Tianjin He Yuan Bio's CAR-T Therapy 'Naqi Orun Sai Injection' Approved for Market Launch!
Juventas
Innovative Cell Therapy Drug Developer
On October 8, 2023, the National Medical Products Administration (NMPA) granted conditional approval for the marketing of Naciorlen Cell Injection (brand name: Yuanruida), submitted by Juventas Biotechnology (Tianjin) Co., Ltd., through the priority review and approval process. This drug is used to treat adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Naciorlen Cell Injection is an autologous T-cell immunotherapy product prepared using gene modification technology to express chimeric antigen receptors (CAR) targeting CD19 on the surface of T cells. After infusion into the body, it binds to target cells expressing CD19, activates downstream signaling pathways, induces CAR-T cell activation and proliferation, and triggers cytotoxic effects on target cells. The marketing of this product provides a new treatment option for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Natio-cel Injection (CNCT19 Cell Injection, Inaticabtagene Autoleucel) is a CAR-T cell therapy product independently developed by Juventas (Tianjin) with proprietary intellectual property rights. It targets CD19 and features a globally unique CD19 scFv (HI19a) structure along with internationally leading production and manufacturing processes.
As of September 27, 2022, 39 adult patients with r/r B-ALL had received infusion treatment with Naciorlumab Injection. The overall response rate (ORR) reached 82.1%. At a median follow-up of 9.3 months, the median duration of response (DOR) had not yet been reached; among patients who were still in remission at 3 months, it was estimated that 80% would remain in continuous remission at 1 year. Regardless of whether they subsequently underwent hematopoietic stem cell transplantation, sustained remission and long-term survival benefits were observed.
Chimeric Antigen Receptor T-cell (CAR-T) therapy has developed rapidly and was rated as the top global technological innovation by the 2013 issue of Science magazine.CAR-T cells are genetically engineered T cells expressing chimeric antigen receptors (CARs). A CAR is a fusion protein consisting of three parts: the tandem antigen-binding domain of an antibody, a transmembrane domain, and the signaling components of the T-cell receptor complex. The CAR antigen-binding domain seeks out tumor cells expressing surface antigens on target cells. Once the CAR identifies its target, it sends molecular signals through its intracellular module to activate the CAR-T cell, leading to the destruction of the targeted tumor cells.
CAR-T Targeted Killing of Tumor Cells (Reference 2)
On August 30, 2017, the U.S. FDA announced the official approval of Novartis' CAR-T therapy tisagenlecleucel (formerly CTL019), marketed under the brand name Kymriah. It is indicated for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL) in patients up to 25 years old. With this approval, Kymriah became the world’s first approved CAR-T therapy, ushering in a new chapter in cancer immunotherapy.
As of June 2023, the FDA has approved six CAR-T cell products for hematologic malignancies, including those targeting the CD19 antigen for B-cell leukemia and non-Hodgkin lymphoma (NHL), and the B-cell maturation antigen (BCMA) for multiple myeloma.
On the evening of June 22, 2021, the CAR-T cell therapy product Yikeli Lun Sai Injection (also known as Axicabtagene Ciloleucel, code name: FKC876), introduced by Fosun Kite, was officially approved by the NMPA. This means that China has ushered in the first approved CAR-T cell therapy product to be marketed. On September 3, 2021, the CAR-T cell therapy product Relma-cel Injection (brand name: Benuo Da) from WuXi Jumo was officially approved by the NMPA. This means that China has ushered in the second approved CAR-T cell therapy product to be marketed. On June 30, 2023, the NMPA conditionally approved the listing of Idecabtagene Vicleucel Injection (brand name: FocuSu), submitted by Nanjing Icarus Biopharmaceutical Co., Ltd., through the priority review and approval process. The drug is used to treat adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
Juventas, founded in June 2018, is a next-generation biopharmaceutical company driven by innovative cell and gene technologies. Collaborating deeply with top national institutions and clinical research centers, Juventas has established an international new drug R&D innovation system centered on technology platforms such as CAR, iPSCs, and gene editing. The company focuses on the research and commercialization of innovative drugs like immune cell therapies and aims to create a world-leading platform for cell therapy drug development, clinical translation, and commercialization.
Reference:
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20231108092415187.html
2.https://legendbiotech.cn/research-development/technology-platforms/
3.http://www.juventas.cn/
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