中国国家药品监督管理局（NMPA）批准VYLOYTM（唑贝妥昔单抗）用于晚期胃或胃食管交界处腺癌的一线治疗-动脉网

China’s National Medical Products Administration (NMPA) Approves VYLOYTM (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

安斯泰来等信源发布 2025-01-06 15:01

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可切换为仅中文

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- China has the highest number of cases and deaths from gastric cancer of any country worldwide

-（笑声）

- Zolbetuximab is the first and only therapy approved in China to target claudin 18.2, a biomarker expressed by 35% of Chinese patients with advanced gastric and gastroesophageal junction (GEJ) cancer

-唑倍妥昔单抗是中国批准的第一种也是唯一一种靶向claudin 18.2的疗法，claudin 18.2是一种生物标志物，在中国35%的晚期胃癌和胃食管癌患者中表达

-（笑声）

- Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in the Phase 3 GLOW and SPOTLIGHT trials

-在3期GLOW和SPOTLIGHT试验中，用claudin 18.2靶向单克隆抗体治疗显示可显着延长无进展生存期和总生存期

3,4

-（笑声）

TOKYO, Jan. 06, 2025

东京，2025年1月6日

– Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved VYLOY

–Astellas Pharma Inc.（TSE:4503，总裁兼首席执行官：冈村直树，“Astellas”）今天宣布，中国国家医药产品管理局（NMPA）已批准VYLOY

TM公司

(zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.

（唑倍妥昔单抗）联合含氟嘧啶和铂类化疗，用于局部晚期不可切除或转移性人表皮生长因子受体2（HER2）阴性胃或胃食管交界处（GEJ）腺癌患者的一线治疗，其肿瘤为claudin（CLDN）18.2阳性。

Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment..

Zolbetuximab是NMPA批准的第一种靶向表达生物标志物CLDN18.2的胃肿瘤细胞的单克隆抗体，为癌症治疗提供了高度靶向的方法。。

Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported from the disease in 2022.

胃癌是中国癌症相关死亡的第三大原因，2022年该病报告死亡人数超过260000人。

As early symptoms are often hard to detect, approximately 60% of Chinese patients are diagnosed at the advanced stage of the disease

由于早期症状通常很难发现，因此大约60%的中国患者被诊断为疾病晚期

where treatment options are limited and outcomes are often poor. The average five-year survival rate for patients with advanced gastric cancer in China is 9.1%, driving the urgent need for novel therapeutic options that can slow disease progression and extend lives.

治疗选择有限，结果往往很差。中国晚期胃癌患者的平均五年生存率为9.1%，迫切需要能够减缓疾病进展和延长寿命的新型治疗选择。

Professor Xu Ruihua, Lead Primary Investigator of the Phase 3 GLOW Study, Director of the Cancer Prevention and Treatment Center of Sun Yat-sen University, President of the Chinese Society of Clinical Oncology (CSCO):

徐瑞华教授，GLOW 3期研究首席首席研究员，中山大学癌症防治中心主任，中国临床肿瘤学会（CSCO）会长：

“Approximately 30% of patients enrolled in the global Phase 3 GLOW trial were from mainland China. The results of this study demonstrated that the combination of zolbetuximab and chemotherapy provided significant survival benefits to patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction (GEJ) cancers.

“参加全球3期GLOW试验的患者中约有30%来自中国大陆。这项研究的结果表明，唑倍妥昔单抗联合化疗对CLDN18.2阳性，HER2阴性的晚期胃癌和胃食管癌（GEJ）患者提供了显着的生存益处。

The analysis of the China subgroup data showed that Chinese gastric cancer patients benefited substantially in terms of both survival and quality of life. We are excited that the NMPA has approved zolbetuximab, which will provide a valuable and effective first-line treatment option for patients with advanced gastric cancer in China.”.

对中国亚组数据的分析表明，中国胃癌患者在生存率和生活质量方面都受益匪浅。我们很高兴NMPA已经批准了唑倍妥昔单抗，这将为中国晚期胃癌患者提供有价值和有效的一线治疗选择。”。

Professor Xu Jianming, Lead Primary Investigator of the Phase 3 SPOTLIGHT Study in China, Fifth Medical Center of the Chinese People's Liberation Army General Hospital:

中国人民解放军总医院第五医学中心中国第三阶段聚光灯研究首席研究员徐建明教授：

“We are extremely encouraged that the NMPA has approved zolbetuximab in China. The SPOTLIGHT study explored the efficacy and safety of zolbetuximab combined with chemotherapy as a first-line treatment for patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction cancer.

