{"id":24764,"date":"2022-10-31T23:45:00","date_gmt":"2022-10-31T15:45:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24764"},"modified":"2025-02-01T23:50:13","modified_gmt":"2025-02-01T15:50:13","slug":"nmpa-approves-kyowa-hakko-kirins-mogamulizumab-for-sezary-syndrome-and-mycosis-fungoides","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24764","title":{"rendered":"NMPA Approves Kyowa Hakko Kirin\u2019s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides"},"content":{"rendered":"\n<p>Kyowa Hakko Kirin China Pharmaceutical Co., Ltd\u2019s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III\/IV) mycosis fungoides (MF) who have previously received systemic treatment. Mycosis fungoides is a form of T-cell lymphoma where malignant lymphocytes affect the skin.<\/p>\n\n\n\n<p><strong>Approval Based on MAVORIC Study<\/strong><br>The approval is based on the results of the MAVORIC study, the largest clinical trial conducted in patients with SS and MF to date. The study demonstrated that the duration of disease control in patients treated with mogamulizumab was more than twice as long as that in patients treated with the control drug vorinostat (median progression-free survival: 7.7 months vs. 3.1 months). Additionally, the response rate of mogamulizumab was higher across all disease stages compared to vorinostat. The confirmed complete remission rates were 28% for mogamulizumab and 5% for vorinostat (P&lt;0.001). Mogamulizumab exhibited good overall tolerability and controllable safety.<\/p>\n\n\n\n<p><strong>Technology and Global Recognition<\/strong><br>Mogamulizumab utilizes Kyowa Hakko Kirin\u2019s proprietary POTELLIGENT technology, which enhances the natural immune response of the human body to the treatment, thereby improving the effectiveness in killing cancer cells. The drug has previously been awarded breakthrough therapy designation (BTD) and orphan drug designation (ODD) in the US, as well as ODD in Europe. Mogamulizumab is the first and only approved CCR4-targeted biologic product in China and other regions worldwide.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kyowa Hakko Kirin China Pharmaceutical Co., Ltd\u2019s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4)&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[2090,15,24],"class_list":["post-24764","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-kyowa-hakko-kirin","tag-product-approvals","tag-rare-orphan-disease-drugs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NMPA Approves Kyowa Hakko Kirin\u2019s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Kyowa Hakko Kirin China Pharmaceutical Co., Ltd\u2019s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III\/IV) mycosis fungoides (MF) who have previously received systemic treatment. Mycosis fungoides is a form of T-cell lymphoma where malignant lymphocytes affect the skin.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=24764\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Approves Kyowa Hakko Kirin\u2019s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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