佐妥昔单抗(Zolbetuximab) - 药物靶点：CLDN18.2_在研适应症：晚期胃食管交界处腺癌，CLDN18.2阳性胃食管交界处腺癌，CLDN18.2阳性胃腺癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Claudiximab、Zolbetuximab-CLZB、佐贝妥昔单抗

+ [9]

靶点

CLDN18.2

作用方式

抑制剂

作用机制

CLDN18.2抑制剂(Claudin 18.2蛋白抑制剂)、ADCC(抗体依赖的细胞毒作用)、补体依赖的细胞毒性作用

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病

在研适应症

晚期胃食管交界处腺癌CLDN18.2阳性胃食管交界处腺癌CLDN18.2阳性胃腺癌+ [9]

非在研适应症

腺癌CLDN18.2阳性胃肠道肿瘤食管癌+ [1]

原研机构

Ganymed Pharmaceuticals AG

在研机构

Astellas Pharma Canada, Inc.Astellas Pharma Global Development, Inc.Astellas Pharma Europe BV

+ [5]

非在研机构

Ganymed Pharmaceuticals AG

权益机构

上药控股有限公司

Ganymed Pharmaceuticals AG

Astellas Pharma, Inc.

最高研发阶段批准上市

首次获批日期

日本 (2024-03-26),

CLDN18.2阳性胃癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (韩国)、孤儿药 (澳大利亚)

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结构/序列

Sequence Code 431594752L

来源: *****

Sequence Code 524309292H

来源: *****

关联

18

项与佐妥昔单抗相关的临床试验

JPRN-UMIN000060223

/ RecruitingN/AIIT

Investigation of gastric cancer treatment using zolbetuximab - Zolbetuximab Gastric Analysis 1

开始日期2025-12-09

申办/合作机构-

NCT06396091

/ Active, not recruiting临床1期

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.

开始日期2025-09-24

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT06901531

/ Recruiting临床3期

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.

开始日期2025-05-22

申办/合作机构

Astellas Pharma Global Development, Inc.

100 项与佐妥昔单抗相关的临床结果

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100 项与佐妥昔单抗相关的转化医学

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100 项与佐妥昔单抗相关的专利（医药）

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154

项与佐妥昔单抗相关的文献（医药）

2026-04-01·International Journal of Clinical Oncology

Intratumoral heterogeneity and chemotherapy-induced alteration of CLDN18.2 expression in resectable gastric cancer

Article

作者: Hagi, Takaomi ; Momose, Kota ; Makino, Tomoki ; Yamashita, Kotaro ; Kurokawa, Yukinori ; Morii, Eiichi ; Doki, Yuichiro ; Saito, Takuro ; Eguchi, Hidetoshi ; Nagano, Shinnosuke ; Tanaka, Koji ; Takahashi, Tsuyoshi ; Motoyama, Yuichi ; Nakajima, Kiyokazu

Abstract:

Background:

Claudin-18 isoform-2 (CLDN18.2) is a novel biomarker and therapeutic target for gastric cancer (GC). It may exhibit the intratumoral heterogeneity and varying expressions between biopsy and surgically resected specimens as well as pre- and post-chemotherapy, which could impact patient selection for the targeted agents.

Methods:

CLDN18.2 expression was immunohistochemically evaluated in pretreatment biopsy and surgically resected specimens from 183 patients with pT2-T4 GC who underwent upfront gastrectomy. The intratumoral heterogeneity was evaluated by classifying the distribution of CLDN18.2 positive cells as superficial, invasive-front, or random pattern. Furthermore, a separate cohort of 38 patients who underwent neoadjuvant chemotherapy without zolbetuximab were analyzed to compare the pre- and post-treatment CLDN18.2 status.

Results:

CLDN18.2 positivity was observed in 31% (56/183) of patients. Among the 93 patients with 2 + /3 + expression in ≥ 10% of the tumor cells, 81 (87%) had heterogeneous expression patterns, including superficial (n = 46), random (n = 24), and invasive-front (n = 11) patterns. The overall biopsy–surgery concordance rate was 86% (157/183), but it decreased to 73% (59/81) in patients with a heterogeneous expression pattern. Notably, the concordance rate was particularly low in the superficial pattern, at only 65% (30/46). Among the 38 patients who underwent neoadjuvant chemotherapy, only 4 of 11 initially CLDN18.2-positive cases remained positive after treatment, although the overall concordance rate was 82% (31/38).

