News from the Beijing News (Reporter Zhang Xiulan) On March 24, the Center for Drug Evaluation of the State Food and Drug Administration (hereinafter referred to as CDE) announced that Ruiki Aurenzai Injection (adult relapsed or refractory injection) Follicular lymphoma) and sucrose iron oxyhydroxide chewable tablets were included in the priority review category, and the publicity period is until March 31.
Rikiorenza injection is a product of WuXi Junuo, which was approved by the State Food and Drug Administration in September 2021 for the treatment of second-line or Relapsed or refractory large B-cell lymphoma (r/r LBCL) in adult patients following systemic therapy above. The drug is WuXi Junuo’s first innovative product approved for marketing, and also the second approved CAR-T product in China. The priority review of Ruikiorenza injection is its new indication, that is, adult relapsed or refractory follicular lymphoma after second-line or above systemic therapy, including histological grades 1, 2, Grade 3a follicular lymphoma.
Another sucrose ferric oxyhydroxide chewable tablet to be included in priority review is a product of Tigermed. The proposed indication is hyperphosphatemia and is used to receive blood Treatment of hyperphosphatemia in adult chronic kidney disease (CKD) patients on dialysis (HD) or peritoneal dialysis (PD); for CKD stages 4-5 (defined as glomerular filtration rate <30>< div>
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