的适应证，阿斯利康不推荐任何未被批准的药品使用。参考文献: 1.National Medical Products Administration approval, August 2024 2.O'Quinn S,et al. JAsthma Allergy 2019;12-21-33 3.Menzies-Gow A, et al. Lancet Respir Med. 2022;10(1):47-58 4.Jackson Dy, et al Lancet, 2024;403(10423):271-281 5.Korn S, et al. J Allergy Clin lmmunol Pract. 2021;9(12):4381-4392.e4 6.Lai K, et al. Benralizumab efficacy and safety in severe asthma: a randomized trial in Asia. Respir Med. 2024 7.Huang K, et al. China Pulmonary Health (CPH) Study Group. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019;394(10196):407-418 8.Wang WY, et al. A survey on clinical characteristics and risk factors of severe asthma in China. Zhonghua Yi Xue Za Zhi. 2020;100(14):1106-1111 9.Su N, et al. A cross-section study of severe asthma in eight provinces of China. Zhonghua Nei Ke Za Zhi. 2016;55(12):917-921 10.Zhang Q, et al. C-BIOPRED consortium. Severe eosinophilic asthma in Chinese C-BIOPRED asthma cohort. Clin Transl Med. 2022;12(2):e710 11.Menzies-Gow A, et al. A Charter to Improve Patient Care in Severe Asthma. Adv Ther. 2018 Oct;35(10):1485-1496 12.Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005;172:149-60 13.Peters SP, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006;100(7): 1139-51 14.Wang E, et al. Characterization of Severe Asthma Worldwide. Data from the International Severe Asthma Registry. Chest. 2020;157(4): 790-804 15.Matucci A, et al. Respir Med. 2019;160:105819 16.Brusselle GG, et al. N Engl J Med. 2022;386(2):157-171 17.本瑞利珠单抗注射液说明书. 2024 18. Chastek B, et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016;22: 848–861 19. Hartert TV, et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73 20. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009 21. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php. [Last accessed: August 2024] 22.AstraZeneca news release. Available at: https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-approved-in-the-us-for-self-administration-in-a-new-pre-filled-auto-injector-the-fasenra-pen-04102019.html#. [Last accessed: August 2024]. 23.AstraZeneca news release. Available at: https://www.astrazeneca.com/media-centre/press-releases/2018/astrazeneca-receives-eu-approval-of-fasenra-for-severe-eosinophilic-asthma-10012018.html#. [Last accessed: August 2024] 24.AstraZeneca Annual Report 2023. Available at: https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf. [Last accessed: August 2024] 25.AstraZeneca news release. Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA). Available at: https://www.astrazeneca.com/media-centre/press-releases/2023/fasenra-phase-iii-egpa-trial-met-primary-endpoint.html#:~:text=Positive%20high%2Dlevel%20results%20from,EGPA)%20who%20were%20receiving%20oral. [Last accessed: August 2024] 26. AstraZeneca news release. Available at https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html[Last accessed: March 2025] AstraZeneca news release: Available at https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-eu-for-eosinophilic-granulomatosis-with-polyangiitis.html [Last accessed: March 2025] AstraZeneca Annual Report 2024. Available at https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2024/pdf/AstraZeneca_AR_2024.pdf [Last accessed: March 2025] 27. Reference: Data on file. AstraZeneca; 2025. REF-261125 28.Clinicaltrials.gov. Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations (RESOLUTE). Available from: https://clinicaltrials.gov/ct2/show/NCT04053634 [Last accessed: August 2024] 29.Wechsler ME, et al. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Available at: https://www.nejm.org/stoken/default+domain/REPRINTS_36237/full?redirectUri=/doi/full/10.1056/NEJMoa2311155 [Last accessed: August 2024] 30.Clinicaltrials.gov. A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON). Available from: https://clinicaltrials.gov/ct2/show/NCT04191304 [Last accessed: August 2024] 文章来源：阿斯利康美编排版：朱玲欣文章审核：周碧远朱玲欣罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由国家教育部主管、中国药科大学和中国药学会共同主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

