On December 29, according to the official website of the Center for Drug Evaluation (CDE), Juventas Biotechnology's HY001N cell injection has been approved for clinical trials, with the proposed indication being autoimmune hemolytic anemia (AIHA) that has failed at least three lines of therapy. It is worth noting that this is the company's first CAR-T therapy developed based on its innovative, rapidly prepared NexT platform. CDE Official Website
HY001N cell injection is the first product developed on Juventas innovative rapid NexT technology platform. Compared to traditional autologous CAR-T technology platforms, the rapid NexT process reduces the in vitro expansion and culture steps of CAR-T cells, shortening the in-plant production time from 9-14 days to less than 2 days. Patient waiting time is reduced by 50%, down to 10 days, and production costs are significantly lower than existing technologies. Simultaneously, the rapid CAR-T process significantly increases the proportion of T naïve cells in the final product, laying the foundation for its efficacy and safety.
Currently, Juventas has an independently developed CD19 CAR-T product, Nagi-Olensai Injection, which has been approved for marketing. It is the only CAR-T cell therapy product in China that covers the two major hematological malignancies of leukemia and lymphoma.
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