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Article source: Medical Rubik's Cube Info
Author: Sunshine
On August 16, WuXi Giant Nuo issued an announcement stating that its targeting CD19 auto-chimeric antigen receptor (CAR) T cell therapy relma-cel injection was used as the third line of relapsed or refractory B-cell lymphoma The new drug marketing application of the therapy is still under review and approval
According to the official website of the Food and Drug Administration, Ruijilunsai entered the administrative approval stage on August 1
According to the PharmaGo database of Medicine Rubik's Cube, the review timeline of Ruijilunsai was changed on August 16, and the acceptance number (CXSS2000036) entered the review sequence of therapeutic biological products-supplementary information-comprehensive review technology
Timeline of part of the review of Ruijilun Competition (Source: PharmaGo)
WuXi Junuo stated that it will actively communicate with the Drug Evaluation Center of the National Medical Products Administration and other competent government departments and pay close attention to the progress of the approval
Ruijilunzai is a CAR-T cell therapy targeting CD19 developed by Juno, an American cell therapy company