Conclusion:

The CLDN18.2 expression demonstrated an acceptable concordance between biopsy and surgically resected specimens. However, high prevalence of heterogeneous expression and tendency for CLDN18.2 positivity to shift to negativity following chemotherapy existed.

2026-04-01·DEN open

Endoscopic Complete Response to Zolbetuximab for Advanced Gastric Cancer With Claudin 18.2 Positive: A Case Report

Article

作者: Kimura, Rika ; Yoshioka, Tsubasa ; Yamaba, Tomohiro ; Uchiyama, Gaku ; Sasaki, Akinori ; Tachibana, Ayu ; Okamoto, Risa

ABSTRACT:

Recently, zolbetuximab combined with chemotherapy has been approved as a first‐line treatment for advanced gastric cancer (GC). However, to date, no endoscopic images demonstrating endoscopic complete response (eCR) to zolbetuximab plus chemotherapy have been reported. Herein, we report the case of an 80‐year‐old man who presented with epigastric pain and loss of appetite and was diagnosed with undifferentiated GC and peritoneal metastasis. The patient received modified FOLFOX6 plus zolbetuximab because genetic testing revealed HER2‐negative and claudin 18.2‐positive. He experienced grade 2 nausea, which improved with the administration of antiemetic agents. Computed tomography performed at month 5 showed resolution of peritoneal dissemination. Endoscopic examination during the same period showed the disappearance of the primary gastric tumor with scarring. Biopsy of the scar area revealed only inflammatory cells; therefore, the primary lesion was defined as an eCR. To the best of our knowledge, this is the first report of eCR to zolbetuximab and chemotherapy in a patient with GC and claudin 18.2 positive. This case report suggested that chemotherapy combined with zolbetuximab may offer greater therapeutic benefit than chemotherapy combined with immune checkpoint inhibitors in patients with undifferentiated GC. Further analysis is expected to enable the identification of patients with claudin 18.2‐positive GC in whom zolbetuximab treatment is effective.

2026-03-28·Future Oncology

Zolbetuximab for gastroesophageal adenocarcinoma: drug review and lessons from the frontlines

Review

作者: Rogers, Jane E. ; Aune, Hannah ; Mathew, Shiba ; Sobocinski, Stacey ; Ajani, Jaffer A. ; Leung, Michael ; Covert, Wendy M. ; Gulbis, Alison M. ; Esmaily-Fard, Amin

Molecular distinctions have started to define treatment decisions in advanced gastric adenocarcinoma (GAC) and gastroesophageal junction adenocarcinoma (GEJAC), malignancies in need of improved outcomes. Claudin 18.2 (CLDN18.2) represents a new selective GAC/GEJAC target, with multiple agents currently in the developmental pipeline. Zolbetuximab, an anti-CLDN18.2 monoclonal antibody, is the first agent to market for this target. It received FDA approval following Phase III trials in which zolbetuximab combined with upfront fluoropyrimidine plus platinum therapy resulted in improved coveted endpoints compared to fluoropyrimidine plus platinum alone in CLDN18.2 positive advanced GAC patients (2+ or 3+ intensity in ≥75% of tumor cells). The most common adverse events are gastrointestinal, primarily nausea and vomiting during initial treatment cycles, particularly in those with an intact stomach (i.e. no prior surgery). Real-world implementation of zolbetuximab is complicated by cumbersome administration times, short drug stability, extended observation time, and difficult tolerability. This report describes our experience in implementing zolbetuximab in clinical practice and provides an extensive drug evaluation.

