JW Therapeutics announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (hereafter abbreviated as relma-cel, trade name: Carteyva(R)) for 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). This is the second approved indication for relma-cel following its initial approval and launch in September last year, and makes it the first cell immunotherapy product approved in China for the treatment of r/r FL patients. This approval is based on the 6 months clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva(R) in adult patients with relapsed or refractory B cell non-Hodgkin lymphoma in China.

The 3 months data were presented at the 63(rd) American Society of Hematology (ASH) Annual Meeting in December 2021. The cohort B results showed that Carteyva(R) demonstrated very high rates of durable disease response (overall response rate (ORR)=100%, complete response rate (CRR)=85.19% at month 3; ORR=92.58%, CRR=77.78% at month 6) and controllable CAR-T associated toxicities in patients with r/r FL. Given the currently available treatments in China, Carteyva(R) may become a treatment option with a higher benefit-risk ratio for patients with r/r FL, and has the potential to become a best-in- class CAR-T product.

As the first product of JW Therapeutics and the first CAR-T product approved as a Category 1 biologics product in China, relma-cel has been approved for two indications in China, including for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, and 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). Currently, to fully explore the clinical potential of Carteyva®, JW Therapeutics is conducting or planning to conduct more clinical studies on hematologic malignancies and autoimmune diseases, including third-line mantle cell lymphoma (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).