{"id":44558,"date":"2025-10-27T20:55:01","date_gmt":"2025-10-27T12:55:01","guid":{"rendered":"https:\/\/flcube.com\/?p=44558"},"modified":"2025-10-27T20:55:02","modified_gmt":"2025-10-27T12:55:02","slug":"leo-pharma-submits-nda-for-anzupgo-in-china-for-chronic-hand-eczema","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=44558","title":{"rendered":"LEO Pharma Submits NDA for Anzupgo in China for Chronic Hand Eczema"},"content":{"rendered":"\n

LEO Pharma announced on October 17, 2025, that it has submitted a New Drug Application (NDA) for Anzupgo (delgocitinib cream) to China’s National Medical Products Administration (NMPA). The application targets moderate-to-severe Chronic Hand Eczema (CHE) in adults who have had an inadequate response to or are not suitable for treatment with topical corticosteroids (TCS). The NDA has been accepted and has entered the review process.<\/p>\n\n\n\n

Clinical Trial Basis<\/strong>
The marketing application is supported by the DELTA China study, a Phase III clinical trial conducted in China, along with data from the global delgocitinib clinical development program, including DELTA 1, 2, and 3, DELTA FORCE, and DELTA TEEN trials. The DELTA China study met its primary endpoint, showing a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to the cream vehicle.<\/p>\n\n\n\n

Market Progress<\/strong>
In September 2025, the first prescription for Anzupgo was issued in the Greater Bay Area, marking an important step in the drug’s commercialization.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

LEO Pharma announced on October 17, 2025, that it has submitted a New Drug Application…<\/p>\n","protected":false},"author":1,"featured_media":44563,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[819,38],"class_list":["post-44558","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-leo-pharma","tag-market-approval-filings"],"yoast_head":"\nLEO Pharma Submits NDA for Anzupgo in China for Chronic Hand Eczema - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"LEO Pharma announced on October 17, 2025, that it has submitted a New Drug Application (NDA) for Anzupgo (delgocitinib cream) to China's National Medical Products Administration (NMPA). 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