534

项与佐妥昔单抗相关的新闻（医药）

2026-04-28

·氨基观察

CLDN18.2单抗，年销售额突破4亿美元

氨基观察-创新药组原创出品作者 | 沙晓威 CLDN18.2单抗的市场需求正持续高增。 4月27日，安斯泰来公布2025财年（2025年4月1日—2026年3月31日）业绩报告。报告期内，CLDN18.2单抗（佐妥昔单抗, VYLOY）营收达631亿日元，折合4.01亿美元，同比大幅增长415.6%。亮眼的商业化表现，充分印证了CLDN18.2靶点的临床价值与赛道潜力。巨大的市场吸引着全球药企的入局，随着多款下一代创新药物陆续推进落地，CLDN18.2领域的竞争格局与发展热度，后续还将持续升温。 / 01 / 全球都在增长从年报来看，VYLOY的爆发式增长，由全球业务快速扩张驱动的。具体来看，美国市场是增长的核心引擎，2025年销售额达到299亿日元，同比增长514.2%。美国市场的爆发增长得益于此前胃癌治疗选择的匮乏，NCCN指南的及时更新，加速了VYLOY的临床渗透；同时，商业保险覆盖与患者援助计划降低了支付门槛，确保了患者长期留存。销售排名第二的是日本市场，贡献了137亿日元销售额，同比增长164.5%。相比之下，尽管VYLOY在中国获批晚了一年，但在胃癌高发背景下以及指南推荐下，中国市场也贡献了67亿日元的销售增量。而VYLOY之所以能够在全球迅速放量，另一关键因素是Claudin 18.2检测普及率走高，带动产品销售表现强劲。随着检测方法标准化以及病理科室对该标志物认知的提升，Claudin 18.2检测已逐步嵌入胃癌诊疗流程之中，成为与HER2一样的分层工具。指南的更新与共识的发布，进一步强化了CLDN18.2靶点的临床价值。包括NCCN与ESMO在内的国际指南，已陆续提升对CLDN18.2检测的推荐等级，将其纳入胃癌分层诊疗体系。2024年，中国CSCO胃癌诊疗指南也进行了更新，将Claudin 18.2靶点纳入胃癌诊疗规范从III级推荐改为II级推荐。在巨大的市场空间下，检测与治疗的同步推进，加速VYLOY的销售增长。 / 02 / 未来属于谁虽然VYLOY以一己之力开启了CLDN18.2时代，并取得了不错的商业化表现，但是CLDN18.2的时代却不一定属于VYLOY。着眼长期，其市场地位并不够牢固。核心在于，无论是疗效还是安全性上，VYLOY均是一款不完美的FIC，后来者的优化空间很大。疗效层面，VYLOY获批Claudin18.2阳性胃腺癌及胃食管交界部腺癌（G/GEJ）依据的SPOTLIGHT和GLOW临床试验显示，该药对比化疗的优势并不突出，PFS获益不超2个月，OS获益不超3个月。更重要的是，其获批人群高度集中于CLDN18.2高表达（≥75%）患者，而这一人群仅占整体胃癌患者的约20%。这意味着绝大多数CLDN18.2中低表达患者仍未被覆盖。安全性问题则进一步削弱了其长期竞争力。由于CLDN18.2在正常胃黏膜上皮细胞中同样存在表达，导致抗体在治疗过程中会出现“on-target、off-tumor”毒性，包括胃黏膜损伤、溃疡、出血甚至穿孔等不良事件。VYLOY治疗指南中明确提示其存在过敏、输液相关反应、重度恶心呕吐等风险。在此背景下，下一代产品的开发策略围绕疗效和安全性展开。其中，ADC通过靶向递送细胞毒性药物，实现肿瘤杀伤的同时避免全身毒性，是最具前景的策略之一。也正因此，当前CLDN18.2 ADC赛道的竞争已经十分激烈。包括礼新医药的LM-302、康诺亚的CMG901、信达生物的IBI343、君实生物的JS107均是靶向CLDN18.2的ADC，搭载MMAE、Exatecan不同载荷，目前均已启动Ⅲ期临床。 CLDN18.2 ADC需要竞争的，也不只是ADC本身，还包括TCE/CLDN18.2双抗、CLDN18.2/4-1BB双抗等诸多不同路线。面对来势汹汹的入局者，安斯泰来也只能被迫押注，除了继续推进VYLOY在一线治疗中的拓展，目前其在成人胃癌联合K药与化疗的Ⅲ期临床正在进行，还在推进CLDN18.2 ADC、TCE药物的临床研究。其中，ADC产品ASP546C侧重于规避免疫依赖，并探索其他CLDN18.2阳性肿瘤治疗可能。双抗TCE产品ASP2138则通过直接募集T细胞进入肿瘤微环境，强化免疫杀伤能力，目标人群指向单抗响应不足或CLDN18.2中低表达患者。安斯泰来试图通过自我“颠覆”，谋求在CLDN18.2赛道更好地活下去。这也提醒我们，当一个靶点过于火热，被革命的不只是FIC本身，还有包括许多后来者。对于火热的CLDN18.2 靶点来说，未来到底属于谁，拭目以待。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

