CARsgen Therapeutics Co. Ltd.

CARsgen Therapeutics, a CAR T-cell therapy developer headquartered in Shanghai, plans to invest up to $51 million (RMB370 million) to establish a commercial CAR T-cell manufacturing base through its indirectly wholly owned subsidiary CARsgen Diagnostics. The new site in Shanghai is intended to support commercialization of the company’s CAR T pipeline, including marketed product zevorcabtagene autoleucel and satricabtagene autoleucel (CT041), which is currently in the NDA stage for solid tumors, as well as future allogeneic programs, according to the announcement. CARsgen said the structure of the agreement is designed to limit early capital expenditures, preserve cash for research and development and market expansion, as well as allow the company to repurchase the assets after long-term operation to maintain production stability and flexibility. In a previous collaboration, CARsgen partnered with Moderna to combine its Claudin18.2-targeted CAR T candidate CT041 with Moderna’s mRNA cancer vaccine technology, with plans to evaluate the approach in preclinical studies and a Phase I trial. In 2021, CARsgen announced plans to invest $157 million in its first manufacturing hub in North America . The company said the new plants will help the company expand its global cGMP manufacturing capacity, while targeting patients in the U.S. and supporting ongoing clinical trials for two therapies.

SHANGHAI, Feb. 12, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that through its indirectly wholly-owned subsidiary CARsgen Diagnostics, it has signed Strategic Cooperation Agreements agreements with Shanghai Jingong Enterprise, which is a key platform enterprise in the Bay Area High-Tech Zone of Jinshan District, Shanghai. With a total investment amount not exceeding RMB370 million, the Company will establish an advanced commercial manufacturing base for CAR T-cell products in Jinshan District, Shanghai. This move closely aligns with the commercialization progress of the Company's multiple CAR T-cell products, including the marketed product zevorcabtagene autoleucel and the CAR T-cell product satricabtagene autoleucel (R&D code "CT041") for solid tumor currently in the NDA stage. It also lays the foundation for the future mass production of multiple allogeneic CAR T-cell products (such as CT0596 and CT1190B). Under this background, enhancing CAR T-cell manufacturing capacity that meets international standards has become a core initiative to support the commercialization of multiple products and strengthen global competitiveness. This transaction requires no significant capital expenditure from CARsgen Therapeutics in early stage, thus effectively preserving valuable cash flow for core research and development as well as market expansion. In addition, the repurchase mechanism ensures the Company can fully acquire asset control after long-term operation, maintaining production stability and enhancing the flexibility of asset layout. This collaboration demonstrates CARsgen Therapeutics' prudent financial planning and deep layout in the CAR T-cell therapy industry ecosystem. It also indicates that the project is highly in line with national and local policies on the biopharmaceutical industry and has received high attention and strong support from the government. This strategic partnership will further consolidate CARsgen Therapeutics' leading position in the global CAR T-cell therapy industry while creating long-term value for shareholders. About CARsgen Therapeutics Holdings Limited 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'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. Forward-looking Statements 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'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'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 "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . 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. For more information, please visit SOURCE CARsgen Therapeutics 21% more press release views with Request a Demo

February 2026 — Global Biotech News Shanghai, China / Global — CARsgen Therapeutics Holdings Ltd., a clinical-stage biotechnology company focused on innovative chimeric antigen receptor T-cell (CAR-T) therapies, announced that its allogeneic CAR-T candidate KJ-C2219 has been administered to the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated clinical trial. KJ-C2219 is an allogeneic (donor-derived) CAR-T therapy engineered to target CD19/CD20, antigens implicated in pathogenic B-cell activity. The therapy is being evaluated in systemic lupus erythematosus — an autoimmune disease in which the body’s immune system attacks healthy tissue, leading to widespread inflammation and organ damage. Photo by Diane Serik on Unsplash Unlike conventional CAR-T therapies that are manufactured individually using a patient’s own cells, allogeneic CAR-T products like KJ-C2219 are produced from healthy donor cells, potentially enabling off-the-shelf availability and broader clinical applicability. This administration to a lupus patient marks one of the earliest reported uses of an allogeneic CAR-T therapy in autoimmune disease outside oncology. The trial is investigator-initiated, with researchers following a predefined protocol to evaluate safety, tolerability and early signs of clinical benefit. Early clinical experience in autoimmune settings remains limited relative to cancer indications, so this dosing milestone is being closely watched by clinicians and investors alike. Photo by Sangharsh Lohakare on Unsplash “This first dosing in lupus reflects the growing interest in extending CAR-T approaches beyond hematologic malignancies into autoimmune disorders,” said a biotechnology analyst following CAR-T development trends. “If safety and efficacy are demonstrated, allogeneic CAR-T could address significant unmet needs in autoimmune disease.” Source: CARsgen’s Allogeneic CD19/CD20 CAR-T Therapy Administers First Dose in a Patient With Autoimmune Disease — PR Newswire / CARsgen Therapeutics (February 2025 reporting)