JW Therapeutics announced that the National Medical Products Administration (NMPA) of China accepted the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL). This is the third marketing application on Carteyva®? submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of patients r/r MCL.

Carteyva was granted, by NMPA, Breakthrough Therapy Designation in March 2022, as well as Priority Review in Dec. 2023. MCL is a rare and heterogeneous B cell non-Hodgkin lymphoma which is currently incurable with existing therapies.

MCL, associated with a poor prognosis, mainly occurs in elderly men who were not diagnosed until advanced stage. Significant progress has been made in the last decade as the treatment paradigm has shifted from traditional chemoimmunotherapy toward targeted therapies such as bruton tyrosine kinase inhibitors (BTKi). Despite the use of BTKi in r/r MCL has improved their survival outcomes, many patients will ultimately relapse with shortened remission durations (6 to 10 months).

Notwithstanding the above, there are still unmet medical needs for a safe, effective novel approach to overcome the limitations of current treatments of r/r MCL. The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva®? in adult participants with r/r MCL in China.

In the study, participants with r/r M CL who had been treated with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis were included. After being treated with lymphodepleting chemotherapy, participants received relma-cel (100x106 CAR+ T cells). As of Oct.

25, 2023, a total of 59 participants received relma-cel infusion. Of 56 efficacy evaluable participants, relma-cel demonstrated remarkable clinical responses achieving high rates of objective response rate (ORR) and complete response rate (CRR) (3 months best ORR 81.36%, 3 months best CRR 66.10%) and the incidence of severe (grade 3) neurotoxicity (NT) was 6.8%.