SAN MATEO, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending an extended authorization for TEVIMBRA® (tislelizumab) in gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC)..

加利福尼亚州圣马特奥（商业新闻短讯）--全球肿瘤学公司BeiGene，Ltd.（纳斯达克：BGNE；香港交易所：06160；苏格兰证券交易所：688235）今天宣布，欧洲药品管理局（European Medicines Agency）人用药品委员会（CHMP）发表了积极意见，建议在胃或胃食管交界处（G/GEJ）腺癌和食管鳞状细胞癌（ESCC）中延长TEVIMBRA®（tislelizumab）的授权。。

In G/GEJ adenocarcinoma, the CHMP positive opinion is for TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%.

在G/GEJ腺癌中，CHMP阳性意见是TEVIMBRA联合铂类和氟嘧啶类化疗用于HER2阴性局部晚期不可切除或转移性G/GEJ癌的成年患者的一线治疗，其肿瘤表达PD-L1，肿瘤面积阳性（TAP）评分≥5%。

In ESCC, the CHMP positive opinion is for TEVIMBRA in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors express PD-L1 with a TAP score ≥ 5%..

在ESCC中，CHMP的积极意见是将TEVIMBRA与铂类化疗联合用于无法切除，局部晚期或转移性ESCC的成年患者的一线治疗，这些患者的肿瘤表达PD-L1，TAP评分≥5%。。

“Survival rates in the advanced stages of gastric/gastroesophageal and esophageal cancers are among the lowest of all cancer types despite recent advances, and new treatment options are needed,” said Prof. Florian Lordick, Director and Professor of Oncology of the University Cancer Center Leipzig, Germany.

德国莱比锡大学癌症中心主任兼肿瘤学教授FlorianLordick教授说：“尽管取得了最新进展，但晚期胃癌/胃食管癌和食管癌的生存率在所有癌症类型中最低，需要新的治疗选择。”。

“The RATIONALE-305 and 306 trials showed that tislelizumab plus chemotherapy improved survival compared to treatment with placebo plus chemotherapy, highlighting its potential to deliver better outcomes for eligible patients.”.

“TRIANCE-305和306试验显示，与安慰剂加化疗相比，tislelizumab加化疗改善了生存率，突出了其为符合条件的患者提供更好结果的潜力。”。

“TEVIMBRA is foundational for BeiGene’s solid tumor portfolio. In line with our commitment to help patients affected by cancer in Europe and across the globe, we recently launched TEVIMBRA in the EU for eligible patients in both the first- and second-line NSCLC settings and second-line ESCC,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene.

“TEVIMBRA是BeiGene实体瘤投资组合的基础。根据我们帮助欧洲和全球癌症患者的承诺，我们最近在欧盟推出了TEVIMBRA，用于一线和二线NSCLC以及二线ESCC的合格患者，”BeiGene实体瘤首席医疗官马克·拉纳萨（Mark Lanasa）医学博士说。

“With these CHMP opinions, we are one step closer to bringing this innovative therapy to eligible patients with untreated G/GEJ cancer and ESCC , who face a poor prognosis and limited treatment options.”.

“有了这些CHMP的意见，我们离将这种创新疗法带给未经治疗的G/GEJ癌症和ESCC的合格患者又近了一步，这些患者的预后较差，治疗选择有限。”。

The extension of indication application for first-line G/GEJ cancer is based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase 3 trial to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for patients with advanced unresectable or metastatic G/GEJ cancer.

一线G/GEJ癌症适应症应用的扩展是基于BeiGene的Rational-305（NCT03777657）的结果，这是一项随机，双盲，安慰剂对照的全球3期临床试验，旨在评估TEVIMBRA联合化疗作为晚期不可切除或转移性G/GEJ癌症患者的一线治疗的疗效和安全性。

The study enrolled 997 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with TEVIMBRA in combination with investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in the risk of death.

