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关于惠尔金<\/b>®<\/sup><\/b>（莫格利珠单抗）<\/b><\/p> \n

惠尔金®<\/sup><\/b>是一款同类首创人源化单克隆抗体（mAb），旨在与C-C趋化因子受体4（CCR4）相结合。惠尔金®<\/sup><\/b>与CCR4结合后，会在人体免疫系统中激活更多的免疫细胞，进而破坏癌细胞[7]<\/span><\/sup>。惠尔金®<\/sup><\/b>使用协和麒麟专有的POTELLIGENT®<\/sup><\/b>技术，可增强人体对治疗的自然免疫反应，从而提高对癌细胞的杀伤力。FDA已授予惠尔金®<\/sup><\/b>突破性疗法和孤儿药认定[19],[20<\/span>]<\/sup>。此外，惠尔金®<\/sup><\/b>还于2016年被欧盟委员会（EC）授予孤儿药认定[21]<\/span><\/sup>。惠尔金®<\/sup><\/b>是首个也是唯一<\/span>在中国和世界其他地区获批的靶向CCR4的生物制剂[22]<\/span><\/sup>。<\/p> \n

*伏立诺他是美国FDA批准用于治疗蕈样肉芽肿和塞扎里综合征的药物，目前尚未在中国获批<\/p> \n

参考文献<\/b><\/p> \n

[1] Until July 2022<\/span>, the data source: Ding Xiang Yuan database.
<\/sup>[2] Placeholder (To be updated with NMPA approval news release)  
<\/sup>[3] Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol<\/i>. 2018;19(9):1192-1204.
<\/sup>[4] Ferenczi K, Fuhlbrigge RC, Pinkus J, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol<\/i>. 2002;119:1405-10.
<\/sup>[5] Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood<\/i>. 2002;99(5):1505-11.
<\/sup>[6] Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia\/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res<\/span><\/i>. 2003;9:3625-34.
<\/sup>[7] Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol<\/i>. 2016;7(3):171-174.
<\/sup>[8] Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood<\/i>. 2019;133(16):1703-1714.
<\/sup>[9] Olsen E,  Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood<\/i>. 2007;110(6):1713-22.
<\/sup>[10] Orphanet: Prevalence and incidence of rare diseases: Bibliographic data. Available from: https:\/\/www.orpha.net\/orphacom\/cahiers\/docs\/GB\/Prevalence_of_rare_diseases_by_decreasing_prevalence_or_cases.pdf<\/a>. Last accessed: June 2020<\/span>.
<\/sup>[11] Orphanet: Mycosis Fungoides. Available from: https:\/\/www.orpha.net\/consor\/cgi-bin\/OC_Exp.php?Lng=GB&Expert=2584<\/a>. <\/u>Last Accessed: June 2020<\/span>.
<\/sup>[12] Orphanet: Sézary syndrome. Available from: https:\/\/www.orpha.net\/consor\/cgi-bin\/OC_Exp.php?Expert=3162<\/a>. Last Accessed: June 2020<\/span>.
<\/sup>[13] Haun P, et al. Fast Facts : Diagnosing Cutaneous T-Cell Lymphoma. Karger Publishing<\/i>. 2016.
<\/sup>[14] Cutaneous Lymphoma Foundation, Lymphoma Action and Lymphoma Coalition Europe. Cutaneous lymphoma – a patient's guide. 2019. Available from: https:\/\/lymphoma-action.org.uk\/sites\/default\/files\/media\/documents\/2019-06\/Cutaneous%20lymphoma%20-%20patient%26%23039%3Bs%20guide%20-%20English%20language%20source%20document%20-%20final%20version%20for%20publication%20-%20April%202019.pdf<\/a>. Last accessed: June 2020<\/span>.
<\/sup>[15] CL Foundation: A Patient's Guide. Available from: https:\/\/www.clfoundation.org\/sites\/default\/files\/2018-04\/a_patients_guide.pdf<\/a>. Last Accessed: 18 November 2019<\/span>.
<\/sup>[16] Scarisbrick JJ, Prince M, Vermeer MH, et al. Cutaneous Lymphoma International Consortium Study of Outcome in Advanced Stages of Mycosis Fungoides and Sézary Syndrome: Effect of Specific Prognostic Markers on Survival and Development of a Prognostic Model. J Clin Oncol<\/i>. 2015;33(32):3766-3773.
<\/sup>[17] Kim YH, Bagot M, Zinzani PL et al. Safety of Mogamulizumab in Mycosis Fungoides and Sézary Syndrome: Final Results from the Phase 3 Mavoric Study. Blood. 2019;134 (1):5300.
<\/sup>[18] Clin Lymphoma Myeloma Leuk. 2021 Feb; 21(2):97-105
<\/sup>[19] Search Orphan Drug Designations and Approvals (fda.gov). Available from https:\/\/www.accessdata.fda.gov\/scripts\/opdlisting\/oopd\/detailedIndex.cfm?cfgridkey=322010<\/a>. Last accessed: July 2022<\/span>.
<\/sup>[20] FDA approves treatment for two rare types of non-Hodgkin lymphoma. Available from: https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-treatment-two-rare-types-non-hodgkin-lymphoma<\/a>. Last accessed: July 2022<\/span>.
<\/sup>[21] EU\/3\/16\/1756: Orphan designation for the treatment of cutaneous T-cell lymphoma. Available from: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/orphan-designations\/eu3161756. Last accessed: July 2022<\/span>.<\/sup><\/p> \n

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