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BeiGene's US NDA Filing for BTK Inhibitor Accepted by FDA

publication date: Aug 26, 2019

Beijing's BeiGene announced its US NDA for the company's BTk inhibitor was accepted by the FDA, its first NDA accepted in the US. The company presented data on zanubrutinib from a China Phase II trial that enrolled 123 MCL patients, along with safety data from 641 patients in five clinical trials for other indications. BeiGene wants to expand the ex-China use of data from China trials to contain clinical costs. The FDA has granted Breakthrough Status for zanubrutinib and will review the candidate under Priority rules. More details....

Stcok Symbol: (NSDQ: BGNE; HKEX: 06160)

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