Chinese-Origin CAR-T Therapy Inaticabtagene Autoleucel (YuaneRuida®) Receives NMPA Acceptance for Pediatric r/r B-ALL Indication
Juventas
Innovative Cell Therapy Drug Developer
Recently, a portfolio company of Danlu CapitalJuventasannounced the New Drug Application (NDA) for its core product, Yuanruida® (Naxicabtagene Autoleucel Injection), for the treatment of pediatric relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)Has been officially accepted by the National Medical Products Administration (NMPA).
This is the third marketing authorization application submitted for Yuanruida® following those for adult relapsed or refractory B-cell acute lymphoblastic leukemia and adult relapsed or refractory large B-cell lymphoma, marking the further expansion of China's original CAR-T products into pediatric indications with high unmet clinical needs.
Significant Unmet Need Remains in Pediatric ALL
Acute lymphoblastic leukemia (ALL) is one of the most common hematologic malignancies in children. Although current treatments have significantly improved overall survival rates, patients with relapsed or refractory disease still face substantial challenges, including limited therapeutic efficacy and severe adverse effects associated with long-term chemotherapy.The development of CAR-T cell therapy has brought new therapeutic hope to pediatric patients with r/r B-ALL.
From Adults to Children: China's Original CAR-T Continuously Expands Indication Boundaries
Yuanruida® (Injucabtagene autoleucel injection) is a CD19-targeted CAR-T cell therapy product independently developed by Juventas, featuring a proprietary CD19 scFv (HI19a) structure and manufacturing process.
In 2023, the product was approved for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia in adults, becoming the first CAR-T product approved in China for the treatment of leukemia; subsequently, its indication for large B-cell lymphoma also achieved a breakthrough.The acceptance of the marketing authorization application for the pediatric relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) indication signifies that Yuanruida® is progressively establishing an indication portfolio covering hematological malignancies in both adult and pediatric populations.
Clinical Data Demonstrate Favorable Efficacy and Safety
PublicData show that naxicabtagene autoleucel injection demonstrated favorable efficacy and safety in the pivotal registration clinical trial for pediatric r/r B-ALL:
Objective Response Rate (ORR) reached 90%
Complete response (CR) rate exceeds 70%
All responding patients achieved MRD negativity.
Some pediatric patients maintained disease-free survival for over 2 years.
Regarding safety, adverse reactions were generally manageable, predominantly consisting of grade 1–2 cytokine release syndrome (CRS), with no treatment-related deaths.
China's Cell Therapy Industry Accelerates Toward Value Realization
In recent years, China's CAR-T industry has been gradually transitioning from technological breakthroughs to the realization of clinical value and commercialization. As a key innovative enterprise in China's cell therapy sector, Juventas has established a diversified R&D system centered on CAR technology and gene editing platforms, continuously advancing its strategic pipeline across hematological malignancies, solid tumors, and autoimmune diseases.
Danlu Capital has long focused on the foundational innovation capabilities and clinical translational value within the medical technology sector. We believe that next-generation biotechnologies, represented by cell and gene therapy, are continuously driving China's innovative pharmaceutical industry toward a stage of higher-quality development.
About Juventas
The Company’s first core product, Yuanruida® (Naxicabtagene Autoleucel Injection, CNCT19), was officially approved for marketing by the National Medical Products Administration in November 2023. It is the first CAR-T therapy in China for the treatment of leukemia, as well as the first fully independently developed CD19 CAR-T drug in China.
The Company has established in-depth collaborations with top-tier national research institutions, building an internationally-oriented innovative drug R&D system centered on core platforms such as CAR technology and gene editing. It currently has over 10 pipeline products under development, spanning therapeutic areas including hematological malignancies, solid tumors, and autoimmune diseases.
Yuanruida® (Inaticabtagene Autoleucel Injection, CNCT19, Inaticabtagene Autoleucel Injection) is a proprietary CD19-targeted CAR-T cell therapy product featuring a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. It has successively obtained three Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for the treatment of adult relapsed or refractory acute lymphoblastic leukemia, relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia. Additionally, it has been granted the "Breakthrough Therapy" designation by the Center for Drug Evaluation (CDE) of the NMPA and Orphan Drug Designation (ODD) by the U.S. FDA.
In December 2022, the National Medical Products Administration (NMPA) officially accepted the New Drug Application (NDA) for Naxicabtagene Autoleucel Injection for the treatment of adult relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and included it in the priority review program. In March 2023, the Investigational New Drug (IND) application for Naxicabtagene Autoleucel Injection for the treatment of adult r/r B-ALL was also cleared by the U.S. Food and Drug Administration (U.S. FDA). In November 2023, Yuanruida® (Naxicabtagene Autoleucel Injection) was officially granted marketing approval by China's National Medical Products Administration (NMPA).
Guided by the commitment to meeting clinical needs, Juventas leverages a stringent production and quality management system for cell therapy products to deliver safe, effective, and accessible immune cell therapies to patients. The Company features world-class R&D technology platforms, a process development platform, a quality control system, and a commercial-scale production facility, and obtained Tianjin’s first “Drug Production License” for cell therapy products in June 2021. The Company holds multiple invention patents and was selected for the National Key R&D Program of the Ministry of Science and Technology, specifically the “2020 Key Special Project on Science and Technology to Boost the Economy.” It has also been awarded the title of “National Intellectual Property Advantage Enterprise,” recognized as a “Tianjin Specialized, Refined, Differential, and Innovative (SRDI) Small and Medium-sized Enterprise,” among other honors.
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Data and image source: WeChat Official Account @Juventas
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