{"id":63030,"date":"2026-04-30T10:02:23","date_gmt":"2026-04-30T08:02:23","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/curocells-rimqarto-inj-wins-full-regulatory-approval-poised-to-enter-car-t-market-with-67-complete-response-rate\/"},"modified":"2026-04-30T10:02:23","modified_gmt":"2026-04-30T08:02:23","slug":"curocells-rimqarto-inj-wins-full-regulatory-approval-poised-to-enter-car-t-market-with-67-complete-response-rate","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/curocells-rimqarto-inj-wins-full-regulatory-approval-poised-to-enter-car-t-market-with-67-complete-response-rate\/","title":{"rendered":"Curocell&#8217;s RIMQARTO Inj. Wins Full Regulatory Approval, Poised to Enter CAR-T Market with 67% Complete Response Rate"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Secured formal approval from local authorities instead of conditional approval, demonstrating the competitiveness of the CAR T-cell therapy<\/i><\/li>\n<li>\n<i>RIMQARTO<\/i>\u00ae<i> marks Korea\u2019s first commercialization of CAR T-cell therapy and 42nd domestically developed drug<\/i><\/li>\n<li>\n<i>The approval marks a key step in the push for global expansion, thanks to expedited review and inter-agency coordination<\/i><\/li>\n<\/ul>\n<p>\n\u00a0<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20260429207749\/en\/2790586\/5\/5852065cRimqarto-Logo-ENG_rev.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260429207749\/en\/2790586\/22\/5852065cRimqarto-Logo-ENG_rev.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20260429207749\/en\/2790586\/5\/5852065cRimqarto-Logo-ENG_rev.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260429207749\/en\/2790586\/21\/5852065cRimqarto-Logo-ENG_rev.jpg\"><\/a><\/p>\n<p>SEOUL, South Korea&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/AutologousCellTherapy?src=hash\" target=\"_blank\">#AutologousCellTherapy<\/a>&#8212;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fcurocellbtx.com%2F&amp;esheet=54526066&amp;newsitemid=20260429207749&amp;lan=en-US&amp;anchor=Curocell&amp;index=1&amp;md5=4241652fdbca3f7c86badd8e8a311f51\" rel=\"nofollow\" shape=\"rect\">Curocell<\/a> (KOSDAQ: 372320) said that RIMQARTO\u00ae Inj. (anbalcabtagene autoleucel), South Korea\u2019s first domestically developed CAR T-cell therapy, has secured full regulatory approval from the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.mfds.go.kr%2Feng%2Findex.do&amp;esheet=54526066&amp;newsitemid=20260429207749&amp;lan=en-US&amp;anchor=Ministry+of+Food+and+Drug+Safety&amp;index=2&amp;md5=f54da42f38c139dd8a1f236a653bc8fb\" rel=\"nofollow\" shape=\"rect\">Ministry of Food and Drug Safety<\/a> (MFDS) on April 29. With this approval, RIMQARTO\u00ae becomes the 42<sup>nd<\/sup> drug domestically developed under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products for manufacture and sale. This represents the first commercialization of CAR T-cell therapy by a Korean company.<\/p>\n<p>\nThe CAR T-cell therapy is a personalized autologous T-cell immunotherapy in which a patient\u2019s immune cells are genetically modified to selectively target cancer cells. RIMQARTO\u00ae has drawn attention as a next-generation CD19 CAR T-cell therapy powered by Curocell\u2019s proprietary OVIS\u2122 (Overcome Immune Suppression) technology. This technology is designed to regulate immunosuppressive signals in the tumor microenvironment, addressing \u201cT-cell exhaustion,\u201d and enabling more sustained anticancer activity over the long term.<\/p>\n<p>\nRIMQARTO\u00ae is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adults following two or more lines of systemic therapy.<\/p>\n<p>\nIn the pivotal Phase 2 trial supporting the approval, RIMQARTO\u00ae achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. The therapy also showed its safety profile, with cytokine release syndrome (CRS), a key adverse event associated with CAR T-cell therapy, reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 5%.