{"id":28561,"date":"2024-08-06T00:00:00","date_gmt":"2024-08-06T00:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4476332_AE76332_0"},"modified":"2024-08-06T00:00:00","modified_gmt":"2024-08-06T00:00:00","slug":"antengene-announces-xpovio-selinexor-approved-for-commercialization-in-malaysia","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=28561","title":{"rendered":"Antengene Announces XPOVIO\u00ae (selinexor) Approved for Commercialization in Malaysia"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2355066\/ANTENGENE_EN_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><i> XPOVIO<sup>\u00ae <\/sup>is the first and only approved XPO1 inhibitor in <span class=\"xn-location\">Malaysia<\/span>.<\/i><\/li>\n<li><i> XPOVIO<sup>\u00ae<\/sup> has been approved for multiple indications in eight markets across the APAC region. Antengene has submitted new drug applications (NDAs) for XPOVIO<sup>\u00ae<\/sup> in other ASEAN markets including <span class=\"xn-location\">Thailand<\/span> and <span class=\"xn-location\">Indonesia<\/span> with approvals expected in the second half of 2024.<\/i><\/li>\n<li><i> XPOVIO<sup>\u00ae<\/sup> has been approved for health insurance coverage in the mainland of <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Singapore<\/span> and <span class=\"xn-location\">South Korea<\/span>.<\/i><\/li>\n<\/ul>\n<p><span class=\"xn-location\">SHANGHAI<\/span> and <span class=\"xn-location\">HONG KONG<\/span>, <span class=\"xn-chron\">Aug. 6, 2024<\/span> \/PRNewswire\/ &#8212; Antengene Corporation Limited (&#8220;<b>Antengene<\/b>&#8220;, SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and\/or best-in-class medicines for cancer, today announced that <b>the Malaysian National Pharmaceutical Regulatory Agency has approved a New Drug Application (NDA) for XPOVIO<sup>\u00ae<\/sup> (selinexor) for two indications: <\/b>(1)&nbsp;In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy; and&nbsp;(2)&nbsp;in combination with dexamethasone for the treatment of adult patients with MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.<\/p>\n<p>With a novel mechanism of action, XPOVIO<sup>\u00ae<\/sup> is the world&#8217;s first approved orally-available, selective XPO1 inhibitor, which has already been approved in eight markets in APAC. This successful approval for XPOVIO<sup>\u00ae<\/sup> in <span class=\"xn-location\">Malaysia<\/span> will introduce novel therapies to the clinical management of patients with MM in <span class=\"xn-location\">Malaysia<\/span>, benefiting many patients and their families in the country. To date, XPOVIO<sup>\u00ae<\/sup> has also been included in national health insurance or reimbursement schemes in the mainland of <span class=\"xn-location\">China<\/span>, <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Singapore<\/span> and <span class=\"xn-location\">South Korea<\/span>.<\/p>\n<p>The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a significant potential market for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Antengene, in efforts to fulfill its commitment to enhancing the health and well-being of the ASEAN population, has submitted NDAs for XPOVIO<sup>\u00ae<\/sup> in <span class=\"xn-location\">Thailand<\/span> and <span class=\"xn-location\">Indonesia<\/span>, with approvals expected in the second half of 2024. Looking ahead, the company aims to introduce more innovative medicines to the ASEAN market, bringing improved healthcare to more patients in the region.<\/p>\n<p>While bringing XPOVIO<sup>\u00ae<\/sup> to more APAC markets, Antengene is also striving to expand the indications of XPOVIO<sup>\u00ae<\/sup>. Leveraging the drug&#8217;s novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO<sup>\u00ae<\/sup> for the treatment of various indications including myelofibrosis (MF), T-cell non-Hodgkin&#8217;s lymphoma (T-NHL), and endometrial cancer.<\/p>\n<p><b>About XPOVIO<sup>\u00ae<\/sup> (selinexor)<\/b><\/p>\n<p>XPOVIO<sup>\u00ae<\/sup> is the world&#8217;s first approved orally-available, selective inhibitor of the nuclear export protein XPO1.&nbsp;<b>It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.<\/b><\/p>\n<p>By blocking the nuclear export protein XPO1, XPOVIO<sup>\u00ae<\/sup> can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO<sup>\u00ae<\/sup> delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO<sup>\u00ae<\/sup> is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO<sup>\u00ae<\/sup> in the mainland of <span class=\"xn-location\">China<\/span> for the treatment of relapsed\/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]).<\/p>\n<p><b>About Antengene<\/b><\/p>\n<p>Antengene Corporation Limited (<b>&#8220;Antengene&#8221;<\/b>, SEHK: 6996.HK) is a leading commercial-stage R&amp;D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class\/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of <b>&#8220;Treating Patients Beyond Borders&#8221;<\/b>.<\/p>\n<p>Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and <span class=\"xn-location\">Asia<\/span>, and submitted 10 new drug applications (NDAs) in multiple <span class=\"xn-location\">Asia Pacific<\/span> markets, with the NDA for XPOVIO<sup>\u00ae<\/sup> (selinexor) already approved in Mainland of <span class=\"xn-location\">China<\/span>, Taiwan China, <span class=\"xn-location\">Hong Kong China<\/span>, Macau China, <span class=\"xn-location\">South Korea<\/span>, <span class=\"xn-location\">Singapore<\/span>, <span class=\"xn-location\">Malaysia<\/span> and <span class=\"xn-location\">Australia<\/span>.<\/p>\n<p><b>Forward-looking statements<\/b><\/p>\n<p>The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company&#8217;s Annual Report for the year ended <span class=\"xn-chron\">December 31, 2023<\/span>, and the documents subsequently submitted to the Hong Kong Stock Exchange.<\/p>\n<p>For more information, please contact:<\/p>\n<p>Investor Contacts:&nbsp;<br \/><span class=\"xn-person\">Donald Lung<\/span><br \/>E-mail: <a href=\"mailto:Donald.Lung@antengene.com\" target=\"_blank\" rel=\"nofollow noopener\">Donald.Lung@antengene.com<\/a> &nbsp;<br \/>Mobile: +86 18420672158<\/p>\n<p>PR Contacts:<br \/><span class=\"xn-person\">Peter Qian<\/span><br \/>E-mail: <a href=\"mailto:Peter.Qian@antengene.com\" target=\"_blank\" rel=\"nofollow noopener\">Peter.Qian@antengene.com<\/a>&nbsp;<br \/>Mobile: +86 13062747000<\/p>\n","protected":false},"excerpt":{"rendered":"<p>XPOVIO\u00ae is the first and only approved XPO1 inhibitor in Malaysia. XPOVIO\u00ae has been approved for multiple indications in eight markets across the APAC region. Antengene has submitted new drug applications (NDAs) for XPOVIO\u00ae in other ASEAN markets including Thailand and Indonesia with approvals expected in the second half of 2024. XPOVIO\u00ae has been approved [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-28561","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Antengene Announces XPOVIO\u00ae (selinexor) Approved for Commercialization in Malaysia - My Blog<\/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:\/\/transmediavictoria.net.au\/?p=28561\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Antengene Announces XPOVIO\u00ae (selinexor) Approved for Commercialization in Malaysia - My Blog\" \/>\n<meta property=\"og:description\" content=\"XPOVIO\u00ae is the first and only approved XPO1 inhibitor in Malaysia. 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