BeiGene's Pediatric Tumor Drug Scores Conditional Approval In China

The China National Medical Products Administration (NMPA) granted conditional approval for BeiGene Ltd (NASDAQ: BGNE) - EUSA Pharma's (UK) Qarziba (dinutuximab beta) in high-risk neuroblastoma patients.
The approval comes for 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.
Related content: Benzinga's Full FDA Calendar.
Dinutuximab beta is targeted immunotherapy approved by the European Medicines Agency.
The approval of dinutuximab beta in China is based on SIOPEN trial data in 514 patients.
The five-year event-free survival rate in the dinutuximab arm was 57% vs. 42% of historical controls in the trial.
The five-year overall survival (OS) rate was 64% vs. 50%.
Price Action: BGNE shares are up 0.34% at $81.52 during the market session on the last check Tuesday.