该研究在欧洲、北美和亚太地区的研究中心招募了997名患者。该研究达到了其主要终点，并证明了统计学上显着且临床上有意义的总生存期（OS）益处，TEVIMBRA联合研究者选择的化疗患者的中位OS为15.0个月，而安慰剂加化疗患者的中位OS为12.9个月（n=997；HR:0.80[95%CI:0.70,0.92]；P=0.0011），导致死亡风险降低20%。

In the PD-L1 ≥ 5% population, the median OS was 16.4 months for TEVIMBRA plus chemotherapy compared to 12.8 months for the placebo arm (HR: 0.71 [95% CI, 0.58-0.86]), which represents a 29% reduction in the risk of death..

在PD-L1≥5%的人群中，TEVIMBRA加化疗的中位OS为16.4个月，而安慰剂组为12.8个月（HR:0.71[95%CI，0.58-0.86]），死亡风险降低29%。。

The extension of indication application for first-line ESCC is based on results from BeiGene’s RATIONALE-306 (NCT03783442), a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment in patients with unresectable, locally advanced recurrent or metastatic ESCC.

一线ESCC适应症应用的扩展是基于BeiGene的Rational-306（NCT03783442）的结果，这是一项随机，安慰剂对照，双盲，全球3期研究，旨在评估替维布拉联合化疗作为不可切除，局部晚期复发或转移性ESCC患者的一线治疗的疗效和安全性。

The study enrolled 649 patients at research centers across Europe, North America and Asia-Pacific. The study met its primary endpoint, with first-line TEVIMBRA in combination with chemotherapy resulting in statistically significant and clinically meaningful OS benefit compared with placebo plus chemotherapy in the intent-to-treat population.

该研究在欧洲、北美和亚太地区的研究中心招募了649名患者。该研究达到了其主要终点，一线TEVIMBRA联合化疗与安慰剂加化疗相比，在意向治疗人群中产生了统计学上显着且临床上有意义的OS益处。

The median OS was 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo plus chemotherapy (HR: 0.66 [95% CI, 0.54-0.80, 1-sided p-value of < 0.0001]), a 34% reduction in the risk of death. Three-year OS in the PD-L1 ≥ 5% population was also substantially improved in favor of the TEVIMBRA arm (median 19.1 versus 10.0 months, respectively; HR: 0.62 [95% CI, 0.49-0.79]), demonstrating a 38% reduction in the risk of death..

TEVIMBRA联合化疗的中位OS为17.2个月，而安慰剂联合化疗的中位OS为10.6个月（HR:0.66[95%CI，0.54-0.80，单侧p值<0.0001]），死亡风险降低34%。PD-L1≥5%人群的三年OS也显着改善，有利于TEVIMBRA组（中位数分别为19.1和10.0个月；HR:0.62[95%CI，0.49-0.79]），表明死亡风险降低了38%。。

The safety data in the applications included 1,534 patients who received TEVIMBRA monotherapy at the approved dosing regimen, and 1,319 patients with G/GEJ cancer, ESCC or NSCLC who received TEVIMBRA at the approved dosing regimen (200 mg every 3 weeks) in combination with various chemotherapies. The most common Grade 3 or 4 adverse reactions for TEVIMBRA given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, pneumonitis, and hepatitis..

应用中的安全性数据包括1534名在批准的给药方案下接受TEVIMBRA单药治疗的患者，以及1319名在批准的给药方案（每3周200 mg）下接受TEVIMBRA治疗的G/GEJ癌症，ESCC或NSCLC患者。各种化疗。TEVIMBRA联合化疗最常见的3或4级不良反应是中性粒细胞减少症，血小板减少症，贫血，疲劳，低钾血症，低钠血症，肺炎，食欲下降，皮疹，淋巴细胞减少，丙氨酸氨基转移酶升高，天冬氨酸氨基转移酶升高，腹泻，肺炎和肝炎。。

TEVIMBRA is approved in the EU for eligible patients with advanced or metastatic ESCC after prior platinum-based chemotherapy and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings.

