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On August 15, CARsgen Therapeutics (stock code: 2171.HK) released its 2025 interim results, with revenue of RMB 509.61 million, representing a year-on-year increase of 703.8%. The reduction in losses was mainly due to the decrease in R&D expenses during the period, the decrease in administrative expenses, the increase in net foreign exchange gains, and the increase in gross profit.
In the 2025 interim report disclosed by CARsgen Therapeutics: For the six months ended June 30, 2025, the Group's revenue was RMB 50.961 million, mainly from Zevorcabtagene Autoleucel(zevorcabtagene autoleucel injection, an autologous BCMA CAR-T cell product), calculated at ex-factory price rather than terminal market price. Revenue is recognized upon ex-factory delivery of completed products. Due to the necessary time cycle for CAR-T production, there is a difference between the number of orders obtained from Huadong Medicine and the number of ex-factory deliveries.
As of June 30, 2025, cash and bank balances were approximately RMB 1.261 billion, a decrease of approximately RMB 218 million compared with approximately RMB 1.479 billion as of December 31, 2024. This decrease was mainly due to the payment of R&D expenses, administrative expenses, and capital expenditures. The cash and cash equivalents and deposits at the end of 2025 are expected to be no less than RMB 1.1 billion.
In the first half of 2025, Zevorcabtagene Autoleucelcompleted certification and filing in medical institutions covering more than 20 provinces and cities across the country, and CARsgen Therapeutics obtained a total of 111 valid orders from its commercialization partner Huadong Medicine. The NDA of shurecabtagene autoleucel injection was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The results of the confirmatory phase II clinical trial of shurecabtagene autoleucel injection in China were published in The Lancet and presented at the 2025 ASCO Annual Meeting. Multiple allogeneic CAR-T products are under development, covering hematologic malignancies, solid tumors, autoimmune diseases, and other fields. Zhuhai SoftBank Xinchang Investment was introduced to accelerate the R&D process of allogeneic CAR-T cell products in mainland China.
Zevorcabtagene Autoleucel(zevorcabtagene autoleucel injection, R&D code: CT053) is a fully human B-cell maturation antigen (BCMA) autologous CAR-T cell product, approved by the China NMPA for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 lines of prior therapy (at least having received a proteasome inhibitor and an immunomodulatory agent). This is the first approved product launched by CARsgen Therapeutics to the market in March 2024, with an initial price of RMB 1.15 million per injection.
CARsgen Therapeutics has signed a commercialization cooperation agreement with Huadong Medicine (000963.SZ) for Zevorcabtagene Autoleucelin mainland China. In terms of commercialization, Huadong Medicine has established an independent, professional, and comprehensive commercialization team to fully promote Zevorcabtagene Autoleucel;, leveraging China's multi-level insurance system to improve patient accessibility. In the first half of 2025, Zevorcabtagene Autoleucelcompleted certification and filing in medical institutions covering more than 20 provinces and cities across the country, and CARsgen Therapeutics obtained a total of 111 valid orders from Huadong Medicine. It is expected that with the continued implementation of marketing activities and the expansion of insurance coverage, the sales revenue of Zevorcabtagene Autoleucelwill further accelerate growth.
Shurecabtagene autoleucel injection (R&D code: CT041) is an autologous humanized CAR-T cell product targeting Claudin18.2 (CLDN18.2). In June 2025, the CDE of China's NMPA accepted the NDA of shurecabtagene autoleucel injection for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) with Claudin18.2 expression positive and failure of at least two lines of therapy. Shurecabtagene autoleucel injection is the world's first and only CAR-T cell product for solid tumors that has entered the NDA stage. In May 2025, shurecabtagene autoleucel injection was included in priority review by the CDE, and in March 2025, it was granted Breakthrough Therapy Designation (BTD).
The study results of the confirmatory phase II clinical trial (NCT04581473) of shurecabtagene autoleucel injection in China have been published in The Lancet and presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study results showed that compared with standard therapy, shurecabtagene autoleucel injection significantly improved progression-free survival (PFS), demonstrated clinically meaningful overall survival (OS) benefits, and had a controllable safety profile.
CT011 is an autologous CAR-T cell product, which has accumulated certain proof-of-concept clinical data for the treatment of hepatocellular carcinoma (HCC). Dr. Zonghai Li, co-founder, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, led the world's first successful identification, validation, and reporting of GPC3 as a tumor-associated target for developing CAR-T cell products for the treatment of HCC. In January 2024, CT011 obtained IND approval from the NMPA for the treatment of patients with stage IIIa GPC3-positive hepatocellular carcinoma who are at risk of recurrence after surgical resection.
CT071 is an autologous CAR-T cell therapy targeting GPRC5D, developed through CARsgen's proprietary CARcelerate? platform, for the treatment of R/R MM and R/R pPCL. It contains a fully human scFv developed by CARsgen. The proprietary CARcelerate? platform can shorten the manufacturing time of CT071 to about 30 hours, thereby producing younger and potentially more potent CAR-T cells compared with traditional production methods. The improvement in manufacturing efficiency further enhances supply capacity, reduces manufacturing costs, and improves patient accessibility.
The study results of the investigator-initiated clinical trial (NCT06407947) of CT071 for newly diagnosed multiple myeloma (NDMM) have been presented in a poster at the 30th EHA Annual Meeting, titled "A phase I study of GPRC5D targeting CAR T-cell therapy CT071 for high-risk newly diagnosed multiple myeloma." The overall response rate (ORR) was 100%, of which 70% (7/10) achieved stringent complete response (sCR).
CARsgen Therapeutics is advancing differentiated allogeneic CAR-T cell products using its proprietary THANK-uCAR? platform. The company recently developed the THANK-u Plus? platform, an upgraded version of THANK-uCAR?, to overcome the potential impact of NKG2A expression levels on the efficacy of allogeneic CAR-T cell products.
CT0596 is a BCMA-targeted allogeneic CAR-T cell product developed using the THANK-u Plus? platform for the treatment of R/R MM or R/R plasma cell leukemia (PCL). It is undergoing investigator-initiated clinical trials in China. Preliminary clinical data were released on the company's official website in May 2025. According to preliminary safety and efficacy data, CT0596 showed overall good tolerability in patients with R/R MM, with CAR-T cell expansion observed in all preset dose groups and encouraging efficacy signals.
Several other allogeneic CAR-T products are also under development:
[1]. https://www.carsgen.com/media/3vsj00ph/2024-annual-report.pdf
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