{"id":54976,"date":"2026-01-21T15:19:23","date_gmt":"2026-01-21T07:19:23","guid":{"rendered":"https:\/\/flcube.com\/?p=54976"},"modified":"2026-01-21T15:19:26","modified_gmt":"2026-01-21T07:19:26","slug":"mersons-bemejing-wins-first-cnmr-overseas-version-drug-price-certificate","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=54976","title":{"rendered":"Merson\u2019s Bemejing Wins First CNMR \u201cOverseas Version\u201d Drug Price Certificate"},"content":{"rendered":"\n<p><strong>Beijing Merson Pharmaceutical Co., Ltd.<\/strong> announced that its <strong>Bemejing (timolol maleate gel)<\/strong> has obtained <strong>China\u2019s first \u201cOverseas Version\u201d drug price certificate<\/strong> issued by the <strong>China Medicine Registration (CNMR)<\/strong> system, according to the <strong>National Healthcare Security Administration (NHSA)<\/strong>. The certificate is expected to accelerate the product\u2019s entry into international markets.<\/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>Beijing Merson Pharmaceutical Co., Ltd.<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Bemejing (timolol maleate gel)<\/td><\/tr><tr><td><strong>Certificate<\/strong><\/td><td>First \u201cOverseas Version\u201d drug price certificate (CNMR)<\/td><\/tr><tr><td><strong>Issuing Authority<\/strong><\/td><td>National Healthcare Security Administration (NHSA)<\/td><\/tr><tr><td><strong>Approval Date<\/strong><\/td><td>Last September 2025 (China marketing approval)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Superficial infantile hemangiomas<\/td><\/tr><tr><td><strong>Global Incidence<\/strong><\/td><td>5\u201112% (common benign tumor)<\/td><\/tr><tr><td><strong>Certificate Date<\/strong><\/td><td>Week of 13\u202fJan\u202f2026<\/td><\/tr><tr><td><strong>System Launch<\/strong><\/td><td>CNMR launched Dec\u202f2025<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-cnmr-system-overview\">CNMR System Overview<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Model:<\/strong> <strong>Single\u2011point acceptance, nationwide sharing, global disclosure<\/strong><\/li>\n\n\n\n<li><strong>Purpose:<\/strong> Creates drug\u2011price archives to provide pricing references for Chinese firms seeking overseas market access<\/li>\n\n\n\n<li><strong>Current Status (as of Jan\u202f18, 2026):<\/strong><\/li>\n\n\n\n<li><strong>60 pharma companies<\/strong> registered<\/li>\n\n\n\n<li><strong>22 drug products<\/strong> listed<\/li>\n\n\n\n<li><strong>14 products<\/strong> with publicly available price details<\/li>\n\n\n\n<li><strong>Strategic Value:<\/strong> <strong>First certificate<\/strong> awarded to Bemejing validates CNMR\u2019s role in facilitating global expansion for domestic innovators<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-market-context\">Drug Profile &amp; Market Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> <strong>Timolol maleate gel<\/strong> \u2013 non\u2011selective beta\u2011blocker that <strong>constricts blood vessels<\/strong> and <strong>inhibits angiogenesis<\/strong>, reducing hemangioma growth<\/li>\n\n\n\n<li><strong>Advantage:<\/strong> <strong>Topical formulation<\/strong> offers <strong>safety and convenience<\/strong> vs. oral propranolol (standard of care)<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> <strong>First topical beta\u2011blocker<\/strong> approved for infantile hemangiomas in China<\/li>\n\n\n\n<li><strong>Global Standard:<\/strong> Competing products include <strong>Hemangeol<\/strong> (oral propranolol, US\/EU) and <strong>Timoptic<\/strong> (ophthalmic solution, off\u2011label use)<\/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>Infantile Hemangiomas (Annual Cases)<\/strong><\/td><td>950,000<\/td><td>6.8\u202fmillion<\/td><\/tr><tr><td><strong>Superficial (Topical\u2011Eligible)<\/strong><\/td><td>380,000<\/td><td>2.7\u202fmillion<\/td><\/tr><tr><td><strong>Current Standard<\/strong><\/td><td>Oral propranolol (side effects, monitoring burden)<\/td><td><\/td><\/tr><tr><td><strong>Bemejing Market Share<\/strong><\/td><td>0%<\/td><td>0%<\/td><\/tr><tr><td><strong>Addressable Market (2030E)<\/strong><\/td><td>\u00a51.2\u202fbillion<\/td><td>$850\u202fmillion<\/td><\/tr><tr><td><strong>Bemejing Peak Revenue<\/strong><\/td><td>\u00a5480\u202fmillion<\/td><td>$170\u202fmillion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pricing:<\/strong> CNMR certificate enables <strong>transparent pricing reference<\/strong> (estimated \u00a5200\u2011300\/tube) for <strong>registration in ASEAN, Latin America, and Middle East<\/strong><\/li>\n\n\n\n<li><strong>Regulatory Pathway:<\/strong> Certificate streamlines <strong>pricing negotiations<\/strong> in target markets, potentially <strong>reducing time\u2011to\u2011market by 12\u201118 months<\/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>Manufacturing:<\/strong> Merson\u2019s <strong>Beijing topical gel facility<\/strong> (capacity 5\u202fmillion tubes\/year) meets <strong>US FDA and EU GMP standards<\/strong>, enabling <strong>dual\u2011market supply<\/strong><\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> CNMR certificate positions Bemejing as <strong>reference\u2011priced innovator<\/strong> for <strong>WHO Pre\u2011qualification<\/strong> and <strong>UNICEF procurement<\/strong><\/li>\n\n\n\n<li><strong>Pipeline Leverage:<\/strong> Success builds Merson\u2019s <strong>pediatric dermatology franchise<\/strong>, supporting follow\u2011on products for <strong>vascular malformations<\/strong> and <strong>port\u2011wine stains<\/strong><\/li>\n\n\n\n<li><strong>Next Steps:<\/strong><\/li>\n\n\n\n<li><strong>ASEAN filing<\/strong>: Q2\u202f2026 (Singapore, Malaysia, Thailand)<\/li>\n\n\n\n<li><strong>Latin America<\/strong>: Q4\u202f2026 (Brazil, Mexico)<\/li>\n\n\n\n<li><strong>EU decentralized procedure<\/strong>: H1\u202f2027<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding CNMR certificate benefits, international market penetration, and revenue forecasts for Bemejing. Actual results may differ due to regulatory acceptance of CNMR pricing, competitive responses, and market access challenges.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Beijing Merson Pharmaceutical Co., Ltd. announced that its Bemejing (timolol maleate gel) has obtained China\u2019s&#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":[7,11,4],"tags":[4564,67],"class_list":["post-54976","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","category-policy-regulatory","tag-merson-pharmaceutical","tag-nhsa-prev-smia"],"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>Merson\u2019s Bemejing Wins First CNMR \u201cOverseas Version\u201d Drug Price Certificate - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Beijing Merson Pharmaceutical Co., Ltd. announced that its Bemejing (timolol maleate gel) has obtained China\u2019s first \u201cOverseas Version\u201d drug price certificate issued by the China Medicine Registration (CNMR) system, according to the National Healthcare Security Administration (NHSA). 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