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On March 24, the CDE official website recently showed that the new indication of WuXi Junuo CAR-T therapy Ruikiorenzae injection is to be included in the priority review
.
The newly added indication for this application is: adult relapsed or refractory follicular lymphoma after second-line or above systemic therapy, including follicular lymphoma with histological grades 1, 2, and 3a
It is reported that the previously approved indications are: adult patients with relapsed or refractory large B-cell lymphoma after second-line or above systemic therapy, including diffuse large B-cell lymphoma unspecified, follicular lymphoma transformed Diffuse large B-cell lymphoma, grade 3b follicular lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements (double hit/triple hit fight lymphoma)
.
Ruiji Orenxai Injection (formerly known as Ruijilunxi Injection) is an anti-CD19 CAR-T product developed by WuXi Junuo, and it is also the core candidate product of WuXi Junuo
.
CD19 is a specific antigen expressed on the surface of B cells