SAN MATEO, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data across a range of B-cell malignancies and assets, including best-in-class Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib), at the 66th ASH Annual Meeting and Exposition in San Diego, December 7-10.

加利福尼亚州圣马特奥（商业新闻短讯）--BeiGene，Ltd.（纳斯达克：BGNE；香港交易所：06160；苏格兰证券交易所：688235），一家全球肿瘤公司，今天宣布将在12月7日至10日于圣地亚哥举行的第66届ASH年会和博览会上分享一系列B细胞恶性肿瘤和资产的新数据，包括一流的布鲁顿酪氨酸激酶（BTK）抑制剂BRUKINSA®（zanubrutinib）。

BeiGene has 21 abstracts accepted at ASH 2024, with four selected for oral presentation..

BeiGene有21篇摘要被ASH 2024接受，其中四篇被选为口头陈述。。

“In the five years since its initial approval, BRUKINSA has become a standard of care for patients facing many B-cell malignancies, and our data featured at ASH demonstrated how long-term follow-up of treatment with BRUKINSA elicited deep and durable responses, including in patients with chronic lymphocytic leukemia and Waldenström’s macroglobulinemia,” 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医学博士说：“自最初批准以来的五年中，布鲁金莎已成为面临许多B细胞恶性肿瘤患者的标准治疗方法，我们在ASH上的数据表明，布鲁金莎治疗的长期随访如何引起深度和持久的反应，包括慢性淋巴细胞白血病和Waldenström巨球蛋白血症患者。”。

“BRUKINSA is just the starting point – pipeline data for our BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax showcase our continued leadership across the hematology landscape and our commitment to bringing innovative medicines to as many people with cancer as possible.”.

“BRUKINSA只是一个起点-我们的BTK降解剂BGB-16673和BCL2抑制剂sonrotoclax的管道数据展示了我们在血液学领域的持续领导地位，以及我们致力于为尽可能多的癌症患者提供创新药物的承诺。”。

Presentations Highlight Sustained Progression-Free Survival and Deepening Durable Responses for Patients Treated with BRUKINSA in Treatment-Naïve and Relapsed/Refractory (R/R) Settings

演讲强调了在未接受治疗和复发/难治性（R/R）治疗的情况下，接受BRUKINSA治疗的患者的持续无进展生存期和加深的持久反应

Five-year follow-up results from Cohort 1 of the Phase 3 SEQUOIA study showed sustained progression-free survival (PFS) benefit with BRUKINSA in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with no new safety signals observed.

3期红杉研究队列1的五年随访结果显示，未接受治疗的慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者的BRUKINSA持续无进展生存期（PFS）获益，未观察到新的安全信号。

Results from the LTE (long-term extension rollover) study of patients with treatment-naïve and R/R CLL also showed that treatment with BRUKINSA as a single agent or as an investigational treatment in combination with obinutuzumab achieved high overall and complete response rates. With a median follow-up of up to 6.5 years, the responses were sustained, and no new safety signals were observed..

对未接受治疗和R/R CLL患者进行的LTE（长期延长滚动）研究的结果也表明，使用布鲁金沙作为单一药物或作为研究性治疗与obinutuzumab联合使用可获得较高的总体和完全缓解率。中位随访时间长达6.5年，反应持续，未观察到新的安全信号。。

Results from an LTE study of patients with Waldenström macroglobulinemia (WM) from the Phase 3 ASPEN study, with a median follow-up of up to 5.8 years, demonstrated that treatment with BRUKINSA monotherapy remained durable and the safety/tolerability profile remained favorable.

来自ASPEN 3期研究的Waldenström巨球蛋白血症（WM）患者的LTE研究结果显示，中位随访时间长达5.8年，BRUKINSA单药治疗仍然持久，安全性/耐受性仍然良好。

Data from a Phase 2 study showed patients with prior intolerance to acalabrutinib were able to safely and effectively switch to BRUKINSA, with the majority of patients not experiencing recurrence of prior acalabrutinib-intolerance events while maintaining or deepening responses.