临床结果临床3期抗体药物偶联物

2025-03-25

·微信

凡舒卓®正式在华上市，用于重度嗜酸粒细胞性哮喘（SEA）的维持治疗

3月24日，阿斯利康宣布重度嗜酸粒细胞性哮喘（SEA）创新靶向生物制剂凡舒卓®（通用名:本瑞利珠单抗注射液）在中国正式商业上市，用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗[1]。本瑞利珠单抗是精准靶向嗜酸性粒细胞（EOS）的抗IL-5R创新生物制剂。一项汇总分析研究，在基线bEOS≥300/μL的患者中，与安慰剂组相比，本瑞利珠单抗治疗3天后即可快速改善哮喘症状[2]。PONENTE及SHAMAL研究显示，与基线相比，超90%的重度哮喘患者减少口服糖皮质激素（OCS）及吸入激素（ICS-福莫特罗）使用[3,4]，长期治疗安全性良好[5]。 2024年8月，本瑞利珠单抗已基于III期临床试验MIRACLE研究的积极结果在中国获批。这项研究于中国、韩国以及菲律宾开展[6]。研究显示，MIRACLE研究达到所有主要研究终点和关键次要研究终点，接受标准治疗的重度嗜酸粒细胞性哮喘患者（基线血液EOS≥300/μL），在使用本瑞利珠单抗治疗后，与安慰剂组相比，其年急性发作率（AAER）显著降低达74%（本瑞利珠单抗治疗组AAER 0.49，安慰剂组1.88，风险比0.26，p<0.0001）[6]，本瑞利珠单抗有助于改善肺功能和哮喘症状[6]。中国约有300万重度嗜酸粒细胞性哮喘患者[7-10]，且重度哮喘被误诊和未充分治疗的情况仍然经常出现[7]。由于频繁的急性发作、肺功能严重受限以及生活质量的下降，患者面临沉重的疾病负担[11-14]。EOS是重度哮喘2型炎症的关键效应细胞[15]，既是重要的生物标志物也是治疗的关键靶标[16]。本瑞利珠单抗直接作用于嗜酸粒细胞表面的IL-5R，不仅阻碍IL-5与嗜酸粒细胞结合，还可通过抗体依赖的细胞毒作用直接快速地清除嗜酸粒细胞，并高效抑制相关的炎症循环，降低重度哮喘急性发作、改善肺功能、降低激素用量。同时，维持期每年仅需6针[17]，在方便使用的同时为患者带来临床获益。 MIRACLE研究的国际协调研究者、中国工程院院士钟南山院士表示：哮喘是一种慢性气道炎症性疾病，ICS-LABA足剂量足疗程是基石；随着生物靶向治疗时代的到来，重度哮喘患者正确的诊断分型是关键。EOS型是重度哮喘患者最常见的表型，其中，MIRACLE试验结果显示，对于我国重度嗜酸粒细胞性哮喘患者，抗IL-5受体单抗可以快速并持久控制哮喘症状，显著降低年急性发作率。研究也显示，其在中、高剂量ICS/LABA控制不佳的哮喘人群中应用疗效显著。阿斯利康中国总经理，中国生物制药业务总经理林骁表示：以哮喘为代表的呼吸慢病在中国面临患病人群数量庞大、公众知晓率低、治疗诊断率低等挑战，患者存在巨大未被满足的治疗需求。阿斯利康在慢病领域积淀深厚，尤其是在慢性呼吸疾病领域深耕超五十年，拥有丰富的产品管线及广阔的布局。扎根中国三十多年来，阿斯利康始终坚持以患者为中心，致力于推动创新药物迭代，不断革新呼吸慢病治疗方案。希望本瑞利珠单抗在中国的上市应用，能够尽早让患者实现疾病控制，摆脱重度哮喘的束缚。同时，我们也将继续携手多方重塑慢病治疗格局，让中国呼吸慢病患者的健康需求不断得到满足。阿斯利康中国副总裁，呼吸和自体免疫生物制药、疫苗及免疫疗法事业部负责人陈曦表示：非常高兴看到本瑞利珠单抗在中国成功上市，这是阿斯利康在呼吸领域的首款生物制剂，也标志着中国重度哮喘的治疗步入了精准靶向治疗时代。目前我们在中国上市的产品涵盖了哮喘轻中度到重度的完整产品组合和解决方案，满足了不同分型哮喘患者全病程管理的需求。未来，我们也将持续加速引入创新药物，为患者提供更加个性、精准化的治疗服务。关于重度哮喘中国约有300万重度嗜酸粒细胞性哮喘患者[7-10]。该疾病在中国发病率高，且重度哮喘被误诊和未充分治疗的情况仍然经常出现[7]。由于频繁的急性发作、肺功能严重受限以及生活质量的下降，患者面临沉重的疾病负担[11-14]。同时，重度哮喘患者死亡风险更高，且哮喘相关住院风险是持续性哮喘患者的2倍[18-20]。此外，重度哮喘相关医疗费用约占哮喘患者医疗总成本的50%，为社会带来沉重的经济负担[21]。关于MIRACLE研究 MIRACLE研究是在中国、韩国和菲律宾进行的一项随机、双盲、平行组、安慰剂对照的III期临床研究，评估本瑞利珠单抗在亚太人群中的疗效和安全性。共有695例年龄介于12岁至75岁之间的未得到有效控制的哮喘患者纳入研究。所有患者均接受中高剂量吸入性糖皮质激素加长效β2-受体激动剂（ICS-LABA）治疗。在此基础上，部分患者同时接受口服糖皮质激素（OCS）及其他哮喘控制药物的辅助治疗，而另一部分患者则未接受上述额外治疗[6]。研究的主要终点是与安慰剂组相比，使用30毫克本瑞利珠单抗（30mg Q8W, 前三剂Q4W）的重度嗜酸粒细胞哮喘患者（基线血液EOS≥300/μL）在48 周内的哮喘年急性发作率（AAER）的下降。所有患者按照1:1的比例被随机分配到安慰剂组或本瑞利珠单抗治疗组。结果显示，与安慰剂组相比，本瑞利珠单抗组患者的年急性发作率（AAER）显著降低了74% (本瑞利珠单抗治疗组0.49，安慰剂组1.88，风险比0.26，95%CI 0.19, 0.36，p<0.0001)[6]。在研究中，患者按国家/地区、年龄组（成人或青少年）和第1次访视时基线外周血嗜酸粒细胞计数（<300或≥300 cells/μL）进行了分层。研究的关键次要疗效终点为第48周时支气管扩张剂前（pre-BD）1秒用力呼气容积（pre-BD FEV1）和总哮喘症状评分（TASS）相对于基线的变化。