CARsgen Announced 2024 Annual Results
SHANGHAI, March 18, 2025 /PRNewswire/ -- 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's National Medical Products Administration (NMPA).
As of December 31, 2024, certification and filings for 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 Huadong Medicine.
Satri-cel ST-01 confirmatory Phase II trial for gastric cancer in China: 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.
Results from the investigator-initiated trial (IIT) of satri-cel were published in Nature Medicine and at the 2024 ASCO Annual Meeting.
The results of the IIT of an allogeneic BCMA-targeting CAR-T product CT0590, which deploys the THANK-uCAR® technology platform, were presented at the 2024 ASH Annual Meeting.
Developed THANK-u Plus™ platform as an enhanced version of THANK-uCAR® allogeneic CAR-T platform. Multiple allogeneic CAR-T products in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases.
Introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland China.
Cash and bank balances were around RMB1,479 million as of December 31, 2024. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,080 million. Expect to have adequate cash into the 2028.
"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," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.
Zevor-cel: Approved by the NMPA and Launched in China
Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA). On February 23, 2024, zevor-cel was approved by China's 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 Huadong Medicine for the commercialization of zevor-cel in mainland China. As of December 31, 2024, 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 Huadong Medicine.
Updated results of the pivotal Phase II registrational trial of zevor-cel in China 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.
Satri-cel: Confirmatory Phase II trial Met Primary Endpoint, Plans to Submit an NDA
Satri-cel ...
