全球 Claudin 18.2 标靶治疗市场机会、治疗方法、已核准药物定价、销售及临床试验展望（2030 年）

全球 Claudin 18.2 标靶治疗市场机会、治疗方法、已核准药物定价、销售及临床试验展望（2030 年）报告的主要发现与亮点

• 全球 Claudin 18.2 标靶治疗市场机会：到 2030 年将超过 8 亿美元
• 已批准的 Claudin 18.2 标靶治疗药物数量：1
• 已核准的 Claudin 18.2 标靶治疗药物：1 项－Claudin 18.2 标靶治疗药物剂量、定价与销售洞察
• 超过 70 项 Claudin 18.2 标靶治疗临床试验洞察
• 全球 Claudin 18.2 标靶治疗临床试验依公司、适应症及研发阶段划分的试验
• Claudin 18.2标靶治疗研发的技术与临床平台
• 竞争格局

Claudin 18.2标靶治疗的需求及本报告的意义

对新型有效癌症疗法的需求依然迫切。许多癌症，包括胰臟癌和胃癌，通常在晚期才被发现，导致治疗选择有限，疗效往往不尽人意。传统的治疗方法，例如放射疗法和化疗，通常无法带来长期生存，并且可能伴随严重的副作用。这些挑战促使人们对标靶癌症疗法越来越感兴趣。 Claudin 18.2 (CLDN18.2) 是一种通常存在于胃上皮细胞中的跨膜蛋白，是一个很有前景的标靶。 CLDN18.2 在多种癌症中异常高表达，包括大肠直肠癌、胰臟癌和胃癌，并暴露于肿瘤细胞表面，可被治疗药物选择性识别。其肿瘤特异性表现使其成为理想的治疗标靶，能够选择性地破坏癌细胞，同时保留大部分健康组织。

本报告全面深入地分析了 CLDN18.2 标靶治疗的现状，并详细回顾了最新进展。报告涵盖了正在进行的各项临床试验、试验阶段和治疗方法、相应的技术平台，以及对参与这些疗法研发的关键公司和机构的评估。本报告旨在评估 CLDN18.2 标靶治疗领域的现状，并协助识别新兴趋势和未来创新方向。其目的是帮助利害关係人就 CLDN18.2 标靶治疗的未来发展方向以及这些疗法如何显着改善胃肠道癌症和其他实体瘤的治疗效果做出明智的决策。

本报告包​​含的临床研究和试验见解

本报告的重点之一是对正在进行的针对 CLDN18.2 的临床研究和试验进行全面分析，涵盖了 70 多种处于不同研发阶段的疗法的见解。这些试验在多个地区开展，主要针对最有可能从 CLDN18.2 标靶疗法中获益的患者群体。在晚期胃癌的治疗中，包括使用佐贝妥昔单抗（Vyloy）等单株抗体的早期临床试验，已显示出令人鼓舞的结果，凸显了这些疗法在改善无恶化存活期方面的潜力。本报告也探讨了单药疗法以及将 CLDN18.2 标靶药物与其他癌症疗法（例如化疗和免疫检查点抑制剂）合併使用的联合疗法的疗效。这种双管齐下的方法因其能够从多个角度攻击癌细胞，从而增强治疗效果而备受关注。

本报告也概述了临床试验申办方，包括大型製药公司、学术机构和生物技术公司，使利害关係人能够清晰了解该领域研究的领先参与者。报告还透过识别CLDN18.2标靶疗法正在兴起的新兴市场以及监管挑战可能减缓其应用的地区，提供了详细的区域分析。

参与Claudin 18.2标靶疗法研发的主要公司

CLDN18.2标靶疗法的研发由众多致力于推进癌症治疗的公司主导。这些公司正在探索多种策略，从单株抗体到双特异性抗体再到CAR-T细胞疗法，以有效靶向肿瘤细胞上的CLDN18.2。由安斯泰来公司开发的佐贝妥昔单抗在该领域发挥重要作用，在胃癌治疗中显示出积极的临床结果，并正在推进监管审批流程。其他公司，例如施维雅製药（Servier Pharmaceuticals），正在探索抗体药物偶联物（ADC）的潜力，将靶向CLDN18.2的抗体与细胞毒性药物结合，旨在将靶向化疗药物直接递送至癌细胞。针对CLDN18.2的CAR-T细胞疗法也正在进行早期临床试验，目标是增强人体对癌症的免疫反应。