2026-04-28

·安斯泰来中国

安斯泰来公布2025财年财务业绩丨中国区实现强劲增长

安斯泰来制药集团（TSE:4503）近日发布了2025财年全球财务业绩（2025财年为2025年4月1日至2026年3月31日）。用于治疗尿路上皮癌的PADCEV、用于治疗与年龄相关的黄斑变性所致地理萎缩的IZERVAY、用于治疗胃和胃食管交界处腺癌的VYLOY以及用于治疗围绝经引起的血管舒缩症的VEOZAH1在内的战略品牌的销售额均表现出稳健增长。此外，用于治疗前列腺癌的XTANDI销售规模扩大，同样推动了营收增长。最终，2025财年的营业收入为：21,392亿日元，较上一财年同比增长11.9%，核心营业利润为5,557亿日元，同比增长41.6%。主要品牌表现 PADCEV 销售额同比增长34.8% 达到2212亿日元 IZERVAY 销售额同比增长33.2% 达到776亿日元 VYLOY 销售额同比增长415.6% 达到631亿日元 VEOZAH1 销售额同比增长37.7% 销售额为466亿日元 XOSPATA 销售额同比增长5.7% 达到718亿日元 XTANDI 销售额同比增长5.3% 达到9608亿日元稳定投资未来成长 2025财年的研发费用为3,148亿日元。中国区2强劲增长得益于肿瘤药和特药产品组合展现的强大潜力，中国商业区实现收入1015亿日元，同比增长：29.6%，实现强劲增长。关于安斯泰来安斯泰来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。我们在肿瘤、眼科、泌尿、免疫以及女性健康等领域提供变革性的治疗方案，并通过研究与开发项目，为具有高度未满足医疗需求的疾病开创全新的解决方案。了解更多信息，请访问：www.astellas.com 延伸阅读 Fezolinetant被纳入广东省粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录中国首个！威络益伴随诊断试剂(CLDN18)重磅获批推动中国AML精准诊疗规范化进程首部《吉瑞替尼治疗伴FLT3突变成年人急性髓系白血病临床应用指导原则（2025年版）》发布安斯泰来将在2026年ASCO胃肠道癌症研讨会(ASCO GI)上公布其胃肠道肿瘤产品管线的最新临床数据注释 1-VEOZAH：在美国以外市场获批名为“VEOZA” 2-中国区包括：中国大陆地区和香港地区

2026-04-27

·FiercePharma

Astellas counts on new medicines to offset projected Xtandi decline in fiscal 2026

