BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi), in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior lines of systemic therapy..

瑞士巴塞尔和马萨诸塞州北京和剑桥-全球生物技术公司BeiGene（纳斯达克股票代码：BGNE；HKEX:06160；SSE:688235）今天宣布人用药品委员会（CHMP）欧洲药品管理局（EMA）发布了积极意见，建议批准布鲁顿酪氨酸激酶抑制剂（BTKi）BRUKINSA®（zanubrutinib），联合obinutuzumab治疗成人复发或难治性（R/R）滤泡性淋巴瘤（FL）患者，这些患者至少接受过两次全身治疗。。

“Follicular lymphoma remains an incurable disease and an ongoing challenge for healthcare providers. Despite advances in the treatment landscape, patients often relapse and experience shorter response times to subsequent treatments,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.

BeiGene血液学首席医疗官Mehrdad Mobasher博士，M.P.H.说：“滤泡性淋巴瘤仍然是一种无法治愈的疾病，也是医疗服务提供者面临的持续挑战。尽管治疗领域取得了进展，但患者往往复发，对后续治疗的反应时间较短。”。

“Today’s positive CHMP opinion is a testament to our continued commitment to bringing innovative medicines to patients and demonstrates the value of BRUKINSA, which – if approved in FL – will become the BTK inhibitor with the broadest label in the EU.”.

“今天积极的CHMP意见证明了我们继续致力于向患者带来创新药物，并证明了BRUKINSA的价值，如果获得FL批准，BRUKINSA将成为欧盟最广泛标签的BTK抑制剂。”。

The CHMP recommendation is based on positive results from the ROSEWOOD study and supported by the BGB-3111-GA101-001 study. The pivotal ROSEWOOD study (BGB-3111-212; NCT03332017) is an ongoing global Phase 2 study of BRUKINSA plus obinutuzumab compared with obinutuzumab alone in 217 patients with R/R FL who received at least two prior lines of systemic therapy.

CHMP建议基于ROSEWOOD研究的积极结果，并得到BGB-3111-GA101-001研究的支持。关键的ROSEWOOD研究（BGB-3111-212；NCT03332017）是一项正在进行的全球2期BRUKINSA加obinutuzumab研究，与217例接受至少两次全身治疗的R/R FL患者单用obinutuzumab相比。

In the randomized, open-label study, the overall response rate was 69.0% in the BRUKINSA plus obinutuzumab arm versus 45.8% in the obinutuzumab arm (p = 0.0012), with a median follow-up of approximately 20 months. BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.

在随机，开放标签研究中，BRUKINSA加obinutuzumab组的总有效率为69.0%，obinutuzumab组为45.8%（p=0.0012），中位随访时间约为20个月。BRUKINSA加obinutuzumab通常耐受性良好，安全性结果与之前对两种药物的研究一致。

BGB-3111-GA101-001 (NCT02569476) is a Phase 1b study designed to assess the safety, tolerability and antitumor activity of BRUKINSA with obinutuzumab in participants with B-cell lymphoid malignancies..

BGB-3111-GA101-001（NCT02569476）是一项1b期研究，旨在评估BRUKINSA与obinutuzumab在B细胞淋巴恶性肿瘤患者中的安全性，耐受性和抗肿瘤活性。。

Following the CHMP positive opinion, the European Commission will consider BeiGene’s Marketing Application, with a final decision expected within 67 days. The decision will be applicable to all 27 member states of the European Union (EU), plus Iceland and Norway.

根据CHMP的积极意见，欧盟委员会将考虑BeiGene的营销申请，最终决定将在67天内完成。该决定将适用于欧盟（EU）的所有27个成员国，以及冰岛和挪威。

BRUKINSA is currently approved in the EU as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia and as monotherapy for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy. It is also approved in the EU for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy..

BRUKINSA目前在欧盟被批准为治疗成人慢性淋巴细胞白血病患者的单一疗法，以及用于治疗已接受至少一种基于抗CD20的治疗的边缘区淋巴瘤成人患者的单一疗法。它也被欧盟批准用于治疗Waldenström巨球蛋白血症的成年患者，这些患者至少接受过一次治疗，或者用于不适合化疗免疫治疗的患者的一线治疗。。

BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities in the United States and China. Additionally, BeiGene’s submission for BRUKINSA in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom as part of the Access Consortium New Active Substance Work-sharing Initiative..

BeiGene目前正在提交美国和中国监管机构审查的R/R FL中的BRUKINSA。此外，作为Access联盟新活性物质工作共享计划的一部分，加拿大，瑞士和英国的监管机构正在审查BeiGene提交的BRUKINSA在R/R FL中的申请。。

BRUKINSA is approved in more than 65 markets, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland in selected indications and under development for additional approvals globally. Product information may differ from country to country. Prescribers should consult the product information approved in their respective countries.

BRUKINSA已在65多个市场获得批准，其中包括美国，中国，欧盟，英国，加拿大，澳大利亚，韩国和瑞士，这些市场在选定的适应症中获得批准，并正在开发中以获得全球额外批准。产品信息可能因国家而异。处方者应咨询各自国家批准的产品信息。

The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions..