“NMPA在中国批准了唑倍妥昔单抗，我们深感鼓舞。SPOTLIGHT研究探讨了唑倍妥昔单抗联合化疗作为CLDN18.2阳性，HER2阴性晚期胃癌和胃食管交界癌患者的一线治疗的有效性和安全性。

The results showed statistically significant differences in key endpoints such as progression-free survival and overall survival. The survival and safety benefits seen in the China subgroup were consistent with the global trial population, and the results are expected to have far-reaching implications for meeting the clinical needs of Chinese patients with advanced gastric cancer.

结果显示关键终点（如无进展生存期和总生存期）的统计学显着差异。在中国亚组中观察到的生存和安全益处与全球试验人群一致，预计结果将对满足中国晚期胃癌患者的临床需求产生深远影响。

The trial provides valuable insights to guide the first-line treatment of advanced gastric cancer in China.”.

该试验为指导中国晚期胃癌的一线治疗提供了有价值的见解。”。

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas:

Moitreyee Chatterjee Kishore博士，工商管理硕士，高级副总裁兼免疫肿瘤学发展负责人，Astellas：

“Approximately 35% of Chinese patients with advanced and metastatic gastric and GEJ cancers have tumors that positively express CLDN18.2. By specifically targeting this biomarker with zolbetuximab we are able to stimulate selective cell death, reducing the overall number of CLDN18.2-positive cells in a tumor.

“大约35%的中国晚期和转移性胃癌和GEJ癌患者的肿瘤阳性表达CLDN18.2。。

The NMPA approval of zolbetuximab offers a new precision medicine for first-line use in China, supporting our ongoing ambition to drive progress and innovation in cancer care.”.

NMPA对唑倍妥昔单抗的批准为中国的一线使用提供了一种新的精准药物，支持了我们推动癌症治疗进步和创新的持续雄心。”。

The NMPA’s approval of zolbetuximab is supported by data from the global Phase 3 GLOW and SPOTLIGHT clinical trials which included 145 and 36 patients from mainland China, respectively.

NMPA对唑倍妥昔单抗的批准得到了全球3期GLOW和SPOTLIGHT临床试验数据的支持，该试验分别包括来自中国大陆的145名和36名患者。

3,4

The GLOW trial evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX.

GLOW试验评估了唑倍妥昔单抗联合CAPOX（包括卡培他滨和奥沙利铂的联合化疗方案）与安慰剂加CAPOX相比。

The SPOTLIGHT trial evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6.

SPOTLIGHT试验评估了唑倍妥昔单抗加mFOLFOX6（包括奥沙利铂，亚叶酸钙和氟尿嘧啶的联合方案）与安慰剂加mFOLFOX6相比。

Treatment with zolbetuximab was shown to provide statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers.

与符合条件的胃癌和GEJ癌症患者的其他标准化疗相比，唑倍妥昔单抗治疗显示出无进展生存期（PFS）和总生存期（OS）的统计学显着改善。

3,4

In the GLOW trial, a median PFS of 8.21 months was achieved with zolbetuximab plus CAPOX as first-line treatment versus 6.80 months with placebo plus CAPOX. The median OS was 14.39 months versus 12.16 months in the respective treatment groups.

在GLOW试验中，唑倍妥昔单抗加CAPOX作为一线治疗的中位PFS为8.21个月，而安慰剂加CAPOX为6.80个月。中位OS为14.39个月，而各治疗组为12.16个月。

Similar efficacy results were seen in the SPOTLIGHT trial, where the median PFS was 10.61 months versus 8.67 months, and the median OS was 18.23 months versus 15.54 months, with zolbetuximab plus mFOLFOX6, compared to placebo plus mFOLFOX6.

在SPOTLIGHT试验中观察到类似的疗效结果，与安慰剂加mFOLFOX6相比，唑倍妥昔单抗加mFOLFOX6的中位PFS为10.61个月，中位OS为18.23个月，中位OS为15.54个月。

In both the GLOW and SPOTLIGHT trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite..

在GLOW和SPOTLIGHT试验中，与对照组相比，唑倍妥昔单抗治疗组严重治疗紧急不良事件（TEAE）的发生率相似。唑倍妥昔单抗治疗组报告的最常见的全级TEAE是恶心，呕吐和食欲下降。。

3,4

Astellas has already reflected the impact from the NMPA approval of zolbetuximab in its financial forecast for the current fiscal year ending March 31, 2025.

