{"id":62338,"date":"2024-12-04T12:04:41","date_gmt":"2024-12-04T12:04:41","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/12\/04\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/"},"modified":"2024-12-04T12:04:41","modified_gmt":"2024-12-04T12:04:41","slug":"china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/","title":{"rendered":"China NMPA approves Simcere&#8217;s Sanbexin\u00ae sublingual tablets for the treatment of Acute Ischemic Stroke"},"content":{"rendered":"<div>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">NANJING<\/span>, <span class=\"xn-location\">China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Dec. 4, 2024<\/span><\/span> \/PRNewswire\/ &#8212; On <span class=\"xn-chron\">November 2<\/span>, 2024,\u00a0Simcere Pharmaceutical announced that Sanbexin<sup>\u00ae<\/sup> sublingual tablets (generic name: edaravone and dexborneol sublingual tablets), an innovative drug for stroke, has been approved for marketing by the National Medical Products Administration. This product is indicated for the improvement of neurological symptoms, daily activities, and functional impairment due to acute ischemic stroke.<\/p>\n<p>Sanbexin<sup>\u00ae<\/sup> sublingual tablets is a dual-target brain cytoprotective agent composed of edaravone and dexborneol. These two active ingredients exert synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell damage caused by acute ischemic stroke.<\/p>\n<p>The sublingual tablets are designed for quick disintegration once in contact with saliva under the tongue. This facilitates the active ingredients&#8217; rapid absorption into the blood and brain through the sublingual venous plexus. Compared to conventional oral formulations, sublingual tablets bypass the first-pass hepatic metabolism, which is conducive to higher drug bioavailability and faster onset of action.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder6255\">\n<p style=\"TEXT-ALIGN: center; WIDTH: 100%\"><a href=\"https:\/\/mma.prnasia.com\/media2\/2573306\/Packaging_Sanbexin__sublingual_tablets.html\" target=\"_blank\" rel=\"nofollow\"><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2573306\/Packaging_Sanbexin__sublingual_tablets.jpg?p=medium600\" title=\"Packaging of Sanbexin\u00ae sublingual tablets\" alt=\"Packaging of Sanbexin\u00ae sublingual tablets\"><\/a><br \/><span>Packaging of Sanbexin\u00ae sublingual tablets<\/span><\/p>\n<\/p><\/div>\n<p>Previously, Sanbexin<sup>\u00ae<\/sup> injection was approved for marketing in <span class=\"xn-location\">China<\/span> in 2020. As the world&#8217;s only innovative drug approved for stroke since 2015, it has helped over 3 million patients in the past 4 years.<\/p>\n<p>The phase III clinical trial led by Professor <span class=\"xn-person\">Fan Dongsheng<\/span> of Peking University Third Hospital showed that the patients in the Sanbexin<sup>\u00ae<\/sup> sublingual tablets group after 14 consecutive days of drug administration, \u00a0obtained a significantly higher proportion of functional independence outcome at 90 days post-treatment than those in the placebo group (64.4% vs. 54.7%,). \u00a0The latest data was published in JAMA Neurology on <span class=\"xn-chron\">February 19, 2024<\/span>.<\/p>\n<p><b>Professor <span class=\"xn-person\">Fan Dongsheng<\/span>, Principal Investigator of TASTE-SL and Professor at Peking University Third Hospital<\/b><b>\u00a0mentioned:<\/b>&#8220;Sanbexin<sup>\u00ae<\/sup> sublingual tablets has shown significant effects and good safety in improving recovery of cerebral cells and independent living ability during the acute phase in patients with acute ischemic stroke. The more convenient administration allows for sequential therapy with Sanbexin<sup>\u00ae<\/sup> injection, facilitating stroke patients to receive a complete course of brain cytoprotection in and outside of the hospital during the acute phase of stroke.&#8221;<\/p>\n<p><b>Professor Wang Yongjun, Director of Beijing Tiantan Hospital, Capital Medical University<\/b>\u00a0&#8220;The average length of hospital stay for stroke patients in <span class=\"xn-location\">China<\/span> is about one week, while clinical studies suggest that brain cytoprotective drugs need to be used for 14 consecutive days. Sanbexin<sup>\u00ae<\/sup> sublingual tablets is easy to take, allowing patients to receive treatment at home. This can better reduce disability among patients and is also expected to lower medical costs.&#8221;<\/p>\n<p>In <span class=\"xn-chron\">August 2024<\/span>, Sanbexin<sup>\u00ae<\/sup> sublingual tablets was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for AIS, making it the world&#8217;s first innovative drug in the field of stroke treatment to have received such acknowledgment. Currently, a global multi-centered clinical trial of Sanbexin<sup>\u00ae<\/sup> sublingual tablets is under preparation.