本报告旨在帮助利害关係人全面了解这些公司采用的研发策略以及临床管线中治疗方案的进展。对研究重点的分析将为这一前景广阔的治疗领域的发展方向提供宝贵的见解。

报告展现了标靶Claudin 18.2疗法的潜力

靶向CLDN18.2疗法的未来前景光明，正在进行的临床试验在胃癌和胰腺癌治疗中均显示出积极的结果。随着对CLDN18.2在癌症中作用的研究不断深入，有望开发出更先进的新型疗法。双特异性抗体、CAR-T细胞疗法和抗体药物偶联物（ADC）等方法具有巨大的潜力，能够以比传统化疗更高的精准度和更少的副作用革新癌症治疗。本报告预测，未来CLDN18.2标靶疗法的应用范围将从胃癌扩展到其他恶性肿瘤，例如胰臟癌、大肠直肠癌和食道癌。此外，基于个体特定基因谱的个人化医疗无疑将在未来的CLDN18.2治疗中发挥重要作用。

随着临床试验和研究的不断进展，CLDN18.2标靶疗法有望在癌症治疗中发挥重要作用，尤其是在难治性胃肠道癌症的治疗中。

目录

第一章：Claudin 18.2标靶治疗简介

• 了解Claudin和Claudin 18.2蛋白
• Claudin 18.2标靶治疗的必要性
• 已核准的Claudin 18.2标靶疗法

第二章：Claudin 18.2癌症免疫疗法的标靶策略

• 抗体（单株抗体和双特异性抗体）
• CAR-T细胞疗法
• 抗体药物偶联物

第三章：Vyloy－首个核准的Claudin 18.2标靶药物治疗

• 临床见解
• 定价和剂量见解
• 销售见解

第四章 全球 Claudin 18.2 标靶治疗市场概况

• 当前市场概览
• 未来市场展望

第五章 Claudin 18.2 标靶治疗趋势分析（按地区划分）

• 美国
• 中国
• 欧洲
• 日本
• 韩国
• 澳大利亚
• 英国

第六章 全球 Claudin 18.2 标靶治疗临床试验概览

• 按公司
• 依国家/地区
• 按适应症
• 依阶段

第七章：全球 Claudin 18.2 标靶治疗临床试验（按公司、适应症和分期划分）

• 研究
• 临床前
• 0 期
• I 期
• I/II 期
• II 期
• III 期
• 预先註册

第八章：市售 Claudin 18.2 标靶治疗的临床见解

第九章：按适应症划分的 Claudin 18.2 标靶治疗的临床趋势与创新

• 胃肠道癌症
• 妇科癌症
• 肺癌

第十章：全球 Claudin 18.2标靶治疗市场概况

• 市场驱动因素与机遇
• 市场挑战与策略解决方案

第11章 Claudin 18.2标靶疗法的技术与临床平台

第12章：竞争格局

• Abpro Therapeutics
• Antengene Corporation
• Arovella Therapeutics
• Astellas Pharma
• AstraZeneca
• Beijing Mabworks Biotech
• BioNTech
• CARsgen
• Dragonboat Biopharmaceutical
• Gracell Biotechnology
• Harbour BioMed
• Innovent Biologics
• Klus Pharma
• LaNova Medicines
• Leap Therapeutics
• Luye Pharma Group
• Nanjing KAEDI Biotech
• OriCell Therapeutics
• RemeGen
• Shandong Boan Biotechnology
• Shanghai Junshi Biosciences
• SmartNuclide Biopharma
• TORL Biotherapeutics
• Transcenta Holding
• Xilio Therapeutics

Global Claudin18.2 Targeted Therapy Market Opportunity, Therapeutic Approaches, Approved Drug Price, Sales & Clinical Trials Insight 2030 Report finding & Highlights

• Global Claudin18.2 Targeted Therapy Market Opportunity: > US$ 800 Million By 2030
• Number Of Approved Claudin18.2 Targeted Therapy: 1
• Approved Claudin18.2 Targeted Therapy Dosage, Price & Sales Insight
• Insight On More Than 70 Claudin18.2 Targeted Therapies Clinical Trials
• Global Claudin18.2 Targeted Therapies Clinical Trials By Company, Indication & Phase
• Technical & Clinical Platforms For Developing Claudin18.2 Targeted Therapies
• Competitive Landscape

Claudin 18.2 Targeted Therapy Need and Why This Report?

