• Multiple presentations to showcase the efficacy and safety of BRUKINSA^® across a range of B-cell malignancies
• Company to present three-year data from RATIONALE-306 study of TEVIMBRA^® in advanced or metastatic esophageal squamous cell carcinoma (ESCC)

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Apr 24, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31 - June 4, 2024.

“Our presentations at this year’s ASCO highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “The exciting data we will share during ASCO showcase BRUKINSA’s uniquely differentiated clinical profile and add to the growing body of evidence supporting its role across the blood cancer treatment paradigm.”

BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include:

• A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and
• A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications.

Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include:

• New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and
• Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA.

“Our data at ASCO are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC.”

BeiGene Presentations During ASCO 2024

About BRUKINSA® (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

Please see full U.S. Prescribing Information for BRUKINSA® (zanubrutinib), including U.S. Patient Information or visit www.brukinsa.com.

About TEVIMBRA^® (tislelizumab-jsgr)

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Please see full U.S. Prescribing Information for TEVIMBRA® (tislelizumab-jsgr), including Medication Guide.

About Sonrotoclax (BGB11417)

Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations.

About BeiGene

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), and Facebook.

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 strength and future growth of BeiGene’s oncology portfolio; BeiGene’s ability to develop treatments that address the unmet needs of patients with B-cell malignancies and solid tumors; the versatility of tislelizumab across tumor types; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” 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 or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, 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.