About 50% of patients with CLL/SLL have high-risk molecular features limiting effectiveness of certain treatments; a blood test can identify these features and help guide which therapy is most likely to be efficacious

Campaign highlights national treatment guidelines supporting targeted therapies rather than chemotherapy for improved CLL outcomes

BeiGene and CLL Society launch partnership during the American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 7-10 in San Diego, California

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced its new partnership with CLL Society, the world’s leading authority for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) cancer patients. Together, they are advancing Test Before Treat™, an awareness campaign that aims to connect with healthcare providers (HCPs) and educate patients with CLL/SLL about the critical importance of biomarker testing before initial treatment and retesting at each subsequent treatment to help ensure each patient receives the most effective, personalized therapy. BeiGene and CLL Society will spotlight the campaign and partnership launch during the upcoming American Society of Hematology (ASH) 2024 Annual Meeting and Exposition.

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"While scientific advancements have significantly expanded treatment options for people with CLL, too many patients do not receive the therapies that will work best for them based on their unique disease prognostic parameters. In particular, high-risk CLL, including disease with deletion(17p) and/or TP53 mutations^1,2, has vastly different outcomes depending on the choice of therapy,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology, BeiGene. “By partnering with CLL Society for the Test Before Treat campaign, we hope to educate people living with CLL on the importance of biomarker testing and how it can help chart a course for better individualized care and ultimately improved patient outcomes.”

The Test Before Treat campaign highlights how a patient’s genetic profile can change over time and encourages the use of a blood test to identify mutations to provide important insights into disease aggressiveness and help guide treatment.^1,3 The campaign is anchored by a real patient’s journey with CLL and how his experience with testing before treatment helped him select a treatment that offered a potentially better outcome.

• For example, about 50% of CLL/SLL patients have high-risk molecular features that may limit the effectiveness of some treatments and increase the likelihood of disease progression if not treated correctly.^4,5
• In fact, of those patients, about 10% of CLL/SLL patients have the high-risk del(17p) and/or TP53 mutation before starting treatment, and about 40% of patients will develop del(17p) and/or TP53 mutation after relapsing or not responding to treatment.^6,7 This reinforces the critical importance of biomarker testing before initial treatment and retesting at each subsequent treatment to ensure patients get the best treatment at each stage of their disease.
• Unmutated IGHV is present in approximately 40% of patients and is associated with unfavorable prognosis and significantly shorter survival compared to mutated IGHV in patients treated with chemotherapy-based regimens, independent of the stage of the disease.^8,9
• Guidelines from the National Comprehensive Cancer Network^® (NCCN®) recommend covalent Bruton’s tyrosine kinase (BTK) inhibitors as a preferred treatment for people with CLL/SLL who have or haven’t been treated before and with or without certain genetic mutations (e.g., del(17p) or TP53 mutations).^1,10 BTK inhibitors work to shut down (or inhibit) a protein within cancerous B cells called Bruton’s tyrosine kinase.¹ By shutting down the BTK protein it can stop sending signals to cancerous B cells, such as those that cause CLL/SLL to grow and spread.¹

"Highlighting the important connections between biomarker testing with regard to personalized targeted therapies versus outdated chemotherapy may offer better patient outcomes. This is core to CLL Society’s commitment to addressing the needs of the CLL/SLL communities through education, advocacy, support and research," said Brian Koffman, MDCM (retired), DCFP, FCFP, DABFP, MSEd, Co-Founder, EVP, Chief Medical Officer, CLL Society. "Through our partnership with BeiGene on the Test Before Treat campaign, we hope to further empower patients and healthcare providers with information to advance shared decision-making and optimal care.”

Test Before Treat empowers CLL patients and HCPs to make informed, personalized treatment decisions through a comprehensive awareness initiative. Through targeted digital outreach, direct-to-consumer efforts and tailored in-office HCP resources, Test Before Treat equips patients and HCPs with tools for shared decision-making, ensuring treatments align with each patient’s unique genetic profile to drive better outcomes in CLL management.

