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BeiGene's CD3/CD19 dual-antibody new indications will be included in the priority review

 Last Update: 2021-03-27
 Source: Internet
 Author: User

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On March 17, BeiGene submitted a new indication of belintoomab for injection marketing application on the grounds of "new varieties, dosage forms and specifications of children’s drugs that meet the physiological characteristics of children, and drugs that meet conditional approval".

Belintoomab is a bispecific antibody targeting CD3-CD19 developed based on Amgen's most advanced bispecific T cell adapter system (BiTE®).

Belinto Oumab was approved by the NMPA on December 4 last year through the priority review method for the treatment of adult relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).

Belintoux received accelerated FDA approval for marketing as early as December 2014.

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