其他次要疗效终点包括早晚呼气峰值流量（PEF）、哮喘控制问卷6（ACQ-6）、圣乔治呼吸问卷（SGRQ）、与急诊（ER）/紧急照护（UC）就诊或住院相关的AAER、首次出现哮喘急性发作的时间和出现过≥1次哮喘急性发作的患者比例以及血液嗜酸粒细胞水平较基线的变化[6]。关于本瑞利珠单抗本瑞利珠单抗重度嗜酸粒细胞性哮喘（SEA）适应症目前已在美国、欧盟、日本、中国等80多个国家和地区获批[22-25]。嗜酸性肉芽肿病伴多血管炎（EGPA）适应症也已经在美国、欧盟和日本等全球35多个国家和地区获批[26]。该药惠及的全球患者人数已超过14万[27]。阿斯利康也在对本瑞利珠单抗的其它适应症进行开发，包括慢性阻塞性肺疾病（COPD）和嗜酸粒细胞增多综合征[28-30]。本瑞利珠单抗由阿斯利康开发，并获得日本协和麒麟株式会社的全资子公司百讴瓦股份有限公司的授权许可而引进。关于阿斯利康呼吸及免疫治疗领域呼吸与免疫是阿斯利康生物制药业务的重要组成部分，是公司聚焦的关键疾病领域和业务增长的主要驱动力。阿斯利康是呼吸领域的领先企业，深耕呼吸领域50多年，在免疫疾病领域也拥有日益丰富的产品线。公司致力于通过对吸入制剂、生物制剂和针对全新靶点的新疗法的管线开发和产品组合，来满足慢性且具有衰竭性特征的疾病领域的巨大未满足需求。我们的目标是提供改变患者生命的药物，帮助消除慢性阻塞性肺病这一主要死亡原因，消除哮喘发作，并实现免疫介导疾病的临床缓解。本文涉及尚未在中国大陆获批的适应症，阿斯利康不推荐任何未被批准的药品使用。 *内容来源：新闻稿 (内部审批号: CN-156712) - 上下滑动查看参考资料 - [1]National Medical Products Administration approval, August 2024 [2]O'Quinn S,et al. JAsthma Allergy 2019;12-21-33 [3]Menzies-Gow A, et al. Lancet Respir Med. 2022;10(1):47-58 [4]Jackson Dy, et al Lancet, 2024;403(10423):271-281 [5]Korn S, et al. J Allergy Clin lmmunol Pract. 2021;9(12):4381-4392.e4 [6]Lai K, et al. Benralizumab efficacy and safety in severe asthma: a randomized trial in Asia. Respir Med. 2024 [7]Huang K,et al. China Pulmonary Health (CPH) Study Group. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019;394(10196):407-418 [8]Wang WY,et al. A survey on clinical characteristics and risk factors of severe asthma in China. Zhonghua Yi Xue Za Zhi. 2020;100(14):1106-1111 [9]Su N,et al. A cross-section study of severe asthma in eight provinces of China. Zhonghua Nei Ke Za Zhi. 2016;55(12):917-921 [10]Zhang Q,et al. C-BIOPRED consortium. Severe eosinophilic asthma in Chinese C-BIOPRED asthma cohort. Clin Transl Med. 2022;12(2):e710 [11]Menzies-Gow A,et al. A Charter to Improve Patient Care in Severe Asthma. Adv Ther. 2018 Oct;35(10):1485-1496 [12]Wenzel S. Severe asthma in adults.Am J Respir Crit Care Med. 2005;172:149-60 [13]Peters SP,et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006;100(7): 1139-51 [14]Wang E,et al. Characterization of Severe Asthma Worldwide. Data from the International Severe Asthma Registry. Chest. 2020;157(4): 790-804 [15]Matucci A, et al. Respir Med. 2019;160:105819 [16]Brusselle GG, et al. N Engl J Med. 2022;386(2):157-171 [17]本瑞利珠单抗注射液说明书. 2024 [18]Chastek B,et al. Economic Burden of Illness Among Patients with Severe Asthma in a Managed Care Setting. J Manag Care Spec Pharm. 2016;22: 848–861 [19]Hartert TV,et al. Risk factors for recurrent asthma hospital visits and death among a population of indigent older adults with asthma. Ann Allergy Asthma Immunol. 