{"id":50260,"date":"2025-12-09T13:21:57","date_gmt":"2025-12-09T05:21:57","guid":{"rendered":"https:\/\/flcube.com\/?p=50260"},"modified":"2025-12-09T13:21:58","modified_gmt":"2025-12-09T05:21:58","slug":"ignis-therapeutics-solriamfetol-nmpa-approval-targets-osa-sleepiness","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50260","title":{"rendered":"Ignis Therapeutics Solriamfetol NMPA Approval Targets OSA Sleepiness"},"content":{"rendered":"\n<p><strong>Ignis Therapeutics<\/strong> announced that <strong>Solriamfetol Hydrochloride Tablets<\/strong> received approval from China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for improving wakefulness in adult patients with <strong>obstructive sleep apnea (OSA)<\/strong> accompanied by excessive daytime sleepiness (EDS).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-approval-amp-product-profile\">Regulatory Approval &amp; Product Profile<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Ignis Therapeutics<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Solriamfetol Hydrochloride Tablets<\/td><\/tr><tr><td><strong>Approval<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>OSA with EDS in adult patients<\/td><\/tr><tr><td><strong>Mechanism<\/strong><\/td><td>Dual dopamine (DA) and norepinephrine (NE) reuptake inhibition<\/td><\/tr><tr><td><strong>Global Status<\/strong><\/td><td>Already approved in Europe and US for OSA-EDS and narcolepsy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-efficacy-tones-studies-amp-chinese-phase-3\">Clinical Efficacy: TONES Studies &amp; Chinese Phase 3<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Efficacy Parameter<\/th><th>Result<\/th><th>Clinical Significance<\/th><\/tr><\/thead><tbody><tr><td><strong>Onset of Action<\/strong><\/td><td>Within 1 hour<\/td><td>Rapid wakefulness improvement<\/td><\/tr><tr><td><strong>Duration<\/strong><\/td><td>9 hours<\/td><td>Covers full daytime\/work period<\/td><\/tr><tr><td><strong>MWT Improvement<\/strong><\/td><td>Significant enhancement<\/td><td>Objective measure of wakefulness maintenance<\/td><\/tr><tr><td><strong>ESS Score (12 weeks)<\/strong><\/td><td>-7.7 points (150mg group)<\/td><td>Clinically meaningful reduction in sleepiness<\/td><\/tr><tr><td><strong>Symptom Improvement<\/strong><\/td><td>~90% of patients reported improvement<\/td><td>High responder rate<\/td><\/tr><tr><td><strong>Long-term Efficacy (1 year)<\/strong><\/td><td>&gt;96% sustained improvement<\/td><td>Durable benefit with continued treatment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-safety-amp-tolerability-profile\">Safety &amp; Tolerability Profile<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Adverse Events<\/strong>: Mostly mild-to-moderate, occurring within first week, subsiding over time<\/li>\n\n\n\n<li><strong>Nighttime Sleep<\/strong>: Does not affect nighttime sleep architecture<\/li>\n\n\n\n<li><strong>Cardiovascular<\/strong>: Minimal impact on blood pressure in OSA patients<\/li>\n\n\n\n<li><strong>Discontinuation<\/strong>: No rebound sleepiness after treatment cessation<\/li>\n\n\n\n<li><strong>Validation<\/strong>: Positive conclusions confirmed by Chinese Phase 3 clinical study<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-rights-amp-partnership\">Commercial Rights &amp; Partnership<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Agreement<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Partner<\/strong><\/td><td>SK Biopharmaceuticals<\/td><\/tr><tr><td><strong>Deal Signed<\/strong><\/td><td>November\u202f2021<\/td><\/tr><tr><td><strong>Territory<\/strong><\/td><td>Greater China (Mainland, Hong Kong, Macau, Taiwan)<\/td><\/tr><tr><td><strong>Rights<\/strong><\/td><td>Exclusive development, registration, local production, and commercialization<\/td><\/tr><tr><td><strong>Strategic Value<\/strong><\/td><td>Leverages SK&#8217;s global development data for accelerated China entry<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-strategic-outlook\">Market Opportunity &amp; Strategic Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>OSA Prevalence<\/strong>: <strong>180 million<\/strong> adults in China affected by OSA; <strong>60 million<\/strong> experience EDS<\/li>\n\n\n\n<li><strong>Market Gap<\/strong>: Limited pharmacologic options for OSA\u2011related EDS; solriamfetol offers first oral non\u2011stimulant alternative<\/li>\n\n\n\n<li><strong>Competitive Positioning<\/strong>: Differentiated from modafinil\/armodafinil through dual mechanism and longer duration<\/li>\n\n\n\n<li><strong>Revenue Forecast<\/strong>: Analysts project <strong>\u00a5500\u2011800 million<\/strong> (US$70\u2011110 million) peak China sales by 2029<\/li>\n\n\n\n<li><strong>Next Steps<\/strong>: Pricing negotiations with NHSA; hospital listing campaign Q1\u202f2026<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding solriamfetol commercialization timelines, market penetration, and revenue projections. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ignis Therapeutics announced that Solriamfetol Hydrochloride Tablets received approval from China&#8217;s National Medical Products Administration&#8230;<\/p>\n","protected":false},"author":1,"featured_media":50262,"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":[4493,15],"class_list":["post-50260","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-ignis-therapeutics","tag-product-approvals"],"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>Ignis Therapeutics Solriamfetol NMPA Approval Targets OSA Sleepiness - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Ignis Therapeutics announced that Solriamfetol Hydrochloride Tablets received approval from China&#039;s National Medical Products Administration (NMPA) for improving wakefulness in adult patients with obstructive sleep apnea (OSA) accompanied by excessive daytime sleepiness (EDS).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=50260\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ignis Therapeutics Solriamfetol NMPA Approval Targets OSA Sleepiness\" \/>\n<meta property=\"og:description\" content=\"Ignis Therapeutics announced that Solriamfetol Hydrochloride Tablets received approval from China&#039;s National Medical Products Administration (NMPA) for improving wakefulness in adult patients with obstructive sleep apnea (OSA) accompanied by excessive daytime sleepiness (EDS).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=50260\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-09T05:21:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-09T05:21:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/0901.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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