Inaticabtagene Autoleucel (YuaneRuiDa®) Approved for Lymphoma, Marking a New Era of Dual-Indication CAR-T Therapy from China

This is the second new drug marketing approval in China for Nakiolumab Injection following its approval in November 2023 for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This marks the first CD19 CAR-T product with full independent intellectual property rights in China, becoming a...The only CAR-T cell therapy product in China that currently covers two major hematological tumor indications: leukemia and lymphoma.

Lymphoma is one of the most common malignant tumors of the hematologic system, and large B-cell lymphoma (LBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults. After first-line treatment, approximately 40% of patients experience progression or relapse. These patients have a poor prognosis, posing significant challenges in clinical treatment. The approval of the new drug, Naciorlen Injection, for lymphoma brings accessible hope of a cure to LBCL patients.

Nakio Cell Injection (Yuanruida®) is a China-developed CD19-targeted CAR-T cell therapy product, originating from the long-term technological innovation accumulation of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS). It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. As China’s first CD19 CAR-T cell therapy product with full independent intellectual property rights, the successive approvals for its two major indications—adult leukemia and lymphoma—have provided new treatment options for more patients with hematological malignancies. This milestone achievement not only strongly validates its clinical value, further solidifying its leading position in China's CAR-T therapy field, but also highlights the original innovation capabilities 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 Naciorl Injection for the treatment of r/r LBCL. The study, led jointly by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Ruijin Hospital affiliated with Shanghai Jiao Tong University, was conducted across more than ten clinical centers in China. Key clinical research data demonstrated that Naciorl Injection provided durable remission and long-term survival benefits for lymphoma patients, while also showing excellent safety.

Blood Disease Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences):

Congratulations on the approval of the new drug, Nakyrelsen Injection, for the treatment of relapsed or refractory large B-cell lymphoma, offering patients a new breakthrough therapeutic option. Once large B-cell lymphoma recurs or becomes refractory, traditional treatments have limited efficacy and prognosis is extremely poor. In pivotal registrational clinical trials, Nakyrelsen Injection demonstrated excellent efficacy, durable remission, and long-term survival benefits. Alongside its superior efficacy, Nakyrelsen Injection exhibited outstanding safety, with no cases of ≥Grade 3 cytokine release syndrome (CRS) and only one case of ≥Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS), significantly outperforming similar products abroad. We look forward to further evidence accumulation in real-world settings following the approval and market launch of Nakyrelsen Injection, promoting earlier treatment lines and exploration of combination strategies, benefiting more patients with large B-cell lymphoma.

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine:

The approval of Naciorlen Cell Injection for the treatment of large B-cell lymphoma marks another significant milestone for China-developed CAR-T cell therapy products and stands as a typical example of China's independent innovation in the cell drug industry. With its unique CD19 scFv structure, advanced manufacturing technology, rigorous quality control system, and outstanding clinical data demonstrated across multiple studies, Naciorlen Cell Injection will become a high-quality and effective treatment option for patients with relapsed or refractory large B-cell lymphoma. We look forward to the real-world performance of Naciorlen Cell Injection in treating large B-cell lymphoma, its journey from China to the global stage, and more innovative "China power" in cell therapy.

Chief Clinical Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences:

Nakio Cell Therapy Liberates Patients from Long-Term Hospitalization. As a China-developed CAR-T therapy, it has demonstrated definitive efficacy and excellent safety. The innovative combination of Nakio Cell Therapy with ASCT allows patients to achieve better treatment outcomes, with the best overall response rate (ORR) reaching 92% and the best complete remission (CR) rate at 72%. At three and six months post-infusion of Nakio Cell Therapy, 80% and 72% of patients, respectively, continued to experience sustained remission. By 24 months, 64.9% of patients still maintained durable remission. This breakthrough enables more patients to return to their normal lives and be with their families, representing a dual advancement in medical technology and humanistic care — cancer treatment can be warmer and more dignified!

Chief Clinical Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; Director of the National Clinical Research Center for Hematological Diseases:

Najiolun Injection, a China-developed CD19 CAR-T product, has demonstrated excellent efficacy and safety in treating hematological malignancies such as adult acute lymphoblastic leukemia, large B-cell lymphoma, pediatric acute lymphoblastic leukemia, as well as various autoimmune diseases including systemic lupus erythematosus and hemolytic anemia. To date, it has been used to treat over 500 patients. Relevant clinical research data have been continuously published in international academic journals and conferences, drawing widespread attention. In November 2023, after Najiolun Injection was approved for its first indication for the treatment of adult acute lymphoblastic leukemia, its real-world effectiveness rate reached an impressive 92.8%. It has been incorporated into authoritative Chinese clinical guidelines and is gradually becoming a standard treatment option. Congratulations on the approval and market launch of Najiolun Injection for the treatment of large B-cell lymphoma. We look forward to the subsequent approvals for pediatric acute lymphoblastic leukemia and autoimmune disease indications, which will benefit more patients.

CEO of Juventas:

Najiceloleucel Injection Approved for New Drug Launch in Lymphoma Treatment: Another Significant Achievement by Juventas in Upholding Independent Innovation and Focusing on Clinical Needs. Najiceloleucel Injection has also become the only CAR-T product in China to be marketed with dual indications covering both leukemia and lymphoma. As a self-developed CD19 CAR-T product in China, the company will further accelerate the research, development, and market launch of Najiceloleucel Injection for treating pediatric acute lymphoblastic leukemia and various types of autoimmune diseases. It will actively promote its inclusion in the National Medical Insurance Innovative Drug List to continuously enhance drug accessibility. Meanwhile, Juventas will advance the global registration of Najiceloleucel Injection, enabling more patients in China and worldwide to benefit from this innovative CAR-T cell therapy made in China.