To learn more about the Test Before Treat campaign visit https://CLLTestBeforeTreat.org.

About Chronic Lymphocytic Leukemia

A life-threatening cancer of adults, chronic lymphocytic leukemia (CLL) is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow and lymphoid tissues.^11,12 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases of leukemia.^12,13 Approximately 20,700 new cases of CLL will be diagnosed in the U.S. in 2024.¹³

About BeiGene

BeiGene, which plans to change its name to BeOne Medicines, 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 nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

About CLL Society

CLL Society is a leading authority for chronic lymphocytic leukemia patients, families, caregivers and medical professionals. Founded in 2013 by Dr. Brian Koffman, a physician, CLL patient and advocate, and Patricia Koffman, a care partner and advocate, the nonprofit organization addresses the unmet needs of the chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) community through patient education, advocacy, support and research. CLL Society is a registered 501(c)(3) tax-exempt organization. To learn more, visit https://cllsociety.org/.

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 ability of biomarker testing to provide better individualized care and improved patient outcomes; the success of the Test Before Treat™ campaign in educating patients and HCPs; and BeiGene’s plans, commitments, aspirations and goals under the caption “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 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.

To access BeiGene media resources, please visit our News & Media site.

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References:

1. NCCN. (2024). NCCN Guidelines for Patients: Chronic Lymphocytic Leukemia. National Comprehensive Cancer Network. https://www.nccn.org/patients/guidelines/content/PDF/cll-patient.pdf
2. Nguyen, T. T., Nhu, N. T., Tran, V. K., et al. (2023). Efficacy and Safety of Bruton Tyrosine Kinase Inhibitor Monotherapy Compared with Combination Therapy for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma: A Systematic Review and Meta-Analysis. Cancers, 15(7), 1996. https://doi.org/10.3390/cancers15071996
3. Hallek, M., Cheson, B. D., Catovsky, D., et al. (2018). iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood, 131(25), 2745–2760. https://doi.org/10.1182/blood-2017-09-80639
4. Leukemia and Lymphoma Society. Chronic Lymphocytic Leukemia. Revised June 2021. Accessed November 5, 2024. https://www.lls.org/sites/default/files/2021-07/PS34_CLL_Booklet_2021.pdf
5. Döhner H., Stilgenbauer S., James M.R., et al. 11q deletions identify a new subset of B-cell chronic lymphocytic leukemia characterized by extensive nodal involvement and inferior prognosis. Blood. 1997;89(7):2516-2522.
6. Griffin, R., Wiedmeier-Nutor, J.E., Parikh, S.A., et al. (2023). Differential prognosis of single and multiple TP53 abnormalities in high-count MBL and untreated CLL. Blood advances, 7(13), 3169–3179. https://doi.org/10.1182/bloodadvances.2022009040
7. Brieghel, C., Aarup, K., Torp, M. H., et al. (2021). Clinical Outcomes in Patients with Multi-Hit TP53 Chronic Lymphocytic Leukemia Treated with Ibrutinib. Clinical Cancer Research, 27(16), 4531–4538. https://doi.org/10.1158/1078-0432.ccr-20-4890
8. Gaidano G, Rossi D. The mutational landscape of chronic lymphocytic leukemia and its impact on prognosis and treatment. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):329-337. doi: 10.1182/asheducation-2017.1.329. PMID: 29222275; PMCID: PMC6142556.
9. Education, M. (2023, October 16). IGHV and TP53 sequencing: Clinical utility in chronic lymphocytic leukemia (CLL). Mayo Clinic Laboratories.
10. Wierda, W. G., Brown, J., Abramson, J. S., et al. (2022). NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 3.2022. Journal of the National Comprehensive Cancer Network: JNCCN, 20(6), 622–634. https://doi.org/10.6004/jnccn.2022.0031
11. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2024. https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq.
12. American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
13. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Updated July 1, 2024. Accessed November 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.

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