{"id":54857,"date":"2026-01-20T20:03:24","date_gmt":"2026-01-20T12:03:24","guid":{"rendered":"https:\/\/flcube.com\/?p=54857"},"modified":"2026-01-20T20:03:25","modified_gmt":"2026-01-20T12:03:25","slug":"chiesis-raxone-begins-lhon-treatment-in-china-first-world-approved-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54857","title":{"rendered":"Chiesi\u2019s Raxone Begins LHON Treatment in China, First World\u2011Approved Therapy"},"content":{"rendered":"\n<p><strong>Chiesi Group<\/strong> announced that the first patients have initiated treatment with <strong>Raxone (idebenone 150\u202fmg)<\/strong> at <strong>Ruijin Hainan Hospital<\/strong>, affiliated with Shanghai Jiao Tong University School of Medicine, less than one month after the drug received approval in the <strong>Boao Lecheng International Medical Tourism Pilot Zone<\/strong>. Raxone is the <strong>world\u2019s first and only approved therapy<\/strong> for visual impairment in adolescent and adult patients with <strong>Leber\u2019s Hereditary Optic Neuropathy (LHON)<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">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>Chiesi Group (Italy\u2011based)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>Raxone (idebenone 150\u202fmg)<\/td><\/tr><tr><td><strong>Approval<\/strong><\/td><td>Boao Lecheng Pilot Zone (China)<\/td><\/tr><tr><td><strong>Treatment Initiation<\/strong><\/td><td>First patients at Ruijin Hainan Hospital<\/td><\/tr><tr><td>**Indication<\/td><td>Visual impairment in adolescent and adult LHON patients<\/td><\/tr><tr><td>**Mechanism<\/td><td>Antioxidant + mitochondrial electron transport chain cofactor<\/td><\/tr><tr><td>**Unique Position<\/td><td>World\u2019s first and only approved LHON therapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-disease-profile-leber-s-hereditary-optic-neuropathy-lhon\">Disease Profile: Leber\u2019s Hereditary Optic Neuropathy (LHON)<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Etiology:<\/strong> Mitochondrial DNA mutations in <strong>Complex I<\/strong> (ND genes) affecting retinal ganglion cells (RGCs)<\/li>\n\n\n\n<li><strong>Clinical Manifestations:<\/strong> Acute\/subacute <strong>vision loss<\/strong>, typically in young adults; leads to <strong>central scotoma<\/strong> and <strong>legal blindness<\/strong><\/li>\n\n\n\n<li><strong>Epidemiology:<\/strong><\/li>\n\n\n\n<li><strong>Global prevalence:<\/strong> 1 in 30,000\u201150,000<\/li>\n\n\n\n<li><strong>China:<\/strong> ~3,500\u20115,000 patients<\/li>\n\n\n\n<li><strong>Onset:<\/strong> 90% male, typically aged 15\u201135 years<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> No approved treatments until Raxone; disease causes <strong>irreversible vision loss<\/strong> within months<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-mechanism\">Drug Profile &amp; Mechanism<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dual Mechanism:<\/strong><\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Antioxidant:<\/strong> Scavenges free radicals, protecting RGCs from oxidative damage<\/li>\n\n\n\n<li><strong>Mitochondrial Cofactor:<\/strong> Transfers electrons directly to <strong>Complex III<\/strong>, <strong>bypassing defective Complex I<\/strong><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ATP Restoration:<\/strong> Restores cellular <strong>ATP production<\/strong> in dysfunctional RGCs<\/li>\n\n\n\n<li><strong>Cellular Reactivation:<\/strong> Reactivates <strong>surviving but dysfunctional RGCs<\/strong>, leading to <strong>improved visual outcomes<\/strong><\/li>\n\n\n\n<li><strong>Administration:<\/strong> Oral tablets (150\u202fmg), typically dosed three times daily<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-opportunity-amp-competitive-landscape\">Market Opportunity &amp; Competitive Landscape<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>China<\/th><th>Global<\/th><\/tr><\/thead><tbody><tr><td><strong>LHON Patients<\/strong><\/td><td>3,500\u20115,000<\/td><td>60,000\u2011100,000<\/td><\/tr><tr><td><strong>Diagnosed &amp; Eligible<\/strong><\/td><td>1,500<\/td><td>25,000<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>No approved therapy; supportive care only<\/td><td><\/td><\/tr><tr><td><strong>Raxone Annual Cost (USD)<\/strong><\/td><td>$25,000\u201130,000<\/td><td>$40,000\u201150,000<\/td><\/tr><tr><td><strong>Market Value (2030E)<\/strong><\/td><td>$45\u202fmillion<\/td><td>$1.25\u202fbillion<\/td><\/tr><tr><td><strong>Raxone Peak Share<\/strong><\/td><td>80%<\/td><td>60%<\/td><\/tr><tr><td><strong>Peak Revenue (2032E)<\/strong><\/td><td>$36\u202fmillion<\/td><td>$750\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Key Competitors:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Gene Therapies:<\/strong> LUMEVOQ (GenSight Biologics) \u2013 EU approved, not yet in China; addresses only ND4 mutation<\/li>\n\n\n\n<li><strong>Practical Vitamin Supplements<\/strong> \u2013 Unproven efficacy<\/li>\n\n\n\n<li><strong>Raxone<\/strong> \u2013 <strong>Only approved therapy<\/strong> with <strong>global regulatory approval<\/strong> and <strong>broad LHON mutation coverage<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-positioning\">Strategic Positioning<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Market Access:<\/strong> Boao Pilot Zone approval enables <strong>early commercialization<\/strong> while NMPA review proceeds; Raxone eligible for <strong>NRDL fast\u2011track<\/strong><\/li>\n\n\n\n<li><strong>Manufacturing:<\/strong> Chiesi\u2019s <strong>Parma, Italy facility<\/strong> supplies global markets; <strong>cold\u2011chain logistics<\/strong> established for China distribution<\/li>\n\n\n\n<li><strong>Clinical Validation:<\/strong> <strong>>15 years of real\u2011world data<\/strong> from EU and US confirms <strong>visual acuity improvement<\/strong> in 30\u201140% of patients<\/li>\n\n\n\n<li><strong>Patient Support:<\/strong> Launching <strong>RaxONE Patient Program<\/strong> in China for <strong>access and adherence support<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding market penetration, revenue forecasts, and regulatory expansion for Raxone in China. Actual results may differ due to pricing negotiations, competitive gene therapies, and market access challenges.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chiesi Group announced that the first patients have initiated treatment with Raxone (idebenone 150\u202fmg) at&#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_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":[91,1919,24],"class_list":["post-54857","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-boao-lecheng-pilot-zone","tag-chiesi-farmaceutici","tag-rare-orphan-disease-drugs"],"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>Chiesi\u2019s Raxone Begins LHON Treatment in China, First World\u2011Approved Therapy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Chiesi Group announced that the first patients have initiated treatment with Raxone (idebenone 150\u202fmg) at Ruijin Hainan Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, less than one month after the drug received approval in the Boao Lecheng International Medical Tourism Pilot Zone. 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