Heyuan Bio Announces CDE Approval of HY001N CAR-T Therapy for Clinical Trial in Refractory Autoimmune Hemolytic Anemia

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HY001N Cell Injection is the first product developed on Juventas' innovative rapid preparation NexT technology platform. Compared with traditional autologous CAR-T technology platforms, the rapid preparation NexT process reduces the steps for ex vivo expansion and culture of CAR-T cells, shortening the production time in the workshop from 9-14 days to less than 2 days. Patient waiting time is reduced by 50%, potentially up to 10 days, while production costs are significantly lowered compared to existing preparation technologies. Additionally, the proportion of T naïve cells in the final rapid preparation CAR-T product is significantly increased, laying a foundation for its efficacy and safety.

Currently, Juventas has one self-innovated CD19 CAR-T product, Najiolumab Injection, approved for marketing in China. It is the only CAR-T cell therapy product in China that covers two major hematological tumor indications: leukemia and lymphoma.

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Juventas