JW (Cayman) Therapeutics (HKG:2126) has submitted Phase 1 clinical data for its CAR-T therapy Relmacabtagene autoleucel (Relma-cel) in adult patients with active systemic lupus erythematosus to China's National Medical Products Administration, according to a Tuesday bourse filing.
Shares of the firm gained nearly 1% in Wednesday morning trade.
The submission includes data from a single-arm, multicenter, dose-finding study involving 12 Chinese patients with moderately to severely active SLE, the filing said.
All participants achieved SRI-4 remission at six months, while 50% reached lupus low disease activity state, and all became drug-free, it added.
JW Therapeutics said the data support advancement toward a Phase 2 pivotal trial and potential biologics license application in China.