<\/p>\n<p>&#8220;The approval of Sanbexin<sup>\u00ae<\/sup> sublingual tablets in <span class=\"xn-location\">China<\/span> is believed to significantly reduce the number of stroke-related disabilities in <span class=\"xn-location\">China<\/span>.&#8221;<\/p>\n<p><b>Professor <span class=\"xn-person\">Gregory W. Albers<\/span>, Director of the Stroke Center and the Medical Center at <span class=\"xn-org\">Stanford University<\/span> commented, <\/b>&#8221;\u00a0We are planning to conduct a large-scale Phase III clinical trial of Sanbexin<sup>\u00ae<\/sup> sublingual tablets in <span class=\"xn-location\">the United States<\/span>, hoping to replicate the success of the trial in <span class=\"xn-location\">China<\/span> and help reduce the global burden of stroke-related disabilities.&#8221;<\/p>\n<p><b>Dr. <span class=\"xn-person\">Marc Fisher<\/span>, former President of the World Stroke Organization and Professor at <span class=\"xn-org\">Harvard Medical School<\/span>, commented on this new approval:<\/b>&#8220;Sanbexin<sup>\u00ae<\/sup> has gradually gained popularity in <span class=\"xn-location\">China<\/span> and is now available in a sublingual tablets formulation, with clinical data confirming its safety and efficacy. We are hoping to see trials of Sanbexin<sup>\u00ae<\/sup> sublingual tablets conducted outside <span class=\"xn-location\">China<\/span>. If the trial results are positive and it receives approval in other countries, such as the U.S., it will have a huge impact globally on the treatment of acute ischemic stroke.&#8221;<\/p>\n<p>The Sanbexin<sup>\u00ae<\/sup> sublingual tablets, with its convenient delivery method, will make stroke prevention and treatment more comprehensive and accessible. Its therapeutic area is expected to be expanded to pre-hospital emergency treatment for the acute phase of stroke, as well as to the treatment for the sub-acute and chronic phases of cerebrovascular diseases, to further promote the recovery of neurological functions and to improve the functional prognosis of stroke patients.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder0\">  <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>NANJING, China, Dec. 4, 2024 \/PRNewswire\/ &#8212; On November 2, 2024,\u00a0Simcere Pharmaceutical announced that Sanbexin\u00ae sublingual tablets (generic name: edaravone and dexborneol sublingual tablets), an innovative drug for stroke, has been approved for marketing by the National Medical Products Administration. This product is indicated for the improvement of neurological symptoms, daily activities, and functional impairment [&#8230;]\n","protected":false},"author":1,"featured_media":79226,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-62338","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>China NMPA approves Simcere&#039;s Sanbexin\u00ae sublingual tablets for the treatment of Acute Ischemic Stroke - Biz and Live in Saigon<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"China NMPA approves Simcere&#039;s Sanbexin\u00ae sublingual tablets for the treatment of Acute Ischemic Stroke\" \/>\n<meta property=\"og:description\" content=\"NANJING, China, Dec. 4, 2024 \/PRNewswire\/ &#8212; On November 2, 2024,\u00a0Simcere Pharmaceutical announced that Sanbexin\u00ae sublingual tablets (generic n\" \/>\n<meta property=\"og:url\" content=\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/\" \/>\n<meta property=\"og:site_name\" content=\"Biz and Live in Saigon\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/SaigonbizGroup\" \/>\n<meta property=\"article:published_time\" content=\"2024-12-04T12:04:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnasia.com\/media2\/2573306\/Packaging_Sanbexin__sublingual_tablets.jpg?p=medium600\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#\/schema\/person\/267b348e6cf32a66aab33637c2d399a6\"},\"headline\":\"China NMPA approves Simcere&#8217;s Sanbexin\u00ae sublingual tablets for the treatment of Acute Ischemic Stroke\",\"datePublished\":\"2024-12-04T12:04:41+00:00\",\"dateModified\":\"2024-12-04T12:04:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/\"},\"wordCount\":697,\"publisher\":{\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/#organization\"},\"articleSection\":[\"Pr Newswire\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/\",\"url\":\"https:\/\/english.saigonbiz.com\/vn\/china-nmpa-approves-simceres-sanbexin-sublingual-tablets-for-the-treatment-of-acute-ischemic-stroke\/\",\"name\":\"China NMPA approves Simcere's Sanbexin\u00ae sublingual tablets for the treatment of Acute Ischemic Stroke - 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