The need for new and effective forms of cancer treatment remains a pressing concern. Many cancers, including pancreatic and stomach cancer, are frequently discovered at an advanced stage, with few treatment options and unsatisfactory results. Conventional treatments, such as radiation and chemotherapy, often do not result in long term survival and can have serious side effects. These challenges have caused focus to shift to targeted cancer treatments. Claudin 18.2 (CLDN18.2), a transmembrane protein typically present in the gastric epithelium, is one potential target. CLDN18.2 is abnormally overexpressed in a number of cancers, such as colorectal, pancreatic, and gastric cancers, and it is exposed on the surface of tumor cells where therapeutic agents can selectively recognize it. Because of its tumor-specific expression, CLDN18.2 is a desirable target for treatment because it permits targeted destruction of cancer cells while sparing the majority of healthy tissues.

This research report gives comprehensive insight on the current status of CLDN18.2 targeted therapy development and presents a detailed review of the latest advancements. It includes information about the various ongoing clinical trials, the stages and treatment approaches of these trials and the corresponding technology platforms, and the assessment of the current key companies and institutions contributing to the development of these therapies. The report evaluates the current circumstances and helps identify the innovation trends and the future directions being established in the CLDN18.2 targeted therapy area. It aims to enable stakeholders to make informed decisions about the future directions that CLDN18.2 targeted therapies can take and how these therapies can help bring about significant improvements in gastrointestinal and other solid cancers.

Clinical Studies & Trials Insight Included In Report

One of the critical areas of focus in this report is the comprehensive analysis of ongoing clinical studies and trials targeting CLDN18.2, encompassing insights on more than 70 therapies across various stages of development. These trials are being conducted across various geographies, with a focus on patient segments most likely to benefit from CLDN18.2 targeted therapies. Early clinical trials, including those involving monoclonal antibodies like zolbetuximab (Vyloy), have shown promising results in the treatment of advanced stage gastric cancer, thereby underlining the potential of these therapies to bring improvements in progression free survival. The report provides insights into the effectiveness of monotherapies as well as combination therapies that pair CLDN18.2 targeted agents with other cancer treatments such as chemotherapy or immune checkpoint inhibitors. This dual approach is gaining momentum as it promises to enhance therapeutic efficacy by attacking cancer cells from multiple angles.

The report also covers trial sponsors, including pharmaceutical giants, academic institutions, and biotech companies that offer stakeholders a clear view of who is driving the research in this space. It provides detailed insight into regional insights by identifying emerging markets where CLDN18.2 targeted therapies are gaining traction and regions where adoption may be slowed due to regulatory challenges.

Leading Companies Engaged In RandD Of Claudin 18.2 Targeted Therapies

The development of CLDN18.2 targeted therapies is being spearheaded by a range of companies committed to the advancement of cancer treatment. These companies are pursuing a range of strategies, from monoclonal antibodies to bispecific antibodies and CAR-T cell therapies, in their efforts to effectively target CLDN18.2 on tumor cells. Zolbetuximab, developed by Astelas, has been a key player in the field, showing positive clinical results and advancing through regulatory approvals for the treatment of gastric cancer. Other companies, such as Servier Pharmaceuticals, are looking into the potential of ADCs linking CLDN18.2 targeting antibodies with cytotoxic agents to deliver targeted chemotherapy directly to the cancer cells. CAR-T cell therapies that also target CLDN18.2 are under investigation in early phase clinical trials with the aim of enhancing the body's immune response to cancer.

The report provides stakeholders with a comprehensive understanding of the R&D strategies being employed by these companies, as well as their progress in moving these therapies through the clinical pipeline. Analysis of the research priorities will hence provide valuable insights for stakeholders on the direction this exciting therapeutic area is taking.

Report Indicating Future Direction Of Claudin 18.2 Targeted Therapies

The future for therapies targeting CLDN18.2 looks promising, with ongoing clinical trials showing positive results in gastric and pancreatic cancers. As research into the role of CLDN18.2 in cancer deepens, new, more sophisticated therapies could be developed. Approaches such as bispecific antibodies, CAR-T cell therapies, and ADCs hold great potential to transform treatment with more precision and fewer side effects than traditional chemotherapy. The report predicts that in the future, treatments targeting CLDN18.2 will also expand beyond gastric cancer into other malignancies, including pancreatic, colorectal, and esophageal cancers. Further, personalized medicine will doubtless feature strongly in CLDN18.2 treatments in future, based on the particular genetic profile of each individual.

