{"id":79189,"date":"2026-09-07T12:29:45","date_gmt":"2026-09-07T04:29:45","guid":{"rendered":"https:\/\/flcube.com\/?p=79189"},"modified":"2026-09-07T12:29:46","modified_gmt":"2026-09-07T04:29:46","slug":"santens-atropine-eye-drops-ryjusea-wins-nda-acceptance-from-chinas-nmpa-for-myopia-progression","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=79189","title":{"rendered":"Santen&#8217;s Atropine Eye Drops RYJUSEA Wins NDA Acceptance From China&#8217;s NMPA for Myopia Progression"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Santen Pharmaceutical<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/4536:TYO\">TYO: 4536<\/a>) announced that the New Drug Application (NDA) for its <strong>atropine sulfate 0.025% eye drops (RYJUSEA)<\/strong> has been accepted by China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for the proposed indication of delaying the progression of <strong>myopia<\/strong>. The acceptance marks a key regulatory step for the preservative\u2011free pediatric myopia control candidate in the world&#8217;s largest myopia market.<\/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>Field<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>Agency<\/td><td><strong>National Medical Products Administration (NMPA)<\/strong>, China<\/td><\/tr><tr><td>Filing Type<\/td><td>New Drug Application (NDA) \u2014 accepted<\/td><\/tr><tr><td>Product<\/td><td><strong>RYJUSEA<\/strong> (atropine sulfate 0.025% eye drops)<\/td><\/tr><tr><td>Proposed Indication<\/td><td>Delaying the progression of <strong>myopia<\/strong><\/td><\/tr><tr><td>Company<\/td><td><strong>Santen Pharmaceutical<\/strong> (TYO: 4536)<\/td><\/tr><tr><td>Date<\/td><td>04 Sep 2026<\/td><\/tr><tr><td>Next Steps<\/td><td><strong>NMPA<\/strong> review of the NDA toward potential approval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Active Ingredient:<\/strong> Atropine sulfate, formulated at a 0.025% concentration.<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Controls <strong>myopia<\/strong> progression by inhibiting axial length elongation of the eye.<\/li>\n\n\n\n<li><strong>Formulation Advantage:<\/strong> Preservative\u2011free design intended to ensure long\u2011term safety, particularly for pediatric patients.<\/li>\n\n\n\n<li><strong>Target Population:<\/strong> Children and adolescents with progressing <strong>myopia<\/strong>, a population requiring chronic, safety\u2011sensitive treatment.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-china-access-pathway-hainan-boao-lecheng-pilot-zone\" class=\"wp-block-heading\">China Access Pathway \u2013 Hainan Boao Lecheng Pilot Zone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>Policy Leveraged<\/td><td>&#8220;Designated medical device and drug&#8221; policy of the <strong>Hainan Boao Lecheng International Medical Tourism Pilot Zone<\/strong><\/td><\/tr><tr><td>Regional Approval<\/td><td><strong>RYJUSEA<\/strong> approved in Boao, Hainan \u2014 August 2025<\/td><\/tr><tr><td>First Prescription<\/td><td>Issued at <strong>Hainan Eye &amp; Optometry Hospital<\/strong> \u2014 September 2025<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Leveraging the pilot zone&#8217;s special access policy, <strong>Santen Pharmaceutical<\/strong> secured regional approval for <strong>RYJUSEA<\/strong> in Boao, Hainan in August 2025, with the first prescription issued at <strong>Hainan Eye &amp; Optometry Hospital<\/strong> in September 2025. That early\u2011access experience provided real\u2011world clinical application in China ahead of the nationwide <strong>NMPA<\/strong> NDA acceptance now announced.<\/p>\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>Large Addressable Market:<\/strong> China carries an exceptionally high pediatric <strong>myopia<\/strong> burden, positioning <strong>RYJUSEA<\/strong> in a growing myopia control category.<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> The preservative\u2011free, low\u2011concentration (0.025%) atropine sulfate formulation addresses long\u2011term safety concerns central to chronic pediatric use.<\/li>\n\n\n\n<li><strong>Regulatory Momentum:<\/strong> NDA acceptance by the <strong>NMPA<\/strong> advances <strong>Santen<\/strong> toward potential nationwide commercialization, building on the Hainan Boao Lecheng early\u2011access approval.<\/li>\n\n\n\n<li><strong>Portfolio Strength:<\/strong> The milestone reinforces <strong>Santen Pharmaceutical<\/strong>&#8216;s ophthalmology franchise and its strategic commitment to the China market.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2014 This brief contains forward\u2011looking statements regarding <strong>Santen Pharmaceutical<\/strong>&#8216;s <strong>RYJUSEA<\/strong> (atropine sulfate 0.025% eye drops), including the <strong>NMPA<\/strong> review of the New Drug Application and potential approval for delaying the progression of <strong>myopia<\/strong>. Such statements are based on current expectations and are subject to risks and uncertainties, including regulatory review, clinical, and commercialization risks. Actual results may differ materially. Nothing herein constitutes investment advice or an offer to buy or sell any securities.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Santen Pharmaceutical (TYO: 4536) announced that the New Drug Application (NDA) for its atropine sulfate&#8230;<\/p>\n","protected":false},"author":1,"featured_media":79191,"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":[7,11,4908],"tags":[38,44,415,2079],"class_list":["post-79189","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","category-pic","tag-market-approval-filings","tag-ophthalmology","tag-santen-pharmaceutical","tag-tyo-4536"],"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>Santen&#039;s Atropine Eye Drops RYJUSEA Wins NDA Acceptance From China&#039;s NMPA for Myopia Progression - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Santen Pharmaceutical (TYO: 4536) announced that the New Drug Application (NDA) for its atropine sulfate 0.025% eye drops (RYJUSEA) has been accepted by China&#039;s National Medical Products Administration (NMPA) for the proposed indication of delaying the progression of myopia. 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