On a corporate level, drug pricing uncertainty in the U.S. has been a major overhang for Astellas and other mid-sized pharma companies alike. With Xtandi's growth days numbered, an unfazed Astellas expects a group of new products will more than offset the decline of the Pfizer-partnered blockbuster in fiscal year 2026.Xtandi global sales hit 960.8 billion Japanese yen ($6 billion) in Astellas’ fiscal 2025, “reaching projected peak sales levels 13 years after launch,” CEO Naoki Okamura said during an English-dubbed investor call Monday.However, compared with a 5.3% increase in Xtandi sales in fiscal 2025, Astellas expects the prostate cancer drug’s revenue to drop by 5.3% in fiscal 2026, which ends in March 2027. Growth will likely not return for Xtandi. Astellas attributed the projected decline to a price reduction under the Inflation Reduction Act beginning in 2027, the same year that the drug is also slated to lose U.S. market exclusivity. Astellas is bracing for a group-wide revenue decline once the anti-androgen med falls off the patent cliff. But at least for fiscal 2026, the Japanese pharma hopes five strategic brands will deliver 130 billion yen in additional sales—which would represent 27% growth—and will therefore, drive overall company growth by 4% year over year based on unchanged exchange rates.The five products are Pfizer-partnered antibody-drug conjugate Padcev, eye med Izervay, CLDN18.2 cancer drug Vyloy, menopause therapy Veozah and leukemia treatment Xospata. Together, the five brands contributed 480.3 billion yen (around $3 billion) in fiscal 2025 sales, up 43% year over year. Starting from this year, Astellas will not provide sales forecasts for each individual strategic brand.“We believe it is important to grow five strategic brands as one whole, and we hope to engage in dialogue focused on mid- to long-term growth trajectory, rather than being preoccupied with the short-term fluctuations in individual products,” Okamura said. Among the five brands, Padcev is clearly the star. Following a landmark FDA approval as part of a Keytruda combination for the perioperative treatment of cisplatin-ineligible muscle-invasive bladder cancer patients in November, year-on-year U.S. sales growth of the Nectin-4 agent accelerated to roughly 33% in Astellas’ fourth quarter, reaching 38 billion yen ($239 billion), compared with 13% in the three months before.Padcev is on track to expand its perioperative MIBC indication even further to reach cisplatin-eligible patients based on the positive EV-304 trial. With priority review, the FDA is scheduled to make a decision by Aug. 17, 2026. Based on Padcev’s fast growth, as well as strong demand for Vyloy—which saw sales up 133% in Astellas’ fourth quarter—plus continued uptake of Izervay, Jefferies analysts argued in an April 27 note that Astellas’ 130-billion-yen growth projection for the strategic brands may be conservative.However, during Monday’s call, Astellas’ chief commercial and medical affairs officer, Claus Zieler, cautioned that although Padcev’s uptake in MIBC shot up quickly, a plateau is expected about six months into the launch. For ex-U.S., the company expects the first-line metastatic indication will drive growth for the drug. To potentially maximize Padcev’s value, Astellas has started developing the drug for bladder-sparing treatment of MIBC, Okamura said on the call. By Astellas’ estimate, about 30% of MIBC patients are ineligible for or refuse radical cystectomy, which is a necessary step in Padcev’s existing perioperative indication. A single-arm phase 2 trial was initiated in April for patients who elected not to undergo bladder-removal surgery, and a separate registrational phase 3, EV-309, is planned for the first half of fiscal 2026. Bladder-sparing MIBC, plus potential perioperative approval in China, could further boost Padcev’s outlook as these opportunities are not currently baked into Astellas’ peak sales forecast, Okamura said. On a corporate level, drug pricing uncertainty in the U.S. has been a major overhang for Astellas and other mid-sized pharma companies. The Trump administration has signed “most favored nation” deals with all 17 large pharma companies initially targeted by President Donald Trump, offering price reductions and making certain drugs available on the government’s direct-to-consumer portal, Trumprx.gov, in exchange for tariff exemptions and other benefits. “We haven’t received a letter from the U.S. government,” Okamura said on the call, “but we try to open a channel to discuss with the government authorities.”While Astellas cannot currently quantify the potential impact of the policy, the company has examined information from existing deals to evaluate its options, the CEO said.Astellas launched a multi-year cost optimization program, called “sustainable margin transformation,” in 2024. Through organizational restructuring, streamlining certain infrastructure and reducing investments in mature products, Astellas saved about 11 billion yen in selling, general and administrative expenses during fiscal 2025. Through ongoing cost-reduction efforts, Astellas expects SG&A expenses to decrease by 7% to 800 billion yen in fiscal 2026.

