{"id":39782,"date":"2025-11-27T12:44:00","date_gmt":"2025-11-27T05:44:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=39782"},"modified":"2025-11-27T12:44:00","modified_gmt":"2025-11-27T05:44:00","slug":"iaso-bio-announces-bla-approval-of-fucaso-equecabtagene-autoleucel-by-the-hong-kong-department-of-health-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=39782","title":{"rendered":"IASO Bio Announces BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of Relapsed or Refractory Multiple Myeloma"},"content":{"rendered":"<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span> and <span class=\"xn-location\">NANJING<\/span>, <span class=\"xn-location\">China<\/span> and <span class=\"xn-location\">PLEASANTON, Calif.<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 27, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0IASO Biotechnology (&#8220;IASO Bio&#8221;), a commercial-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that the Biologics License Application (BLA) for its independently developed fully human anti-BCMA CAR-T therapy Fucaso (Equecabtagene Autoleucel) has been approved by the Hong Kong Department of Health. The therapy is indicated for adult patients with relapsed or refractory multiple myeloma (R\/R MM) who have received three or more prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent.<\/p>\n<p>This approval marks the first authorization of a <span class=\"xn-location\">China<\/span>-developed\u00a0CAR-T cell therapy in <span class=\"xn-location\">Hong Kong<\/span> (<span class=\"xn-location\">China<\/span>) and the first <span class=\"xn-location\">China<\/span>-developed\u00a0ATMP (Advanced Therapy Medicinal Product) to obtain PIC\/S GMP recognition following Hong Kong DoH inspection. PIC\/S (The Pharmaceutical Inspection Co-operation Scheme) consists of more than 56 regulatory authorities, including the U.S. FDA and <span class=\"xn-location\">Japan&#8217;s<\/span> PMDA, and is widely regarded as a benchmark for international GMP standards.<\/p>\n<p>The approval was granted under <span class=\"xn-location\">Hong Kong&#8217;s<\/span> &#8220;1+&#8221; innovative regulatory mechanism, which considers: Prior\u00a0BLA approval of Fucaso in Mainland China; Clinical evidence from the FUMANBA-1 registrational study (CTR20192510; NCT05066646). The Hong Kong Department of Health conducted an independent review of the submitted quality, nonclinical, clinical, and manufacturing information.<\/p>\n<p>Since <span class=\"xn-chron\">November 2024<\/span>, Fucaso has been accessible in <span class=\"xn-location\">Hong Kong<\/span> through the Named Patient Programme (NPP). Following this approval, IASO Bio plans to expand its &#8220;Manufactured in <span class=\"xn-location\">Nanjing<\/span>, Supplied Globally&#8221; model to support access for patients in additional regions subject to local regulatory requirements.<\/p>\n<p>Ms. <span class=\"xn-person\">Jinhua Zhang<\/span>, Founder, Chairperson, and CEO of IASO Bio, commented: &#8220;This approval in <span class=\"xn-location\">Hong Kong<\/span> represents an important milestone in our global strategy. We appreciate the rigorous and efficient review conducted by the Hong Kong Department of Health as well as the clarity of the &#8216;1+&#8217; pathway. We remain committed to quality, patient safety, and global regulatory collaboration to bring innovative cell therapies to more patients worldwide.&#8221;<\/p>\n<p>Global Registration Progress of Fucaso<\/p>\n<ul type=\"disc\">\n<li>Mainland <span class=\"xn-location\">China<\/span>: BLA approved by the National Medical Products Administration (NMPA) in <span class=\"xn-chron\">June 2023<\/span>;<\/li>\n<li><span class=\"xn-location\">Macau<\/span>, <span class=\"xn-location\">China<\/span>: BLA\u00a0approved in <span class=\"xn-chron\">March 2025<\/span> by the the Macau Pharmaceutical Administration Bureau;<\/li>\n<li>Hongkong, <span class=\"xn-location\">China<\/span>: BLA approved in <span class=\"xn-chron\">November 2025<\/span> by the Hong Kong Department of Health<\/li>\n<li><span class=\"xn-location\">Singapore<\/span> and Saudi Arabia:\u00a0BLA under review<\/li>\n<li><span class=\"xn-location\">South Korea<\/span>: Orphan Drug Designation and\u00a0ATMP Fast Track designation granted<\/li>\n<li><span class=\"xn-location\">Japan<\/span>: Clinical Trial Notification approved<\/li>\n<li>Other Countries and Regions: Registration work is ongoing\u00a0\u00a0<\/li>\n<\/ul>\n<p><b>About Multiple Myeloma<\/b><\/p>\n<p>Global annual incidence increased from ~164,300 in 2019 to ~197,200 in 2024, projected to reach 273,600 by 2040. In <span class=\"xn-location\">China<\/span>, incidence rose from 28,100 in 2019 to 31,800 in 2024, with an estimated 30\u201340% progressing to third-line therapy.<\/p>\n<p><b>About IASO Bio<\/b><\/p>\n<p>Founded in 2017, we are one of the few commercial-stage biopharmaceutical companies in the advanced therapy medicinal product (ATMP) sector that are bringing <span class=\"xn-location\">China&#8217;s<\/span> breakthrough innovations to the global market. We are focused on cell therapies and biologics targeting hematological malignancies and autoimmune diseases. Our industry-leading, fully integrated platforms leverage cutting-edge technologies that span the entire product lifecycle\u2014from discovery and development to manufacturing and commercialization.