2023年6月15日 23:55
中国北京，美国麻省剑桥和瑞士巴塞尔——2023年6月15日——百济神州（纳斯达克代码：BGNE；香港联交所代码：06160；上交所代码：688235）是一家全球性生物科技公司，公司关注到，Pharmacyclics LLC 公司对百济神州（BeiGene, Ltd.和BeiGene USA, Inc.）提出申诉，声称百济神州的百悦泽®（BRUKINSA®）侵犯了Pharmacyclics于2023年6月13日授权的一项专利。百济神州的研发是原创性的，我们将对所有此类专利侵权指控开展坚决的辩护。
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(June 15, 2023) – BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, is aware that Pharmacyclics LLC has filed a complaint against BeiGene, Ltd. and BeiGene USA, Inc., alleging that BeiGene’s BRUKINSA® infringes a Pharmacyclics patent issued on June 13, 2023. BeiGene’s work is original, and we will vigorously defend against all allegations of patent infringement.
对于一款有竞争力的产品，一些公司可能对其发起知识产权潜在侵权的指控，这是一件令人遗憾但的确常有发生的事情，尤其是针对一款像百悦泽®这样对癌症患者而言具备显著差异化的药物来说，更是如此。
It is an unfortunate but rather regular occurrence that companies make allegations that a competitive product potentially infringes their intellectual property rights, even more so in response to a clearly differentiated medicine for cancer patients as BRUKINSA.
百济神州针对百悦泽®已经建立了具有原创性和创新性的全球知识产权体系，以彰显百悦泽®差异化的疗效和安全性。百悦泽®在全球范围内开展了广泛的临床开发与注册项目，包括在全球29个市场开展的35项临床试验，全球入组患者超过4,900人。目前，百悦泽®已经在全球超过65个市场获批，其中在美国已获批用于慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）、华氏巨球蛋白血症（WM）、套细胞淋巴瘤（MCL）、复发/难治性（R/R）边缘区淋巴瘤（MZL）。
BeiGene has developed original and novel intellectual properties around BRUKINSA to demonstrate its differentiated profile. BRUKINSA’s broad global development and registration program includes more than 4,900 patients in 35 trials across 29 markets. BRUKINSA is now approved in more than 65 markets around the world and is approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL) in the United States.
最近，在一项评估百悦泽®头对头对比亿珂®、用于治疗R/R CLL/SLL的ALPINE试验中，百悦泽®展示了相比亿珂®更优越的疗效（包括PFS和ORR）以及安全性（房颤）。研究显示，在百悦泽®组，由心脏疾病引起的猝死事件的发生率为0，而亿珂®组为1.9%。这些结果已被刊载于《新英格兰医学杂志》，并同时在2022年12月举办的美国血液学会年会上作为最新突破摘要进行发表。
Most recently, the ALPINE study, a head-to-head comparison between BRUKINSA and IMBRUVICA® in R/R CLL/SLL, demonstrated BRUKINSA’s superior efficacy (PFS and ORR) and safety (atrial fibrillation) over IMBRUVICA. The study also reported zero sudden cardiac death events for BRUKINSA versus a 1.9% rate for IMBRUVICA. Those results were published in the New England Journal of Medicine and presented as a simultaneous late breaker presentation at the American Society of Hematology meeting in December 2022.
作为一家立足于科学的全球性生物科技公司，百济神州在五大洲拥有超过9,400人的团队及运营体系。公司高度重视和尊重有效且可执行的知识产权。我们对百悦泽®的知识产权保有充分信心，并将继续践行使命——为患者研发更有效、更安全的创新型肿瘤治疗方案。百济神州也将一如既往地致力于为全世界癌症患者提供更多可及、可负担的药物。
As a science-based, global biotech company with over 9,400 people and operations on five continents, BeiGene highly values and respects valid and enforceable intellectual property rights. BeiGene remains confident in BRUKINSA’s intellectual property and will continue its mission to discover and develop innovative oncology treatments that are more efficacious and safer. BeiGene also remains committed to making medicines that are more affordable and accessible to cancer patients worldwide.
关于百济神州
百济神州是一家全球性生物科技公司，专注于为全球癌症患者发现和开发创新抗肿瘤药物，提高药物可及性和可负担性。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9,400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。
About BeiGene
BeiGene is a global biotechnology company that is discovering and developing innovative oncology 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 9,400 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
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定义的前瞻性声明，包括百济神州关于其知识产权保护的声明，以及在“关于百济神州”副标题下提及的百济神州计划、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有重大差异。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；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。
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 BeiGene’s protection of its intellectual property right; 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, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene’s clinical development, regulatory, commercial, manufacturing, and other operations, as well as 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.