{"id":69920,"date":"2026-07-14T13:54:48","date_gmt":"2026-07-14T05:54:48","guid":{"rendered":"https:\/\/flcube.com\/?p=69920"},"modified":"2026-07-14T13:54:49","modified_gmt":"2026-07-14T05:54:49","slug":"haisco-submits-nmpa-marketing-application-for-crisugabalins-new-indication-in-neuropathic-pain-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=69920","title":{"rendered":"Haisco Submits NMPA Marketing Application for Crisugabalin&#8217;s New Indication in Neuropathic Pain Treatment"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Haisco Pharmaceutical Group Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/002653:SHE\">SHE: 002653<\/a>) announced that it has submitted a <strong>marketing application<\/strong> to China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> for a <strong>new indication<\/strong> of its proprietary drug <strong>Crisugabalin capsules<\/strong>, intended for the treatment of <strong>neuropathic pain in adults<\/strong>.<\/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>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>NMPA (China)<\/td><\/tr><tr><td><strong>Application Type<\/strong><\/td><td>New indication marketing authorization<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>Crisugabalin capsules (third-generation voltage-gated calcium channel modulator)<\/td><\/tr><tr><td><strong>Proposed Indication<\/strong><\/td><td>Treatment of neuropathic pain in adults<\/td><\/tr><tr><td><strong>Submission Date<\/strong><\/td><td>14 Jul 2026<\/td><\/tr><tr><td><strong>Existing Approvals<\/strong><\/td><td>Adult diabetic peripheral neuropathic pain and postherpetic neuralgia<\/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>Molecule:<\/strong> Third-generation voltage-gated calcium channel modulator<\/li>\n\n\n\n<li><strong>Intellectual Property:<\/strong> Proprietary compound independently developed by Haisco with full IP rights<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Binds with high affinity to the \u03b1\u2082\u03b4 subunit of presynaptic neuronal membranes<\/li>\n\n\n\n<li><strong>Pharmacological Effects:<\/strong> Inhibits calcium influx and reduces release of excitatory neurotransmitters (glutamate, norepinephrine, substance P)<\/li>\n\n\n\n<li><strong>Therapeutic Activities:<\/strong> Anti-epileptic, analgesic, and anti-anxiety properties through alleviation of central sensitization<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-development-status\" class=\"wp-block-heading\">Clinical Development Status<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Status<\/th><\/tr><\/thead><tbody><tr><td><strong>Drug Class<\/strong><\/td><td>Proprietary third-generation calcium channel modulator<\/td><\/tr><tr><td><strong>Previous Approvals<\/strong><\/td><td>Diabetic peripheral neuropathic pain, postherpetic neuralgia<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Broad neuropathic pain in adults<\/td><\/tr><tr><td><strong>Development Stage<\/strong><\/td><td>Marketing application submitted<\/td><\/tr><tr><td><strong>Expected Review Timeline<\/strong><\/td><td>Standard NMPA review period of 180-270 days<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Neuropathic pain affects an estimated 7-10% of the global population and represents a significant therapeutic challenge due to limited treatment options and variable patient response to existing medications. Haisco&#8217;s expansion of Crisugabalin&#8217;s indication could address this substantial unmet medical need.<\/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>Market Opportunity:<\/strong> The global neuropathic pain market is projected to reach $9.5 billion by 2028, with China representing one of the fastest-growing segments due to aging demographics and increasing diabetes prevalence.<\/li>\n\n\n\n<li><strong>Competitive Advantage:<\/strong> As a third-generation calcium channel modulator with established safety data from previous approvals, Crisugabalin may offer improved efficacy and tolerability compared to first and second-generation agents.<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Analysts estimate peak annual sales of \u00a5800 million-\u00a51.2 billion ($110-165 million) if the new indication is approved, representing a 30-40% expansion of the drug&#8217;s current market potential.<\/li>\n\n\n\n<li><strong>Strategic Significance:<\/strong> This application demonstrates Haisco&#8217;s commitment to maximizing the value of its proprietary compounds through indication expansion, a strategy that has proven successful for other Chinese pharmaceutical innovators.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory approvals, market opportunities, and revenue projections for Crisugabalin. Actual results may differ due to risks including regulatory decisions, competitive dynamics, and market adoption rates.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u83b7\u5f97\u521b\u65b0\u836f\u82ef\u78fa\u9178\u514b\u5229\u52a0\u5df4\u6797\u80f6\u56ca\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u300a\u53d7\u7406\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of \u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u83b7\u5f97\u521b\u65b0\u836f\u82ef\u78fa\u9178\u514b\u5229\u52a0\u5df4\u6797\u80f6\u56ca\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u300a\u53d7\u7406\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-312be8a7-4a43-4a7c-9408-f062351bdd17\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u83b7\u5f97\u521b\u65b0\u836f\u82ef\u78fa\u9178\u514b\u5229\u52a0\u5df4\u6797\u80f6\u56ca\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u300a\u53d7\u7406\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\">\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u83b7\u5f97\u521b\u65b0\u836f\u82ef\u78fa\u9178\u514b\u5229\u52a0\u5df4\u6797\u80f6\u56ca\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u300a\u53d7\u7406\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/07\/\u6d77\u601d\u79d1\uff1a\u5173\u4e8e\u83b7\u5f97\u521b\u65b0\u836f\u82ef\u78fa\u9178\u514b\u5229\u52a0\u5df4\u6797\u80f6\u56ca\u65b0\u9002\u5e94\u75c7\u4e0a\u5e02\u8bb8\u53ef\u7533\u8bf7\u300a\u53d7\u7406\u901a\u77e5\u4e66\u300b\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-312be8a7-4a43-4a7c-9408-f062351bdd17\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that it has submitted a marketing application&#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":[7,11],"tags":[139,38,929],"class_list":["post-69920","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-haisco-pharmaceutical","tag-market-approval-filings","tag-she-002653"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Haisco Submits NMPA Marketing Application for Crisugabalin&#039;s New Indication in Neuropathic Pain Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Haisco Pharmaceutical Group Co., Ltd. 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