来自第二阶段研究的数据显示，先前对阿卡鲁替尼不耐受的患者能够安全有效地改用布鲁金沙，大多数患者在维持或加深反应的同时没有经历先前阿卡鲁替尼不耐受事件的复发。

Pipeline Data Show Early Safety and Efficacy Across Multiple B-cell Malignancies

管道数据显示多种B细胞恶性肿瘤的早期安全性和有效性

First-in-human Phase 1/2 CaDAnCe-101 presentations (two oral, one poster) highlighted generally manageable safety and promising efficacy results for BTK degrader, BGB-16673, in patients with R/R CLL/SLL, WM, and R/R indolent non-Hodgkin’s lymphoma. BGB-16673, which induces BTK degradation, is the first and most advanced asset from BeiGene’s chimeric degradation activation compound (CDAC) platform..

首先在人类1/2期CaDAnCe-101演示（两张口服，一张海报）中强调了BTK降解剂BGB-16673在R/R CLL/SLL，WM和R/R惰性非霍奇金淋巴瘤患者中的一般可控安全性和有希望的疗效结果。诱导BTK降解的BGB-16673是BeiGene嵌合降解活化化合物（CDAC）平台的第一个也是最先进的资产。。

Oral presentation of the BGB-11417-101 Phase 1 study demonstrated B-cell lymphoma 2 (BCL2) inhibitor sonrotoclax in combination with BRUKINSA continued to show promising efficacy and was generally well-tolerated in patients with treatment-naïve CLL/SLL; this combination is being evaluated in the Phase 3 CELESTIAL-TNCLL study (NCT06073821)..

BGB-11417-101 1期研究的口服介绍表明，B细胞淋巴瘤2（BCL2）抑制剂sonrotoclax联合BRUKINSA继续显示出有希望的疗效，并且在未接受治疗的CLL/SLL患者中通常耐受性良好；这种组合正在第三阶段天体TNCLL研究（NCT06073821）中进行评估。。

BeiGene Presentations During ASH 2024

BeiGene在2024年ASH期间的演讲

Abstract Title

摘要标题

Presentation Details

演示文稿详细信息

Lead Author

主要作者

BRUKINSA

屏幕

Prospective patient preference study for Bruton tyrosine kinase inhibitor (BTKi) treatment attributes and factors affecting patient shared decision-making CLL/SLL in the USA

美国布鲁顿酪氨酸激酶抑制剂（BTKi）治疗属性和影响患者共同决策CLL/SLL的因素的前瞻性患者偏好研究

Publication #2265

出版物#2265

Poster

海报

Dec. 7, 5:30-7:30 p.m.

12月7日下午5:30-7:30。

S. Ailawadhi

S.艾拉瓦迪

Real-world Bruton tyrosine kinase inhibitor (BTKi) utilization and clinical outcomes among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者的现实世界布鲁顿酪氨酸激酶抑制剂（BTKi）利用和临床结果

Publication #2353

出版物#2353

Poster

海报

Dec. 7, 5:30-7:30 p.m.

12月7日下午5:30-7:30。

J. Hou

J、 侯

Long-term clinical outcomes in patients with Waldenström macroglobulinemia (WM) who received zanubrutinib in the phase 3 ASPEN study: A report from the zanubrutinib extension study

在3期ASPEN研究中接受扎鲁替尼治疗的Waldenström巨球蛋白血症（WM）患者的长期临床结果：扎鲁替尼扩展研究的报告

Publication #3031

出版物#3031

Poster

海报

Dec. 8, 6-8 p.m.

12月8日下午6-8点。

S. D’Sa

S、 德萨

Patient medication preferences in follicular lymphoma (FL) in the United States (USA): A discrete choice experiment (DCE)

美国滤泡性淋巴瘤（FL）患者的药物偏好：离散选择实验（DCE）

Publication #3655

出版物#3655

Poster

海报

Dec. 8, 6-8 p.m.

12月8日下午6-8点。

S. Gaballa

S.Gaballa

Evaluating reasons for differences in real-world (RW) clinical outcomes among patients with R/R MCL on covalent BTKis

评估共价BTKis上R/R MCL患者现实世界（RW）临床结局差异的原因

Publication #3732

出版物#3732

Poster

海报

Dec. 8, 6-8 p.m.