2002;89: 467–73 [20]Price D,et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009 [21]World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at:https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php. [Last accessed: August 2024] [22]AstraZeneca news release. Available at:https://www.astrazeneca.com/media-centre/press-releases/2019/fasenra-approved-in-the-us-for-self-administration-in-a-new-pre-filled-auto-injector-the-fasenra-pen-04102019.html#. [Last accessed: August 2024]. [23]AstraZeneca news release. Available at: https://www.astrazeneca.com/media-centre/press-releases/2018/astrazeneca-receives-eu-approval-of-fasenra-for-severe-eosinophilic-asthma-10012018.html#. [Last accessed: August 2024] [24]AstraZeneca Annual Report 2023. Available at:https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_AR_2023.pdf. [Last accessed: August 2024] [25]AstraZeneca news release. Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA). Available at:https://www.astrazeneca.com/media-centre/press-releases/2023/fasenra-phase-iii-egpa-trial-met-primary-endpoint.html#:~:text=Positive%20high%2Dlevel%20results%20from,EGPA)%20who%20were%20receiving%20oral. [Last accessed: August 2024] [26]AstraZeneca news release. Available at https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html[Last accessed: March 2025] AstraZeneca news release: Available at https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-eu-for-eosinophilic-granulomatosis-with-polyangiitis.html[Last accessed: March 2025] AstraZeneca Annual Report 2024. Available at https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2024/pdf/AstraZeneca_AR_2024.pdf[Last accessed: March 2025] [27]Reference: Data on file. AstraZeneca; 2025. REF-261125 [28]Clinicaltrials.gov. Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations (RESOLUTE). Available from: https://clinicaltrials.gov/ct2/show/NCT04053634 [Last accessed: August 2024] [29]Wechsler ME, et al. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Available at: https://www.nejm.org/stoken/default+domain/REPRINTS_36237/full?redirectUri=/doi/full/10.1056/NEJMoa2311155 [Last accessed: August 2024] [30]Clinicaltrials.gov. A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON). Available from: https://clinicaltrials.gov/ct2/show/NCT04191304 [Last accessed: August 2024] Copyright © 2025 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床结果临床3期抗体药物偶联物

