BeiGene (BGNE) Approved by China FDA to Commence BGB-290 Clinical Trials

August 18, 2016 8:15 AM EDT
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BeiGene, Ltd. (Nasdaq: BGNE) announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with BGB-290, a highly potent and selective PARP inhibitor. China is the third territory in which BGB-290 has received approval to conduct clinical trials, in addition to Australia and the United States. Data from the Phase I proof-of-concept trial of BGB-290 were previously presented at the 2015 AACR-NCI-EORTC conference.

“The CTA approval for BGB-290 represents the third molecule from the BeiGene portfolio to receive regulatory clearance for initiation of clinical trials in China. We look forward to commencing the development of BGB-290 in China, in addition to continuing global development of BGB-290, both as a monotherapy and in combination with BGB-A317, our PD-1 antibody,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman.

“The CTA approval for BGB-290 is supported by the progress that we have made so far in our trials in Australia, which were initiated in July 2014. We believe that BGB-290 is the first PARP inhibitor to be developed in China under the domestic regulatory pathway to enter the clinic globally,” said Wendy Yan, Head of Regulatory Affairs at BeiGene.

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