全球BRUKINSA发展计划包括迄今为止在29个国家和地区注册的5000多个科目。。

About Follicular Lymphoma

关于滤泡性淋巴瘤

FL is the second most common type of non-Hodgkin lymphoma (NHL), accounting for 22 percent of all NHL cases.i Across Europe, over 122,000 people each year are diagnosed with NHL.ii FL is a slow-growing cancer but can become more aggressive over time. While FL remains incurable, people with the condition can live a long time.

FL是第二大常见类型的非霍奇金淋巴瘤（NHL），占所有NHL病例的22%。在欧洲，每年有超过122000人被诊断患有NHL.ii FL是一种生长缓慢的癌症，但可以变成随着时间的推移更积极。虽然FL仍然无法治愈，但患有这种疾病的人可以活得很长时间。

The five-year survival rate is about 90 percent, and approximately half of people diagnosed with FL can live with the disease for nearly 20 years.iii,iiii.

五年生存率约为90%，大约一半被诊断患有FL的人可以患有该疾病近20年.iii，iiii。

About BRUKINSA® (zanubrutinib)

关于BRUKINSA® （扎努鲁替尼）

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

BRUKINSA是BeiGene科学家发现的布鲁顿酪氨酸激酶（BTK）的小分子抑制剂，目前正在广泛的临床计划中作为单一疗法进行全球评估，并与其他疗法联合治疗各种B细胞恶性肿瘤。由于新的BTK不断合成，BRUKINSA专门设计用于通过优化生物利用度，半衰期和选择性来完全和持续抑制BTK蛋白。

With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues..

与其他批准的BTK抑制剂相比，具有不同的药代动力学，已证明BRUKINSA可抑制许多疾病相关组织内恶性B细胞的增殖。。

About BeiGene

关于贝金

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.

BeiGene是一家全球生物技术公司，正在发现和开发创新的肿瘤治疗方法，使全球癌症患者更加负担得起和容易获得。凭借广泛的投资组合，我们正在通过内部能力和合作加快我们各种新型治疗药物的开发。

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, Cambridge, and U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter)..

我们致力于为更多需要它们的患者从根本上改善获得药物的机会。我们日益增长的全球团队拥有超过10000名同事，分布在五大洲，在巴塞尔，北京，剑桥和美国设有行政办事处。要了解有关BeiGene的更多信息，请访问www.BeiGene.com并关注LinkedIn和X（以前称为Twitter）。。

Forward-Looking Statements

前瞻性声明

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 commitment to bring innovative medicines to patients; BeiGene’s advancement, anticipated clinical development, regulatory submissions and commercialization of zanubrutinib, particularly as a treatment for R/R FL; 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 and its 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 Bei.

本新闻稿包含1995年“私人证券诉讼改革法案”和其他联邦证券法律含义范围内的前瞻性声明，包括有关BeiGene致力于为患者带来创新药物的声明；BeiGene的进步，预期的临床开发，监管提交和zanubrutinib的商业化，特别是作为R/R FL的治疗；以及BeiGene在“关于BeiGene”标题下的计划，承诺，愿望和目标。由于各种重要因素，包括BeiGene展示其候选药物的有效性和安全性的能力，实际结果可能与前瞻性声明中指出的结果大不相同；其候选药物的临床结果，可能不支持进一步开发或上市批准；监管机构的行动，可能影响临床试验和上市批准的启动，时间和进展；如果获得批准，BeiGene能够为其上市药物和候选药物取得商业成功；BeiGene获得和维护药品和技术知识产权保护的能力；BeiGene依靠第三方进行药物开发，制造，商业化和其他服务；BeiGene在获得监管部门批准和药品商业化方面的经验有限，并且能够为运营获得额外资金，完成候选药物的开发并实现和保持盈利能力；这些风险在BeiGene最近的10-Q季度报告中的“风险因素”部分以及Bei中潜在风险，不确定性和其他重要因素的讨论中得到了更充分的讨论。

References

工具书类

iLeukemia & Lymphoma Society. Treatment for Indolent NHL Subtypes. Available at: https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes/treatment-indolent-nhl-subtypes.

iLeukemia＆Lymphoma Society。治疗惰性NHL亚型。可在：https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes/treatment-indolent-nhl-subtypes.

iiWorld Health Organization. Non-Hodgkin lymphoma. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/34-Non-hodgkin-lymphoma-fact-sheet.pdf.

i世界卫生组织。非霍奇金淋巴瘤。可在：https://gco.iarc.fr/today/data/factsheets/cancers/34-Non-hodgkin-lymphoma-fact-sheet.pdf.

iiiAmerican Cancer Society. Survival Rates and Factors That Affect Prognosis (Outlook) for Non-Hodgkin Lymphoma. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/detection-diagnosis-staging/factors-prognosis.

iiiAmerican癌症协会。影响非霍奇金淋巴瘤预后的生存率和因素（展望）。可在：https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/detection-diagnosis-staging/factors-prognosis.

ivCarton, G, et al., Time for an Individualized Approach to First-Line Management of Follicular Lymphoma. Haematologica. 2022. Vol 107 No. 1.

ivCarton，G，et al。，Time for a Individualized Approach to First Line Management of Follicular Lymphoma。血液学。2022.第107卷第1期。