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Chinese Regulators Clear JW Therapeutics' Carteyva IND for Pediatric ALL

NEW YORK – JW Therapeutics said on Wednesday that China's National Medical Products Administration (NMPA) has cleared an investigational new drug application for the firm's autologous CAR T-cell therapy Carteyva (relmacabtagene autoleucel) allowing for the start of a clinical trial involving pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

Shanghai-based JW will conduct the Phase I study in China and determine the CD19-directed treatment's safety, efficacy, and pharmacokinetic profile as well the recommended Phase II dose.

Carteyva is currently the only CAR T-cell therapy available in China. In September 2021, the NMPA approved Carteyva as a third-line treatment for adult patients with relapsed or refractory large B-cell lymphoma. Recently, the firm announced plans to seek approval for the treatment in the earlier, second-line setting as well. In pursuit of that indication, JW is conducting a Phase III trial comparing Carteyva to standard second-line therapy.

Though JW independently developed Carteyva, it used the process platform developed by Bristol Myers Squibb subsidiary Juno Therapeutics. JW launched in 2016 as a joint venture of Juno and the Shanghai-based firm WuXi AppTec.