BeiGene (BGNE) Approved in China to Conduct BGB-A317 Clinical Trials
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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 investigational agent BGB-A317, a PD-1 antibody, for the treatment of advanced solid tumors. China is the fifth territory in which BGB-A317 has received approval to conduct clinical trials, in addition to Australia, New Zealand, the United States, and Taiwan. To date, BGB-A317 has been dosed in more than 200 patients, and preliminary data from the Phase I dose-escalation study of BGB-A317 were presented at the 2016 American Society of Clinical Oncology Annual Meeting in June.
“This event marks the receipt of regulatory clearance for all four of our clinical-stage molecules for initiation of clinical trials in China. The Chinese pharmaceutical market continues to grow robustly and is an important market for us. We are delighted to receive this clearance and look forward to commencing the development of BGB-A317 in China and updating the clinical data from the ongoing global study of BGB-A317,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman.
“The CTA approval for BGB-A317 is supported by encouraging data from the Phase I dose-escalation trial in patients with advanced solid tumors conducted outside China. We will continue to communicate closely with the CFDA to continue advancing BGB-A317 along the domestic innovative drug development pathway,” said Wendy Yan, Head of Regulatory Affairs at BeiGene.
BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies with the ability to bind Fc gamma receptor I specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
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