On November 28, 2025, Inaticabtagene Autoleucel (Yorwida), an independently developed CAR-T cell therapy, received approval from China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more prior systemic therapies. This marks the product’s second marketing authorization in China, following Yorwida’s approval in November 2023 for adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
With this milestone, China’s first fully homegrown CD19 CAR-T therapy has become the only CAR-T product in China covering both leukemia and lymphoma indications, ushering in a new era of dual-indication CAR-T therapies.
Advancing Clinical Value in LBCL
Large B-cell lymphoma is the most common subtype of adult non-Hodgkin lymphoma. Despite frontline therapy, around 40% of patients experience relapse or disease progression, facing poor outcomes and limited treatment options. The new approval of Naxicorunleucel offers a highly effective and accessible treatment for these patients in China.
Developed from decades of innovation at the Institute of Hematology, Chinese Academy of Medical Sciences, the product features a globally unique CD19 scFv (HI19a) structure and an internationally advanced manufacturing platform. With approvals now covering both adult leukemia and lymphoma, the therapy expands treatment choices for blood cancer patients and further demonstrates China’s growing capabilities in original cell therapy innovation.
The new LBCL indication was supported by a multicenter, open-label, single-arm Phase II pivotal study (NCT04586478), jointly led by the Institute of Hematology, Chinese Academy of Medical Sciences, and Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The study showed durable responses, long-term survival benefits, and excellent safety outcomes.
Expert Opinions
Prof. Dehui Zou
Institute of Hematology, Chinese Academy of Medical Sciences
“Congratulations on the approval of Inaticabtagene Autoleucelfor r/r LBCL, which brings an important breakthrough for patients. Once LBCL relapses or becomes refractory, conventional options deliver poor outcomes. In the pivotal trial, this therapy demonstrated outstanding efficacy, durable responses, and long-term survival benefits. Importantly, no cases of ≥Grade 3 CRS and only one case of ≥Grade 3 ICANS were observed—significantly better than similar international products. We look forward to seeing further real-world evidence and earlier-line use that can help more patients.”
Prof. Weili Zhao
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
“This approval marks another major milestone for China’s homegrown CAR-T therapies. With its unique CD19 scFv, advanced manufacturing, stringent quality system, and excellent clinical data, Naxicorunleucel is set to become a high-quality treatment choice for r/r LBCL. We expect strong real-world performance and hope to see China’s CAR-T innovations reach global patients.”
Prof. Lugui Qiu
Institute of Hematology, Chinese Academy of Medical Sciences
“Inaticabtagene Autoleucel allows patients to avoid prolonged hospitalization. Its strong efficacy and safety—especially in combination with autologous stem cell transplantation—help patients achieve deeper and more durable responses. Best ORR reached 92% and CR 72%, with 80% and 72% of patients maintaining response at 3 and 6 months, respectively. Even at 24 months, 64.9% showed sustained remission. This represents not only progress in medical technology but also improvement in quality of life and humanistic care.”
Prof. Jianxiang Wang
Institute of Hematology, Chinese Academy of Medical Sciences
“Inaticabtagene Autoleucel has shown excellent results across multiple diseases—including adult ALL, LBCL, pediatric ALL, and autoimmune disorders such as lupus and hemolytic anemia. Over 500 patients have been treated to date, with data continuously presented at international conferences. Since its first approval in 2023, real-world response rates for adult ALL reached 92.8%, and it has been included in China’s national treatment guidelines. We look forward to future approvals for pediatric ALL and autoimmune diseases, bringing hope to more patients.”
