BeiGene's first U.S. NDA tests global development strategy

BeiGene believes inclusion of data from trials run in China in the company’s first NDA to be reviewed by FDA could help build industry’s confidence in doing trials in China. BeiGene also hopes the strategy will help it accelerate global clinical development of its candidates.

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) CFO and Chief Strategy Officer Howard Liang told BioCentury that although the NDA for zanubrutinib to treat relapsed or refractory mantle cell lymphoma was supported by efficacy data from both China and global studies, approval of the Btk inhibitor by FDA would be a vote of confidence that China trials can be done with high quality...