BEIJING, Nov. 28, 2025 /PRNewswire/ — On November 28, 2025, Juventas Cell Therapy Co., Ltd. (hereinafter referred to as “Juventas”) announced that its independently developed CAR-T cell therapy product, Inaticabtagene Autoleucel (Ina-cel) (tradename: YORWIDATM), has received new drug marketing approval from the China National Medical Products Administration (NMPA). This approval is 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 approved indication in China for Ina-cel, following its initial approval in November 2023 for the treatment of adult relapsed or refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL). This milestone marks the first proprietary CD19 CAR-T product in China with full intellectual property rights to become the only CAR-T cell therapy product in the country that covers both leukemia and lymphoma, the two major hematological oncology indications.
Clinical Value Upgrade: Starting a New Chapter in Large B-Cell Lymphoma Treatment
Lymphoma is one of the most common malignant tumors of the hematological system. Large B-Cell Lymphoma (LBCL) is the most frequent type of Non-Hodgkin’s Lymphoma (NHL) in adults. Approximately 40% of patients progress or relapse after first-line treatment, and these patients face poor prognosis and significant challenges in clinical treatment. The approval of the new lymphoma indication for Ina-cel brings accessible curative hope to LBCL patients.
Ina-cel (YORWIDATM) is China’s independently developed CD19-targeted CAR-T cell therapy product. It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. As the first CD19 CAR-T cell therapy product in China with full intellectual property rights, the sequential approval of its two indications provides a new therapeutic option for more patients with hematological malignancies. This landmark achievement not only strongly validates its clinical value, further solidifies its leading position in China’s CAR-T treatment field, but also showcases China’s original innovation strength and the high-quality development standard of its cell therapy industry.
The approval of this new indication is based on the positive results of a single-arm, open-label, multi-center pivotal Phase II clinical study (NCT04586478) 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 (IHCAMS) and Ruijin Hospital, affiliated with Shanghai Jiao Tong University. It was conducted at more than ten clinical centers across the country, with key clinical study data demonstrating durable remission and long-term survival benefit for lymphoma patients treated with Ina-cel, alongside excellent safety.
Professor Dehui Zou, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS):
“Congratulations on the new drug marketing approval of Inaticabtagene Autoleucel (Ina-cel) for the treatment of relapsed or refractory Large B-Cell Lymphoma, providing a new breakthrough treatment option for patients. 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 demonstrated excellent efficacy, durable remission, and long-term survival benefit. While achieving excellent efficacy, Ina-cel also demonstrated superior safety, with no cases of ≥ Grade 3 Cytokine Release Syndrome (CRS) and only 1 patient experiencing ≥ Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). We look forward to Ina-cel being approved for marketing and further accumulating real-world evidence to promote earlier lines of treatment and exploration of combination strategies, allowing more Large B-Cell Lymphoma patients to benefit“.
Professor Weili Zhao, Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine:
“The new drug marketing approval of Inaticabtagene Autoleucel (Ina-cel) for the treatment of Large B-Cell Lymphoma is another major milestone for China’s independently developed CAR-T cell therapy products, and a typical representative of independent innovation in China’s cell drug industry. With its unique CD19 scFv structure, advanced manufacturing process technology, strict quality control system, and outstanding clinical data demonstrated in multiple clinical studies, Ina-cel will become a high-quality, effective treatment option for patients with relapsed or refractory Large B-Cell Lymphoma. We look forward to the real-world performance of Ina-cel for Large B-Cell Lymphoma, and we anticipate Ina-cel moving from China to the world, expecting more ‘China Contribution’ to cell therapy innovation”.
Professor Lugui Qiu, Clinical Chief Expert, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS):
“Inaticabtagene Autoleucel (Ina-cel) liberates patients from prolonged hospitalization. As a Chinese original CAR-T with solid efficacy and safety, the innovation of Ina-cel 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%. At 3 and 6 months post-infusion of Ina-cel, 80% and 72% of patients, respectively, continued to achieve sustained remission, and at 24 months, 64.9% of patients still achieved durable remission. This allows more patients to return to their lives and accompany their families, representing a dual breakthrough in medical technology and humanistic care—making anti-cancer treatment warmer and more dignified!”.
Professor Jianxiang Wang, Clinical Chief Expert and Director of the National Clinical Research Center for Hematologic Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS):
“Inaticabtagene Autoleucel (Ina-cel) is China’s self-developed, original CD19 CAR-T product, which has demonstrated excellent efficacy and safety in hematologic oncological diseases including adult Acute Lymphoblastic Leukemia, Large B-Cell Lymphoma, and pediatric Acute Lymphoblastic Leukemia, as well as multiple types of autoimmune diseases including Systemic Lupus Erythematosus and Hemolytic Anemia. It has accumulated treatment for over 500 patients, and the corresponding clinical study data have been continuously published in international academic journals and conferences, receiving widespread attention. After the first indication for adult Acute Lymphoblastic Leukemia was approved for marketing in November 2023, the real-world efficacy rate reached 92.8%. It has been included in domestic authoritative clinical guidelines and is gradually becoming a standard treatment option. Congratulations on the marketing approval of Ina-cel for the Large B-Cell Lymphoma indication this time, and we look forward to the subsequent marketing approvals for the pediatric Acute Lymphoblastic Leukemia and autoimmune disease indications, benefiting more patients“.
Dr. Lulu Lyu, Founder and Chief Executive Officer of Juventas:
“The new drug marketing approval of Inaticabtagene Autoleucel (Ina-cel) for the treatment of lymphoma is another major achievement for Juventas in adhering to innovation and focusing on clinical needs. Ina-cel also becomes the only marketed CAR-T product in China that simultaneously covers the dual indications of leukemia and lymphoma. Ina-cel is China’s self-developed, original CD19 CAR-T product. Next, the company will accelerate the research, development, and marketing process for Ina-cel for the treatment of pediatric Acute Lymphoblastic Leukemia and multiple types of autoimmune diseases. We will actively promote its inclusion in the China’s Innovative Drug List for Medical Insurance, continuously improve drug accessibility, and simultaneously promote the global registration of Ina-cel, allowing more patients in China and globally to benefit from China-manufactured CAR-T cell innovative drugs“.
