By Fineline Cube 
JW Therapeutics (HKG: 2126), a clinical-stage cell therapy company co-founded in 2016 by Juno Therapeutics (a Bristol-Myers Squibb subsidiary) and WuXi AppTec (SHA: 603259), announced that a supplemental Biological License Application (sBLA) for its cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) has been accepted for review by the National Medical Products Administration (NMPA). This marks the fourth sBLA for Carteyva, targeting second-line relapsed or refractory large B-cell lymphoma (r/r LBCL), an indication awarded Breakthrough Therapy Designation by the agency in January this year.
Clinical Trial Results
The sBLA is supported by results from a pivotal Phase II study involving patients with r/r LBCL who were ineligible for autologous stem cell transplant (ASCT) and had failed first-line systemic therapy with CD20-targeted antibodies and anthracyclines. As of January 21, 2025, 49 patients received Carteyva infusion and had at least 3-month follow-up. Among 48 efficacy-evaluable patients, Carteyva demonstrated an objective response rate (ORR) of 81.3% and a complete response rate (CRR) of 54.2%. The incidence of severe (≥Grade 3) cytokine release syndrome (CRS) was 4.1%, with no severe neurological toxicity (NT) observed.
Carteyva’s Approved Indications
Carteyva, an anti-CD19 autologous CAR-T cell immunotherapy developed by JW Therapeutics, has received three indication approvals in China. These include treatment for relapsed or refractory LBCL after two or more lines of systemic therapy, follicular lymphoma (FL) refractory or relapsing within 24 months of second-line or higher systemic treatment, and recurrent or refractory mantle cell lymphoma (r/r MCL) that has undergone second-line or higher systemic treatment, including Bruton tyrosine kinase inhibitors (BTKis).-Fineline Info & Tech