Heyuan Biosciences Announces NEJM Publication of Clinical Data for Naqi O仑赛 Injection (Yuanruida®) in Autoimmune Hemolytic Anemia

Jan 16, 2026 17:30 CST Updated 17:30

Juventas

Innovative Cell Therapy Drug Developer

Newly Published "The New England Journal of Medicine》（The New England Journal of Medicine, NEJM)重磅发表了中国医学科学院血液病医院（中国医学科学院血液学研究所）施均教授团队领衔的CD19 CAR-TCell Therapy for Autoimmune Hemolytic Anemia (AIHA`) Clinical Research Paper.`In this study, Juventas' self-developed Nalkylolone Injection (trade name: Yuan Ruida) was applied.^®），Demonstrated for the first time globallyCD19 CAR-TTherapy inAIHABreakthrough efficacy in the field, benefiting a wide range of difficult-to-treat/RelapseAIHABrings New Hope for Patients. This is the second time that the clinical results of Naciorlen Injection for the treatment of autoimmune diseases have been published in the globally prestigious New England Journal of Medicine. Juventas, as a leader in China's cell therapy field,CAR-TContinuous innovation in technology platforms and disease treatment areas demonstrates the international competitiveness of China's original innovative drugs.

Autoimmune Hemolytic Anemia (autoimmune hemolytic anemia，AIHA) is due to abnormal immune functionBHyperactive lymphocytes produce antibodies against their own red blood cells, and red blood cells adsorb autoantibodies./Or complement, leading to accelerated destruction of red blood cells and affecting the patient's lifespan—a group of hemolytic anemias. If the patient simultaneously has ≥2A type of immune-mediated cytopenia is termedEvansSyndrome.

The research results published this time show,11ExampleAIHAThe patient had received at least three lines of therapy with poor efficacy and was subsequently treated withCAR-TAfter treatment, all patients achieved complete response, with a median time to complete response of only45Days. The patient's hemoglobin level significantly increased, markers of hemolysis returned to normal, and long-term drug-free remission was achieved. This outcome not only validates the outstanding clinical value of the injection Naciorluzumab but also advancesAIHACognitive Breakthrough in Treatment Mechanisms.

As the world's first clinically trial-approved treatmentAIHATheCAR-TProduct: Naciorl Injection (Yuanruida)^®) has successively demonstrated breakthrough therapeutic effects in multiple refractory indications within the fields of hematological tumors and autoimmune diseases. The listing approval for Naciorlen Injection was granted by the National Medical Products Administration (NMPA) for the treatment of relapsed/RefractoryBAcute Lymphoblastic Leukemia, LargeBHematological tumors such as lymphocytic lymphoma have become the only domestically-listed product in China that simultaneously covers the two major disease areas of leukemia and lymphoma.CAR-TProduct. Meanwhile, it has also been approved in the field of autoimmune diseases.3Clinical Trial Registration ItemINDPermission.. this timeNEJMPublished clinical data further demonstrates Juventas'CAR-TThe multi-disease field expansion capability of the technology platform.

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Dr. Shi JunGrant

Chief Physician of the Hematology Hospital, Chinese Academy of Medical Sciences:

Patients with autoimmune hemolytic anemia (AIHA) face a high risk of relapse, and those with multiple relapses lack effective treatment options. Our team has pioneered the exploration of the application potential and mechanism of CD19 CAR-T in this disease. The excellent data achieved by the innovative CAR-T therapy in treating autoimmune hemolytic anemia is encouraging. AIHA patients receiving injections of Naciorlen showed durable remission and manageable safety. We hope this innovative therapy can benefit more patients.

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Dr. Lü Lulu

CEO of Juventas:

Congratulations to Professor Shi Jun and the clinical research team. This is a groundbreaking exploration in the treatment pathway for autoimmune hemolytic anemia globally, and another significant milestone for China's self-developed CAR-T product, Naciorlen Injection. Immunocyte therapies represented by CAR-T are continuously demonstrating remarkably significant therapeutic effects across multiple disease fields such as cancer and autoimmune diseases, offering breakthrough treatment options for patients suffering from these conditions. Juventas will continue to uphold innovation and work diligently with clinical researchers to accelerate the clinical research process, enabling more patients worldwide to benefit from innovative CAR-T therapies.

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About Juventas

Juventas, founded in June 2018, has grown into a leading innovator in China's cell therapy industry, striving to become a globally leading biopharmaceutical company driven by next-generation cell and gene technologies.

The Company's First Core Product: Yuan Ruida^®(Najiolun Injection, CNCT19) was officially approved for marketing by the National Medical Products Administration in November 2023. This product is the first CAR-T drug in China's leukemia treatment field and also the first fully self-innovated CD19 CAR-T drug in China. The company has deeply cooperated with top national institutes to build an international new drug research and development system centered on technology platforms such as the CAR technology platform and gene editing technology platform, with more than 10 pipeline products under research covering diseases such as hematological tumors, solid tumors, and autoimmune diseases. Juventas^®(Inaticabtagene Autoleucel Injection, CNCT19) is a CAR-T cell therapy product independently developed by Juventas, targeting CD19. It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. The product has 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 (r/r B-ALL), relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent r/r B-cell acute lymphoblastic leukemia. It has also been granted the "Breakthrough Therapy Designation" by the Center for Drug Evaluation of the NMPA and Orphan Drug Designation (ODD) by the U.S. FDA. In December 2022, the NMPA officially accepted the New Drug Application (NDA) for Inaticabtagene Autoleucel Injection for the treatment of adult r/r B-ALL and included it in the priority review process. In March 2023, the IND application for Inaticabtagene Autoleucel Injection to treat adult r/r B-ALL was approved by the U.S. FDA. In November 2023, Juventas...^®(Juventas' Naciorl Injection) Officially Approved for Marketing by China's National Medical Products Administration (NMPA).

Guided by clinical needs, the company is committed to creating safe, efficient, and accessible immune cell therapy products for patients through a strict production and quality system for cell therapy products. Juventas boasts world-class R&D technology platforms, process development platforms, quality control systems, and commercial-scale production bases. In June 2021, it obtained the first-ever "Drug Production License" for cell-based drugs in Tianjin, China. The company holds multiple invention patents and has been selected for the National Key Research and Development Program of the Ministry of Science and Technology of China, specifically as part of the “Technology Supporting the Economy 2020 Key Special Project.” Additionally, it has received titles such as "National Intellectual Property Advantage Enterprise" and "Tianjin City's Specialized, Fine, Unique, and Innovative SME Certification."

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