{"id":34845,"date":"2025-03-19T00:15:00","date_gmt":"2025-03-19T00:15:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4643703_CN43703_0"},"modified":"2025-03-19T00:15:00","modified_gmt":"2025-03-19T00:15:00","slug":"carsgen-announced-2024-annual-results","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=34845","title":{"rendered":"CARsgen Announced 2024 Annual Results"},"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\/1722549\/Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span>, March 19, 2025 \/PRNewswire\/ &#8212; CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced its 2024 Annual Results.<\/span><\/p>\n<p><b>Business Highlights<\/b><\/p>\n<ul type=\"disc\">\n<li>Zevor-cel was approved by <span class=\"xn-location\">China&#8217;s<\/span> National Medical Products Administration (NMPA).<\/li>\n<li>As of <span class=\"xn-chron\">December 31, 2024<\/span>, certification and filings for&nbsp;zevor-cel completed in 23 provinces or cities, covering over 200 healthcare institutes; CARsgen has received a total of 154 valid orders from its commercialization partner <span class=\"xn-person\">Huadong Medicine<\/span>.<\/li>\n<li>Satri-cel ST-01 confirmatory Phase II trial for gastric cancer in <span class=\"xn-location\">China<\/span>: enrollment has been completed, and the study has met its primary endpoint. Satri-cel received BTD designation from CDE of China NMPA. CARsgen plans to submit a New Drug Application (NDA) to the China NMPA during the first half of 2025.<\/li>\n<li>Results from the investigator-initiated trial (IIT) of satri-cel were published in <i>Nature Medicine<\/i> and at the 2024 ASCO Annual Meeting.<\/li>\n<li>The results of the&nbsp;IIT of an allogeneic BCMA-targeting CAR-T product CT0590, which deploys the THANK-uCAR<sup>\u00ae<\/sup> technology platform, were presented at the 2024 ASH Annual Meeting.<\/li>\n<li>Developed&nbsp;THANK-u Plus\u2122 platform as an enhanced version of THANK-uCAR<sup>\u00ae<\/sup> allogeneic CAR-T platform. Multiple allogeneic CAR-T products in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases.<\/li>\n<li>Introduced&nbsp;Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland <span class=\"xn-location\">China<\/span>.<\/li>\n<li>Cash and bank balances were around <span class=\"xn-money\">RMB1,479 million<\/span> as of <span class=\"xn-chron\">December 31, 2024<\/span>. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than <span class=\"xn-money\">RMB1,080 million<\/span>. Expect to have adequate cash into the 2028.<\/li>\n<\/ul>\n<p>&#8220;In 2024, CARsgen achieved its first drug commercialization and made remarkable progresses in key pipeline products and technological innovations. Looking ahead, we will continue developing innovative CAR T-cell therapies to address the significant unmet medical needs,&#8221; said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1589\">\n<p><a href=\"https:\/\/mma.prnasia.com\/media2\/2644041\/CARsgen_Pipeline.html\" target=\"_blank\" rel=\"nofollow noopener\"><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2644041\/CARsgen_Pipeline.jpg?p=medium600\" title=\"CARsgen Pipeline\" alt=\"CARsgen Pipeline\"><\/a><br \/><span>CARsgen Pipeline<\/span><\/p>\n<\/p><\/div>\n<p><b>Zevor-cel: Approved by the NMPA and Launched in <span class=\"xn-location\">China<\/span><\/b><\/p>\n<p>Zevorcabtagene autoleucel (zevor-cel, R&amp;D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA). On <span class=\"xn-chron\">February 23, 2024<\/span>, zevor-cel was approved by <span class=\"xn-location\">China&#8217;s<\/span> NMPA for the treatment of adult patients with relapsed or refractory multiple myeloma (R\/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent). CARsgen entered into a collaboration agreement with <span class=\"xn-person\">Huadong Medicine<\/span> for the commercialization of zevor-cel in mainland <span class=\"xn-location\">China<\/span>. As of <span class=\"xn-chron\">December 31, 2024<\/span>, certification and regulatory filings for zevor-cel have been completed in 23 provinces or cities, covering over 200 healthcare institutes and we have received a total of 154 valid orders from <span class=\"xn-person\">Huadong Medicine<\/span>.