BeiGene's Bispecific Antibody Therapy Approved in China to Treat Certain Childhood Leukemia

A few days ago, BeiGene announced that the National Medical Products Administration (NMPA) of China has approved Belito (Belintoumumab for injection, English trade name Blincyto) for the treatment of children with relapsed or refractory (R/R) CD19-positive precursor B-cell acute lymphoblastic leukemia (ALL)

Petrito was developed by Amgen, and BeiGene obtained its authorization in China according to the global oncology strategic cooperation reached by the two parties in 2020

Acute lymphoblastic leukemia (ALL) is a rapidly progressive hematologic and myeloid tumor that affects both adults and children

Belitox is a bispecific T cell engager (BiTE) immuno-oncology therapy that binds to the CD19 antigen expressed on the surface of B-lineage cells

The prior conditional approval of Bilito for the treatment of adult patients with relapsed or refractory CD19-positive precursor B-cell ALL was based on data from clinical trials conducted outside of China and based on Phase 3 clinical trials conducted in adult patients in China.

References:

[1] BeiGene announced the approval of Bélito® (belintuumab for injection) in China for the treatment of children with relapsed or refractory precursor B-cell acute lymphoblastic leukemia