临床3期上市批准临床2期优先审批

100 项与佐妥昔单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	佐妥昔单抗	-	DB15118

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适应症	国家/地区	公司	日期
晚期胃食管交界处腺癌	加拿大	Astellas Pharma Canada, Inc.	2025-01-09
CLDN18.2阳性胃食管交界处腺癌	英国	Astellas Pharma, Inc.	2024-08-14
CLDN18.2阳性胃腺癌	英国	Astellas Pharma, Inc.	2024-08-14
CLDN18.2阳性胃癌	日本	Astellas Pharma, Inc.	2024-03-26

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期胃食管交界处腺癌	临床3期	美国	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	中国	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	日本	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	阿根廷	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	克罗地亚	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	希腊	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	爱尔兰	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	马来西亚	Astellas Pharma Global Development, Inc.	2018-11-28
局部晚期胃食管交界处腺癌	临床3期	荷兰	Astellas Pharma Global Development, Inc.	2018-11-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06901531 (LUCERNA, ASCO_GI2026)	临床3期	局部晚期胃食管交界处腺癌 \| PD-L1阳性实体瘤 \| CLDN18.2阳性胃腺癌一线 CLDN18.2-positive \| HER2-negative \| PD-L1-positive	500	Zolbetuximab + pembrolizumab + CAPOX/mFOLFOX6	繭憲網衊範鏇蓋鏇艱夢(築糧糧衊壓構齋壓製積) = 窪壓鑰鏇鹹範選繭糧範夢觸廠廠膚鏇鬱製簾淵 (網壓襯積顧鏇鏇遞繭鏇, 24.9 ~ NR)	积极	2026-01-08
				Placebo + pembrolizumab + CAPOX/mFOLFOX6	願願淵襯構襯蓋壓淵繭(壓鹹遞膚憲簾選築顧遞) = 壓蓋鏇鹹獵積糧觸製積艱鑰鏇鬱網獵蓋壓糧窪 (膚艱網鬱積鹽築廠壓選, 43.1 ~ 56.9) 更多
ESMO_ASIA2025	N/A	晚期胃食管交界处腺癌一线	22	Zolbetuximab (Zolb) + chemo	糧衊簾觸獵壓製鹽憲鬱(膚膚構窪膚窪遞網積觸) = abdominal pain (18%) 鑰範鑰製壓觸鹹選範顧 (壓糧壓鏇憲繭廠簾膚鹹 ) 更多	积极	2025-12-05
NCT03504397 (SPOTLIGHT, ESMO_ASIA2025)	临床3期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃腺癌一线 CLDN18.2+ \| HER2−	374	Zolbetuximab plus mFOLFOX6/CAPOX	餘膚齋衊鑰鏇鏇積範積(製願廠製膚築餘襯築壓) = The most common grade ≥3 AEs occurring in ≥20% of patients in zolbetuximab arm were neutropenia (20.7%) and vomiting (20.2%). 製製簾鹽遞築網廠簾獵 (餘憲積網憲齋糧鹹積鹹 ) 更多	积极	2025-12-05