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span> and <span class=\"xn-location\">NANJING<\/span>, <span class=\"xn-location\">China<\/span> and <span class=\"xn-location\">PLEASANTON, Calif.<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Nov. 27, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0IASO Biotechnology (&#8220;IASO Bio&#8221;), a commercial-stage biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that the Biologics License Application (BLA) for its independently developed fully human anti-BCMA CAR-T therapy Fucaso (Equecabtagene Autoleucel) has been approved by the Hong Kong Department of Health. The therapy is indicated for adult patients with relapsed or refractory multiple myeloma (R\/R MM) who have received three or more prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory agent.<\/p>\n<p>This approval marks the first authorization of a <span class=\"xn-location\">China<\/span>-developed\u00a0CAR-T cell therapy in <span class=\"xn-location\">Hong Kong<\/span> (<span class=\"xn-location\">China<\/span>) and the first <span class=\"xn-location\">China<\/span>-developed\u00a0ATMP (Advanced Therapy Medicinal Product) to obtain PIC\/S GMP recognition following Hong Kong DoH inspection. PIC\/S (The Pharmaceutical Inspection Co-operation Scheme) consists of more than 56 regulatory authorities, including the U.S. FDA and <span class=\"xn-location\">Japan&#8217;s<\/span> PMDA, and is widely regarded as a benchmark for international GMP standards.<\/p>\n<p>The approval was granted under <span class=\"xn-location\">Hong Kong&#8217;s<\/span> &#8220;1+&#8221; innovative regulatory mechanism, which considers: Prior\u00a0BLA approval of Fucaso in Mainland China; Clinical evidence from the FUMANBA-1 registrational study (CTR20192510; NCT05066646). The Hong Kong Department of Health conducted an independent review of the submitted quality, nonclinical, clinical, and manufacturing information.<\/p>\n<p>Since <span class=\"xn-chron\">November 2024<\/span>, Fucaso has been accessible in <span class=\"xn-location\">Hong Kong<\/span> through the Named Patient Programme (NPP). Following this approval, IASO Bio plans to expand its &#8220;Manufactured in <span class=\"xn-location\">Nanjing<\/span>, Supplied Globally&#8221; model to support access for patients in additional regions subject to local regulatory requirements.<\/p>\n<p>Ms. <span class=\"xn-person\">Jinhua Zhang<\/span>, Founder, Chairperson, and CEO of IASO Bio, commented: &#8220;This approval in <span class=\"xn-location\">Hong Kong<\/span> represents an important milestone in our global strategy. We appreciate the rigorous and efficient review conducted by the Hong Kong Department of Health as well as the clarity of the &#8216;1+&#8217; pathway. We remain committed to quality, patient safety, and global regulatory collaboration to bring innovative cell therapies to more patients worldwide.&#8221;<\/p>\n<p>Global Registration Progress of Fucaso<\/p>\n<ul type=\"disc\">\n<li>Mainland <span class=\"xn-location\">China<\/span>: BLA approved by the National Medical Products Administration (NMPA) in <span class=\"xn-chron\">June 2023<\/span>;<\/li>\n<li><span class=\"xn-location\">Macau<\/span>, <span class=\"xn-location\">China<\/span>: BLA\u00a0approved in <span class=\"xn-chron\">March 2025<\/span> by the the Macau Pharmaceutical Administration Bureau;<\/li>\n<li>Hongkong, <span class=\"xn-location\">China<\/span>: BLA approved in <span class=\"xn-chron\">November 2025<\/span> by the Hong Kong Department of Health<\/li>\n<li><span class=\"xn-location\">Singapore<\/span> and Saudi Arabia:\u00a0BLA under review<\/li>\n<li><span class=\"xn-location\">South Korea<\/span>: Orphan Drug Designation and\u00a0ATMP Fast Track designation granted<\/li>\n<li><span class=\"xn-location\">Japan<\/span>: Clinical Trial Notification approved<\/li>\n<li>Other Countries and Regions: Registration work is ongoing\u00a0\u00a0<\/li>\n<\/ul>\n<p><b>About Multiple Myeloma<\/b><\/p>\n<p>Global annual incidence increased from ~164,300 in 2019 to ~197,200 in 2024, projected to reach 273,600 by 2040. In <span class=\"xn-location\">China<\/span>, incidence rose from 28,100 in 2019 to 31,800 in 2024, with an estimated 30\u201340% progressing to third-line therapy.<\/p>\n<p><b>About IASO Bio<\/b><\/p>\n<p>Founded in 2017, we are one of the few commercial-stage biopharmaceutical companies in the advanced therapy medicinal product (ATMP) sector that are bringing <span class=\"xn-location\">China&#8217;s<\/span> breakthrough innovations to the global market. We are focused on cell therapies and biologics targeting hematological malignancies and autoimmune diseases. Our industry-leading, fully integrated platforms leverage cutting-edge technologies that span the entire product lifecycle\u2014from discovery and development to manufacturing and commercialization.<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-39782","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/39782","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=39782"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/39782\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=39782"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=39782"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=39782"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}