China's First Dual-Indication CAR-T Therapy Receives NMPA Approval for Large B-Cell Lymphoma
核心洞察
Juventas Cell Therapy's Inaticabtagene Autoleucel (YORWIDA (搜索)) received NMPA approval for treating relapsed or refractory Large B-Cell Lymphoma (搜索) after two or more lines of systemic therapy.
The approval makes Ina-cel (搜索) the first proprietary CD19 (搜索) CAR-T product in China with full intellectual property rights to cover both leukemia and lymphoma indications.
The approval was based on positive results from a multi-center Phase II clinical study demonstrating durable remission and long-term survival benefits with excellent safety profile.
Juventas Cell Therapy Co., Ltd. (搜索) announced on November 28, 2025, that its independently developed CAR-T cell therapy product, Inaticabtagene Autoleucel (Ina-cel (搜索), tradename: YORWIDA (搜索)), has received new drug marketing approval from the China National Medical Products Administration (搜索) (NMPA) for treating relapsed or refractory Large B-Cell Lymphoma (搜索) (r/r LBCL) after two or more lines of systemic therapy. This marks the second approved indication for Ina-cel in China, following its initial approval in November 2023 for adult relapsed or refractory B-cell Acute Lymphoblastic Leukemia (搜索).
First Dual-Indication CAR-T Product in China
The approval establishes Ina-cel (搜索) as the first proprietary CD19 (搜索) CAR-T product in China with full intellectual property rights to become the only CAR-T cell therapy product in the country covering both leukemia and lymphoma, the two major hematological oncology indications. The therapy features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes.
Addressing Critical Medical Need
Large B-Cell Lymphoma (搜索) represents the most frequent type of Non-Hodgkin's Lymphoma (搜索) in adults, with approximately 40% of patients progressing or relapsing after first-line treatment. These patients face poor prognosis and significant challenges in clinical treatment, making the approval of Ina-cel (搜索)'s new lymphoma indication particularly significant for providing accessible curative hope to LBCL patients.
Clinical Trial Results Support Approval
The approval is based on positive results from a single-arm, open-label, multi-center pivotal Phase II clinical study (NCT04586478) for treating r/r LBCL. The study was jointly led by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (搜索) (IHCAMS) and Ruijin Hospital, affiliated with Shanghai Jiao Tong University, and conducted at more than ten clinical centers across the country.
Key clinical study data demonstrated durable remission and long-term survival benefit for lymphoma patients treated with Ina-cel (搜索), alongside excellent safety. Notably, the study showed no cases of Grade 3 or higher Cytokine Release Syndrome (搜索) (CRS) and only one patient experiencing Grade 3 or higher Immune Effector Cell-Associated Neurotoxicity Syndrome (搜索) (ICANS).
Expert Perspectives on Clinical Impact
Professor Dehui Zou from IHCAMS emphasized the breakthrough nature of the treatment: "Once LBCL patients relapse or become refractory, conventional treatments have limited efficacy and the prognosis is extremely poor. In the pivotal registration clinical study, Ina-cel (搜索) demonstrated excellent efficacy, durable remission, and long-term survival benefit."
Professor Lugui Qiu, Clinical Chief Expert at IHCAMS, highlighted the therapy's practical benefits: "Inaticabtagene Autoleucel liberates patients from prolonged hospitalization. The innovation of Ina-cel (搜索) combined with Autologous Stem Cell Transplantation (ASCT) can allow patients to achieve better efficacy, with the best Overall Response Rate (ORR) up to 92% and the best Complete Response (CR) rate up to 72%."
The clinical data showed sustained remission rates of 80% and 72% at 3 and 6 months post-infusion, respectively, with 64.9% of patients achieving durable remission at 24 months.
Real-World Performance and Future Expansion
Professor Jianxiang Wang, Director of the National Clinical Research Center for Hematologic Diseases at IHCAMS, noted that Ina-cel (搜索) has accumulated treatment for over 500 patients across multiple conditions, including adult Acute Lymphoblastic Leukemia (搜索), Large B-Cell Lymphoma (搜索), pediatric Acute Lymphoblastic Leukemia, and autoimmune diseases. After the first indication approval in November 2023, the real-world efficacy rate reached 92.8%.
Company's Strategic Vision
Dr. Lulu Lyu, Founder and Chief Executive Officer of Juventas, outlined the company's future plans: "Next, the company will accelerate the research, development, and marketing process for Ina-cel (搜索) for the treatment of pediatric Acute Lymphoblastic Leukemia (搜索) and multiple types of autoimmune diseases. We will actively promote its inclusion in China's Innovative Drug List for Medical Insurance, continuously improve drug accessibility, and simultaneously promote the global registration of Ina-cel."
The approval represents a significant milestone for China's cell therapy industry, showcasing the country's original innovation strength and high-quality development standards in the field.