{"id":63579,"date":"2026-04-20T21:12:26","date_gmt":"2026-04-20T13:12:26","guid":{"rendered":"https:\/\/flcube.com\/?p=63579"},"modified":"2026-04-20T21:12:27","modified_gmt":"2026-04-20T13:12:27","slug":"leo-pharma-secures-nmpa-approval-for-enstilar-foam-in-china-first-and-only-calcipotriol-betamethasone-foam-formulation-for-plaque-psoriasis-demonstrates-superior-efficacy-vs-ointment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=63579","title":{"rendered":"LEO Pharma Secures NMPA Approval for Enstilar Foam in China \u2013 First and Only Calcipotriol\/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment"},"content":{"rendered":"\n<p><strong>LEO Pharma A\/S<\/strong> has received <strong>marketing approval<\/strong> from China&#8217;s <strong>National Medical Products Administration<\/strong> (NMPA) for <strong>Enstilar<\/strong> (calcipotriol 50 mcg\/g, betamethasone dipropionate 0.5 mg\/g), a <strong>foam formulation<\/strong> for the treatment of <strong>plaque psoriasis<\/strong> in adult patients. The approval establishes Enstilar as the <strong>first and only foam-based therapy<\/strong> for this indication in China, backed by Phase III data demonstrating <strong>superior efficacy<\/strong> compared to the established <strong>Daivobet ointment<\/strong>, with enhanced patient convenience through a patented foam applicator designed for even application on hair-bearing skin areas.<\/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>Approval Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>LEO Pharma A\/S (Denmark)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Enstilar (calcipotriol\/betamethasone dipropionate foam)<\/td><\/tr><tr><td><strong>Approving Authority<\/strong><\/td><td>National Medical Products Administration (NMPA)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Adult patients with plaque psoriasis<\/td><\/tr><tr><td><strong>Formulation Status<\/strong><\/td><td>First and only foam formulation approved in China for plaque psoriasis<\/td><\/tr><tr><td><strong>Dosage<\/strong><\/td><td>Once daily application<\/td><\/tr><tr><td><strong>Key Differentiator<\/strong><\/td><td>Patented foam applicator for hair-bearing areas<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-evidence-phase-iii-superiority-trial\">Clinical Evidence \u2013 Phase III Superiority Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Trial Parameter<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Study Design<\/strong><\/td><td>Phase III randomized, controlled trial<\/td><\/tr><tr><td><strong>Patient Population<\/strong><\/td><td>604 adult patients with stable plaque psoriasis<\/td><\/tr><tr><td><strong>Comparator<\/strong><\/td><td>Daivobet (calcipotriol\/betamethasone ointment)<\/td><\/tr><tr><td><strong>Treatment Duration<\/strong><\/td><td>Four weeks, once daily<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Met with statistical significance<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>All met with Enstilar demonstrating superior efficacy<\/td><\/tr><tr><td><strong>Key Finding<\/strong><\/td><td>Enstilar more effective than Daivobet ointment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-technology-amp-formulation-innovation\">Technology &amp; Formulation Innovation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Foam Delivery System:<\/strong> Patented applicator enables easy, even medication distribution across skin surfaces<\/li>\n\n\n\n<li><strong>Hair-Bearing Areas:<\/strong> Specifically designed for application to scalp and other hair-covered regions where traditional formulations struggle<\/li>\n\n\n\n<li><strong>Supersaturated Solution:<\/strong> Forms supersaturated solution on skin surface, accelerating active ingredient penetration<\/li>\n\n\n\n<li><strong>Rapid Symptom Relief:<\/strong> Enhanced bioavailability translates to faster onset of therapeutic effect<\/li>\n\n\n\n<li><strong>Patient Compliance:<\/strong> Improved ease of use expected to enhance treatment adherence compared to ointments<\/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>Market Element<\/th><th>Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>China Psoriasis Prevalence<\/strong><\/td><td>Estimated 6-7 million plaque psoriasis patients, representing significant unmet need<\/td><\/tr><tr><td><strong>Current Treatment Gap<\/strong><\/td><td>Limited topical options optimized for scalp and difficult-to-treat areas<\/td><\/tr><tr><td><strong>Formulation Advantage<\/strong><\/td><td>Foam technology addresses key limitation of existing ointments and creams<\/td><\/tr><tr><td><strong>Pricing Position<\/strong><\/td><td>Premium pricing potential due to superior efficacy and convenience benefits<\/td><\/tr><tr><td><strong>Competitive Differentiation<\/strong><\/td><td>Only foam formulation creates unique market positioning vs. generic ointments<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-strategy-amp-market-access\">Commercial Strategy &amp; Market Access<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Launch Focus:<\/strong> Initial targeting of dermatology specialty centers and major hospitals in Tier 1 cities<\/li>\n\n\n\n<li><strong>Physician Education:<\/strong> Comprehensive training program on foam application advantages and clinical superiority data<\/li>\n\n\n\n<li><strong>Reimbursement Strategy:<\/strong> Pursuing inclusion in provincial reimbursement catalogs leveraging superior efficacy profile<\/li>\n\n\n\n<li><strong>Patient Support:<\/strong> Implementation of adherence programs and educational materials on proper foam application technique<\/li>\n\n\n\n<li><strong>Market Penetration:<\/strong> Leveraging LEO Pharma&#8217;s established dermatology presence in China for rapid commercial rollout<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-for-leo-pharma\">Strategic Implications for LEO