2025-03-25

·Pharmaceutical Technology

EMA to review GSK’s Nucala for COPD treatment expansion

GSK’s mepolizumab programme in chronic obstructive pulmonary disease includes three studies. Credit: HJBC/Shutterstock. The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on maintenance for individuals with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. If approved, the monoclonal antibody is expected to become the initial monthly-dosed biologic for COPD. GSK’s application is underpinned by the positive outcomes from the Phase III MATINEE trial, which demonstrated a significant decrease in the annualised rate of moderate/severe exacerbations in patients treated with the antibody against a placebo. The trial encompassed a broad range of COPD phenotypes and clinical presentations, suggesting that the antibody could provide substantial benefits when used alongside inhaled maintenance therapies. Mepolizumab targets interleukin-5 (IL-5) and has already gained approval for four IL-5-mediated conditions in Europe. These indications cover severe refractory eosinophilic asthma, for which the antibody is used as an add-on treatment in the adult, adolescent and paediatric population aged six years and above. It is also indicated for use as an add-on treatment alongside intranasal corticosteroids for chronic rhinosinusitis with nasal polyps in adults. Mepolizumab is intended for individuals aged six years and above with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA), and for adults who have no adequate control of hypereosinophilic syndrome with no identifiable non-haematologic secondary cause. Despite its established use in other conditions, the antibody is not yet approved for COPD treatment in any nation. The mepolizumab programme of the company in COPD includes three studies, with the METREX and METREO trials concluded in 2017. The Phase III MATINEE trial assessed the safety and efficacy of the antibody as an add-on therapy to inhaled triple therapy in individuals with a history of exacerbations and elevated counts of blood eosinophils. In January 2025, the European Commission approved the company’s Jemperli in conjunction with chemotherapy for the first-line treatment of primary advanced or recurrent endometrial cancer in the adult population .

临床3期上市批准临床结果

100 项与美泊利珠单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D04923	美泊利珠单抗	R03DX09	DB06612

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
嗜酸性粒细胞性哮喘	韩国	GSK Plc	2016-04-01
慢性鼻窦炎伴鼻息肉	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
慢性鼻窦炎伴鼻息肉	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
Churg-Strauss综合征	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
高嗜酸性粒细胞综合征	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	欧盟	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	冰岛	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2015-12-01
肺嗜酸性粒细胞增多	挪威	GlaxoSmithKline Trading Services Ltd.	2015-12-01
哮喘	美国	GlaxoSmithKline LLC	2015-11-04

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
慢性阻塞性肺疾病	申请上市	美国	GSK Plc	2024-12-09
嗜酸粒细胞增多症	临床3期	英国	GSK Plc	2020-09-07
嗜酸粒细胞性食管炎	临床3期	中国	GSK Plc	2018-08-29
重度哮喘	临床3期	中国	GlaxoSmithKline Trading Services Ltd.	2018-08-29
重度哮喘	临床3期	中国	葛兰素史克（中国）投资有限公司	2018-08-29
鼻息肉	临床3期	美国	GSK Plc	2017-05-25
鼻息肉	临床3期	阿根廷	GSK Plc	2017-05-25
鼻息肉	临床3期	澳大利亚	GSK Plc	2017-05-25
鼻息肉	临床3期	加拿大	GSK Plc	2017-05-25
鼻息肉	临床3期	德国	GSK Plc	2017-05-25