				Placebo plus mFOLFOX6/CAPOX
ESMO_ASIA2025	N/A	晚期胃癌	17	Zolbetuximab+antiemetic therapy+atypical antipsychotics	糧衊簾簾糧壓廠網鏇構(蓋壓顧餘鬱製鏇鹹淵膚) = 鏇壓獵艱夢餘衊衊餘觸範醖廠觸鬱蓋襯夢網遞 (繭積衊蓋壓廠廠鑰選衊 ) 更多	积极	2025-12-05
NCT03504397 (SPOTLIGHT \| SPOTLIGHT study, CTgov)	临床3期	-	565	folinic acid+zolbetuximab+oxaliplatin+fluorouracil	憲選鏇積餘鹽鑰鏇簾顧(觸鏇網顧網選衊築壓構) = 糧簾鑰糧憲願顧顧觸衊膚築網餘網窪獵築餘廠 (製憲淵簾範餘網積觸齋, 醖簾膚齋憲艱觸醖範鏇 ~ 夢鬱鹹蓋醖範願淵選衊) 更多	-	2025-02-26
NCT03653507 (GLOW, CTgov)	临床3期	局部晚期胃食管交界处腺癌 \| 转移性胃食管结合部腺癌	507	CAPOX+Zolbetuximab (CAPOX+ Zolbetuximab)	窪醖廠顧餘窪艱鑰網積(網餘餘鹹醖壓鑰艱壓蓋) = 艱壓觸醖構憲廠遞鹽窪鬱壓積膚衊鑰簾顧顧淵 (顧顧網遞齋顧夢網憲憲, 醖鹹淵醖夢鹽壓構艱憲 ~ 選獵醖糧衊積憲窪艱構) 更多	-	2025-01-27
				Placebo (CAPOX+ Placebo)	窪醖廠顧餘窪艱鑰網積(網餘餘鹹醖壓鑰艱壓蓋) = 鬱窪憲選膚艱願糧鏇淵鬱壓積膚衊鑰簾顧顧淵 (顧顧網遞齋顧夢網憲憲, 糧鑰築網遞鏇膚選夢願 ~ 選蓋觸壓淵廠襯獵窪積) 更多
NCT03504397 (SPOTLIGHT, NEWS) 人工标引	临床3期	胃食管交界处腺癌一线 CLDN18.2 Positive \| HER2 Negative	61	佐妥昔单抗+mFOLFOX6	窪艱艱鑰夢齋選淵壓襯(膚鏇鬱壓餘獵觸窪構廠) = 獵壓獵築鏇獵糧鬱淵憲願鏇構廠餘鬱鹹夢衊願 (積廠窪窪積範網壓醖積, 6.7 ~ 16.7) 更多	积极	2024-09-28
				安慰剂+mFOLFOX6	窪艱艱鑰夢齋選淵壓襯(膚鏇鬱壓餘獵觸窪構廠) = 齋窪鬱製艱醖淵窪觸繭願鏇構廠餘鬱鹹夢衊願 (積廠窪窪積範網壓醖積, 6.0 ~ 8.4) 更多
NCT03653507 (GLOW, NEWS) 人工标引	临床3期	胃癌 \| 胃食管交界处腺癌一线 HER2 Negative \| CLDN18.2 Positive	145	佐妥昔单抗联合CAPOX	廠願網製簾簾觸遞餘鏇(簾遞鹽遞蓋鏇蓋餘壓顧) = 醖艱襯壓窪夢鏇鑰獵鏇糧壓廠選築網鬱醖壓範 (構廠顧鹹襯積範獵廠壓, 6.1 ~ 9.1) 更多	积极	2024-09-28
				安慰剂联合CAPOX	廠願網製簾簾觸遞餘鏇(簾遞鹽遞蓋鏇蓋餘壓顧) = 憲壓網糧鏇襯鏇膚糧廠糧壓廠選築網鬱醖壓範 (構廠顧鹹襯積範獵廠壓, 5.0 ~ 8.0) 更多
NCT03653507 \| NCT03504397 (SPOTLIGHT \| GLOW, ESMO2024)	临床3期	CLDN18.2阳性胃食管交界处腺癌一线 CLDN18.2+ \| HER2-	1,072	Zolbetuximab + chemotherapy	餘壓範壓廠壓鹹觸淵顧(齋夢窪襯艱製網壓齋願) = 淵窪糧艱構願簾壓獵壓齋窪網糧鹽遞築顧廠齋 (艱觸艱糧製積範遞蓋顧, 8.4 ~ 10.4) 更多	积极	2024-09-16
				Placebo + chemotherapy	餘壓範壓廠壓鹹觸淵顧(齋夢窪襯艱製網壓齋願) = 積膚廠壓範窪壓簾鑰觸齋窪網糧鹽遞築顧廠齋 (艱觸艱糧製積範遞蓋顧, 7.6 ~ 8.4) 更多
NCT03504397 (SPOTLIGHT, ASCO2024) 人工标引	临床3期	CLDN18.2阳性胃食管交界处腺癌 \| CLDN18.2阳性胃癌一线 HER2 Negative \| CLDN18.2 Positive	565	Zolbetuximab + mFOLFOX6	糧艱製鬱襯鏇顧衊積襯(糧築衊憲襯繭齋齋簾鹽) = 簾鏇齋窪願糧積壓艱窪簾鏇範築窪鑰鬱淵衊淵 (鬱獵淵窪網餘積積餘鹽 ) 更多	积极	2024-05-24
				Placebo + mFOLFOX6	糧艱製鬱襯鏇顧衊積襯(糧築衊憲襯繭齋齋簾鹽) = 廠願簾觸鬱衊觸壓繭齋簾鏇範築窪鑰鬱淵衊淵 (鬱獵淵窪網餘積積餘鹽 ) 更多