{"id":46426,"date":"2025-11-11T17:04:28","date_gmt":"2025-11-11T09:04:28","guid":{"rendered":"https:\/\/flcube.com\/?p=46426"},"modified":"2025-11-11T17:04:29","modified_gmt":"2025-11-11T09:04:29","slug":"grand-pharmaceutical-glenmark-specialty-secure-china-nmpa-approval-for-ryaltris-nasal-spray","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46426","title":{"rendered":"Grand Pharmaceutical &amp; Glenmark Specialty Secure China NMPA Approval for Ryaltris Nasal Spray"},"content":{"rendered":"\n<p><strong>Grand Pharmaceutical Group Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/0512:HKG\">HKG: 0512<\/a>) together with <strong>Glenmark Specialty S.A.<\/strong> announced that the <strong>Ryaltris<\/strong> compound nasal spray has received marketing authorization from China\u2019s <strong>National Medical Products Administration (NMPA)<\/strong> for the treatment of <strong>allergic rhinitis (AR)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-deal-amp-regulatory-highlights\">Deal &amp; Regulatory Highlights<\/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>Product<\/strong><\/td><td>Ryaltris \u2013 fixed\u2011dose combination nasal spray (antihistamine\u202f+\u202fcorticosteroid)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Moderate\u2011to\u2011severe <strong>seasonal<\/strong> AR (adults\u202f+\u202fchildren\u202f\u2265\u202f6\u202fyr) and moderate\u2011to\u2011severe <strong>perennial<\/strong> AR (adults\u202f+\u202fchildren\u202f\u2265\u202f12\u202fyr)<\/td><\/tr><tr><td><strong>Regulatory Milestone<\/strong><\/td><td>NMPA <strong>full approval<\/strong> (11\u202fNov\u202f2025)<\/td><\/tr><tr><td><strong>Partner<\/strong><\/td><td>Glenmark Specialty S.A. (global rights holder)<\/td><\/tr><tr><td><strong>Launch Plan<\/strong><\/td><td>Commercial rollout in China slated for Q1\u202f2026; parallel rollout in Hong\u202fKong and other APAC markets later in 2026<\/td><\/tr><tr><td><strong>Pricing<\/strong><\/td><td>To be disclosed; expected to be positioned competitively against existing intranasal steroids and antihistamine monotherapies<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence\">Clinical Evidence<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Phase\u202f3 China Trial:<\/strong> 535 patients across 12 sites; double\u2011blind, active\u2011comparator design.<\/li>\n\n\n\n<li><strong>Efficacy:<\/strong> Ryaltris achieved statistically significant improvements in <strong>Total Nasal Symptom Score (TNSS)<\/strong> and <strong>Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)<\/strong> versus single\u2011agent antihistamine or corticosteroid arms (p\u202f&lt;\u202f0.001).<\/li>\n\n\n\n<li><strong>Onset of Action:<\/strong> Symptom relief observed within <strong>15\u202fminutes<\/strong> of the first dose; sustained efficacy through the 24\u2011hour dosing interval.<\/li>\n\n\n\n<li><strong>Safety:<\/strong> Comparable adverse\u2011event profile to monotherapy comparators; most common events were mild nasal irritation and transient epistaxis (&lt;\u202f2\u202f%).<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact\">Market Impact<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Allergic Rhinitis Burden:<\/strong> Over <strong>100\u202fmillion<\/strong> Chinese adults experience AR; prevalence in children (\u2265\u202f6\u202fyr) exceeds 30\u202f%.<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Grand Pharmaceutical projects <strong>CNY\u202f1.2\u20131.5\u202fbillion<\/strong> in 2027 sales from Ryaltris, assuming 5\u202f% market capture within the first two years.<\/li>\n\n\n\n<li><strong>Strategic Fit:<\/strong> The combination product differentiates from existing intranasal steroids (e.g., fluticasone) and antihistamine sprays, offering a <strong>single\u2011dose, dual\u2011action<\/strong> therapy that aligns with patient\u2011centric treatment trends.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory timelines, commercial launch expectations, and revenue projections for Ryaltris. Actual results may differ due to risks including clinical outcomes, regulatory actions, market acceptance, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris&#8230;<\/p>\n","protected":false},"author":1,"featured_media":46431,"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":[4450,683,1184,15],"class_list":["post-46426","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-glenmark-specialty","tag-grand-pharmaceutical","tag-hkg-0512","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Grand Pharmaceutical &amp; Glenmark Specialty Secure China NMPA Approval for Ryaltris Nasal Spray - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris compound nasal spray has received marketing authorization from China\u2019s National Medical Products Administration (NMPA) for the treatment of allergic rhinitis (AR).\" \/>\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=46426\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Grand Pharmaceutical &amp; Glenmark Specialty Secure China NMPA Approval for Ryaltris Nasal Spray\" \/>\n<meta property=\"og:description\" content=\"Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris compound nasal spray has received marketing authorization from China\u2019s National Medical Products Administration (NMPA) for the treatment of allergic rhinitis (AR).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=46426\" \/>\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=\"2025-11-11T09:04:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-11T09:04:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/11\/1115.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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