By Fineline Cube 
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene autoleucel injection (English trade name: HICARA), a Class 1 innovative biological product submitted by Shanghai HRAIN Biotechnology Co., Ltd., on July 30, 2025. This milestone marks the first fully independently developed CD19 CAR-T product in China for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL).
Indication and Usage
HICARA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma following two or more lines of systemic therapy. This includes diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); diffuse large B-cell lymphoma transformed from follicular lymphoma; high-grade B-cell lymphoma with MYC and BCL2 rearrangements; and high-grade B-cell lymphoma, not otherwise specified.-Fineline Info & Tech