12月8日下午6-8点。

T. Phillips

T、 菲利普斯

Sustained superiority of zanubrutinib vs bendamustine + rituximab in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL): 5-year follow-up of cohort 1 from the SEQUOIA study

扎鲁替尼与苯达莫司汀+利妥昔单抗治疗初治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（TN CLL）的持续优势：红杉研究队列1的5年随访

Publication #3249

出版物#3249

Poster

海报

Dec. 8, 6-8 p.m.

12月8日下午6-8点。

M. Shadman

M、 沙德曼

Deep and sustained responses in patients with CLL treated with zanubrutinib or zanubrutinib + obinutuzumab in phase 1/2 AU-003 and phase 1b GA-101 studies: A report from the zanubrutinib extension study

Publication #3255

出版物#3255

Poster

海报

Dec. 8, 6-8 p.m.

12月8日下午6-8点。

C. Tam

C、 塔姆

Comparative efficacy of zanubrutinib plus obinutuzumab versus last prior treatment in relapsed/refractory follicular lymphoma: Growth modulation index analysis from ROSEWOOD study

扎鲁替尼联合奥比妥珠单抗与上次治疗复发/难治性滤泡性淋巴瘤的疗效比较：来自ROSEWOOD研究的生长调节指数分析

Publication #3029

出版物#3029

Poster

海报

Dec. 8, 6-8 p.m.

12月8日下午6-8点。

J. Trotman

J、 特罗特曼

Impact of novel therapies (NTs) on real-world (RW) clinical outcomes of patients (pts) with relapsed/refractory (R/R) mantle-cell lymphoma (MCL) by race/ethnicity and TP53 mutation status

新疗法（NTs）对种族/民族和TP53突变状态的复发/难治性（R/R）套细胞淋巴瘤（MCL）患者（pts）现实世界（RW）临床结局的影响

Publication #5097

出版物#5097

Poster

海报

Dec. 9, 6-8 p.m.

12月9日下午6-8点。

T. Phillips

T、 菲利普斯

Zanubrutinib is well tolerated and effective in acalabrutinib-intolerant patients with B-cell malignancies

扎那鲁替尼对不耐受阿卡拉鲁替尼的B细胞恶性肿瘤患者具有良好的耐受性和有效性

Publication #4632

出版物#4632

Poster

海报

Dec. 9, 6-8 p.m.

12月9日下午6-8点。

M. Shadman

M、 沙德曼

Long-term impact of dose interruptions (DIs) of Bruton tyrosine kinase inhibitors (BTKis) on change in IgM levels and clinical outcomes in Waldenström macroglobulinemia (WM)

布鲁顿酪氨酸激酶抑制剂（BTKis）剂量中断（DI）对Waldenström巨球蛋白血症（WM）IgM水平变化和临床结局的长期影响

Publication #4412

出版物#4412

Poster

海报

Dec. 9, 6-8 p.m.

12月9日下午6-8点。

J. Trotman

J、 特罗特曼

Final analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma

扎鲁替尼联合来那度胺治疗复发/难治性弥漫性大B细胞淋巴瘤患者的1期研究最终分析

Publication #986

出版物#986

Oral

口头

Dec. 9, 4:45 p.m.

12月9日下午4:45。

Z. Song

Z、 歌曲

Treatment with zanubrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with another Bruton tyrosine kinase inhibitor in a US community oncology setting

在美国社区肿瘤学环境中，曾接受另一种布鲁顿酪氨酸激酶抑制剂治疗的慢性淋巴细胞白血病或小淋巴细胞淋巴瘤患者使用扎鲁替尼治疗

Publication #7763

出版物#7763

Online

在线

D. Andorsky

D.安多斯基

BGB-16673 (BTK CDAC)

BGB-16673（BTK-CDAC）

Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory (R/R) indolent NHL: Results from the phase 1 CaDAnCe-101 study

布鲁顿酪氨酸激酶降解剂BGB-16673对复发或难治性（R/R）惰性NHL患者的初步疗效和安全性：CaDAnCe-101期研究的结果

Publication #1649

出版物#1649

Poster

海报

Dec. 7, 5:30-7:30 p.m.

