科济药业

We announce the initiation of an investigator-initiated trial (IIT) in China for KJ-C2219, an allogeneic CAR T-cell therapy, targeting CD19/CD20. The trial will evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). https://lnkd.in/gZ7WbGuk

"We are thrilled to see that satri-cel has achieved positive results in the pivotal Phase II clinical trial in China. The study demonstrates that satri-cel provides significant benefits to gastric cancer patients who have failed at least two prior lines of therapy. This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors. We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world's first CAR-T product for solid tumors, bringing hope to more patients as soon as possible. Additionally, we will continue to explore the potential of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics. https://lnkd.in/gk4AQJiu

CARsgen's allogeneic CAR T-cell product developed using the THANK-u Plus platform has administered the first dose to a patient in an investigator-initiated trial (IIT) in China. https://lnkd.in/gBax4zfk

Thanksgiving reminds us to appreciate the trust and collaboration that fuel our innovation. Thank you for being part of our journey to Making Cancer Curable. Wishing you a joyful and meaningful Thanksgiving!

"CARsgen is advancing therapeutic options for hematologic malignancies with robust CAR T-cell pipeline, which includes the autologous CAR T-cell therapy zevor-cel, the single-day-culture CT071, and the allogeneic CAR T-cell candidate CT0590. These initiatives underscore CARsgen's strong commitment to innovation in hematology. Leveraging proprietary technology platforms such as CARcelerate® and THANK-uCAR®, CARsgen is focused on developing differentiated CAR T-cell therapies to address the critical challenges faced by the clinical community. We are excited to share new data and are confident in the potential of our CAR T-cell therapies to benefit patients worldwide," said Raffaele Baffa, M.D., Ph.D., Chief Medical Officer of CARsgen Therapeutics. https://lnkd.in/gjG4dUcG

CARsgen® U.S. Clinical Holds Lifted by FDA https://lnkd.in/gxsmQmj9

CARsgen has submitted the complete response letters to request lifting the clinical holds for zevorcabtagene autoleucel, satricabtagene autoleucel and CT071 to FDA. https://lnkd.in/g3ZD-mdn

"In the past six months, we have made significant progresses in technological innovation, product development, and business operations. Zevor-cel was successfully launched in China and has been included in nearly 20 provincial and municipal healthcare plans. The pivotal Phase II trial of satri-cel in China has completed patient enrollment. We are also actively exploring the potential of satri-cel in adjuvant therapy, aiming for greater clinical benefit for patients. Additionally, we are rapidly advancing CT071, which is manufactured with our CARcelerate® platform, while continuing to develop multiple allogeneic CAR T-cell products based on the THANK-uCAR® platform." said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics. https://lnkd.in/gmubHD2Y #cartcelltherapy #biotech #hematology #oncology