Astellas已经在其截至2025年3月31日的当前财政年度的财务预测中反映了NMPA批准唑倍妥昔单抗的影响。

About Locally Advanced Unresectable Metastatic Gastric and Gastroesophageal Junction Cancer

关于局部晚期不可切除的转移性胃和胃食管交界癌

Gastric and gastroesophageal junction (G/GEJ) cancers are known to be histologically similar, are recommended to be managed in the same way in treatment guidelines, and frequently display aligned responses to treatment.

已知胃和胃食管交界处（G/GEJ）癌症在组织学上相似，建议在治疗指南中以相同的方式进行治疗，并且经常显示出对治疗的一致反应。

Across China, more than 358,000 new cases of gastric cancer were diagnosed in 2022.

2022年，中国共诊断出358000多例胃癌新病例。

Gastric cancer is the third most common cause of cancer-related mortality in China, responsible for more than 260,000 deaths in 2022.

。

GEJ adenocarcinomas start in the first two inches (5 cm) where the esophagus joins the stomach.

GEJ腺癌始于食道与胃连接的前两英寸（5厘米）。

Because early-stage cancer symptoms frequently overlap with more common stomach-related conditions, G/GEJ cancers are often diagnosed in the advanced or metastatic stage, or once they have spread from the tumor’s origin to other body tissues or organs.

由于早期癌症症状经常与更常见的胃相关疾病重叠，因此G/GEJ癌症通常在晚期或转移阶段被诊断出来，或者一旦它们从肿瘤起源扩散到其他身体组织或器官。

Early signs and symptoms can include indigestion or heartburn, pain or discomfort in the abdomen, nausea and vomiting, bloating of the stomach after meals, and loss of appetite.

早期的体征和症状可能包括消化不良或胃灼热，腹部疼痛或不适，恶心和呕吐，饭后胃胀以及食欲不振。

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Signs of more advanced G/GEJ cancer can include unexplained weight loss, weakness and fatigue, sensation of food getting stuck in the throat while eating, vomiting blood or having blood in the stool.

更晚期的G/GEJ癌症的迹象可能包括无法解释的体重减轻，虚弱和疲劳，进食时食物卡在喉咙里的感觉，吐血或大便中有血。

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Risk factors associated with G/GEJ cancer can include older age, male gender, family history,

与G/GEJ癌症相关的危险因素可能包括年龄较大，男性，家族史，

H. pylori

H、幽门螺杆菌

infection, smoking, and gastroesophageal reflux disease (GERD).

感染，吸烟和胃食管反流病（GERD）。

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About the GLOW Phase 3 Clinical Trial

关于GLOW 3期临床试验

GLOW is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive.

GLOW是一项3期全球多中心双盲随机研究，评估唑倍妥昔单抗联合CAPOX（包括卡培他滨和奥沙利铂的联合化疗方案）与安慰剂联合CAPOX作为一线治疗局部晚期不可切除或转移性HER2阴性胃癌或GEJ腺癌患者的疗效和安全性，这些患者的肿瘤为CLDN18.2阳性。

The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America, and Asia, including Japan. The primary endpoint is PFS in participants treated with the combination of zolbetuximab plus CAPOX compared to those treated with placebo plus CAPOX. Secondary endpoints include OS, ORR, DOR, safety and tolerability, and quality-of-life parameters..

该研究在美国，加拿大，英国，欧洲，南美和亚洲（包括日本）的166个研究地点招募了507名患者。主要终点是唑倍妥昔单抗联合CAPOX治疗的参与者与安慰剂联合CAPOX治疗的参与者相比的PFS。次要终点包括OS，ORR，DOR，安全性和耐受性以及生活质量参数。。

Data from the GLOW study were initially presented at the March 2023 ASCO Plenary Series with an updated oral presentation at the 2023 ASCO Annual Meeting on June 3, 2023, and were subsequently published in

GLOW研究的数据最初是在2023年3月的ASCO全体会议上提交的，并在2023年6月3日的2023年ASCO年会上进行了最新的口头介绍，随后发表在

Nature Medicine

自然医学

on July 31, 2023.

