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.
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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.
“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.
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