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On November 28, 2025, Juventas announced that its self-developed CAR-T cell therapy productNaciorl Injection (Brand Name: Yuanruida®)New Drug Approved by the China National Medical Products Administration for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma (r/r LBCL) After Two or More Lines of Systemic Therapy.This is the second approval of Nakiolumab Injection in November 2023 for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL),The Second New Drug Marketing Approval Obtained in China。Marks the first domestically produced CD19 CAR-T product with full independent intellectual property rights in China, becoming the only CAR-T cell therapy product in China that currently covers two major hematological cancer indications: leukemia and lymphoma.Clinical Value Upgrade: A New Chapter in the Treatment of Large B-Cell LymphomaLymphoma is one of the most common malignant tumors of the hematologic system, and large B-cell lymphoma (LBCL) is the most common type of adult non-Hodgkin lymphoma (NHL). After first-line treatment, approximately 40% of patients experience progression or relapse. These patients have a poor prognosis, posing significant clinical challenges. The approval and market launch of the new drug Naciorlen Injection for lymphoma brings accessible hope of a cure to patients with LBCL.Naciorl Injection (Yuanruida®) is a CD19-targeted CAR-T cell therapy product independently developed in China., originating from the long-term technological innovation accumulation of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS), features a globally unique CD19 scFv (HI19a) structure and internationally leading production and manufacturing processes. As China's first fully self-owned intellectual property CD19 CAR-T cell therapy product, the successive approvals of its two major indications—adult leukemia and lymphoma—have provided more patients with hematological malignancies new treatment options. This milestone achievement not only strongly validates its clinical value but also further solidifies its leading position in China’s CAR-T therapy field, showcasing the original innovative strength and high-quality industrial development level of China’s cell therapy sector.This new indication approval is based on the positive results of a single-arm, open-label, multi-center pivotal Phase II clinical study (NCT04586478) of Nangeneolimab Injection for the treatment of r/r LBCL. The study was jointly led by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Ruijin Hospital, Shanghai Jiao Tong University, and conducted across more than ten clinical centers in China.Key clinical research data demonstrate that Nacioran Injection provides durable remission and long-term survival benefits for lymphoma patients, while also exhibiting excellent safety.The pricing of Naciorlens Injection is 9.99 million yuan per vial, making it the lowest-priced CAR-T drug in China. During the National Medical Insurance Catalogue negotiations in early November 2025, Naciorlens Injection from Juventas, as a representative of domestically produced CAR-T therapy in China,Completed price negotiation for the first time through the newly established "Commercial Insurance Innovative Drug List", breaking the long-standing deadlock where high-priced innovative drugs could not enter the national medical insurance system for many years.Professor Dehui Zou from the Blood Disease Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) stated:"Congratulations on the approval of the new drug, Naciorl Injection, for the treatment of relapsed or refractory large B-cell lymphoma, offering patients a new breakthrough therapeutic option. Once patients with large B-cell lymphoma experience relapse or become refractory, traditional treatments have limited efficacy and the prognosis is extremely poor.In the pivotal registration clinical study, the injection of Najiolumab demonstrated excellent efficacy, durable remission, and long-term survival benefits.While demonstrating excellent efficacy, the safety profile of Naciorl Injection is outstanding, with no cases of ≥Grade 3 cytokine release syndrome (CRS) reported, and only one patient experiencing ≥Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS)., significantly superior to similar products abroadWe look forward to further accumulating evidence in the real world after the approval and market launch of Naciorlens Injection, promoting the advancement of treatment lines and the exploration of combination strategies, so that more patients with large B-cell lymphoma can benefit."Dr. Lulu Lv, CEO of Juventas, stated: "The approval and market launch of the new drug, Naciorlen Injection, for the treatment of lymphoma marks another significant achievement for Juventas in its commitment to independent innovation and focus on clinical needs."Nirali-cel Injection Also Becomes the Only CAR-T Product in China That Is Marketed and Covers Dual Indications of Leukemia and Lymphoma.Najio Lunce Injection is a self-developed CD19 CAR-T product in China. Moving forward, the company will also accelerate the research, development, and market launch of Najio Lunce Injection for treating pediatric acute lymphoblastic leukemia and various types of autoimmune diseases. The company will actively promote its inclusion in the National Medical Insurance Innovative Drug List to continuously enhance drug accessibility. At the same time, Juventas will advance the global registration of Najio Lunce Injection, allowing more patients in China and around the world to benefit from this innovative CAR-T cell therapy made in China.Source: Juventas
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