{"id":32934,"date":"2025-05-07T10:21:52","date_gmt":"2025-05-07T02:21:52","guid":{"rendered":"https:\/\/flcube.com\/?p=32934"},"modified":"2025-05-07T10:21:53","modified_gmt":"2025-05-07T02:21:53","slug":"shuangcheng-pharmas-generic-bivalirudin-approved-by-australias-tga","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=32934","title":{"rendered":"Shuangcheng Pharma&#8217;s Generic Bivalirudin Approved by Australia&#8217;s TGA"},"content":{"rendered":"\n<p>China-based Hainan Shuangcheng Pharmaceutical Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/002693:SHE\">SHE: 002693<\/a>) announced that the market filing for its generic version of bivalirudin has been approved by the Therapeutic Goods Administration (TGA) in Australia. Bivalirudin is a direct thrombin inhibitor used as an anticoagulant in patients undergoing various coronary surgeries combined with aspirin.<\/p>\n\n\n\n<p><strong>Bivalirudin Market History<\/strong><br>Bivalirudin first received market approval in December 2000 in the US, where Sandoz Inc holds the patent until January 27, 2029. The originator subsequently obtained approvals in the European Union and China in September 2004 and February 2019, respectively.<\/p>\n\n\n\n<p><strong>Shuangcheng&#8217;s Regulatory Milestones<\/strong><br>Despite the existing patent, Shuangcheng Pharma won a patent challenge and was granted temporary FDA approval for its generic version in October 2019. The drug passed the generic quality consistency evaluation (GQCE) in China in December 2022 and earned marketing approval in Saudi Arabia in February of last year. The latest approval from Australia&#8217;s TGA further expands Shuangcheng&#8217;s global market reach for its generic bivalirudin.<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\/2025\/05\/ST\u53cc\u6210\uff1a\u6d77\u5357\u53cc\u6210\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5173\u4e8e\u6ce8\u5c04\u7528\u6bd4\u4f10\u82a6\u5b9a\u83b7\u5f97\u6fb3\u5927\u5229\u4e9a\u836f\u7269\u7ba1\u7406\u5c40\uff08TGA\uff09\u4e0a\u5e02\u8bb8\u53ef\u7684\u516c\u544a.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of _ST\u53cc\u6210\uff1a\u6d77\u5357\u53cc\u6210\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5173\u4e8e\u6ce8\u5c04\u7528\u6bd4\u4f10\u82a6\u5b9a\u83b7\u5f97\u6fb3\u5927\u5229\u4e9a\u836f\u7269\u7ba1\u7406\u5c40\uff08TGA\uff09\u4e0a\u5e02\u8bb8\u53ef\u7684\u516c\u544a.\"><\/object><a id=\"wp-block-file--media-9de7112f-54ac-49f8-9afb-d57fb8116a6c\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/ST\u53cc\u6210\uff1a\u6d77\u5357\u53cc\u6210\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5173\u4e8e\u6ce8\u5c04\u7528\u6bd4\u4f10\u82a6\u5b9a\u83b7\u5f97\u6fb3\u5927\u5229\u4e9a\u836f\u7269\u7ba1\u7406\u5c40\uff08TGA\uff09\u4e0a\u5e02\u8bb8\u53ef\u7684\u516c\u544a.pdf\">_ST\u53cc\u6210\uff1a\u6d77\u5357\u53cc\u6210\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5173\u4e8e\u6ce8\u5c04\u7528\u6bd4\u4f10\u82a6\u5b9a\u83b7\u5f97\u6fb3\u5927\u5229\u4e9a\u836f\u7269\u7ba1\u7406\u5c40\uff08TGA\uff09\u4e0a\u5e02\u8bb8\u53ef\u7684\u516c\u544a<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/ST\u53cc\u6210\uff1a\u6d77\u5357\u53cc\u6210\u836f\u4e1a\u80a1\u4efd\u6709\u9650\u516c\u53f8\u5173\u4e8e\u6ce8\u5c04\u7528\u6bd4\u4f10\u82a6\u5b9a\u83b7\u5f97\u6fb3\u5927\u5229\u4e9a\u836f\u7269\u7ba1\u7406\u5c40\uff08TGA\uff09\u4e0a\u5e02\u8bb8\u53ef\u7684\u516c\u544a.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-9de7112f-54ac-49f8-9afb-d57fb8116a6c\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>China-based Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) announced that the market filing for its&#8230;<\/p>\n","protected":false},"author":1,"featured_media":32936,"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":[31,15,3321,3320],"class_list":["post-32934","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-generic-drugs","tag-product-approvals","tag-she-002693","tag-shuangcheng-pharmaceutical"],"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>Shuangcheng Pharma&#039;s Generic Bivalirudin Approved by Australia&#039;s TGA - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) announced that the market filing for its generic version of bivalirudin has been approved by the Therapeutic Goods Administration (TGA) in Australia. Bivalirudin is a direct thrombin inhibitor used as an anticoagulant in patients undergoing various coronary surgeries combined with aspirin.\" \/>\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=32934\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shuangcheng Pharma&#039;s Generic Bivalirudin Approved by Australia&#039;s TGA\" \/>\n<meta property=\"og:description\" content=\"China-based Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) announced that the market filing for its generic version of bivalirudin has been approved by the Therapeutic Goods Administration (TGA) in Australia. 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