BeOne Medicines’ Novel BCL2 Inhibitor, Sonrotoclax, Achieves First-in-World Approval in R/R MCL and R/R CLL/SLL

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced the first-in-world approval of sonrotoclax, its foundational, next-generation BCL2 inhibitor, for adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) globally. The approval, granted in China, is supported by data demonstrating deep and durable responses and manageable tolerability, underscoring sonrotoclax’s emerging role as a foundational medicine across B-cell malignancies. The approval was based on parallel submissions of data from two studies, which were presented at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida. In the Phase 1/2 single-arm study of patients with R/R MCL treated with 320 mg of sonrotoclax (n=103), overall response rate (ORR) as assessed by independent review committee (IRC) was 52.4% (95% CI, 42.4-62.4). In the Phase 2 open-label study of patients with R/R CLL/SLL treated with sonrotoclax (n=100), ORR as assessed by IRC was 77%. Across both studies, treatment with sonrotoclax monotherapy was generally well tolerated, and adverse events were manageable. The approval of sonrotoclax in China is part of a global strategy to advance access to sonrotoclax. Notably, data from the Phase 1/2 study of patients with R/R MCL treated with sonrotoclax monotherapy are under Priority Review by the U.S Food and Drug Administration for potential accelerated approval . About Mantle Cell Lymphoma Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL) that develops in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally, affecting an estimated 28,000 people.[1,2,3] MCL is often diagnosed at advanced stages and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.[4,5] The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.[6] About Chronic Lymphocytic Leukemia Chronic lymphocytic leukemia (CLL) is a life-threatening cancer of adults. It 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.[7,8] CLL is the most common type of leukemia in adults, accounting for about one-third of new cases.[2,9] About Sonrotoclax (BGB-11417) Sonrotoclax is a next-generation and potentially best-in-class investigational B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Laboratory studies during early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies and is in development as a monotherapy and in combination with other therapeutics, including BRUKINSA. Notably, in early clinical trials, sonrotoclax plus BRUKINSA has demonstrated rapid and unprecedented rates of undetectable minimal residual disease (uMRD) in treatment-naïve patients with CLL. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for sonrotoclax for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). In addition, the FDA has granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia, as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome. The information provided in this press release is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of nearly 12,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press statement 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 potential benefits of sonrotoclax; BeOne’s expectations regarding sonrotoclax’s clinical development, regulatory milestones, submissions and approvals; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’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; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’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 BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’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 BeOne undertakes no duty to update such information unless required by law. Investor Contact Liza Heapes +1 857-302-5663 [email protected] Media Contact Kyle Blankenship + 667-351-5176 [email protected] To access BeOne media resources, please visit our Newsroom. [1]Jain, P., and Wang, M. L. (2022). Mantle cell lymphoma: 2022 update on diagnosis, risk stratification, and clinical management. American Journal of Hematology, 97(5), 638–656. https://doi.org/10.1002/ajh.26523 [2]Ferlay, J., et al. (2024). Global Cancer Observatory: Non-Hodgkin Lymphoma. International Agency for Research on Cancer. https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf [3]Association of Community Cancer Centers. Relapsed/Refractory Mantle Cell Lymphoma. https://www.accc-cancer.org/home/learn/cancer-types/hematologic-malignancies/mcl [4]Cencini, E., et al. (2024). Survival outcomes of patients with mantle cell lymphoma: A retrospective, 15-year, real-life study. Hematology Reports, 16(1), 50–62. https://doi.org/10.3390/hematolrep16010006 [5]Burkart, M., and Karmali R. (2022). Relapsed/refractory mantle cell lymphoma: Beyond BTK inhibitors. Journal of Personalized Medicine, 12(3), 376. https://doi.org/10.3390/jpm12030376 [6]Cleveland Clinic. (2023). Mantle cell lymphoma. https://my.clevelandclinic.org/health/diseases/24030-mantle-cell-lymphoma [7]National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2024. https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq. [8]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. [9]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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