BeiGene Receives Approval to Initiate Clinical Trials in China With BGB-3111

BEIJING, March 07, 2016 -- BeiGene, Ltd. (Nasdaq:BGNE), (“BeiGene”) a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncological 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 with BGB-3111, a potent and highly selective small molecule BTK inhibitor for the treatment of B-cell malignancies.

“We are excited and eager to commence clinical trials with BGB-3111 in China.  We believe that BGB-3111 is the first BTK inhibitor being developed in China under the domestic regulatory pathway to enter the clinic. We are expanding our clinical trials globally, in Australia, New Zealand, Korea and the United States, This CTA approval is a key milestone for our company as we seek to bring this differentiated agent to patients globally. ” said John V. Oyler, Chief Executive Officer of BeiGene.

“We are pleased to have progressed smoothly through this step in the CFDA process,” said Wendy Yan, Head of Regulatory Affairs at BeiGene. “The approval to begin clinical trials in China in B-cell malignancies is supported by positive early data from the ongoing clinical trials with BGB-3111 in Australia. Our global regulatory team is excited to be at the forefront of bringing this important agent to patients in our domestic market”.

About BGB-3111

BGB-3111 is a potent and highly selective small molecule inhibitor of Bruton’s tyrosine kinase (BTK). BGB-3111 has demonstrated greater selectivity against BTK than ibrutinib, the only BTK inhibitor currently approved by the U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA. In addition, available clinical data have shown that BGB-3111 is able to fully and sustainably suppress its target in both the blood and the disease-relevant tissues such as the lymph node.  

About BeiGene

BeiGene is a global, clinical-stage, research-based biotechnology company focused on targeted and immuno-oncological therapeutics. With a team of over 200 scientists, clinicians and staff, 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 a lasting impact on cancer patients. For more information, please visit our website at www.beigene.com.

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 BeiGene’s expectation to commence clinical trials with BGB-3111 in China, the positioning of BGB-3111 as the first BTK inhibitor being developed in China under the domestic regulatory pathway, BeiGene’s ability to bring novel new medicines to patients globally, the anticipated benefits of CTA approval, and the potential safety, pharmacological effect and efficacy of BGB-3111 as a BTK inhibitor.  Actual results may differ materially from those indicated in these 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, 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 final prospectus related to BeiGene’s initial public offering filed with the U.S. Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended, 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.

Investor/Media Contact

Lucy Li, Ph.D.
Associate Director of Strategy and Investor Relations
US: +1 781-801-1800
China: +86 138-1120-6461
[email protected]
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