Juventas Bio Announces NDA Submission for New Indication of CD19 CAR-T Therapy Naxilogene Celotide in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Juventas
Innovative Cell Therapy Drug Developer
Today (September 26), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) revealed that Juventas' Natarelimab Injection New Indication Marketing Application has been accepted.Naciorlson is aCD19 Chimeric Antigen Receptor Autologous T (CD19 CAR-T) Cell Injection.According to the R&D pipeline on Juventas' official website, the indication for this marketing application may beRelapsed/Refractory B-cell Non-Hodgkin Lymphoma (r/r B-NHL).For this indication,NaciorlcelThe injectable solution is currently in the pivotal Phase 2/3 clinical research stage.
Screenshot source:CDE Official Website
Naciorlens Injection (CNCT19) is a CAR-T cell therapy product targeting CD19. According to public information from Juventas,Naciorl InjectionSuccessively obtained three New Drug Clinical Trial Permits (IND) from the CDE for the treatment ofAdult Relapsed or Refractory Acute Lymphoblastic Leukemia, TreatmentRelapsed or Refractory Aggressive B-Cell Non-Hodgkin LymphomaAnd TreatmentRelapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Children and Adolescents。
In November 2023, the NMPA announced the conditional approval of Naciorlen Injection for marketing through the priority review and approval process, intended for the treatment ofAdult Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL)。
It is worth mentioning that in June this year, Juventas announced the use of natriolimab injection for treatment at the 2024 European Hematology Association Annual Meeting (2024 EHA) in a poster presentation.Relapsed or Refractory Large B-Cell LymphomaLong-term Follow-up Results of Phase 1 Clinical Trial. The study enrolled patients with r/r-LBCL who had received at least two lines of systemic therapy or relapsed after autologous hematopoietic stem cell transplantation. As of November 1, 2022, this study has been completed. The median follow-up time was 24.1 months, with an objective response rate (ORR) of 66.7%, a complete response rate (CR) of 55.6%, and the median duration of response (DOR) and overall survival (OS) not yet reached. The 2-year progression-free survival (PFS) and overall survival (OS) rates were 33.3% and 66.7%, respectively. The researchers concluded that the Naciorlen Injection demonstrated favorable safety and efficacy in patients with relapsed or refractory large B-cell lymphoma.
B-cell non-Hodgkin lymphoma (B-NHL) is a malignant lymphatic system tumor originating from B lymphocytes, mainly including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and marginal zone lymphoma.Among them, DLBCL is an aggressive tumor with high heterogeneity, high malignancy, rapid disease progression, and a relatively high mortality rate, posing a serious threat to patients' lives.The treatment of relapsed/refractory DLBCL remains a serious challenge in clinical practice.
Screenshot source: Juventas official website
According to the R&D pipeline information on Juventas' official website, apart fromNaciorlcelThe company also has dozens of CAR-T cell therapies under development, targeting CD19/CD22, BCMA, CLL1, CD7, etc., with indications covering hematological tumors, solid tumors, and non-tumor diseases.
This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form on other platforms is strictly prohibited. For reprint authorization and other cooperation inquiries, please contact wuxi_media@wuxiapptec.com.
Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.
