BLINCYTO approved in China for leukaemia treatment

pharmafile | May 4, 2022 | News story | Research and Development  

The China National Medical Products Administration (NMPA) has granted conditional approval of BLINCYTO (blinatumomab), as an injection for the treatment of paediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

The NMPA granted conditional approval for adult patients in this indication in December 2020.

The treatment is developed by Amgen and licensed to BeiGene in China under a strategic collaboration, which commenced in 2020. This is the second approval for BLINCYTO in China. The paediatric Supplemental Biologic License Application (sBLA) was submitted by BeiGene.

ALL is a rapidly progressing cancer of the blood and bone marrow, which occurs in both adults and children. ALL accounts for approximately 20% of all adult leukaemia, and in China, there were an estimated 82,607 new cases of leukaemia in 2018. In children, the relapse rate of ALL is nearly 10%, while in adults the relapse rate is closer to 50%.

“This approval of BLINCYTO provides us with an opportunity to offer pediatric patients in China with relapsed or refractory B-cell precursor ALL the first approved biospecific immunotherapy treatment option for their disease,” commented Xiaobin Wu, PhD, President, CCO, and General Manager of China, at BeiGene. “We are proud to be able to offer BLINCYTO to help these young patients as they fight this disease. Our commercial organisation of more than 3,100 people in China is excited to add this BLINCYTO indication to our portfolio, which includes 16 approved cancer treatments.”

Lina Adams

Related Content

No items found

Latest content