12月7日下午5:30-7:30。

C. Tam

C、 塔姆

Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory Waldenström macroglobulinemia: Results from the phase 1 CaDAnCe-101 study

布鲁顿酪氨酸激酶降解剂BGB-16673在复发或难治性Waldenström巨球蛋白血症患者中的初步疗效和安全性：第一阶段CaDAnCe-101研究的结果

Publication #860

出版物#860

Oral

口头

Dec. 9, 3 p.m.

12月9日下午3点。

J. Seymour

J、 西摩

Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the phase 1 CaDAnCe-101 study

布鲁顿酪氨酸激酶降解剂BGB-16673在复发或难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者中的初步疗效和安全性：CaDAnCe-101期研究的结果

Publication #885

出版物#885

Oral

口头

Dec. 9, 3:15 p.m.

12月9日下午3:15。

M. Thompson

M、 汤普森

BGB-16673, a selective BTK degrader, exhibits deeper inhibition of cancer cell signaling pathways and better efficacy in MCL models

选择性BTK降解剂BGB-16673在MCL模型中表现出对癌细胞信号通路的更深入抑制和更好的疗效

Publication #5833

出版物#5833

Online

在线

H. Wang

H、 王

Sonrotoclax (BCL2 Inhibitor)

Sonrotoclax（BCL2抑制剂）

Sonrotoclax and zanubrutinib as frontline treatment for CLL demonstrates high MRD clearance rates with good tolerability: Data from an ongoing phase 1/1b study BGB-11417-101

Sonrotoclax和zanubrutinib作为CLL的一线治疗显示出高MRD清除率和良好的耐受性：来自正在进行的1/1b期研究BGB-11417-101的数据

Publication #1012

出版物#1012

Oral

口头

Dec. 9, 5:15 p.m.

。

J. Soumerai

J.Soumerai

CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive CLL

天球TNCLL：一项正在进行的，开放标签的，多区域的sonrotoclax（BGB-11417）+zanubrutinib与venetoclax+obinutuzumab治疗初治CLL的3期研究

Publication #6807

出版物#6807

Online

在线

P. Patten

P、 图案

BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia

BGB-11417-203，一项正在进行的下一代BCL2抑制剂sonrotoclax（BGB-11417）的2期研究，用于Waldenström巨球蛋白血症患者

Publication #6289

出版物#6289

Online

在线

H. Lee

H、 李

Cell Therapy Research

细胞疗法研究

iPSC-derived CAR-γδT with SOCS1/CISH/BIM/FAS combinatorial KO demonstrated extended longevity and profound anti-tumor efficacy without cytokine support in preclinical studies

在临床前研究中，iPSC衍生的具有SOCS1/CISH/BIM/FAS组合KO的CAR-γδT在没有细胞因子支持的情况下表现出延长的寿命和深远的抗肿瘤功效

Publication #4790

出版物#4790

Poster

海报

Dec. 7, 5:30-7:30 p.m.

12月7日下午5:30-7:30。

J. Yu

J、 于

Select Investigator-Initiated Trial

选择调查员发起的试验

Multicenter Phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in treatment-naïve chronic lymphocytic leukemia: 5-year follow up, retreatment outcomes, and impact of MRD kinetics (ΔMRD400)

扎鲁替尼、奥比妥珠单抗和venetoclax（BOVen）治疗初治慢性淋巴细胞白血病的多中心II期临床试验：5年随访、再治疗结果和MRD动力学的影响（MRD400）

Publication #1867

出版物#1867

Poster

海报

Dec. 7, 5:30-7:30 p.m.

12月7日下午5:30-7:30。

J. Soumerai

J.Soumerai

About BRUKINSA® (zanubrutinib)

关于布鲁金萨® （扎努布鲁替尼）

BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues..

BRUKINSA是一种口服的布鲁顿酪氨酸激酶（BTK）小分子抑制剂，旨在通过优化生物利用度，半衰期和选择性来完全和持续地抑制BTK蛋白。与其他批准的BTK抑制剂相比，BRUKINSA具有不同的药代动力学，已被证明可抑制许多疾病相关组织中恶性B细胞的增殖。。

BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. The global BRUKINSA clinical development program includes about 6,000 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 70 markets, and more than 100,000 patients have been treated globally..

