Satricabtagene autoleucel

SHANGHAI, Aug. 18, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2026 Interim Results. Business Highlights Continue Reading Pipeline Cash and cash equivalents were around RMB1,400 million as of June 30, 2026. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,200 million. In light of operational factors, we expect to have adequate cash into 2030. During H1, 2026, CARsgen has received a total of 110 confirmed orders of zevor-cel from its commercialization partner Huadong Medicine. Satri-cel receives NMPA approval in June 2026 as world's first and only CAR-T for solid tumors. Data of satri-cel as sequential therapy after 1L treatment in patients with G/GEJA have been presented at the 2026 ASCO Annual Meeting. Multiple allogeneic CAR T-cell products are under development based on the proprietary THANK‑u Plus® platform. Among them, research results for CT0596 in the treatment of R/R MM and PCL, as well as for CT1190B in the treatment of R/R B‑NHL, have been presented at the EHA2026 Congress. In August 2026, both products successively received IND approvals from the NMPA. In vivo CAR T-cell products are under development based on the proprietary CARvivo™ platform. An IIT of KJ‑C2529, which targets CD19/CD20 for the treatment of B‑cell malignancies, has been initiated. Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "In the first half of 2026, CARsgen achieved a historic breakthrough—satri-cel became the world's first approved CAR‑T product for solid tumors. This milestone not only validates our decade‑long dedication and persistence in the solid tumor field, but also underscores our leading position in the global CAR T-cell therapy landscape. Meanwhile, the commercialization of zevor-cel is progressing steadily, with continuous improvements to the diversified payment system and increasing product accessibility. The Company maintains a sound financial position, and our ample cash reserves provide a solid foundation for our ongoing global expansion, advancement into earlier lines of treatment, and development of next‑generation allogeneic/in vivo CAR‑T technologies. Looking ahead, we will remain true to our founding mission of 'Making Cancer Curable,' accelerate forward‑looking therapeutic explorations, and actively expand into both domestic and international markets, bringing more innovative CAR T-cell therapy products to cancer patients worldwide." Financial HighlightsCARsgen's revenue was around RMB62 million for the six months ended June 30, 2026 mainly from zevorcabtagene autoleucel (an autologous BCMA CAR T-cell product), in which the primary revenue of zevorcabtagene autoleucel was calculated on the basis of ex-works price, rather than on the basis of end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. CARsgen's gross profit was around RMB42 million for the six months ended June 30, 2026. 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.Cash and cash equivalents were around RMB1,400 million as of June 30, 2026. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,200 million. In light of operational factors, we expect to have adequate cash into 2030. Steady Commercialization Progress of Zevor-celZevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA) approved by the National Medical Products Administration (NMPA) of China 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) in 2024. In December 2025, zevor-cel was included in China's Commercial Health Insurance Innovative Drug Catalogue (2025).CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in Chinese Mainland. In terms of commercialization, Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China's multi-layered insurance system to improve patient accessibility. During the first half of 2026, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 110 confirmed orders from Huadong Medicine. Satri-cel Receives NMPA Approval as World's First CAR-T for Solid TumorsSatricabtagene autoleucel (satri-cel, R&D code: CT041) is a world's first-in-class, autologous humanized CAR T-cell product against Claudin18.2. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer (G/GEJA) and pancreatic cancer (PC).The New Drug Application (NDA) for satri-cel was approved by NMPA for patients with Claudin18.2-positive, HER2-negative advanced G/GEJA who have failed at least two prior lines of therapy in China in June 2026. This marks the world's first and only approved CAR T-cell therapy for solid tumor treatment. The approval is supported by confirmatory Phase II trial (CT041-ST-01, NCT04581473) data, published in The Lancet and presented as an oral presentation at the 2025 ASCO Annual Meeting in June 2025.The latest clinical data of a case report on long-term peritoneal metastasis control in 3 patients with advanced gastric cancer treated with satri-cel monotherapy has been published in the Journal of Hematology & Oncology in July 2026. All patients achieved both clinical and radiographic benefits post-treatment, with durable control of peritoneal disease observed. The maximum follow-up period reached 48 months, significantly outperforming the historical survival data for patients with gastric cancer and peritoneal metastasis and demonstrating remarkable potential to fundamentally alter the natural course of the disease.To translate this landmark clinical value into commercial impact, we have established a competitive in-house commercial team to lead domestic sales. Backed