Clinical-stage biopharmaceutical firm BeiGene has secured the Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to undertake clinical trials of BGB-A317 in China to treat advanced solid tumours.
BGB-A317 is an investigational humanised monoclonal antibody belonging to a class of immuno-oncology agents known as immune checkpoint inhibitors.
It fuses with PD-1, a cell surface receptor responsible for downregulating the immune system by preventing the activation of T-cells.
BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
BeiGene founder, CEO and chairman John Oyler said: “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.
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“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.”
According to BeiGene head of regulatory affairs Wendy Yan, positive results from the Phase I dose-escalation trial in patients with advanced solid tumours conducted outside China have paved the way in securing the CTA approval.
Aside from China, BGB-A317 was approved to conduct clinical trials in Australia, New Zealand, the US and Taiwan.