TEVIMBRA在欧盟被批准用于先前铂类化疗后符合条件的晚期或转移性ESCC患者，以及涵盖一线和二线治疗的三种非小细胞肺癌（NSCLC）适应症。

About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma

关于胃和胃食管交界处（G/GEJ）腺癌

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer mortality.1 Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. Gastroesophageal junction adenocarcinoma occurs at the area where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).2.

胃癌是全球第五大常见癌症，也是癌症死亡率第五高的主要原因。1 2022年，近100万新患者被诊断出患有胃癌，全球报告有66万人死亡。胃食管交界处腺癌发生在食管与胃连接的区域，该区域位于膈肌（肺下呼吸肌的薄层）下方。

About Esophageal Squamous Cell Carcinoma (ESCC)

关于食管鳞状细胞癌（ESCC）

Globally, esophageal cancer (EC) is the sixth most common cause of cancer-related deaths, and ESCC is the most common histologic subtype, accounting for nearly 90% of ECs. An estimated 957,000 new EC cases are projected in 2040, an increase of nearly 60% from 2020, underscoring the need for additional effective treatments.3 EC is a rapidly fatal disease, and more than two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.4.

在全球范围内，食管癌（EC）是癌症相关死亡的第六大常见原因，ESCC是最常见的组织学亚型，占EC的近90%。预计2040年将有957000例新发EC病例，比2020年增加近60%，强调需要额外的有效治疗。EC是一种快速致命的疾病，超过三分之二的患者在诊断时患有晚期或转移性疾病，远处转移患者的预期五年生存率不到6%。

About TEVIMBRA (Tislelizumab)

关于TEVIMBRA（tislelizumab）

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors..

TEVIMBRA是一种独特设计的人源化免疫球蛋白G4（IgG4）抗程序性细胞死亡蛋白1（PD-1）单克隆抗体，对PD-1具有高亲和力和结合特异性。它旨在最大程度地减少与巨噬细胞上Fcγ（Fcγ）受体的结合，有助于帮助身体的免疫细胞检测和对抗肿瘤。。

Important Safety Information

重要安全信息

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

欧洲药品管理局（European Medicines Agency）提供了TEVIMBRA当前的欧洲产品特性总结（SmPC）。

This information is intended for a global audience. Product indications vary by region.

此信息面向全球受众。产品适应症因地区而异。

About 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 tislelizumab’s potential to deliver better outcomes for eligible patients; 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 BeiGene's subsequent filings with the U.S.

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tislelizumab为符合条件的患者提供更好结果的潜力的声明；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，并且能够获得额外的运营资金，完成候选药物的开发，实现和维持盈利能力；。

Securities and Exchange Commission. All information in this press release is as of the date of this press r.

证券交易委员会。。

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1 Ferlay J，Ervik M，Lam F，Laversanne M，Colombet M，Mery L，Piñeros M，Znaor A，Soerjomataram I，Bray F（2020）。全球癌症观察站：今日癌症。。可从以下地址获得：https://gco.iarc.who.int/today.2024年2月9日访问。

2 American Cancer Society. What Is Stomach Cancer? https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.

。什么是胃癌？https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html.

3 Morgan E, et al. The Global Landscape of Esophageal Squamous Cell Carcinoma and Esophageal Adenocarcinoma Incidence and Mortality in 2020 and Projections to 2040: New Estimates From GLOBOCAN 2020. Gastroenterology. 2022 Sep;163(3):649-658.e2. doi: 10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4. PMID: 35671803..

3 Morgan E，et al。2020年食管鳞状细胞癌和食管腺癌发病率和死亡率的全球格局以及到2040年的预测：GLOBOCAN 2020年的新估计。胃肠病学。2022年9月；163（3）：649-658.e2。doi:10.1053/j.gastro.2022.05.054。Epub 2022年6月4日。。。

4 National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html.

4国家癌症研究所。癌症统计事实：食道癌。https://seer.cancer.gov/statfacts/html/esoph.html.