China NMPA approves neuroblastoma drug Qarziba

The China National Medical Products Administration (NMPA) has granted Qarziba (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above, said the drug’s developers, UK-based EUSA Pharma and China’s BeiGene (Nasdaq: BGNE), whose shares rose 1.8% to $286.64 on the news.

The Chinese approval is for the treatment of patients 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 a history of relapsed or refractory (R/R) neuroblastoma with or without residual disease.

“Dinutuximab beta represents an important biologic therapy for pediatric patients in China, having been listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA,” commented Xiaobin Wu, president, chief operating officer and general manager of China at BeiGene, adding: “For these young patients fighting neuroblastoma in China, we are proud to bring the first approved treatment.”