SHANGHAI, CHINA, May 28, 2025 - JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration of China (“NMPA”) accepted the supplemental Biological License Application (“sBLA”) for its cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) as second-line treatment in relapsed or refractory large B-cell lymphoma (“r/r LBCL”). This is the fourth sBLA on Carteyva® submitted by JW Therapeutics. In January 2025, Carteyva® was granted Breakthrough Therapy Designation by NMPA.
Large B-cell lymphoma (“LBCL”) is a highly aggressive non-Hodgkin’s lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30–40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as highdose chemotherapy followed by autologous stem cell transplantation (“ASCT”) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL.
The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva® in Chinese adult patients with r/r LBCL ineligible for ASCT after failure of first-line therapy. In the study, patients with r/r LBCL who were ineligible for ASCT had failed first-line systemic therapy with CD20-targeted antibodies and anthracyclines were included. After lymphodepleting chemotherapy, patients received Carteyva® (100×106 CAR+ T cells). As of January 21, 2025, a total of 49 patients received Carteyva® infusion and had at least 3-month follow-up. Of 48 efficacy evaluable patients, Carteyva® demonstrated remarkable clinical responses and good safety. The best objective response rate (ORR) was 81.3% and the best complete response rate (CRR) was 54.2%. The incidence of severe (≥Grade 3) cytokine release syndrome (CRS) was 4.1%, and no severe neurological toxicity (NT) was observed.
References
- Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. doi:10.1056/NEJMra202761.
- Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077. doi:10.1016/S1470-2045(22)00339-4.
About JW Therapeutics
JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.
About Relmacabtagene Autoleucel Injection
Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.
Forward-Looking Statements
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