BeiGene gains second approval in China of Blincyto in ALL

6 May 2022

Sino-American biotech BeiGene (Nasdaq: BGNE) has announced that the China National Medical Products Administration (NMPA) has granted conditional approval of Blincyto (blinatumomab) for injection for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). The NMPA granted conditional approval for adult patients in this indication in December 2020.

Developed by the USA’s Amgen (Nasdaq: AMGN) and licensed to BeiGene in China under a strategic collaboration commenced in 2020, this is the second approval for Blincyto in China. The pediatric Supplemental Biologic License Application (sBLA) was submitted by BeiGene.

“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, president, chief operating officer, and general manager of China, at BeiGene.

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