{"id":67987,"date":"2026-06-11T15:08:55","date_gmt":"2026-06-11T07:08:55","guid":{"rendered":"https:\/\/flcube.com\/?p=67987"},"modified":"2026-06-11T15:08:55","modified_gmt":"2026-06-11T07:08:55","slug":"hansoh-pharmaceuticals-nda-for-hs-10568-calcium-sensing-receptor-modulator-accepted-by-chinas-nmpa-for-secondary-hyperparathyroidism-in-dialysis-patients","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=67987","title":{"rendered":"Hansoh Pharmaceutical&#8217;s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China&#8217;s NMPA for Secondary Hyperparathyroidism in Dialysis Patients"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Hansoh Pharmaceutical Group Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/3692:HKG\">HKG: 3692<\/a>) announced that China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> has accepted its <strong>New Drug Application (NDA)<\/strong> for <strong>HS-10568 (SHR6508)<\/strong>, a novel <strong>calcium-sensing receptor (CaSR) allosteric modulator<\/strong>, for the treatment of <strong>secondary hyperparathyroidism (SHPT)<\/strong> in adult patients with <strong>chronic kidney disease (CKD)<\/strong> undergoing <strong>hemodialysis<\/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>Company<\/strong><\/td><td>Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692)<\/td><\/tr><tr><td><strong>Drug Candidate<\/strong><\/td><td>HS-10568 (SHR6508)<\/td><\/tr><tr><td><strong>Drug Class<\/strong><\/td><td>Calcium-sensing receptor (CaSR) allosteric modulator<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>Application Type<\/strong><\/td><td>New Drug Application (NDA)<\/td><\/tr><tr><td><strong>Status<\/strong><\/td><td>Accepted for review<\/td><\/tr><tr><td><strong>Target Indication<\/strong><\/td><td>Secondary hyperparathyroidism (SHPT) in CKD patients on hemodialysis<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>11 Jun 2026<\/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> HS-10568 (SHR6508) &#8211; CaSR allosteric modulator<\/li>\n\n\n\n<li><strong>Target:<\/strong> Calcium-sensing receptor (CaSR) on parathyroid gland cells<\/li>\n\n\n\n<li><strong>Mechanism:<\/strong> Enhances receptor sensitivity to extracellular calcium, leading to reduced parathyroid hormone (PTH) secretion<\/li>\n\n\n\n<li><strong>Therapeutic Rationale:<\/strong> Addresses the underlying pathophysiology of SHPT by restoring calcium-mediated feedback inhibition of PTH production<\/li>\n\n\n\n<li><strong>Development Stage:<\/strong> NDA submitted; Phase 3 clinical trials completed<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Secondary hyperparathyroidism affects approximately 40-60% of dialysis patients in China, representing a significant unmet medical need. Current treatments include vitamin D analogs and calcimimetics, but many patients experience inadequate response or treatment-limiting side effects. HS-10568&#8217;s novel mechanism offers potential for improved efficacy and tolerability in this challenging patient population.<\/p>\n\n\n\n<h2 id=\"h-market-opportunity-amp-commercial-outlook\" class=\"wp-block-heading\">Market Opportunity &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population:<\/strong> Estimated 700,000+ hemodialysis patients in China with SHPT indication<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Competes against Amgen&#8217;s Sensipar\/Mimpara (cinacalcet) and newer calcimimetics; first domestically developed CaSR modulator in China<\/li>\n\n\n\n<li><strong>Pricing Strategy:<\/strong> Expected premium pricing reflecting innovative status and improved therapeutic profile<\/li>\n\n\n\n<li><strong>Revenue Potential:<\/strong> Peak annual sales projected at RMB 800 million &#8211; 1.2 billion (USD 110-165 million) in China market<\/li>\n\n\n\n<li><strong>Global Expansion:<\/strong> Hansoh plans international development following Chinese approval, targeting markets in Southeast Asia and Latin America<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The NDA acceptance represents a significant milestone for Hansoh&#8217;s specialty pharmaceutical strategy, demonstrating the company&#8217;s capability to develop innovative therapies for complex chronic conditions prevalent in China&#8217;s aging population.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory review timelines, market opportunities, and commercial projections. Actual outcomes may differ due to regulatory decisions, competitive dynamics, and market adoption factors.<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\/06\/2026061001154_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2026061001154_c.\"><\/object><a id=\"wp-block-file--media-0194c369-6942-49ff-bee6-b77437191572\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/2026061001154_c.pdf\">2026061001154_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/2026061001154_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-0194c369-6942-49ff-bee6-b77437191572\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China&#8217;s National Medical Products Administration (NMPA)&#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":[363,1182,38],"class_list":["post-67987","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hansoh-pharmaceutical","tag-hkg-3692","tag-market-approval-filings"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Hansoh Pharmaceutical&#039;s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China&#039;s NMPA for Secondary Hyperparathyroidism in Dialysis Patients - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Hansoh Pharmaceutical Group Co., Ltd. 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