{"id":76496,"date":"2026-08-25T12:16:36","date_gmt":"2026-08-25T04:16:36","guid":{"rendered":"https:\/\/flcube.com\/?p=76496"},"modified":"2026-08-25T12:16:37","modified_gmt":"2026-08-25T04:16:37","slug":"hengruis-nmpa-accepts-nda-for-hrg2010-a-novel-levodopa-carbidopa-combination-for-parkinsons-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=76496","title":{"rendered":"Hengrui&#8217;s NMPA Accepts NDA for HRG2010, a Novel Levodopa\/Carbidopa Combination for Parkinson&#8217;s Disease"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Jiangsu Hengrui Pharmaceuticals Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/600276:SHA\">SHA: 600276<\/a>; <a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/1276:HKG\">HKG: 1276<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has accepted its <strong>National Drug Application (NDA)<\/strong> for <strong>HRG2010<\/strong>, intended for the treatment of <strong>Parkinson&#8217;s disease<\/strong> \u2014 a key regulatory step for the company&#8217;s next\u2011generation levodopa\/carbidopa combination candidate.<\/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>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276)<\/td><\/tr><tr><td><strong>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>Filing<\/strong><\/td><td>National Drug Application (NDA) accepted<\/td><\/tr><tr><td><strong>Asset<\/strong><\/td><td>HRG2010 (Class 2 innovative drug)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Parkinson&#8217;s disease<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>24 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-formulation\" class=\"wp-block-heading\">Drug Profile &amp; Formulation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Classification:<\/strong> <strong>Class 2 innovative drug<\/strong>, independently developed by Hengrui<\/li>\n\n\n\n<li><strong>Composition:<\/strong> Fixed\u2011dose combination of <strong>levodopa<\/strong> and the peripheral decarboxylase inhibitor <strong>carbidopa<\/strong><\/li>\n\n\n\n<li><strong>Design Advantage:<\/strong> Engineered with an <strong>optimized release mechanism<\/strong> to achieve <strong>rapid onset<\/strong> alongside <strong>prolonged and stable efficacy<\/strong> \u2014 addressing the wearing\u2011off phenomenon common with standard levodopa\/carbidopa regimens<\/li>\n\n\n\n<li><strong>Comparable Marketed Products:<\/strong> Carbidopa\/levodopa sustained\u2011release tablets (<strong>Sinemet<\/strong>), Amneal Pharmaceuticals&#8217; <strong>RYTARY (IPX006)<\/strong> and <strong>CREXONT (IPX203)<\/strong> \u2014 both globally and domestically<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-evidence-confirmatory-phase-iii-study-hrg2010-301\" class=\"wp-block-heading\">Clinical Evidence \u2013 Confirmatory Phase III Study (HRG2010\u2011301)<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint \/ Metric<\/th><th>Result (HRG2010 vs. Control)<\/th><\/tr><\/thead><tbody><tr><td><strong>&#8220;OFF&#8221; Time<\/strong><\/td><td>Significantly reduced<\/td><\/tr><tr><td><strong>Good &#8220;ON&#8221; Time<\/strong><\/td><td>Significantly extended<\/td><\/tr><tr><td><strong>Study Population<\/strong><\/td><td>Parkinson&#8217;s disease patients experiencing motor fluctuations<\/td><\/tr><tr><td><strong>Long\u2011Term Efficacy<\/strong><\/td><td>Maintained over the study period<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Consistent with known carbidopa\/levodopa characteristics; no new safety signals<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The Phase III results demonstrate that <strong>HRG2010 capsules significantly reduced &#8220;OFF&#8221; time and extended good &#8220;ON&#8221; time<\/strong> compared with the control group, with long\u2011term efficacy maintained. On safety, the profile aligned with the established characteristics of carbidopa\/levodopa combination therapies, with <strong>no new safety signals observed<\/strong>.<\/p>\n\n\n\n<h2 id=\"h-strategic-outlook\" class=\"wp-block-heading\">Strategic Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Large Unmet Need:<\/strong> Motor fluctuations \u2014 including &#8220;OFF&#8221; episodes \u2014 remain a central challenge in long\u2011term Parkinson&#8217;s management, making therapies that stabilize &#8220;ON&#8221; time highly valued clinically and commercially.<\/li>\n\n\n\n<li><strong>Competitive Positioning:<\/strong> Against global benchmarks such as <strong>RYTARY<\/strong> and <strong>CREXONT<\/strong>, HRG2010&#8217;s optimized release design positions Hengrui to compete for a meaningful share of China&#8217;s Parkinson&#8217;s disease market.<\/li>\n\n\n\n<li><strong>Portfolio Expansion:<\/strong> The NDA acceptance reinforces Hengrui&#8217;s strategy of broadening beyond oncology into large chronic disease franchises with high commercial durability.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the regulatory review timeline, clinical outcomes and commercial prospects of HRG2010. Actual results may differ due to risks including NMPA review decisions, market adoption and competitive dynamics.<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\/08\/600276_20260825_37QY.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 600276_20260825_37QY.\"><\/object><a id=\"wp-block-file--media-2a274695-ae33-4516-9521-b06e92faf77f\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/600276_20260825_37QY.pdf\">600276_20260825_37QY<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/08\/600276_20260825_37QY.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-2a274695-ae33-4516-9521-b06e92faf77f\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China&#8217;s National Medical Products&#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":[2586,38,852],"class_list":["post-76496","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hengrui-pharmaceuticals","tag-market-approval-filings","tag-sha-600276"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hengrui&#039;s NMPA Accepts NDA for HRG2010, a Novel Levodopa\/Carbidopa Combination for Parkinson&#039;s Disease - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd. 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