In a first, Chi­na’s BeiGene scores FDA ‘break­through’ sta­tus for BTK in­hibitor — po­ten­tial ri­val for Im­bru­vi­ca

BeiGene may have made its rep as a PD-1 pi­o­neer in Chi­na, but it’s com­ing to the US with more can­cer drugs in its ar­se­nal.

The biotech $BGNE says its Bru­ton’s ty­ro­sine ki­nase (BTK) in­hibitor, zanubru­ti­nib, now en­joys break­through sta­tus grant­ed by the FDA — specif­i­cal­ly, in the treat­ment of adult pa­tients with man­tle cell lym­phoma who have been treat­ed with at least one pri­or ther­a­py.

It’s the first can­cer ther­a­py from main­land Chi­na to re­ceive this en­dorse­ment, BeiGene pres­i­dent and gen­er­al man­ag­er of Chi­na Xi­aob­ing Wu told Bio­Cen­tu­ry.

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