As trials and research continue to advance, CLDN18.2 targeting therapies are set to become an important part of cancer care, particularly for intractable gastrointestinal cancers.

Table of Contents

1. Introduction To Claudin18.2 Targeted Therapy

• 1.1 Understanding Claudin & Claudin18.2 Proteins
• 1.2 Need For Claudin18.2 Targeted Therapy
• 1.3 Approved Claudin18.2 Targeted Therapy

2. Claudin18.2 Targeted Approaches For Cancer Immunotherapy

• 2.1 Antibodies (Monoclonal & Bispecific)
• 2.2 CAR T Cell Therapy
• 2.3 Antibody Drug Conjugate

3. Vyloy - 1st Approved Claudin18.2 Targeted Therapy

• 3.1 Clinical Insight
• 3.2 Pricing & Dosing Insight
• 3.3 Sales Insight

4. Global Claudin18.2 Targeted Therapy Market Scenario

• 4.1 Current Market Overview
• 4.2 Future Market Outlook

5. Claudin18.2 Targeted Therapy Trend Analysis By Region

• 5.1 US
• 5.2 China
• 5.3 Europe
• 5.4 Japan
• 5.5 South Korea
• 5.6 Australia
• 5.7 UK

6. Global Claudin18.2 Targeted Therapies Clinical Trials Overview

• 6.1 By Company
• 6.2 By Country
• 6.3 By Indication
• 6.4 By Phase

7. Global Claudin18.2 Targeted Therapies Clinical Trials By Company, Indication & Phase

• 7.1 Research
• 7.2 Preclinical
• 7.3 Phase 0
• 7.4 Phase I
• 7.5 Phase I/II
• 7.6 Phase II
• 7.7 Phase III
• 7.8 Preregistration

8. Marketed Claudin18.2 Targeted Therapies Clinical Insight

9. Claudin18.2 Targeted Therapy Clinical Trends & Innovations By Indication

• 9.1 Digestive Tract Cancers
• 9.2 Gynecological Cancers
• 9.3 Lung Cancer

10. Global Claudin18.2 Targeted Therapy Market Scenario

• 10.1 Market Drivers & Opportunities
• 10.2 Market Challenges & Strategic Solutions

11. Technical & Clinical Platforms For Developing Claudin18.2 Targeted Therapies

12. Competitive Landscape

• 12.1 Abpro Therapeutics
• 12.2 Antengene Corporation
• 12.3 Arovella Therapeutics
• 12.4 Astellas Pharma
• 12.5 AstraZeneca
• 12.6 Beijing Mabworks Biotech
• 12.7 BioNTech
• 12.8 CARsgen
• 12.9 Dragonboat Biopharmaceutical
• 12.10 Gracell Biotechnology
• 12.11 Harbour BioMed
• 12.12 Innovent Biologics
• 12.13 Klus Pharma
• 12.14 LaNova Medicines
• 12.15 Leap Therapeutics
• 12.16 Luye Pharma Group
• 12.17 Nanjing KAEDI Biotech
• 12.18 OriCell Therapeutics
• 12.19 RemeGen
• 12.20 Shandong Boan Biotechnology
• 12.21 Shanghai Junshi Biosciences
• 12.22 SmartNuclide Biopharma
• 12.23 TORL Biotherapeutics
• 12.24 Transcenta Holding
• 12.25 Xilio Therapeutics