<\/p>\n<p>\nAlthough RIMQARTO\u00ae was initially submitted for conditional approval, the MFDS waived the requirement for Phase 3 trial data during the review process, taking into account its use as a third-line treatment for lymphoma and its classification as a novel CAR T-cell therapy. As with other global CAR T-cell therapies, the approval is subject to long-term follow-up studies and risk management plans to monitor the therapy\u2019s safety and efficacy.<\/p>\n<p>\nThe approval reflects the combined impact of the MFDS\u2019s expedited review framework and full-cycle support from government R&amp;D programs. RIMQARTO\u00ae was developed with support from the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.mohw.go.kr%2Feng%2F&amp;esheet=54526066&amp;newsitemid=20260429207749&amp;lan=en-US&amp;anchor=Ministry+of+Health+and+Welfare&amp;index=3&amp;md5=7442708022fd258d4e6e29f75ba1fc06\" rel=\"nofollow\" shape=\"rect\">Ministry of Health and Welfare<\/a> (MOHW) R&amp;D program and the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.kddf.org%2Fen&amp;esheet=54526066&amp;newsitemid=20260429207749&amp;lan=en-US&amp;anchor=Korea+Drug+Development+Fund&amp;index=4&amp;md5=28bb03cdca0866f797d84cceceeef40b\" rel=\"nofollow\" shape=\"rect\">Korea Drug Development Fund<\/a>. In addition, the MFDS\u2019s \u201cBio-Challenger Program\u201d for advanced biopharmaceuticals and RIMQARTO\u00ae\u2019s \u201cGlobal Innovative Products on Fast Track\u201d (GIFT) and fast-track processing designations enhanced both efficiency and speed throughout the development and approval review processes.<\/p>\n<p>\nRIMQARTO\u00ae was also selected for the MOHW\u2019s \u201cConcurrent Pilot Program for Approval-Evaluation-Negotiation,\u201d which is expected to shorten the timeline from its approval to national health insurance reimbursement listing.<\/p>\n<p>\nCurocell CEO Kim Gun-soo said, \u201cThe latest approval is a milestone in Korea\u2019s new drug development history. We would like to express our gratitude to everyone who has worked tirelessly to make this achievement possible. We have been researching because CAR T-cell technology was not available in Korea. We have now secured our first new drug approval. With the capabilities and experience accumulated so far, we are committed to advancing the global success of Korea\u2019s CAR-T technology.\u201d<\/p>\n<p>\nBuilding on RIMQARTO\u00ae, Curocell plans to pursue indication expansion, global market entry, and the development of next-generation pipelines, while further demonstrating the scalability of its CAR-T platform by expanding into solid tumors and autoimmune diseases.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nCurocell (RIMQARTO)<br \/>\n<br \/>Yura Lee<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;&#108;t&#x6f;&#x3a;&#x75;&#114;&#97;&#46;&#x6c;&#x65;&#x65;&#64;&#99;u&#x72;&#x6f;&#x63;&#101;&#108;l&#x62;&#x74;&#x78;&#46;co&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#117;&#x72;a&#x2e;&#x6c;&#101;&#x65;&#64;&#99;&#x75;&#114;&#x6f;c&#101;&#x6c;l&#x62;t&#120;&#x2e;c&#x6f;&#x6d;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Secured formal approval from local authorities instead of conditional approval, demonstrating the competitiveness of the CAR T-cell therapy RIMQARTO\u00ae marks Korea\u2019s first commercialization of CAR T-cell therapy and 42nd domestically developed drug The approval marks a key step in the push for global expansion, thanks to expedited review and inter-agency coordination \u00a0 SEOUL, South Korea&#8211;(BUSINESS &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/curocells-rimqarto-inj-wins-full-regulatory-approval-poised-to-enter-car-t-market-with-67-complete-response-rate\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-63030","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Curocell&#039;s RIMQARTO Inj. 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