He Yuan Bio Announces NMPA Approval of Yuanruida (Inaticabtagene Autoleucel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Recently, Juventas, a biopharmaceutical company, announced that the National Medical Products Administration (NMPA) has officially approved the New Drug Application (NDA) for the company’s immunotherapy CAR-T product, Yuan Ruida (Inaticabtagene Autoleucel Injection, CNCT19 Cell Injection), for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The successful approval and market launch of Inaticabtagene Autoleucel Injection will provide a new clinical treatment option for adult patients with r/r B-ALL.

Yuan Ruida (Nanjio Cell Injection) is a self-developed CD19-targeted CAR-T cell therapy product with a CD19 scFv (HI19a) structure and internationally leading manufacturing processes. The approval of this new drug is based on the results of a single-arm, open-label, multi-center pivotal clinical study (NCT04684147) of Nanjio Cell Injection for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

Prof. Wang Jianxiang, Principal Investigator of the China Registration Clinical Trial of Yuanruida, Deputy Dean of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS), and Director of the National Clinical Research Center for Hematologic Diseases, stated: "Under traditional treatment methods, adult patients with relapsed or refractory acute B lymphoblastic leukemia face the threat of death within months. There is a significant unmet clinical need for treating these patients in China and globally. Yuanruida demonstrates remarkable clinical value and excellent efficacy, with the potential to transform the current treatment landscape for adult r/r B-ALL patients in China. The approval of Yuanruida provides clinicians with a new treatment option and brings long-term survival hope to patients with relapsed or refractory B-cell acute lymphoblastic leukemia."

Dr. Lulu Lv, CEO of Juventas, stated: "We are thrilled to witness the successful approval and market launch of Yuan Ruida, the first China-developed CAR-T product targeting CD19. This marks a significant milestone for Juventas and is a source of pride for the entire Juventas team. Guided by the firm belief in 'clinical value-oriented and patient-centered' principles, and with the care and support from all sectors, we have collectively achieved this milestone. In the multicenter registration clinical trials of Yuan Ruida, we have observed an increasing number of patients achieving sustained remission and long-term survival after receiving a single infusion of CAR-T cells, with their quality of life continuously improving and essentially returning to normalcy. This represents a major breakthrough in the field of leukemia treatment in China. Moving forward, we will continue to collaborate with all parties to enhance the accessibility of Yuan Ruida, establish a patient-focused personalized cell therapy medical and quality control system, enabling more patients to benefit from the treatment with Narligen-cel."