BRUKINSA在全球范围内拥有最广泛的BTK抑制剂标签，是唯一一种能够提供每日一次或两次给药灵活性的BTK抑制剂。全球BRUKINSA临床开发计划包括在30个国家和地区进行的35多项试验中招募的约6000名患者。BRUKINSA已在70多个市场获得批准，全球已有100000多名患者接受治疗。。

U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib)

U、 美国BRUKINSA（zanubrutinib）的适应症和重要安全信息

INDICATIONS

适应症

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

BRUKINSA是一种激酶抑制剂，用于治疗成年患者：

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）。

Waldenström’s macroglobulinemia (WM).

瓦尔登斯特伦巨球蛋白血症（WM）。

Mantle cell lymphoma (MCL) who have received at least one prior therapy.

至少接受过一次治疗的套细胞淋巴瘤（MCL）。

Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

接受至少一种基于抗CD20的方案的复发或难治性边缘区淋巴瘤（MZL）。

Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.

复发或难治性滤泡性淋巴瘤（FL）联合obinutuzumab，经过两种或更多种全身治疗后。

The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

MCL、MZL和FL指示是根据总体响应率和响应持久性在加速批准下批准的。。

IMPORTANT SAFETY INFORMATION

重要安全信息

Warnings and Precautions

警告和注意事项

Hemorrhage

出血

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients.

BRUKINSA治疗的血液系统恶性肿瘤患者发生致命和严重出血。在临床试验中，3.8%的BRUKINSA治疗患者报告了3级或更高级别的出血，包括颅内和胃肠道出血，血尿和血胸，死亡率为0.2%。

Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients..

32%的患者发生任何程度的出血，不包括紫癜和瘀斑。。

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

有或没有伴随抗血小板或抗凝治疗的患者发生出血。BRUKINSA与抗血小板或抗凝药物的共同给药可能会进一步增加出血的风险。

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

监测出血的迹象和症状。如果发生任何级别的颅内出血，请停止使用BRUKINSA。根据手术类型和出血风险，考虑手术前后3-7天停用布鲁金莎的益处风险。

Infections

感染

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients.

。26%的患者发生3级或更高级别的感染，最常见的是肺炎（7.9%），3.2%的患者发生致命感染。

Infections due to hepatitis B virus (HBV) reactivation have occurred..

乙型肝炎病毒（HBV）再激活引起的感染已经发生。。

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

根据感染风险增加的患者的护理标准，考虑预防单纯疱疹病毒，肺孢子虫肺炎和其他感染。监测和评估患者的发烧或其他感染迹象和症状，并进行适当治疗。

Cytopenias

血细胞减少

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

根据实验室测量，在接受BRUKINSA治疗的患者中出现了3或4级血细胞减少症，包括中性粒细胞减少症（21%），血小板减少症（8%）和贫血（8%）。10%的患者发生4级中性粒细胞减少症，2.5%的患者发生4级血小板减少症。

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

在治疗期间定期监测全血细胞计数，并中断治疗，减少剂量或根据需要停止治疗。根据需要使用生长因子或输血治疗。

Second Primary Malignancies

第二原发恶性肿瘤

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%).

BRUKINSA治疗的患者中有14%发生了第二原发性恶性肿瘤，包括非皮肤癌。最常见的第二原发性恶性肿瘤是非黑色素瘤皮肤癌（8%），其次是7%的患者中的其他实体瘤（包括1%的患者中的黑色素瘤）和血液系统恶性肿瘤（0.7%）。

Advise patients to use sun protection and monitor patients for the development of second primary malignancies..

建议患者使用防晒霜并监测患者第二原发性恶性肿瘤的发展。。

Cardiac Arrhythmias

心律不正

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk.

BRUKINSA治疗的患者发生了严重的心律失常。BRUKINSA治疗的患者中有4.4%报告有心房颤动和心房扑动，其中1.9%的患者为3级或更高级别。有心脏危险因素，高血压和急性感染的患者可能会增加风险。

Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients..

