SHANGHAI, March 6, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, has announced its 2025 Annual Results.
Business Highlights
-- Cash and cash equivalents were around RMB1,123 million as of December 31,
2025. Cash and cash equivalents at the end of 2026 are expected to be not
less than RMB1,000 million. The net loss for the year ended December 31,
2025 was RMB103 million, representing a decrease of approximately 87%
compared to the year ended December 31, 2024. In light of operational
factors such as the changes in operating cash flow, we expect to have
adequate cash into the 2030.
-- During 2025, CARsgen has received a total of 218 confirmed orders of
zevor-cel from its commercialization partner Huadong Medicine. In
December 2025, zevor-cel has been included in China's Commercial Health
Insurance Innovative Drug Catalogue (2025).
-- The Center for Drug Evaluation $(CDE)$ of the National Medical Products
Administration (NMPA) of China has accepted the New Drug Application
(NDA) and granted Priority Review for satri-cel. The results of satri-cel
confirmatory Phase II trial in China have been simultaneously published
in The Lancet and at the 2025 ASCO Annual Meeting.
-- Multiple allogeneic CAR-T products are in development, covering treatment
areas such as hematologic malignancies, solid tumors, and autoimmune
diseases.
-- CARsgen independently developed the lentiviral-based CARvivo$(TM)$ platform
for creating in vivo CAR T-cell products.
-- CARsgen entered into strategic cooperation agreements with a key platform
enterprise in Jinshan District, Shanghai to establish an advanced
commercial manufacturing base for CAR T-cell products.
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "2025 is a pivotal year for CARsgen Therapeutics. As we enter the phase of substantial value realization in commercialization, zevor-cel has demonstrated an excellent market performance. Meanwhile, satri-cel, the world's first CAR-T candidate for solid tumors that has entered the NDA review process, is expected to be approved in the first half of 2026 and initiate commercialization. With its strong clinical value and broad market potential, it is poised to become the company's next core growth driver. In 2025, the company has shifted its focus to the field of allogeneic CAR-T cell therapies. We believe that off-the-shelf cell therapies capable of large-scale production are crucial for serving a broad patient population and opening a new chapter for the industry. Leveraging our proprietary THANK-uCAR$(R)$ and THANK-u Plus(TM) platforms, we are advancing multiple allogeneic CAR-T candidates, with encouraging preliminary clinical data demonstrating promising efficacy and a favorable safety profile. Additionally, we are also advancing in vivo CAR T-cell therapies based on our proprietary CARvivo(TM) platform. Looking ahead, we will continue to unite our efforts, move forward with determination, and execute our strategic plans with rigorous precision, bringing renewed hope to patients worldwide."
Financial Highlights
CARsgen's revenue was around RMB125.7 million for the year ended December 31, 2025 mainly from zevor-cel, autologous BCMA CAR T-cell product in which the primary revenue of zevor-cel 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 RMB80 million for the year ended December 31, 2025. 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. Our net loss was around RMB103 million for the year ended December 31, 2025, representing a decrease of around RMB695 million from around RMB798 million for the year ended December 31, 2024.
Cash and cash equivalents were around RMB1,123 million as of December 31, 2025, representing a decrease of around RMB356 million from around RMB1,479 million as of December 31, 2024. The decrease was mainly due to research and development expenses, administrative expenses and investment of capital expenditure. Cash and cash equivalents at the end of 2026 are expected to be not less than RMB1,000 million. In light of operational factors such as the changes in operating cash flow, we expect to have adequate cash into the 2030.
Zevor-cel demonstrates rapids sales growth
Zevorcabtagene 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 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).
CARsgen entered into a collaboration agreement with Huadong Medicine (000963.SZ) for the commercialization of zevor-cel in mainland China. 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 2025, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces or cities and we have received a total of 218 confirmed orders from Huadong Medicine. In December, 2025, zevor-cel was included in China's Commercial Health Insurance Innovative Drug Catalogue (2025). We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage.
The updated long-term follow-up results of Phase I clinical trial of CT053 have been published in Blood Advances. The updated data of Phase II clinical trial, involving 102 patients with a median follow-up of 20 months, were published in Experimental Hematology & Oncology. Zevor-cel demonstrates manageable safety profile while eliciting deep and durable responses in R/R MM patients.
CARsgen entered into a collaboration with Dispatch Bio, to conduct a Phase I trial in China, planned to begin in 2026. The trial will evaluate DISP-11, an investigational therapy leveraging Dispatch's first-in class Flare platform -- including DV-10, the company's novel tumor-specific virus -- and zevor-cel, in patients suffering from solid tumors.
Satri-cel is about to be commercialized in China
Satricabtagene autoleucel (satri-cel, R&D code: CT041) is an autologous humanized CAR T-cell product against Claudin18.2. In China, satri-cel was granted Breakthrough Therapy Designation (BTD) in March 2025 and Priority Review in May 2025 by the CDE. In June 2025, the CDE of NMPA of China has accepted the NDA for satri-cel for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Satri-cel is the first CAR T-cell therapy for the treatment of solid tumors that has advanced to NDA stage worldwide. It is expected to be approved and start commercialization in the first half of 2026.
The results of satri-cel confirmatory Phase II trial (NCT04581473) in China have been published in The Lancet and were orally presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Satri-cel demonstrated significant progression-free survival $(PFS)$ improvement and a clinically meaningful overall survival (OS) benefit with a manageable safety profile, compared to standard therapy.
The research results of the Phase Ib registrational clinical trial of satri-cel for PC adjuvant therapy in China (NCT05911217) has been presented as a poster session at European Society for Medical Oncology (ESMO) Congress in October 2025. The trial represents the world's first proof-of-concept (POC) study exploring CAR T-cell therapy for the adjuvant treatment of solid tumors.
In addition, an investigator-initiated trial (IIT) for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786), and an IIT for satri-cel as a sequential therapy following first-line treatment in patients with advanced G/GEJA (NCT07179484) have been conducted in China.
Multiple allogeneic CAR-T product candidates in development
CARsgen has been advancing differentiated allogeneic CAR T-cell products utilizing the CARsgen's proprietary THANK-uCAR(R) and THANK-u Plus(TM) platform. THANK-u Plus(TM) platform, as an enhanced version of THANK-uCAR(R) , was developed to address the potential impact of NKG2A expression levels on therapeutic efficacy of the allogeneic CAR T-cells.
CT0596 is a BCMA-targeting allogeneic CAR T-cell product candidate deploying our THANK-u Plus(TM) technology. The IITs are ongoing in China to evaluate the safety and efficacy of CT0596 for the treatment of R/R MM and PCL. Two IND applications for R/R MM and primary plasma cell leukemia (pPCL) separately were submitted to the NMPA in December 2025 and have been accepted. Phase Ib registration trials in China are planned to be initiated in 2026. Preliminary results of an IIT have been presented at the 67th ASH in December 2025.
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