List of Figures

• Figure 1-1: General Role Of Claudin In Tight Junctions
• Figure 1-2: Claudin Family & CLDN18.2 In Gastric Epithelium
• Figure 1-3: CLDN18.2 Overexpression In Cancers & Functions
• Figure 1-4: Claudin18.2 Targeted Therapies - Impact On Patient Outcomes
• Figure 2-1: Claudin18.2 Targeted Approaches
• Figure 2-2: Monoclonal Antibody - Mode Of Action
• Figure 2-3: Bispecific Antibody - Advantages
• Figure 2-4: CAR-T Therapy Mechanism Targeting CLDN18.2
• Figure 3-1: Vyloy - Approval Year By Region
• Figure 3-2: Vyloy - Cost Of Supply In US (US$), January'2026
• Figure 3-3: Vyloy - Cost Of Supply In Europe (US$), January'2026
• Figure 3-4: Global - Annual Vyloy Sales (US$ Million), 2024 - 2025
• Figure 3-5: Global - Quarterly Vyloy Sales (US$ Million), Q1-Q3'2025
• Figure 3-6: Global - Quarterly Vyloy Sales (US$ Million), Q2-Q4'2024
• Figure 4-1: Global - Annual Claudin18.2 Targeted Therapy Market (US$ Million), 2024 - 2025
• Figure 4-2: Global -Claudin18.2 Targeted Therapy Market (US$ Million), Q1-Q3'2025
• Figure 4-3: Global -Claudin18.2 Targeted Therapy Market (US$ Million), Q2-Q4'2024
• Figure 4-4: Global Claudin18.2 Targeted Therapy Market - Future Opportunities
• Figure 6-1: Global - Claudin18.2 Drugs Clinical Trials by Company (Numbers), 2026 Till 2030
• Figure 6-2: Global - Claudin18.2 Drugs Clinical Trials by Country (Numbers), 2026 Till 2030
• Figure 6-3: Global - Claudin18.2 Drugs Clinical Trials by Indication (Numbers), 2026 Till 2030
• Figure 6-4: Global - Claudin18.2 Drugs Clinical Trials by Phase (Numbers), 2026 Till 2030
• Figure 9-1: SPOTLIGHT Phase III (NCT03504397) Study - Initiation & Completion Year
• Figure 9-2: GLOW Phase III (NCT03653507) Study - Initiation & Completion Year
• Figure 9-3: TranStar102 Phase I/II (NCT04495296) Study - Initiation & Completion Year
• Figure 9-4: CIBI343A101 Phase I (NCT05458219) Study - Initiation & Completion Year
• Figure 9-5: CLINCH Phase I (NCT05718895) Study - Initiation & Completion Year
• Figure 9-6: TJ033721STM101 Phase I (NCT04900818) Study - Initiation & Completion Year
• Figure 9-7: CT041-ST-01 Phase II (NCT04581473) Study - Initiation & Completion Year
• Figure 9-8: IMC002-CT01 Phase II (NCT05472857) Study - Initiation & Completion Year
• Figure 9-9: XNW27011-I/II-01 Phase II (NCT06792435) Study - Initiation & Completion Year
• Figure 9-10: TACTIC-3 Phase I/II (NCT05862324) Study - Initiation & Completion Year
• Figure 9-11: ZZCART-002 Phase I (NCT03198052) Study - Initiation & Completion Year
• Figure 9-12: XNW27011-I/II-01 Phase I/II (NCT06792435) Study - Initiation & Completion Year
• Figure 9-13: ZZTIL-012 Phase I (NCT04842812) Study - Initiation & Completion Year
• Figure 10-1: Global Claudin18.2 Targeted Therapy Market - Drivers & Opportunities
• Figure 10-2: Global Claudin18.2 Targeted Therapy Market - Challenges & Solutions
• Figure 11-1: CARsgen Pharmaceuticals - CycloCAR platform
• Figure 11-2: LaNova - LX-ADC(TM) Platform
• Figure 11-3: Phanes Therapeutics - PACbody
• Figure 11-4: Phanes Therapeutics - SPECpair
• Figure 11-5: TetraBi Antibody Format
• Figure 11-6: Oricell Platforms
• Figure 11-7: ConjuALL Platform
• Figure 11-8: Arovella - ALA-105 iNKT Cell Therapy
• Figure 11-9: Bolt Biotherapeutics - Boltbody ISAC BDC-4182
• Figure 11-10: SMACTM - NBE Therapeutics

List of Tables

• Table 1-1: Subfamilies Of Claudin Involved in Different Types Of Cancers
• Table 1-2: GI Cancers - Traditional Cancer Treatments Limitations
• Table 1-3: Approved Claudin18.2 Targeted Therapies
• Table 2-1: Claudin18.2 Targeting Monoclonal Antibodies In Development
• Table 2-2: Claudin18.2 Targeting Bispecific Antibodies In Development
• Table 2-3: Claudin18.2 Targeting CAR-T Therapies In Development
• Table 2-4: Claudin18.2 Targeting Antibody Drug Conjugates In Development
• Table 3-1: Vyloy - Recommended Dose Modifications In Case Of Adverse Reactions