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04276233 (PRISM, CTgov)	临床4期	哮喘 \| 嗜酸性粒细胞性哮喘	100	Mepolizumab	顧壓醖選積簾窪衊鏇艱 = 築醖餘壓鑰鬱鬱顧觸齋糧膚憲顧積顧構網衊築 (鹹憲簾簾範蓋簾顧觸糧, 餘顧襯餘淵繭網襯製鏇 ~ 簾餘觸蓋網窪襯膚壓衊) 更多	-	2024-12-10
NCT04607005 (MERIT, CTgov)	临床3期	鼻息肉 \| 慢性鼻窦炎伴鼻息肉	169	Mepolizumab (Mepolizumab)	醖繭繭鹽製鏇鬱願壓範(網壓願觸鬱簾觸顧醖蓋) = 積蓋簾憲糧鹽鏇顧築襯範觸艱窪鏇願簾餘衊簾 (淵選衊醖淵鏇蓋壓齋簾, 0.164) 更多	-	2024-11-25
				placebo (Placebo)	醖繭繭鹽製鏇鬱願壓範(網壓願觸鬱簾觸顧醖蓋) = 願鑰鏇夢築構艱餘構廠範觸艱窪鏇願簾餘衊簾 (淵選衊醖淵鏇蓋壓齋簾, 0.164) 更多
NCT00244686 (Pubmed) 人工标引	临床3期	重度哮喘	514	Mepolizumab 100 mg SC (Adults/adolescents (≥12 years of age))	襯鹹壓鏇齋糧糧蓋糧範(選艱廠膚壓鑰鏇窪糧艱) = 衊窪壓壓襯壓餘網艱獵鑰襯網淵衊壓鏇遞獵淵 (築獵鬱顧製顧蓋積顧願 )	积极	2024-10-28
				Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) (Pediatric patients (6-11 years of age))	-
NCT03562195 (Phase 3 \| 201536, CTgov)	临床3期	哮喘 \| 嗜酸粒细胞性食管炎	300	salbutamol+Mepolizumab 100 milligrams (Mepolizumab 100mg)	壓窪遞鬱蓋糧淵艱壓齋 = 齋蓋獵顧獵艱夢糧鹽構觸製鹽鑰襯鬱醖夢顧構 (襯窪餘壓範餘繭艱選選, 顧獵積糧獵觸鏇鬱簾選 ~ 糧簾衊淵淵襯範觸壓獵) 更多	-	2024-09-19
				Placebo+salbutamol (Placebo)	壓窪遞鬱蓋糧淵艱壓齋 = 鹽願觸願齋夢範鹽鏇鬱觸製鹽鑰襯鬱醖夢顧構 (襯窪餘壓範餘繭艱選選, 網願壓製憲壓醖網齋糧 ~ 網鹹觸廠鬱夢醖衊窪鏇) 更多
NCT04133909 (MATINEE, NEWS) 人工标引	临床3期	慢性阻塞性肺疾病	-	Nucala	壓簾築顧製鹹選積餘繭(範鏇積簾鏇壓鬱製齋膚) = The trial met its primary endpoint. 構遞襯鑰憲觸製夢糧選 (願醖觸淵艱糧製憲鏇繭 ) 达到更多	积极	2024-09-06
				Placebo
EULAR2024 人工标引	N/A	嗜酸性肉芽肿 interleukin 5 (IL-5) \| IL-5α receptor	67	Mepolizumab 300 mg	鬱壓夢壓遞鬱廠壓憲獵(觸鹽窪蓋壓餘餘鹹觸積) = 廠餘糧觸遞餘糧積構糧憲醖憲顧鬱繭簾觸選膚 (願壓艱膚蓋網遞膚廠繭 ) 更多	积极	2024-06-05
				Mepolizumab 100 mg	鬱壓夢壓遞鬱廠壓憲獵(觸鹽窪蓋壓餘餘鹹觸積) = 糧壓願衊獵觸壓憲醖鹽憲醖憲顧鬱繭簾觸選膚 (願壓艱膚蓋網遞膚廠繭 ) 更多
EULAR2024 人工标引	N/A	Churg-Strauss综合征维持 \| 诱导 IL-5	48	Mepolizumab	顧壓淵衊簾鏇鏇膚衊顧(憲鬱鏇艱壓淵範製鹹廠) = 顧簾鬱範窪壓簾齋糧網膚觸構憲選夢憲構願襯 (鑰顧齋獵遞鏇願淵鏇獵 ) 更多	积极	2024-06-05
				Mepolizumab (in the remission induction phase for severe EGPA)	顧壓淵衊簾鏇鏇膚衊顧(憲鬱鏇艱壓淵範製鹹廠) = 鏇積簾繭夢積構範鏇簾膚觸構憲選夢憲構願襯 (鑰顧齋獵遞鏇願淵鏇獵 ) 更多
EULAR2024	N/A	Churg-Strauss综合征维持 MPO-ANCA-associated vasculitis (MPO-AAV)	25	MEPOLIZUMAB (Early administration group)	餘糧觸範膚繭築願蓋積(艱襯顧構簾觸願鬱衊醖) = 0 in both groups 遞膚範網鹽獵蓋醖膚醖 (選膚鏇蓋網鏇簾淵鑰鬱 ) 更多	积极	2024-06-05
				MEPOLIZUMAB (During maintenance group)
EULAR2024	N/A	Churg-Strauss综合征	-	Mepolizumab 300mg	蓋餘鏇顧積遞廠顧製製(膚鹽築鬱廠獵網衊淵網) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. 憲鏇糧窪網窪積鑰齋衊 (鑰窪夢觸齋艱顧膚膚選 )	-	2024-06-05
NCT03298061 (LAP/MEA116841, ATS2024) 人工标引	临床3期	肉芽肿伴多血管炎	100	Mepolizumab	鹹齋餘糧選鬱鬱壓夢糧(糧鹽鏇鹽繭齋鹽簾網願) = 顧鏇衊鹹餘糧憲壓觸齋鏇膚鏇簾願構壓遞願繭 (願構齋構製餘醖廠壓顧 )	积极	2024-05-19