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China's NMPA Clears IND for JW Therapeutics' Multiple Myeloma CAR T-Cell Therapy

NEW YORK – JW Therapeutics said today that China's National Medical Products Administration has cleared the firm's investigational new drug application to evaluate the CAR T-cell therapy JWCAR129 for patients with relapsed or refractory multiple myeloma.

Specifically, Shanghai-based JW has been given the go ahead to evaluate its autologous therapy, which targets the B-cell maturation antigen, or BCMA, on the surface of multiple myeloma cells, in a China-based clinical trial. The therapy involves harvesting patients' immune cells, engineering them to express anti-BCMA chimeric antigen receptors, then reinfusing them as treatment after patients have received lymphodepleting chemotherapy.

JW, which launched in 2016 as a joint venture of Bristol Myers Squibb subsidiary Juno Therapeutics and Shanghai-based pharmaceutical firm WuXi AppTec, designed JWCAR129 based on the same CAR construct as orvacabtagene autoleucel, a product originally developed by Juno.

Earlier this month, the NMPA approved another of JW's autologous CAR T-cell therapies, relmacabtagene autoleucel, for patients with relapsed or refractory large B-cell lymphoma who have received at least two prior systemic therapies. Beyond B-cell lymphoma, the firm is now evaluating the treatment for follicular lymphoma, mantle cell lymphoma, acute lymphoblastic leukemia, and chronic lymphocytic leukemia.