<\/p>\n<p>Updated results of the pivotal Phase II registrational trial of zevor-cel in <span class=\"xn-location\">China<\/span> were reported as an oral presentation at the 29th European Hematology Association (EHA) Annual Congress, and a subgroup analysis was presented a poster at the 66th ASH annual congress. We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage.<\/p>\n<p><b>Satri-cel: Confirmatory Phase II trial Met Primary Endpoint, Plans to Submit an NDA<\/b><\/p>\n<p>Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be first-in-class globally. Satri-cel targets Claudin18.2 positive solid tumors with a primary focus on gastric cancer\/gastroesophageal junction cancer (GC\/GEJ) and pancreatic cancer (PC). Patient enrollment has been completed in confirmatory Phase II trial in <span class=\"xn-location\">China<\/span> (NCT04581473) in advanced GC\/GEJ. The study has met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) as assessed by the Independent Review Committee (IRC). Patients treated with satri-cel infusion achieved statistically significant improvement in PFS compared to those treated with physician&#8217;s choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Based on the confirmatory Phase II clinical data, satri-cel has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China NMPA.<\/p>\n<p>CARsgen plans to submit an NDA to the NMPA in <span class=\"xn-location\">China<\/span> during the first half of 2025. Satri-cel is expected to become the world&#8217;s first CAR-T therapy for solid tumors to be approved for market.<\/p>\n<p>Updated results from the investigator-initiated trial (CT041-CG4006, NCT03874897) were published in <i>Nature Medicine<\/i> in <span class=\"xn-chron\">June 2024<\/span> and presented orally at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in <span class=\"xn-chron\">June 2024<\/span>. Additionally, more research findings have been published in prestigious academic journals such as the <i>Journal of Clinical Oncology<\/i> and the <i>Journal for ImmunoTherapy of Cancer<\/i>.<\/p>\n<p>A Phase I clinical trial for PC adjuvant therapy (CT041-ST-05, NCT05911217), and an investigator-initiated trial for GC\/GEJ adjuvant therapy (CT041-CG4010, NCT06857786) are ongoing in <span class=\"xn-location\">China<\/span>.<\/p>\n<p><b>Advancing the Development of Allogeneic CAR-T Products<\/b><\/p>\n<p>In addition to autologous products, CARsgen has also been advancing differentiated allogeneic CAR T-cell products utilizing the proprietary THANK-uCAR<sup>\u00ae<\/sup> platform. CARsgen has recently developed the THANK-u Plus\u2122 platform as an enhanced version of its proprietary THANK-uCAR<sup>\u00ae<\/sup> allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy.<\/p>\n<p>The results of the IIT proof-of-concept study of an allogeneic BCMA-targeting CAR T-cell product candidate CT0590, which deploys the THANK-uCAR<sup>\u00ae<\/sup> technology platform, were presented as a poster at the 66th ASH Annual Meeting in <span class=\"xn-chron\">December 2024<\/span>. The data indicates that CT0590 has achieved a DoR of over 20 months in patients with sCR, with a peak CAR copy number exceeding 280,000 copies\/\u00b5g gDNA, which is comparable to autologous BCMA CAR-T therapies, preliminarily demonstrating the durability of its efficacy.<\/p>\n<p>In addition, there are several universal CAR-T products under development, covering areas such as hematologic malignancies, solid tumors, and autoimmune diseases:<\/p>\n<ul type=\"disc\">\n<li>CT059X: Targeting&nbsp;BCMA, for the treatment of R\/R MM and R\/R PCL. The first patient in the IIT achieved sCR at the Day-28 assessment.<\/li>\n<li>KJ-C2219: Targeting CD19\/CD20, for the treatment of B-cell malignancies, as well as&nbsp;SLE and SSc. The IITs are ongoing.<\/li>\n<li>KJ-C2320: Targeting CD38, for the treatment of&nbsp;AML. The IIT is ongoing.<\/li>\n<li>KJ-C2114: For the treatment of solid tumors.<\/li>\n<li>KJ-C2526: Targeting NKG2DL, for the treatment of&nbsp;AML, other malignancies, and senescence.