Y-mAbs Reports BLA Submission to the NMPA for Danyelza (naxitamab-gqgk) to Treat Relapsed/Refractory High-Risk Neuroblastoma

July 7, 2021 Auto Bot BLA, China, NMPA, regulatory, Y-mAbs 0

Shots:

  • SciClone has submitted the BLA for Danyelza to treat pediatric patients aged >1 yr. and adult patients with r/r high-risk neuroblastoma to NMPA in China
  • If approved, the therapy will be available in the China imminently. The therapy was approved under accelerated approval based on ORR and DoR while the continued approval for the indication may be contingent upon verification and description of clinical benefits in a confirmatory trial
  • MSK’s researchers have developed the therapy which is exclusively licensed to Y-mAbs. Following the licensing arrangement, MSK has institutional financial interests in the product

Click here to read full press release/ article | Ref: Globe Newswire | Image: Y-mAbs

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