by deep oncology domain expertise and proven clinical promotion experience, the team is well positioned to drive efficient hospital access and product commercialization. In the early commercialization phase, we will prioritize satri-cel rollout across leading oncology hospitals and cell therapy centers at top-tier general hospitals nationwide. Leveraging expert collaborations, we will rapidly set clinical benchmarks and build market recognition.Satri-cel has been included in 2026 China Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Gastric Cancer issued by CSCO, and China Anti-Cancer Association (CACA) Guidelines for Commercial Insurance Application of Innovative Oncology Diagnosis and Treatment Technology issued by the CACA. Satri-cel also passed preliminary formal review for 2026 National Commercial Insurance Innovative Drug Catalogue. The multi-payment system is to be established to reduce the financial burden of Chinese patients.After satri-cel received marketing approval from the NMPA, the Company persistently pushes forward its global development strategy. Prioritizing key regions with high unmet medical needs and accessible regulatory pathways, the Company will adopt diversified overseas development models, with core overseas markets and major regional hubs listed as the top priorities for registration expansion. The Company plans to conduct well-planned marketing authorization filings in selected regional hub markets, aiming to harness the radiating advantages of these hubs to establish a firm foundation for commercial launches in various regions going forward.Building on its proven clinical benefit in later-line populations, satri-cel is being actively advanced into earlier lines of therapy and perioperative care to unlock deeper therapeutic value. The Company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer: including an ongoing Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (CT041-CG4011, NCT07179484).Promising data for early line treatment have been presented at top global oncology congresses. The long-term analysis results of satri-cel, as sequential therapy after first-line treatment in patients with advanced G/GEJA, have been presented as a poster presentation at the 2026 ASCO Annual Meeting. Two patients received satri-cel infusions following first-line sequential therapy and subsequently underwent surgery; one had an OS of more than 58 months, and the other had an OS of more than 51 months. We believe satri-cel has tremendous room for value growth as it moves into earlier lines of care, with the potential to redefine standard of care and bring long-term survival benefits to a wider patient population. Robust Pipeline of Allogeneic CAR T-Cell ProductsIn addition to autologous products, CARsgen has also been advancing differentiated allogeneic CAR-T-cell products utilizing the THANK-u Plus® platform, an update version of THANK-uCAR® technology platform.CT0596 is a BCMA-targeting allogeneic CAR T-cell product candidate deploying our THANK-u Plus® technology. IITs have been initiated in China to evaluate the safety and efficacy of CT0596 for the treatment of R/R MM and plasma cell leukemia (PCL). In August 2026, the IND clearance was achieved from NMPA in China for R/R MM. CT0596 will initiate a Phase I registrational trial. Updated IIT results have been presented at the 2026 Annual Congress of the European Hematology Association ("EHA") in June 2026.CT1190B (KJ-C2219) is an allogeneic CAR T-cell product candidate targeting CD19/CD20 deploying our THANK-u Plus® technology, for B-cell malignancies. IITs for refractory/relapsed B-cell non-Hodgkin lymphoma (R/R B-NHL) have been initiated. In August 2026, the IND clearance was achieved from NMPA in China for the treatment of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) who have failed at least two prior lines of standard therapy. CT1190B will initiate a Phase I registrational trial. Updated IIT results have been presented at the 2026 Annual Congress of the EHA in June 2026.In addition, multiple products against different targets are currently under development: CT1390B against CLL1 for AML; KJ-C2526 against NKG2DL for AML, other malignancies and senescence; KJ-C2527 against Claudin18.2 for G/GEJA, etc.; KJ-C2630 against GPC3 for hepatocellular carcinoma (HCC), etc. Development of In Vivo CAR T-Cell ProductsCARsgen is developing a portfolio of differentiated in vivo CAR T-cell product candidates based on the proprietary CARvivo™ platform, featuring self-developed, patent-protected viral envelopes and T-cell-specific promoters. The platform achieves exceptionally high transduction efficiency and robust cell-type specificity, which reduces the risk of off-target transduction in tumor cells and lowers the incidence of antigen masking and therapeutic resistance.KJ-C2529 is an in vivo CAR T-cell product candidate against CD19/CD20 deploying our CARvivo™ platform for the treatment of B-cell lymphoma. An IIT has been initiated in 2026 for the treatment of R/R B-NHL.Other in vivo CAR T-cell products currently being developed include KJ-C2632 against BCMA/GPRC5D for R/R MM; KJ-C2633 against CD19/BCMA for R/R MM and autoimmune disease; KJ-C2634 against Claudin18.2 for G/GEJA, etc.; KJ-C2635 against GPC3 for HCC, etc. About CARsgen Therapeutics Holdings LimitedCARsgen 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 StatementsAll 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