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On October 9, 2025, Juventas (Tianjin) Biotechnology Co., Ltd. (hereinafter referred to as "Juventas") independently developed an innovative product.HY001N Cell InjectionThe new drug's Investigational New Drug (IND) application has been officially accepted and publicly disclosed by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).Intended for the treatment of autoimmune hemolytic anemia that has failed at least three lines of therapy(Autoimmune Hemolytic Anemia, AIHA) patients.HY001N Cell Injection is the first product developed on Juventas' innovative rapid preparation NexT technology platform. Compared with the traditional autologous CAR-T technology platform process, the rapid preparation NexT process technology reduces the expansion and culture operation steps of CAR-T cells in vitro.The production time of CAR-T cells in the workshop has been shortened from 6~8 days to within 2 days, and the patient waiting time has been reduced by 50%, now reaching 8-10 days.Production costs are significantly reduced based on existing preparation technologies. Meanwhile, the proportion of T naïve cells in the rapid preparation of CAR-T final products is increased to over 25%, laying the foundation for its efficacy and safety.The indication applied for this time is the treatment of autoimmune hemolytic anemia (AIHA) that has failed at least three lines of therapy. The principal investigator is Professor Jun Shi from the Hematology Hospital of the Chinese Academy of Medical Sciences. Clinically, about 50% of AIHA patients still experience recurrence or drug dependence after multiple lines of treatment, with residual mortality risks as high as 10%-30%. Current treatment methods have proven difficult to make breakthroughs for such patients, and the emergence of innovative CAR-T products is expected to bring new treatment options for them.Juventas, founded in June 2018, has grown into a leading innovator in China's cell therapy industry and is committed to becoming a globally leading biopharmaceutical company driven by cutting-edge cell and gene technologies. The company’s first core product, Yuanruida® (Nabasaleucel Injection, CNCT19), was officially approved for marketing by the National Medical Products Administration in November 2023. This product is the first CAR-T drug in the field of leukemia treatment in China and also the first fully China-developed CD19 CAR-T drug. Juventas collaborates deeply with top-tier national research institutions and has established an international new drug R&D system centered on platforms such as CAR technology and gene-editing technology. The company has over 10 pipeline products under development, covering diseases including hematologic malignancies, solid tumors, and autoimmune disorders.Source: Juventas
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