Heyuan Biosciences' Najiorensai Injection Receives IND Approval for Autoimmune Hemolytic Anemia (AIHA)

Apr 11, 2025 10:28 CST Updated 10:28

Juventas

Innovative Cell Therapy Drug Developer

Preface

Preface

On April 10, 2025, information disclosed on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed:Daotong Family Enterprise——JuventasThe New Drug Clinical Trial Application (IND) for the new indication in the field of autoimmune diseases for Naciorl Injection (trade name: Yuanruida®) has received tacit approval.(Acceptance No.: CXSL2500030), for the treatment of autoimmune hemolytic anemia (AIHA) that has failed at least three lines of therapy. This is the world's first CAR-T product to receive clinical trial authorization for the treatment of AIHA.Following its approval in October 2024 for the treatment of refractory systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP), the second clinical trial approval for Najiolun Race Injection in the field of autoimmune disease treatment has been granted., is another milestone breakthrough in the field of autoimmune diseases.

Autoimmune Hemolytic Anemia (AIHA) is a group of hemolytic anemias caused by abnormal immune function, leading to hyperactive B cell function that produces antibodies against the body's own red blood cells. The red blood cells adsorb autoantibodies and/or complements, resulting in accelerated destruction and shortened lifespan of red blood cells. This disease not only affects the patient's physical health but may also lead to a series of complications, which can be life-threatening in severe cases.

At the 66th American Society of Hematology (ASH) Annual Meeting in 2024, a research study by Professor Shi Jun's team from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS), was presented orally. The study demonstrated that 11 patients with refractory AIHA who were unresponsive to multiple drug treatments achieved complete remission after receiving CAR-T cell therapy. The CAR-T cell-related adverse reactions were mild, and the patients showed good tolerance. Currently, all patients remain in treatment-free remission.

Juventas' Najiolumab Injection (brand name: Yuanruida®) is China’s first fully self-owned intellectual property CD19 CAR-T cell therapy product. It has been developed for multiple indications, including adult relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, pediatric relapsed or refractory B-cell acute lymphoblastic leukemia, and various types of autoimmune diseases. Its new drug application for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia was officially approved for marketing by the National Medical Products Administration in November 2023.

Professor Shi Jun

Professor Shi Jun, Deputy Director of the Institute and Vice President of the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), and Director of the Red Blood Cell Disease Diagnosis and Treatment Center:

Autoimmune Hemolytic Anemia (AIHA) remains a challenging disease to cure, with 50% of patients experiencing refractory/relapsed conditions. Currently, there are no clearly indicated therapeutic drugs or effective salvage treatments available, leading to a treatment dilemma. We are very pleased to see the approval of the clinical trial for the new drug, Najiolun Sai, for the treatment of autoimmune hemolytic anemia. This indicates that the product has the potential to offer a new treatment option for many patients.

Professor Wang Jianxiang

Professor Wang Jianxiang, Chief Clinical Expert of the Blood Diseases Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology of the Chinese Academy of Medical Sciences) and Director of the National Clinical Research Center for Hematological Diseases:

Sincerely congratulate the approval of the new drug clinical trial application for China's self-developed CD19 CAR-T drug, Naciorl Injection (Yuanruida®), for the treatment of autoimmune hemolytic anemia (AIHA)! Naciorl Injection has already demonstrated breakthrough efficacy in the treatment of hematological diseases such as leukemia and lymphoma. The approval of this new drug clinical trial for the autoimmune hemolytic anemia indication marks another significant step forward for this drug in the treatment of autoimmune diseases. We look forward to Naciorl Injection making positive progress in the exploration of more indications, benefiting more patients, and promoting the role of CAR-T therapy in a broader range of disease areas.

Dr. Lü Lulu

CEO of Juventas, Dr. Lulu Lv:

Juventas' Naciorlone Injection (brand name: Yuanruida®) expands into new indications in the field of autoimmune diseases, once again demonstrating the broad applicability of CAR-T cell therapy, represented by Naciorlone Injection, across multiple disease areas. The product has shown significant efficacy and good safety in clinical practices for indications such as leukemia, lymphoma, and autoimmune diseases, exhibiting excellent therapeutic potential and clinical value. The team will continue to collaborate with all parties to ensure the smooth progress of registration clinical trials. We will also steadily advance the development and clinical trials of multiple indications and subsequent products, bringing more Chinese innovative drugs with higher safety, better efficacy, and greater accessibility to patients.

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