Pharma<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>China Market Expansion<\/strong> strengthens LEO&#8217;s position in one of the world&#8217;s fastest-growing pharmaceutical markets<\/li>\n\n\n\n<li><strong>Innovation Leadership<\/strong> reinforces reputation for developing differentiated dermatological formulations<\/li>\n\n\n\n<li><strong>Portfolio Enhancement<\/strong> complements existing psoriasis portfolio with premium, patent-protected product<\/li>\n\n\n\n<li><strong>Global Harmonization<\/strong> aligns Chinese launch with international markets where Enstilar is already established<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-industry-context-amp-regulatory-environment\">Industry Context &amp; Regulatory Environment<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Topical Psoriasis Market<\/strong> in China dominated by generic ointments with limited innovation<\/li>\n\n\n\n<li><strong>NMPA Priority Review<\/strong> reflects recognition of meaningful therapeutic advancement over existing options<\/li>\n\n\n\n<li><strong>Patient-Centric Innovation<\/strong> aligns with China&#8217;s healthcare reform emphasis on improving quality of life outcomes<\/li>\n\n\n\n<li><strong>Dermatology Focus<\/strong> benefits from increasing awareness and diagnosis rates of psoriasis in urban Chinese populations<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding commercial performance, market penetration, and competitive dynamics. Actual results may differ due to risks including reimbursement decisions, market adoption rates, competitive pressures, and regulatory developments.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>LEO Pharma A\/S has received marketing approval from China&#8217;s National Medical Products Administration (NMPA) for&#8230;<\/p>\n","protected":false},"author":1,"featured_media":63580,"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":[819,15],"class_list":["post-63579","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-leo-pharma","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>LEO Pharma Secures NMPA Approval for Enstilar Foam in China \u2013 First and Only Calcipotriol\/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"LEO Pharma A\/S has received marketing approval from China&#039;s National Medical Products Administration (NMPA) for Enstilar (calcipotriol 50 mcg\/g, betamethasone dipropionate 0.5 mg\/g), a foam formulation for the treatment of plaque psoriasis in adult patients. The approval establishes Enstilar as the first and only foam-based therapy for this indication in China, backed by Phase III data demonstrating superior efficacy compared to the established Daivobet ointment, with enhanced patient convenience through a patented foam applicator designed for even application on hair-bearing skin areas.\" \/>\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=63579\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"LEO Pharma Secures NMPA Approval for Enstilar Foam in China \u2013 First and Only Calcipotriol\/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment\" \/>\n<meta property=\"og:description\" content=\"LEO Pharma A\/S has received marketing approval from China&#039;s National Medical Products Administration (NMPA) for Enstilar (calcipotriol 50 mcg\/g, betamethasone dipropionate 0.5 mg\/g), a foam formulation for the treatment of plaque psoriasis in adult patients. The approval establishes Enstilar as the first and only foam-based therapy for this indication in China, backed by Phase III data demonstrating superior efficacy compared to the established Daivobet ointment, with enhanced patient convenience through a patented foam applicator designed for even application on hair-bearing skin areas.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=63579\" \/>\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=\"2026-04-20T13:12:26+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-20T13:12:27+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2006.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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The approval establishes Enstilar as the first and only foam-based therapy for this indication in China, backed by Phase III data demonstrating superior efficacy compared to the established Daivobet ointment, with enhanced patient convenience through a patented foam applicator designed for even application on hair-bearing skin areas.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=63579#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=63579"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=63579#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2006.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2006.webp","width":1080,"height":608,"caption":"LEO Pharma Secures NMPA Approval for Enstilar Foam in China \u2013 First and Only Calcipotriol\/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=63579#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"LEO Pharma Secures NMPA Approval for Enstilar Foam in China \u2013 First and Only Calcipotriol\/Betamethasone Foam Formulation for Plaque Psoriasis Demonstrates Superior Efficacy vs. Ointment"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/04\/2006.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/63579","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=63579"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/63579\/revisions"}],"predecessor-version":[{"id":63581,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/63579\/revisions\/63581"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/63580"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=63579"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=63579"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=63579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}