Heyuan Bio's CD19 CAR-T Therapy for Autoimmune Disease Published Again in The New England Journal of Medicine
Juventas
Innovative Cell Therapy Drug Developer
January 19, 2026
eMedClub News
The New England Journal of Medicine, recently published（The New England Journal of Medicine, NEJM）Heavyweight Publication: Chinese Academy of Medical Sciences Blood Diseases Hospital(Institute of Hematology, Chinese Academy of Medical Sciences)Led by Professor Shi Jun's TeamCD19 CAR-T Cell Therapy for Autoimmune Hemolytic Anemia（AIHA）Clinical Research Paper.
The study utilized Juventas' self-developed Nalkaroleucel Injection.(Product Name: Yuan Ruida®）, for the first time globally confirmedBreakthrough Efficacy of CD19 CAR-T Therapy in the AIHA FieldThis is the second time that the clinical results of Naciorlone Injection for the treatment of autoimmune diseases have been published in the globally prestigious New England Journal of Medicine.
Autoimmune Hemolytic Anemia（AIHA）It is a group of hemolytic anemia caused by abnormal immune function leading to hyperfunction of B lymphocytes producing antibodies against their own red blood cells, with red blood cells adsorbing autoantibodies and/or complements, resulting in accelerated destruction of red blood cells and affecting the patient's lifespan. If the patient simultaneously has ≥2 types of immune-mediated cytopenia, it is called Evans syndrome.
The research results published this time showed that 11 patients with AIHA who had undergone at least three lines of treatment with poor efficacy achieved complete response after receiving CAR-T therapy. The median time to complete response was only 45 days. The patients' hemoglobin levels significantly increased, markers of hemolysis returned to normal, and they achieved long-term drug-free remission. This outcome not only verified the excellent clinical value of the injection (Nacjeucel) but also advanced the understanding of AIHA treatment mechanisms.
As the world's first CAR-T product to receive clinical trial approval for the treatment of AIHA, the injection of Naciorlase has successively demonstrated breakthrough therapeutic effects in multiple refractory indications within the fields of hematological tumors and autoimmune diseases. The clinical data published this time in NEJM further demonstrates Juventas' capability to expand its CAR-T technology platform across multiple disease areas.
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