2023年7月31日。

For more information, please visit clinicaltrials.gov under

有关更多信息，请访问clinicaltrials.gov

Identifier NCT03653507

标识符NCT03653507

About the SPOTLIGHT Phase 3 Clinical Trial

关于SPOTLIGHT 3期临床试验

SPOTLIGHT is a Phase 3, global, multi-center, double-blind, randomized study, assessing the efficacy and safety of zolbetuximab plus mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) compared to placebo plus mFOLFOX6 as a first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors were CLDN18.2 positive.

SPOTLIGHT是一项3期全球多中心双盲随机研究，评估唑倍妥昔单抗联合mFOLFOX6（一种包括奥沙利铂，亚叶酸钙和氟尿嘧啶的联合化疗方案）与安慰剂联合mFOLFOX6作为局部晚期不可切除或转移性HER2阴性胃癌或肿瘤CLDN18.2阳性的GEJ腺癌患者的一线治疗的疗效和安全性。

The study enrolled 565 patients at 215 study locations in the U.S., Canada, United Kingdom, Australia, Europe, South America, and Asia. The primary endpoint is progression-free survival (PFS) of participants treated with the combination of zolbetuximab plus mFOLFOX6 compared to those treated with placebo plus mFOLFOX6.

该研究在美国，加拿大，英国，澳大利亚，欧洲，南美和亚洲的215个研究地点招募了565名患者。主要终点是用唑倍妥昔单抗联合mFOLFOX6治疗的参与者与用安慰剂加mFOLFOX6治疗的参与者相比的无进展生存期（PFS）。

Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), safety and tolerability, and quality-of-life parameters..

次要终点包括总生存期（OS），客观缓解率（ORR），缓解持续时间（DOR），安全性和耐受性以及生活质量参数。。

Data from the SPOTLIGHT clinical trial were presented during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium in an oral presentation on January 19, 2023, and were subsequently published in

SPOTLIGHT临床试验的数据于2023年1月19日在2023年美国临床肿瘤学会（ASCO）胃肠道（GI）癌症研讨会上进行了口头介绍，随后发表在

The Lancet

刺胳针

on April 14, 2023.

2023年4月14日。

For more information, please visit clinicaltrials.gov under

有关更多信息，请访问clinicaltrials.gov

Identifier NCT03504397

标识符NCT03504397

About Zolbetuximab

关于左贝妥昔单抗

Zolbetuximab is a first-in-class monoclonal antibody (mAb) specifically designed to target tumor cells that express CLDN18.2, a transmembrane protein. Zolbetuximab is the only CLDN18.2 targeted therapy to be approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive..

Zolbetuximab是一种一流的单克隆抗体（mAb），专门设计用于靶向表达跨膜蛋白CLDN18.2的肿瘤细胞。唑倍妥昔单抗是唯一被批准与含氟嘧啶和铂的化疗联合使用的CLDN18.2靶向治疗方法，用于局部晚期不可切除或转移性人表皮生长因子受体2（HER2）阴性胃或胃食管交界处（GEJ）腺癌患者的一线治疗，其肿瘤为claudin（CLDN）18.2阳性。。

Zolbetuximab has been approved in a number of countries around the world including Japan, the UK, Korea, the US, Canada, Brazil and China, plus has received marketing authorization from the European Commission which is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Regulatory approvals were based on the positive results of the SPOTLIGHT and GLOW Phase III trials where zolbetuximab demonstrated statistically significant improvements in progression-free survival and overall survival compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers..

Zolbetuximab已在世界各地的许多国家获得批准，包括日本，英国，韩国，美国，加拿大，巴西和中国，并且已获得欧盟委员会的上市授权，该授权在所有27个欧盟成员国以及冰岛，列支敦士登和挪威有效。监管部门的批准是基于SPOTHELL和GLOW III期试验的积极结果，在这些试验中，唑倍妥昔单抗在符合条件的胃癌和GEJ癌症患者中，与其他标准治疗化疗相比，在无进展生存期和总生存期方面表现出统计学上的显着改善。。

3,4

In both the GLOW and SPOTLIGHT Phase 3 clinical trials, approximately 38% of all patients screened, and 35% of patients screened in China, had tumors that were CLDN18.2 positive, defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed and confirmed using the VENTANA.

。

CLDN18 (43-14A) RxDx Assay.

