CARsgen Therapeutics Announces 2025 Interim Results

Core Viewpoint - CARsgen Therapeutics has made significant advancements in technology innovation, product development, and commercialization in the first half of 2025, particularly with the sales growth of zevor-cel and the filing of the NDA for satri-cel, the first CAR-T targeting solid tumors [2][9]. Business Highlights - Zevor-cel sales have surged, and it is being commercialized in collaboration with Huadong Medicine, which has established a dedicated team to promote its use [2][6]. - The company has received 111 confirmed orders for zevor-cel from Huadong Medicine, with regulatory filings completed in over 20 provinces [7]. - Satri-cel has become the first CAR T-cell product globally to file an NDA for solid tumors, with significant clinical trial results published [9][10]. Financial Highlights - CARsgen's revenue for the first half of 2025 was approximately RMB51 million, primarily from zevor-cel, with a gross profit of around RMB29 million [3]. - Cash and bank balances were approximately RMB1,261 million as of June 30, 2025, down from RMB1,479 million at the end of 2024, mainly due to R&D and administrative expenses [4][7]. - The company expects to maintain cash balances of not less than RMB1,100 million by the end of 2025, ensuring adequate cash flow into 2028 [4][7]. Product Development - Multiple allogeneic CAR-T therapies are in development, including CT0596, which targets BCMA for treating relapsed or refractory multiple myeloma [11][12]. - CARsgen has introduced the THANK-u Plus™ platform to enhance the efficacy of allogeneic CAR T-cells [11]. - The company has entered agreements to secure funding for UCARsgen, focusing on allogeneic CAR T-cell therapies for hematologic malignancies [13][14]. Clinical Trials and Regulatory Approvals - The confirmatory Phase II trial results for satri-cel have shown significant improvements in progression-free survival and overall survival compared to standard therapies [10]. - Satri-cel has received Priority Review and Breakthrough Therapy Designation from the CDE of NMPA in China [9].