(MENAFN- Newsfile Corp) Juventas Cell Therapy Announces the Approval of Its First Cell Therapy Product - Inaticabtagene Autoleucel by China NMPA
Juventas Cell Therapy Ltd. announces China National Medical Product Administration (NMPA) has approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-tarrgeted autologous chimeric antigen receptor (CAR)-T cell therapy for adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
Inaticabtagene Autoleucel is Juventas first proprietary CD19 CAR-T cell therapy product. The pivotal study of Inaticabtagene Autoleucel demonstrated deep durable remission with marginal toxicity profile for the treatment of adult r/r B-ALL. Inaticabtagene Autoleucel has been granted Breakthrough Therapy Designation and Priority Review Status by the China's National Medical Products Administration (NMPA). The approval of Inaticabtagene Autoleucel by NMPA delivers a breakthrough clinical option adult r/r B-ALL patients.
Beijing, China and Tianjin, China and Shanghai, China--(Newsfile Corp. - November 10, 2023) - Juventas Cell Therapy Ltd. announces China National Medical Product Administration (NMPA) has approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-tarrgeted autologous chimeric antigen receptor (CAR)-T cell therapy for adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product, featured with a unique CD19 scFv (HI19a) and advanced manufacturing processes. The pivotal study of Inaticabtagene Autoleucel has demonstrated high efficacy, durable remission, and substantially improved safety profile with adult r/r B-ALL. Inaticabtagene Autoleucel is the first proprietary CD19-targeted CAR-T product invented in China, and the first commercialized CAR-T cell therapy product for B-ALL in China.
This approval is based on the clinical results from a single-arm, multi-center, pivotal study for adult r/r B-ALL in China. The 9.3-month follow-up data demonstrated very high durable response (overall response rate ("ORR") 82.1%, complete response rate ("CR") 66.7% within 3 month post infusion, while median DOR hasn't reached. The safety profile shown the decreased severity of CAR T-Cell related adverse events. Inaticabtagene Autoleucel will potentially be best-in-class CAR-T cell therapy for adult r/r B-ALL, meeting long-seeking unmet clinical need.
Prof. Wang Jianxiang, the Principal Investigator of the clinical study of Inaticabtagene Autoleucel (CNCT19 Injection) in China, deputy president of Institute of Hematology & Blood Diseases Hospital, Director of the National Clinical Research Center for Hematology commented:
Under traditional treatment strategies, adult r/r B-ALL patients usually end up with fatal situation within a few months after diagnosis. There is an enormous unmet clinical need for adult r/r B-ALL world-wide. Inaticabtagene Autoleucel has demonstrated outstanding clinical value, excellent efficacy, and sustained remission. This product will be the game-changer for adult r/r B-ALL treatment in China. The approval not only provides clinical physicians an effective treatment option, also offers a great hope of life for adult r/r B-ALL patients.
Dr. Lyv Lulu, CEO of Juventas Cell Therapy Ltd. remarked:
"Directed by the Clinical Value, Oriented by the Patients" has long been our principle. During clinical study, we have witnessed many patients who have received our product achieved long-term survival and returned normal life, not to mention the improvement of their life quality. This is the breakthrough in China leukemia treatment area. Looking at the future, as planned we will continuously join hands with all parties to alleviate patient accessibility of Inaticabtagene Autoleucel, and have more patients benefit from this China home-made innovative CAR-T cell therapy. Our mission is to Originate the Force of Health and Ignite the Hope of Strength!
Established in June 2018, Juventas Cell Therapy Ltd, a biopharmaceutical company powered by cutting-edge cell and gene technologies, has become the leader of innovative CGT drug development in China. Juventas' innovation is stemmed from its integrated R&D platforms including CAR, iPSCs, and gene-editing technologies. With more than 10 drug candidates in its pipeline, featured with solo, dual, or multiple target autologous CAR-T and universal cellular products, Juventas is well on its way to fulfil its mission - providing novel solutions to unmet clinical needs in the treatment of blood cancers, solid tumors, and other diseases.
Beside self-driven innovation, Juventas is open for domestic and international collaborations, and has developed close partnership cooperation with China national top scientific institutes and clinical research centers, to diligently translate frontier science and technology advancement into bedside therapies/treatments.
In Nov 8, 2023, Juventas' first core product - Inaticabtagene Autoleucel (CNCT19) was approved by China NMPA, for the treatment of adult B-cell relapsed and refractory acute lymphoblastic leukemia (r/r B-ALL).
Name: Mr. Li
Organization: Juventas Cell Therapy
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