CLDN18（43-14A）RxDx测定。

3,4

By binding to CLDN18.2, zolbetuximab induces cancer cell death and tumor growth inhibition by activating two distinct immune system pathways — antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

通过与CLDN18.2结合，唑倍妥昔单抗通过激活两种不同的免疫系统途径-抗体依赖性细胞毒性（ADCC）和补体依赖性细胞毒性（CDC）诱导癌细胞死亡和肿瘤生长抑制。

This targeted approach that specifically focuses on CLDN18.2, a biomarker shown to be positively expressed in gastric and GEJ cancers, could help to identify patients who are most likely to respond to treatment.

这种专门针对CLDN18.2（一种在胃癌和GEJ癌中呈阳性表达的生物标志物）的靶向方法可能有助于确定最有可能对治疗产生反应的患者。

Investigational Pipeline in CLDN18.2

CLDN18.2中的研究管道

An expanded Phase 2 trial of zolbetuximab in metastatic pancreatic adenocarcinoma is in progress involving 393 patients worldwide. The trial is a randomized, multi-center, open-label study, evaluating the safety and efficacy of investigational zolbetuximab in combination with gemcitabine plus nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic adenocarcinoma with CLDN18.2 positive tumors (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining based on a validated immunohistochemistry assay).

。该试验是一项随机，多中心，开放标签研究，评估研究性唑倍妥昔单抗联合吉西他滨加nab-紫杉醇作为转移性胰腺癌CLDN18.2阳性肿瘤患者的一线治疗的安全性和有效性（定义为≥75%的肿瘤细胞，基于验证的免疫组织化学测定显示中度至强烈的膜性CLDN18染色）。

For more information, please visit clinicaltrials.gov under .

有关更多信息，请访问clinicaltrials.gov。

Identifier NCT03816163

标识符NCT03816163

In addition to zolbetuximab, ASP2138 is under development in our

除唑倍妥昔单抗外，我们正在开发ASP2138

Primary Focus Immuno-Oncology

主要关注免疫肿瘤学

area and is currently recruiting patients. ASP2138 is a bispecific monoclonal antibody that binds to CD3 and CLDN18.2, and it is currently in a Phase 1/1b study in participants with metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma or metastatic pancreatic adenocarcinoma whose tumors have CLDN18.2 expression.

目前正在招募患者。ASP2138是一种与CD3和CLDN18.2结合的双特异性单克隆抗体，目前正在对转移性或局部晚期不可切除的胃腺癌或GEJ腺癌或转移性胰腺癌患者进行1/1b期研究，这些患者的肿瘤具有CLDN18.2表达。

The safety and efficacy of the agent under investigation have not been established for the uses being considered. For more information, please visit clinicaltrials.gov under .

所研究药物的安全性和有效性尚未确定用于所考虑的用途。有关更多信息，请访问clinicaltrials.gov。

Identifier NCT05365581

There is no guarantee that the agent(s) will receive regulatory approval and become commercially available for the uses being investigated.

不保证该代理将获得监管部门的批准，并可用于正在调查的用途。

About Astellas

关于安斯泰来

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

Astellas是一家全球生命科学公司，致力于将创新科学转化为患者的价值。我们在包括肿瘤学、眼科、泌尿学、免疫学和女性健康在内的疾病领域提供变革性疗法。通过我们的研发计划，我们正在为医疗需求未得到满足的疾病开创新的医疗保健解决方案。

Learn more at .

更多信息，请访问。

www.astellas.com

Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties.

在本新闻稿中，有关当前计划、估计、战略和信念的声明以及其他非历史事实的声明都是关于阿斯特拉斯未来表现的前瞻性声明。这些声明基于管理层目前的假设和信念，并根据目前可获得的信息，涉及已知和未知的风险和不确定性。

A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.

许多因素可能导致实际结果与前瞻性声明中讨论的结果存在重大差异。这些因素包括但不限于：（i）与药品市场有关的一般经济条件和法律法规的变化，（ii）货币汇率波动，（iii）新产品发布的延迟，（iv）Astellas无法有效营销现有产品和新产品，（v）Astellas无法继续在竞争激烈的市场上有效研究和开发客户接受的产品，以及（vi）第三方侵犯Astellas的知识产权。

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice..

本新闻稿中包含的有关药品（包括目前正在开发的产品）的信息无意构成广告或医疗建议。。

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上次访问时间：2025年1月。

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Astellas数据存档。癌症公约

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治疗结构-胃癌，中国。2023年5月出版。根据2023年3月进行的实地调查。

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