Heyuan Bio's Domestically Developed CAR-T Therapy Naje-cel Receives Second Indication Approval in China, Covering Both Leukemia and Lymphoma

On November 28, 2025, Juventas announced that its self-developed CAR-T cell therapy product, Nalkiorensai Injection, has been approved for marketing by the China National Medical Products Administration., used to treat relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy（r/r LBCL）。

This is the second approval for Juventas' CAR-T therapy, following the approval in November 2023 for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), obtained in China.Second New Drug Marketing Approval. Marks the first domestically produced CD19 CAR-T product with full independent intellectual property rights in China, becomingThe only CAR-T cell therapy product in China that currently covers two major hematological cancer 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 prevalent type of non-Hodgkin lymphoma (NHL) in adults. After first-line treatment, approximately 40% of patients experience progression or relapse, and these patients have a poor prognosis, presenting significant clinical challenges. The approval of the new drug, Naciorlen Injection, for lymphoma has brought accessible hope of a cure to patients with LBCL.

Najiolunsa Injection is a CD19-targeted CAR-T cell therapy product independently developed in China.

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 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 demonstrated that Naciorl Injection provided durable remission and long-term survival benefits for lymphoma patients, while also showing excellent safety.

As of now, five CAR-T products targeting CD19 have been approved for marketing in China, including those introduced by Fosun Kite.Axicabtagene Ciloleucel、JW Therapeutics'Relma-cel、JuventasNaciorlcel, and Hengrui Dasheng'sRelmacabtagene Autoleucel, Chongqing Precision BiotechPurilun Race。

Sina Medicine Comprehensive

Join the reader communication group:

Business Cooperation:Xiaoyu Yang 15210041717