{"id":68781,"date":"2026-06-24T00:24:52","date_gmt":"2026-06-23T16:24:52","guid":{"rendered":"https:\/\/flcube.com\/?p=68781"},"modified":"2026-06-24T00:24:53","modified_gmt":"2026-06-23T16:24:53","slug":"china-launches-12th-national-drug-volume-based-procurement-batch-with-65-products-patent-disputes-highlighted","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68781","title":{"rendered":"China Launches 12th National Drug Volume-Based Procurement Batch with 65 Products, Patent Disputes Highlighted"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The <strong>National Organized Drug Joint Procurement Office<\/strong> announced the <strong>12th batch of national organized drug volume-based procurement (VBP)<\/strong> on June 23, 2026, including <strong>65 products<\/strong> with strict submission deadlines and explicit handling of patent disputes that could impact market participation.<\/p>\n\n\n\n<h2 id=\"h-procurement-timeline-amp-key-deadlines\" class=\"wp-block-heading\">Procurement Timeline &amp; Key Deadlines<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Milestone<\/th><th>Deadline<\/th><th>Extension Window<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Information Submission<\/strong><\/td><td>June 26, 2026 (16:00)<\/td><td>2 hours for modifications\/supplements<\/td><\/tr><tr><td><strong>Enrollment Completion<\/strong><\/td><td>July 13, 2026 (16:00)<\/td><td>&#8211;<\/td><\/tr><tr><td><strong>Enrollment Modifications<\/strong><\/td><td>July 14, 2026 (16:00)<\/td><td>&#8211;<\/td><\/tr><tr><td><strong>Eligibility Requirement<\/strong><\/td><td>Must complete enrollment AND pass verification to participate in bidding<\/td><td>Late submissions deemed as waiver<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-patent-dispute-management-framework\" class=\"wp-block-heading\">Patent Dispute Management Framework<\/h2>\n\n\n\n<h3 id=\"h-products-with-active-patent-claims-8-total\" class=\"wp-block-heading\">Products with Active Patent Claims (8 total):<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Baricitinib<\/li>\n\n\n\n<li>Alogliptin<\/li>\n\n\n\n<li>Dapagliflozin\/metformin<\/li>\n\n\n\n<li>Vonoprazan<\/li>\n\n\n\n<li>Sacubitril\/valsartan<\/li>\n\n\n\n<li>Azilsartan<\/li>\n\n\n\n<li>Edoxaban<\/li>\n\n\n\n<li>Indobufen<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-ip-compliance-requirements\" class=\"wp-block-heading\">IP Compliance Requirements:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Enterprises must bear <strong>sole responsibility<\/strong> for intellectual property status of their products<\/li>\n\n\n\n<li><strong>IP commitment letter<\/strong> or <strong>&#8220;non-infringement commitment&#8221;<\/strong> required before submission deadline<\/li>\n\n\n\n<li>Failure to submit commitment results in <strong>restricted listing<\/strong> on provincial procurement platforms<\/li>\n\n\n\n<li>Applies even to products already listed on platforms that choose to waive submission<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-excluded-products-analysis-12-total\" class=\"wp-block-heading\">Excluded Products Analysis (12 total)<\/h2>\n\n\n\n<h3 id=\"h-generic-consistency-evaluation-issues\" class=\"wp-block-heading\">Generic Consistency Evaluation Issues:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Lidocaine\/prilocaine topical ointment<\/strong>: Generic consistency evaluation channel not yet opened<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-clinical-usage-grouping-concerns\" class=\"wp-block-heading\">Clinical Usage Grouping Concerns:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Fluticasone inhalants<\/strong><\/li>\n\n\n\n<li><strong>Compound electrolyte injections<\/strong><\/li>\n\n\n\n<li><strong>Adenosine injections<\/strong><\/li>\n\n\n\n<li><em>Rationale: Grouped based on clinical usage differences per expert panel; failed competitive landscape criteria<\/em><\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-insufficient-non-infringement-commitments\" class=\"wp-block-heading\">Insufficient Non-Infringement Commitments:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ibrutinib<\/strong><\/li>\n\n\n\n<li><strong>Crisaborole ointment<\/strong><\/li>\n\n\n\n<li><em>Rationale: Patent disputes exist but insufficient enterprises provided non-infringement commitments<\/em><\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-critical-medication-protections\" class=\"wp-block-heading\">Critical Medication Protections:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ganirelix, cetrorelix, triptorelin<\/strong>: Critical assisted reproduction medications (excluded per department\/expert recommendations)<\/li>\n\n\n\n<li><strong>Methotrexate, cytarabine, nitroglycerin<\/strong>: National short-supply or clinically essential drugs prone to shortages<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-strategic-market-implications\" class=\"wp-block-heading\">Strategic Market Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Pressure<\/strong>: 65-product batch represents significant revenue exposure for multinational and domestic manufacturers<\/li>\n\n\n\n<li><strong>Patent Strategy Impact<\/strong>: Clear signal that patent disputes will not automatically exclude products, but IP compliance is mandatory<\/li>\n\n\n\n<li><strong>Supply Chain Security<\/strong>: Explicit protection of short-supply and critical medications demonstrates policy balance between cost control and supply assurance<\/li>\n\n\n\n<li><strong>Market Access Risk<\/strong>: Provincial platform restrictions for non-compliant IP submissions create significant commercial consequences beyond VBP exclusion<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-operational-requirements\" class=\"wp-block-heading\">Operational Requirements<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Enterprises must submit comprehensive information during enrollment including <strong>drug production capacity<\/strong>, quality documentation, and pricing data. The two-hour extension window for modifications suggests authorities expect high submission volumes and potential technical issues, while maintaining strict overall deadlines to ensure procurement schedule adherence.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This 12th batch continues China&#8217;s systematic approach to pharmaceutical cost containment while introducing more sophisticated handling of intellectual property and supply chain considerations compared to earlier VBP rounds.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding China&#8217;s healthcare procurement policies and market implications. Actual implementation may vary based on regulatory decisions, industry compliance rates, and evolving policy guidance.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The National Organized Drug Joint Procurement Office announced the 12th batch of national organized drug&#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_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":[4],"tags":[82],"class_list":["post-68781","post","type-post","status-publish","format-standard","hentry","category-policy-regulatory","tag-vbp-voluem-based-procurement"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>China Launches 12th National Drug Volume-Based Procurement Batch with 65 Products, Patent Disputes Highlighted - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The National Organized Drug Joint Procurement Office announced the 12th batch of national organized drug volume-based procurement (VBP) on June 23, 2026, including 65 products with strict submission deadlines and explicit handling of patent disputes that could impact market participation.\" \/>\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=68781\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"China Launches 12th National Drug Volume-Based Procurement Batch with 65 Products, Patent Disputes Highlighted\" \/>\n<meta property=\"og:description\" content=\"The National Organized Drug Joint Procurement Office announced the 12th batch of national organized drug volume-based procurement (VBP) on June 23, 2026, including 65 products with strict submission deadlines and explicit handling of patent disputes that could impact market participation.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=68781\" \/>\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=\"2026-06-23T16:24:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-23T16:24:53+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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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