关于百济神州 百济神州是一家全球性生物科技公司,专注于开发和商业化创新、可负担的抗肿瘤药物,旨在为全球患者改善治疗效果,提高药物可及性。通过强大的自主研发能力和外部战略合作,我们不断加速开发多元、创新的药物管线。我们致力于为全球更多患者全面改善药物可及性。百济神州在全球五大洲打造了一支超过9,000人的团队,并在中国北京、美国麻省剑桥和瑞士巴塞尔设立了主要办事处。欲了解更多信息,请访问www.beigene.com.cn。 前瞻性声明 本新闻稿包含根据《1995年私人证券诉讼改革法案》(Private Securities Litigation Reform Act of 1995)以及其他联邦证券法律中定义的前瞻性声明,包括有关百悦泽®为CLL或R/R MZL患者提供临床获益的潜力、百悦泽®未来在大不列颠和其他市场开展的开发、药政申报和批准、商业化和市场准入、百悦泽®潜在的商业机会、以及百济神州在"关于百济神州"标题下提及的计划、承诺、抱负和目标。由于各种重要因素的影响,实际结果可能与前瞻性声明中的结果存在实质性差异。这些因素包括:百济神州证明其候选药物功效和安全性的能力;候选药物的临床结果可能不支持进一步开发或上市审批;药政部门的行动可能会影响到临床试验的启动、时间表和进展以及药物上市审批;百济神州的上市药物及候选药物(如能获批)获得商业成功的能力;百济神州获得和维护对其药物和技术的知识产权保护的能力;百济神州依赖第三方进行药物开发、生产和其他服务的情况;百济神州取得监管审批和商业化医药产品的有限经验,及其获得进一步的营运资金以完成候选药物开发、商业化及实现并保持盈利的能力;新冠肺炎全球疫情对百济神州的临床开发、监管、商业化运营、生产以及其他业务带来的影响;以及百济神州在最近季度报告的10-Q表格中"风险因素"章节里更全面讨论的各类风险;以及百济神州向美国证券交易委员会期后呈报中关于潜在风险、不确定性以及其他重要因素的讨论。本新闻稿中的所有信息仅及于新闻稿发布之日,除非法律要求,百济神州并无责任更新该等信息。 *亿珂®是Pharmacyclics LLC和Janssen Biotech,Inc.的注册商标。 References [1] Tam CS, Robak T, Ghia P, et al. Zanubrutinib monotherapy for patients with treatment naive chronic lymphocytic leukemia and 17p deletion. Haematologica. 2020;106(9):2354-2363. https://www.ncbi.nlm.nih.gov/pubmed/33054121. [2] A study of zanubrutinib (BGB-3111) versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia. ClinicalTrials.gov. Accessed September 25, 2022. https://clinicaltrials.gov/ct2/show/NCT03734016 [3] Opat S, Tedeschi A, Linton K, et al. The MAGNOLIA Trial: Zanubrutinib, a next-generation bruton tyrosine kinase inhibitor, demonstrates safety and efficacy in relapsed/refractory marginal zone lymphoma. Clin Cancer Res. Published online September 15, 2021. doi: 10.1158/1078-0432. CCR-21-1704 [4] National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Leukemia —Chronic Lymphocytic Leukemia (CLL). Accessed December, 2022. https://seer.cancer.gov/statfacts/html/clyl.html [5] American Cancer Society. What is chronic lymphocytic leukemia? Updated May 10, 2018. Accessed December 8, 2022. https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html [6] Yao Y, Lin X, Li F, Jin J, Wang H. The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019. Biomed Eng Online. 2022 Jan 11;21(1):4. doi:10.1186/s12938-021-00973-6. PMID: 35016695; PMCID: PMC8753864. [7] Miranda-Filho, A., et al., Epidemiological patterns of leukaemia in 184 countries: a population-based study. The Lancet Haematology, 2018. 5(1): p. e14-e24. [8] Sant, M., et al., Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood, 2010. 116(19): p. 3724-34. [9] Annals of Oncology, Marginal Zone Lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, January 6, 2020. [10] Cerhan, J.R. and T.M. Habermann, Epidemiology of Marginal Zone Lymphoma. Ann Lymphoma, 2021. [11] Smith, A., et al., Lymphoma incidence, survival and prevalence 2004-2014: sub-type analyses from the UK's Haematological Malignancy Research Network. Br J Cancer, 2015. 112(9): p. 1575-84. [12] Maynadie, M., et al., Splenic Marginal Zone Lymphoma: French Registries Population-Based Treatment and Survival Analyses (2002-2014). Blood, 2020. 136. [13] Leukemia & Lymphoma Society, Marginal Zone Lymphoma. Available at: https://www.lls.org/research/marginal-zone-lymphoma-mzl.lg...