Benzinga | Aug 17, 2021 10:09AM EDT

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.