Benzinga | Nov 9, 2020 07:36AM EST

EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for QARZIBA (Dinutuximab Beta) in China

EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))) today announced that the Biologics License Application (BLA) for QARZIBA(r) (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (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. High-risk neuroblastoma is an aggressive neoplasm and the most common childhood solid tumour that originates outside of the brain. Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.

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"Dinutuximab beta represents an important biologic, which is already available to patients with high-risk neuroblastoma in Europe," commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "For paediatric patients fighting this disease in China, we are hopeful that dinutuximab beta will soon be available as a new treatment option. Our collaboration with EUSA and the progress thus far demonstrate our joint commitment to bringing high-quality therapies to the people who need them."

Lee Morley, Chief Executive Officer of EUSA Pharma, said, "This milestone brings us and BeiGene closer to delivering on our promise of bringing innovative cancer and rare disease therapies to patients around the world. We look forward to working with BeiGene and the NMPA to potentially make dinutuximab beta available in China."

About QARZIBA(r) (dinutuximab beta)

QARZIBA(r) is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Commission in 2017 and is indicated 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. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).