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BioWorld - Thursday, July 2, 2026
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Home » Beigene wins its first FDA nod with BTK inhibitor Brukinsa
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Beigene wins its first FDA nod with BTK inhibitor Brukinsa

Nov. 19, 2019
By Elise Mak
BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.
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