{"id":33264,"date":"2025-05-13T15:21:52","date_gmt":"2025-05-13T07:21:52","guid":{"rendered":"https:\/\/flcube.com\/?p=33264"},"modified":"2025-05-13T15:21:52","modified_gmt":"2025-05-13T07:21:52","slug":"fosun-pharmas-fcn-159-granted-breakthrough-therapy-designation-for-pediatric-lch","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=33264","title":{"rendered":"Fosun Pharma&#8217;s FCN-159 Granted Breakthrough Therapy Designation for Pediatric LCH"},"content":{"rendered":"\n<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/600196:SHA\">SHA: 600196<\/a>, <a href=\"https:\/\/www.google.com\/finance\/quote\/2196:HKG\">HKG: 2196<\/a>) announced that its novel small-molecule chemical drug FCN-159 has received Breakthrough Therapy Designation (BTD) from China&#8217;s National Medical Products Administration (NMPA) for the treatment of Langerhans cell histiocytosis (LCH) in children. This designation underscores the drug&#8217;s potential to address significant unmet medical needs in pediatric patients.<\/p>\n\n\n\n<p><strong>FCN-159 Development and Applications<\/strong><br>FCN-159 is a highly selective MEK1\/2 inhibitor. It is currently in development for the treatment of advanced solid tumors, Type 1 neurofibromatosis, dendritic cell and histiocytosis, and low-grade gliomas. Marketing applications for the drug are under review in China for the treatment of dendritic and histiocytic tumors in adults and plexiform neurofibroma (PN) associated with Type 1 neurofibromatosis (NF1) in children aged two and above. The drug is also undergoing Phase III studies in adult Type 1 neurofibromatosis and Phase II studies in low-grade gliomas, extracranial arteriovenous malformations, and pediatric LCH in mainland China.<\/p>\n\n\n\n<p><strong>Previous Breakthrough Therapy Designations<\/strong><br>FCN-159 has previously received BTD in China for histiocytoma and NF1-related plexiform neurofibromas in adult patients.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/600196_20250513_4NOI.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600196_20250513_4NOI.\"><\/object><a id=\"wp-block-file--media-ce6d1047-b55a-49f5-8119-5e4f473a1eb8\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/600196_20250513_4NOI.pdf\">600196_20250513_4NOI<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/600196_20250513_4NOI.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ce6d1047-b55a-49f5-8119-5e4f473a1eb8\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its novel small-molecule&#8230;<\/p>\n","protected":false},"author":1,"featured_media":33266,"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":[34,159,893,892],"class_list":["post-33264","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-breakthrough-therapy","tag-fosun-pharmaceutical","tag-hkg-2196","tag-sha-600196"],"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>Fosun Pharma&#039;s FCN-159 Granted Breakthrough Therapy Designation for Pediatric LCH - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its novel small-molecule chemical drug FCN-159 has received Breakthrough Therapy Designation (BTD) from China&#039;s National Medical Products Administration (NMPA) for the treatment of Langerhans cell histiocytosis (LCH) in children. 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