JW Therapeutics (HKG: 2126), a clinical-stage cell therapy company co-founded in 2016 by Juno Therapeutics (a Bristol-Myers Squibb subsidiary) and WuXi AppTec (SHA: 603259, HKG: 2359), announced that the New Drug Application (NDA) for its CD19-targeted autologous CAR-T cell therapy Carteyva (relmacabtagene autoleucel injection) has been approved by the Health Bureau of Macau. This marks the product’s first overseas market authorization following its earlier approval in mainland China.
Approved Indications
The approval covers three indications, including relapsed/refractory large B-cell lymphoma (r/r LBCL) in adults after ≥2 lines of systemic therapy, refractory or relapsed (within 24 months) follicular lymphoma (r/r FL) in adults after ≥2 lines of systemic therapy, and relapsed/refractory mantle cell lymphoma (r/r MCL) in adults after ≥2 lines of systemic therapy, including Bruton’s tyrosine kinase inhibitor (BTKi) therapy.-Fineline Info & Tech
