Juventas Cell Therapy Ltd.

Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-directed CAR-T product developed by Juventas with independent Chinese IP rights, received Breakthrough Therapy Designation from China's Center for Drug Evaluation and Orphan Drug Designation from US FDA. It was formally approved by China's National Medical Product Administration in November 2023 to treat adult relapsed/refractory B-cell acute lymphoblastic leukemia[1][9]. The drug has demonstrated efficacy in hematologic malignancies including r/r ALL and aggressive NHL subtypes. Other pipeline candidates are advancing through early clinical phases targeting hematologic cancers and autoimmune diseases[2][3][8].