{"id":78174,"date":"2026-09-02T15:17:34","date_gmt":"2026-09-02T07:17:34","guid":{"rendered":"https:\/\/flcube.com\/?p=78174"},"modified":"2026-09-02T15:17:35","modified_gmt":"2026-09-02T07:17:35","slug":"beijing-huasu-wins-nmpa-clinical-trial-approval-for-methylphenidate-er-chewable-tablets-first-domestic-generic-for-adhd-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78174","title":{"rendered":"Beijing Huasu Wins NMPA Clinical Trial Approval for Methylphenidate ER Chewable Tablets, First Domestic Generic for ADHD Treatment"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Beijing Huasu Pharmaceutical Co., Ltd.<\/strong>, a subsidiary of <strong>Beijing Centergate Technologies<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/000931:SHE\">SHE: 000931<\/a>), has received clinical trial approval from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for its <strong>methylphenidate hydrochloride extended-release chewable tablets<\/strong>. The drug will be assessed as a treatment for attention deficit hyperactivity disorder (<strong>ADHD<\/strong>) in patients aged 6 years and older.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Agency<\/th><th>Approval Type<\/th><th>Product<\/th><th>Indication<\/th><th>Date<\/th><th>Next Steps<\/th><\/tr><\/thead><tbody><tr><td><strong>NMPA<\/strong> (China)<\/td><td>Clinical Trial Approval<\/td><td><strong>Methylphenidate hydrochloride extended-release chewable tablets<\/strong><\/td><td><strong>ADHD<\/strong> in patients aged 6 years and older<\/td><td>02 Sep 2026<\/td><td>Clinical trials to establish safety and efficacy of the generic formulation in China<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-competitive-landscape\" class=\"wp-block-heading\">Drug Profile &amp; Competitive Landscape<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> Methylphenidate hydrochloride extended-release chewable tablets, a central nervous system (CNS) stimulant indicated for the treatment of <strong>ADHD<\/strong><\/li>\n\n\n\n<li><strong>Originator:<\/strong> <strong>Quillichew ER<\/strong>, developed by US-based <strong>Tris Pharma<\/strong><\/li>\n\n\n\n<li><strong>China commercialization:<\/strong> Introduced to the Chinese market by <strong>Pediatrix Therapeutics<\/strong>, where it has already received marketing approval<\/li>\n\n\n\n<li><strong>Market structure:<\/strong> The originator currently remains the only approved product for this formulation in China<\/li>\n\n\n\n<li><strong>First-mover status:<\/strong> <strong>Beijing Huasu<\/strong> becomes the first domestic pharmaceutical company to receive clinical trial authorization for a generic version of this chewable sustained-release tablet<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First domestic entrant:<\/strong> The clinical trial approval gives <strong>Beijing Huasu<\/strong> a potential head start in China&#8217;s generic race for methylphenidate extended-release chewable tablets<\/li>\n\n\n\n<li><strong>Growing demand:<\/strong> Pediatric <strong>ADHD<\/strong> diagnosis and treatment rates in China continue to rise, supporting demand for patient-friendly formulations such as chewable tablets<\/li>\n\n\n\n<li><strong>Import substitution:<\/strong> A successful domestic generic could challenge the current monopoly of originator <strong>Quillichew ER<\/strong>, with implications for pricing and market access<\/li>\n\n\n\n<li><strong>Strategic fit:<\/strong> The approval strengthens the CNS portfolio of <strong>Beijing Centergate Technologies<\/strong> and its subsidiary <strong>Beijing Huasu<\/strong><\/li>\n\n\n\n<li><strong>Sector signal:<\/strong> The milestone reflects increasing domestic capability among Chinese generics developers in complex formulations like extended-release chewable CNS products<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2013 This brief contains forward-looking statements regarding the clinical development and potential commercialization of methylphenidate hydrochloride extended-release chewable tablets. Actual results may differ materially due to clinical, regulatory, and market risks. This content is for informational purposes only and does not constitute investment advice.<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\/2026\/09\/\u4e2d-\u5173-\u6751\uff1a\u5173\u4e8e\u4e0b\u5c5e\u516c\u53f8\u5317\u4eac\u534e\u7d20\u76d0\u9178\u54cc\u7532\u916f\u7f13\u91ca\u5480\u56bc\u7247\u6536\u5230\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u4e2d \u5173 \u6751\uff1a\u5173\u4e8e\u4e0b\u5c5e\u516c\u53f8\u5317\u4eac\u534e\u7d20\u76d0\u9178\u54cc\u7532\u916f\u7f13\u91ca\u5480\u56bc\u7247\u6536\u5230\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-ca70bf81-92e4-4a68-87e4-3710eb76b6f9\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/09\/\u4e2d-\u5173-\u6751\uff1a\u5173\u4e8e\u4e0b\u5c5e\u516c\u53f8\u5317\u4eac\u534e\u7d20\u76d0\u9178\u54cc\u7532\u916f\u7f13\u91ca\u5480\u56bc\u7247\u6536\u5230\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\">\u4e2d \u5173 \u6751\uff1a\u5173\u4e8e\u4e0b\u5c5e\u516c\u53f8\u5317\u4eac\u534e\u7d20\u76d0\u9178\u54cc\u7532\u916f\u7f13\u91ca\u5480\u56bc\u7247\u6536\u5230\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/09\/\u4e2d-\u5173-\u6751\uff1a\u5173\u4e8e\u4e0b\u5c5e\u516c\u53f8\u5317\u4eac\u534e\u7d20\u76d0\u9178\u54cc\u7532\u916f\u7f13\u91ca\u5480\u56bc\u7247\u6536\u5230\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-ca70bf81-92e4-4a68-87e4-3710eb76b6f9\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Beijing Huasu Pharmaceutical Co., Ltd., a subsidiary of Beijing Centergate Technologies (SHE: 000931), has received&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[238,62,4921,1034],"class_list":["post-78174","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-centergate-technologies","tag-clinical-trial-approval-initiation","tag-huasu-pharmaceutical","tag-she-000931"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Beijing Huasu Wins NMPA Clinical Trial Approval for Methylphenidate ER Chewable Tablets, First Domestic Generic for ADHD Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Beijing Huasu Pharmaceutical Co., Ltd., a subsidiary of Beijing Centergate Technologies (SHE: 000931), has received clinical trial approval from China&#039;s National Medical Products Administration (NMPA) for its methylphenidate hydrochloride extended-release chewable tablets. 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