BeiGene Announces Oral Presentations on BTK Inhibitor BGB-3111 at the 2016 American Society of Hematology Annual Meeting

WALTHAM, Mass., Nov. 03, 2016 -- BeiGene, Ltd. (NASDAQ:BGNE) (“BeiGene”), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it will present updated data from the Phase I study of BGB-3111, its Bruton’s tyrosine kinase (BTK) inhibitor, in patients with Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) and Waldenström’s Macroglobulinemia (WM) at the 2016 American Society of Hematology (ASH) Annual Meeting. The ASH Annual Meeting will take place December 3–6, 2016 in San Diego, California.

Oral Presentation, Abstract # 642

Title: Twice Daily Dosing with the Highly Specific BTK Inhibitor, BGB-3111, Achieves Complete and Continuous BTK Occupancy in Lymph Nodes, and is Associated with Durable Responses in Patients (pts) with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Authors: Constantine S. Tam, Stephen Opat, Gavin Cull, Judith Trotman, David Gottlieb, David Simpson, Paula Marlton, Mary Ann Anderson, Matthew Ku, David Ritchie, Sumita Ratnasingam, Bradley Augustson, Mark Kirschbaum, Lai Wang, Ling Xue, Jianxin Yang, Eric Hedrick, John F. Seymour, Andrew W. Roberts

Presenter: Dr. Constantine Tam
Session: 642. CLL: Therapy, excluding Transplantation: Targeted Therapy: Novel Agents and Combinations
Date: Monday, December 5, 2016
Time: 8:15 AM PT
Location: San Diego Convention Center, Room 5AB

Oral Presentation, Abstract # 1216

Title: High Major Response Rate, including Very Good Partial Responses (VGPR), in Patients (pts) with Waldenstrom Macroglobulinemia (WM) Treated with the Second Generation BTK Inhibitor BGB-3111: Expansion Phase Results from an Ongoing Phase I Study

Authors: Constantine S. Tam, Judith Trotman, Stephen Opat, Paula Marlton, Gavin Cull, David Simpson, Matthew Ku, David Ritchie, Emma Verner, Sumita Ratnasingam, Mary Ann Anderson, Peter Wood, Mark Kirschbaum, Lai Wang, Ling Xue, Jianxin Yang, Eric Hedrick, John F. Seymour, Andrew W. Roberts

Presenter: Dr. Constantine Tam
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma Clinical Studies: Novel Targeted Therapy in Low Grade NHL
Date: Monday, December 5, 2016
Time: 7:00 PM PT
Location: San Diego Convention Center, Ballroom 20BC

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays, higher exposure than ibrutinib based on their respective Phase I experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.

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.

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 encouraging preliminary clinical data of BGB-3111, the potential implications of these data for the future development of BGB-3111, and BeiGene’s advancement of, and anticipated clinical development and regulatory milestones and plans related to, BGB-3111. 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.

Investor/Media Contact

Lucy Li, Ph.D.
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