Heyuan Bio Submits NDA for Third Indication of CD19 CAR-T Therapy Yuanruida® in Pediatric Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

On May 12, Juventas announced that the National Medical Products Administration (NMPA) has officially accepted the New Drug Application (NDA) for its core product, Yuanruida® (Natie Orencel Injection), for the treatment of pediatric relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

According to the press release, this is the third new drug marketing application submitted by Yuanruida® after the National Medical Products Administration approved two previous applications for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia and adult relapsed or refractory large B-cell lymphoma. Previously,Nacijaolumab Injection for the Treatment of Pediatric Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Granted "Breakthrough Therapy" Designation by China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) in August 2025.

Data from the pivotal registration clinical study (Phase I/II, multi-center, single-arm, open-label) of Naciorl Injection for the treatment of pediatric r/r B-ALL showed: High Objective Response Rate (ORR): The ORR in evaluable patients reached 90%, with a complete remission (CR) rate exceeding 70%, significantly superior to traditional salvage chemotherapy; Deep MRD negativity: All responding patients achieved minimal residual disease (MRD) negativity, with an MRD negativity rate of 100%, laying a core foundation for long-term disease-free survival. Rapid response and durable benefits: Responding patients all achieved MRD-negative remission at the first assessment 28 days after cell infusion, with some children achieving sustained disease-free survival of over two years, returning to normal life and studies. Adverse reactions were mainly Grade 1-2 cytokine release syndrome (CRS), with a low incidence of ≥Grade 3 CRS, and no treatment-related deaths; the incidence of immune effector cell-associated neurotoxicity syndrome (ICANS) was low and all cases recovered without sequelae after clinical management. Overall safety was consistent with adult patients and met the tolerability requirements for pediatric treatment.

END