0.3%的患者报告有3级或更高级别的室性心律失常。。

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

监测心律失常的体征和症状（例如心悸，头晕，晕厥，呼吸困难，胸部不适），进行适当管理，并考虑持续BRUKINSA治疗的风险和益处。

Hepatotoxicity, Including Drug-Induced Liver Injury

肝毒性，包括药物引起的肝损伤

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.

用布鲁顿酪氨酸激酶抑制剂（包括布鲁金莎）治疗的患者发生了肝毒性，包括严重，危及生命和可能致命的药物性肝损伤（DILI）病例。

Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA..

在基线和整个BRUKINSA治疗期间评估胆红素和转氨酶。。如果怀疑帝力，扣留布鲁金萨。在确认帝力后，停止使用布鲁金萨。。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily.

根据在动物身上的发现，布鲁金莎给孕妇服用时会对胎儿造成伤害。在器官发生期间向怀孕大鼠施用扎鲁替尼会导致胚胎-胎儿毒性，包括暴露时的畸形，比推荐剂量160 mg的患者每天两次报告的畸形高5倍。

Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus..

建议女性在服用BRUKINSA和最后一剂后1周内避免怀孕。建议男性在治疗期间和最后一次给药后1周内避免生孩子。。。

Adverse Reactions

不良反应

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

接受BRUKINSA治疗的患者（N=1729）最常见的不良反应（≥30%），包括实验室异常，是中性粒细胞计数减少（51%），血小板计数减少（41%），上呼吸道感染（38%），出血（32%）和肌肉骨骼疼痛（31%）。

Drug Interactions

药物相互作用

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A抑制剂：当BRUKINSA与强CYP3A抑制剂共同给药时，每天一次将BRUKINSA剂量减少至80 mg。对于与中度CYP3A抑制剂共同给药，每天两次将BRUKINSA剂量减少至80 mg。

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

CYP3A诱导剂：避免与强或中度CYP3A诱导剂共同给药。建议使用中度CYP3A诱导剂进行剂量调整。

Specific Populations

特定人群

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

肝功能损害：严重肝功能损害患者推荐的BRUKINSA剂量为80 mg，每日两次口服。

Please see full U.S. Prescribing Information including U.S. Patient Information.

请参阅完整的美国处方信息，包括美国患者信息。

About BeiGene

关于BeiGene

BeiGene 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.

BeiGene是一家全球肿瘤学公司，正在发现和开发创新的治疗方法，这些治疗方法对全球癌症患者来说更实惠、更容易获得。凭借广泛的投资组合，我们正在通过内部能力和合作，加快开发多样化的新型治疗药物。

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

我们致力于从根本上改善更多需要药物的患者获得药物的机会。我们不断壮大的全球团队拥有10000多名员工，跨越五大洲。要了解更多关于BeiGene的信息，请访问www.BeiGene.com，并在LinkedIn、X（以前称为Twitter）、Facebook和Instagram上关注我们。。

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 continued leadership in hematology and commitment to bringing innovative medicines to as many people with cancer as possible; the safety and efficacy of BeiGene’s pipeline assets; 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; 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 wit.

本新闻稿包含1995年《私人证券诉讼改革法案》和其他联邦证券法所指的前瞻性声明，包括关于贝基因在血液学领域的持续领导地位以及致力于为尽可能多的癌症患者提供创新药物的声明；贝基因管道资产的安全性和有效性；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证明其候选药物有效性和安全性的能力，实际结果可能与前瞻性声明中所示的结果存在实质性差异；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，可能会影响临床试验和上市批准的启动，时间和进度；BeiGene的上市药物和候选药物取得商业成功的能力（如果获得批准）；BeiGene获得和维护其药物和技术知识产权保护的能力；BeiGene依赖第三方进行药物开发、制造、商业化和其他服务；BeiGene在获得监管批准和药品商业化方面的经验有限；；这些风险在BeiGene最近的10-Q表季度报告中题为“风险因素”的部分中得到了更充分的讨论，以及BeiGene随后提交的文件中对潜在风险、不确定性和其他重要因素的讨论。