{"id":35326,"date":"2025-06-17T00:27:10","date_gmt":"2025-06-16T16:27:10","guid":{"rendered":"https:\/\/flcube.com\/?p=35326"},"modified":"2025-06-17T00:27:12","modified_gmt":"2025-06-16T16:27:12","slug":"cde-accepts-nda-for-ark-bios-azstarys-a-priority-reviewed-adhd-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35326","title":{"rendered":"CDE Accepts NDA for Ark Bio’s Azstarys, a Priority-Reviewed ADHD Treatment"},"content":{"rendered":"\n

China’s Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for Shanghai Ark Biopharmaceutical Co., Ltd.\u2019s Azstarys (serdexmethylphenidate, dexmethylphenidate), granting the filing Priority Review designation. The proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and above.<\/p>\n\n\n\n

Innovative Compound Formulation<\/strong><\/p>\n\n\n\n

Azstarys is the world\u2019s first and only compound formulation combining immediate-release dexmethylphenidate (d-MPH) and prodrug serdexmethylphenidate (SDX). It was originated by Commave Therapeutics, SA.<\/p>\n\n\n\n

Market Authorization and Licensing Deal<\/strong><\/p>\n\n\n\n

The drug received approval in the US in March 2021, making it the new-generation methylphenidate drug in nearly two decades. Ark Bio secured development and marketing rights to the drug through a USD 105.5 million licensing deal with the Swiss firm in December 2021.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China’s Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for…<\/p>\n","protected":false},"author":1,"featured_media":35327,"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":[1443,4157,38,80],"class_list":["post-35326","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-ark-biopharmaceutical","tag-commave-therapeutics","tag-market-approval-filings","tag-priority-reviews"],"yoast_head":"\nCDE Accepts NDA for Ark Bio's Azstarys, a Priority-Reviewed ADHD Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China's Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for Shanghai Ark Biopharmaceutical Co., Ltd.\u2019s Azstarys (serdexmethylphenidate, dexmethylphenidate), granting the filing Priority Review designation. 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