<\/li>\n<\/ul>\n<p>On <span class=\"xn-chron\">February 25, 2025<\/span>, CARsgen announced reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) (&#8220;Zhuhai SB Xinchuang&#8221;) to jointly invest in UCARsgen Biotech Limited (&#8220;UCARsgen&#8221;), to accelerate allogeneic CAR-T development in mainland <span class=\"xn-location\">China<\/span>. Under the agreements, UCARsgen has secured the exclusive rights in mainland <span class=\"xn-location\">China<\/span> for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19\/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies. An investment fund managed by Zhuhai SB Xinchuang (currently undergoing registration and filing procedures) subscribed to the newly increased registered capital of UCARsgen for a consideration of <span class=\"xn-money\">RMB 80,000,000<\/span>, thus retaining an 8% equity stake in the registered capital of UCARsgen upon completion of the transaction, equity stake of CARsgen Therapeutics in UCARsgen will be diluted from 100% to 92%.<\/p>\n<p><b>Financial Highlights<\/b><\/p>\n<p>The revenue was around <span class=\"xn-money\">RMB39.4 million<\/span> for the year ended <span class=\"xn-chron\">December 31, 2024<\/span> mainly from zevor-cel, in which was calculated on the basis of ex-works price, rather than end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Besides, the Company received a milestone payment of <span class=\"xn-money\">RMB75 million<\/span> from <span class=\"xn-person\">Huadong Medicine<\/span> for zevor-cel for the year ended <span class=\"xn-chron\">December 31, 2024<\/span>. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from <span class=\"xn-person\">Huadong Medicine<\/span> and number of ex-works deliveries. The gross profit was around <span class=\"xn-money\">RMB14.8 million<\/span> for the year ended <span class=\"xn-chron\">December 31, 2024<\/span>, with the selling and distribution expenses around <span class=\"xn-money\">RMB0.88 million<\/span>. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch.<\/p>\n<p>Cash and bank balances were around <span class=\"xn-money\">RMB1,479 million<\/span> as of <span class=\"xn-chron\">December 31, 2024<\/span>. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than <span class=\"xn-money\">RMB1,080 million<\/span>. We expect to have adequate cash into the 2028 excluding subsequent cash inflows.<\/p>\n<p><b>About CARsgen Therapeutics Holdings Limited<\/b><\/p>\n<p>CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen&#8217;s mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.<\/p>\n<p><b>Forward-looking Statements<\/b><\/p>\n<p>All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group&#8217;s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group&#8217;s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading &#8220;Principal Risks and Uncertainties&#8221; in our most recent annual report and interim report and other announcements and reports made available on our corporate website, <a href=\"https:\/\/www.carsgen.com\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.carsgen.com<\/a>. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.<\/p>\n<p><b>Contact CARsgen<\/b><\/p>\n<p>For more information, please visit <a href=\"https:\/\/www.carsgen.com\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.carsgen.com\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>SHANGHAI, March 19, 2025 \/PRNewswire\/ &#8212; CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced its 2024 Annual Results. Business Highlights Zevor-cel was approved by China&#8217;s National Medical Products Administration (NMPA). As of December 31, 2024, certification and filings for&nbsp;zevor-cel completed in 23 provinces or cities, covering [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":34846,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-34845","post","type-post","status-publish","format-standard","has-post-thumbnail","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>CARsgen Announced 2024 Annual Results - 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=34845\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CARsgen Announced 2024 Annual Results - My Blog\" \/>\n<meta property=\"og:description\" content=\"SHANGHAI, March 19, 2025 \/PRNewswire\/ &#8212; CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced its 2024 Annual Results. Business Highlights Zevor-cel was approved by China&#8217;s National Medical Products Administration (NMPA). 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Business Highlights Zevor-cel was approved by China&#8217;s National Medical Products Administration (NMPA). 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