BeiGene Announces First Patient Dosing in China Phase I Trial with Investigational Anti-PD-1 Monoclonal Antibody BGB-A317

BEIJING, China I December 30, 2016 I BeiGene, Ltd. (BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the dosing of the first patient in a Phase I clinical trial of BGB-A317, an anti-PD-1 monoclonal antibody, in mainland Chinese patients with advanced solid tumors.

“We are pleased to report that BGB-A317 is now in Phase I clinical evaluation in mainland China. To date, all four of our clinical-stage molecules are active in the clinic in China. We are enthusiastic about the agent’s therapeutic potential, with promising data from an ongoing Phase I study of BGB-A317 in Australia, New Zealand, the United States, and Taiwan recently reported at the 2016 Society for Immunotherapy of Cancer Annual Meeting. We are committed to developing BGB-A317 for patients in China, where this exciting class of immuno-oncology agents is still not approved,” commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

The Phase I open-label, multi-center study of BGB-A317 is designed to investigate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-A317 in Chinese patients with advanced solid tumors. Professor Yilong Wu from Guangdong General Hospital is the lead principal investigator of the study. The co-lead investigators are Professor Lin Shen and Professor Jun Guo, both of Beijing Cancer Hospital.

About BGB-A317

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.

About BeiGene

BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 300 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients.


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