9 November 2020 - EUSA Pharma and BeiGene today announced that the biologics license application for Qarziba (dinutuximab beta) was accepted by the China National Medical Products Administration and granted priority review.
Dinutuximab beta is a targeted immunotherapy approved by the EMA for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma with or without residual disease.
Dinutuximab beta is listed in the first batch of new drugs in urgent clinical need marketed overseas by the National Medical Products Administration.