BeiGene Receives Approval to Initiate Clinical Trials in China with PD-1 Antibody BGB-A317

BEIJING, Sept. 11, 2016 -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company focused on developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today 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.

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 250 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the future clinical development and regulatory milestones of BGB-A317.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in the BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission.  All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

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