全球 Claudin 18.2 標靶治療市場機會、治療方法、已核准藥物定價、銷售及臨床試驗展望（2030 年）

全球 Claudin 18.2 標靶治療市場機會、治療方法、已核准藥物定價、銷售及臨床試驗展望（2030 年）報告的主要發現與亮點

• 全球 Claudin 18.2 標靶治療市場機會：到 2030 年將超過 8 億美元
• 已批准的 Claudin 18.2 標靶治療藥物數量：1
• 已核准的 Claudin 18.2 標靶治療藥物：1 項－Claudin 18.2 標靶治療藥物劑量、定價與銷售洞察
• 超過 70 項 Claudin 18.2 標靶治療臨床試驗洞察
• 全球 Claudin 18.2 標靶治療臨床試驗依公司、適應症及研發階段劃分的試驗
• Claudin 18.2標靶治療研發的技術與臨床平台
• 競爭格局

Claudin 18.2標靶治療的需求及本報告的意義

對新型有效癌症療法的需求依然迫切。許多癌症，包括胰臟癌和胃癌，通常在晚期才被發現，導致治療選擇有限，療效往往不盡人意。傳統的治療方法，例如放射療法和化療，通常無法帶來長期生存，並且可能伴隨嚴重的副作用。這些挑戰促使人們對標靶癌症療法越來越感興趣。 Claudin 18.2 (CLDN18.2) 是一種通常存在於胃上皮細胞中的跨膜蛋白，是一個很有前景的標靶。 CLDN18.2 在多種癌症中異常高表達，包括大腸直腸癌、胰臟癌和胃癌，並暴露於腫瘤細胞表面，可被治療藥物選擇性識別。其腫瘤特異性表現使其成為理想的治療標靶，能夠選擇性地破壞癌細胞，同時保留大部分健康組織。

本報告全面深入地分析了 CLDN18.2 標靶治療的現狀，並詳細回顧了最新進展。報告涵蓋了正在進行的各項臨床試驗、試驗階段和治療方法、相應的技術平台，以及對參與這些療法研發的關鍵公司和機構的評估。本報告旨在評估 CLDN18.2 標靶治療領域的現狀，並協助識別新興趨勢和未來創新方向。其目的是幫助利害關係人就 CLDN18.2 標靶治療的未來發展方向以及這些療法如何顯著改善胃腸道癌症和其他實體瘤的治療效果做出明智的決策。

本報告包​​含的臨床研究和試驗見解

本報告的重點之一是對正在進行的針對 CLDN18.2 的臨床研究和試驗進行全面分析，涵蓋了 70 多種處於不同研發階段的療法的見解。這些試驗在多個地區開展，主要針對最有可能從 CLDN18.2 標靶療法中獲益的患者群體。在晚期胃癌的治療中，包括使用佐貝妥昔單抗（Vyloy）等單株抗體的早期臨床試驗，已顯示出令人鼓舞的結果，凸顯了這些療法在改善無惡化存活期方面的潛力。本報告也探討了單藥療法以及將 CLDN18.2 標靶藥物與其他癌症療法（例如化療和免疫檢查點抑制劑）合併使用的聯合療法的療效。這種雙管齊下的方法因其能夠從多個角度攻擊癌細胞，從而增強治療效果而備受關注。

本報告也概述了臨床試驗申辦方，包括大型製藥公司、學術機構和生物技術公司，使利害關係人能夠清晰了解該領域研究的領先參與者。報告還透過識別CLDN18.2標靶療法正在興起的新興市場以及監管挑戰可能減緩其應用的地區，提供了詳細的區域分析。

參與Claudin 18.2標靶療法研發的主要公司

CLDN18.2標靶療法的研發由眾多致力於推進癌症治療的公司主導。這些公司正在探索多種策略，從單株抗體到雙特異性抗體再到CAR-T細胞療法，以有效靶向腫瘤細胞上的CLDN18.2。由安斯泰來公司開發的佐貝妥昔單抗在該領域發揮重要作用，在胃癌治療中顯示出積極的臨床結果，並正在推進監管審批流程。其他公司，例如施維雅製藥（Servier Pharmaceuticals），正在探索抗體藥物偶聯物（ADC）的潛力，將靶向CLDN18.2的抗體與細胞毒性藥物結合，旨在將靶向化療藥物直接遞送至癌細胞。針對CLDN18.2的CAR-T細胞療法也正在進行早期臨床試驗，目標是增強人體對癌症的免疫反應。

本報告旨在幫助利害關係人全面了解這些公司採用的研發策略以及臨床管線中治療方案的進展。對研究重點的分析將為這一前景廣闊的治療領域的發展方向提供寶貴的見解。

報告展現了標靶Claudin 18.2療法的潛力

靶向CLDN18.2療法的未來前景光明，正在進行的臨床試驗在胃癌和胰腺癌治療中均顯示出積極的結果。隨著對CLDN18.2在癌症中作用的研究不斷深入，有望開發出更先進的新型療法。雙特異性抗體、CAR-T細胞療法和抗體藥物偶聯物（ADC）等方法具有巨大的潛力，能夠以比傳統化療更高的精準度和更少的副作用革新癌症治療。本報告預測，未來CLDN18.2標靶療法的應用範圍將從胃癌擴展到其他惡性腫瘤，例如胰臟癌、大腸直腸癌和食道癌。此外，基於個體特定基因譜的個人化醫療無疑將在未來的CLDN18.2治療中發揮重要作用。

隨著臨床試驗和研究的不斷進展，CLDN18.2標靶療法有望在癌症治療中發揮重要作用，尤其是在難治性胃腸道癌症的治療中。

目錄

第一章：Claudin 18.2標靶治療簡介

• 了解Claudin和Claudin 18.2蛋白
• Claudin 18.2標靶治療的必要性
• 已核准的Claudin 18.2標靶療法

第二章：Claudin 18.2癌症免疫療法的標靶策略

• 抗體（單株抗體和雙特異性抗體）
• CAR-T細胞療法
• 抗體藥物偶聯物

第三章：Vyloy－首個核准的Claudin 18.2標靶藥物治療

• 臨床見解
• 定價和劑量見解
• 銷售見解

第四章 全球 Claudin 18.2 標靶治療市場概況

• 當前市場概覽
• 未來市場展望

第五章 Claudin 18.2 標靶治療趨勢分析（按地區劃分）

• 美國
• 中國
• 歐洲
• 日本
• 韓國
• 澳大利亞
• 英國

第六章 全球 Claudin 18.2 標靶治療臨床試驗概覽

• 按公司
• 依國家/地區
• 按適應症
• 依階段

第七章：全球 Claudin 18.2 標靶治療臨床試驗（按公司、適應症和分期劃分）

• 研究
• 臨床前
• 0 期
• I 期
• I/II 期
• II 期
• III 期
• 預先註冊

第八章：市售 Claudin 18.2 標靶治療的臨床見解

第九章：按適應症劃分的 Claudin 18.2 標靶治療的臨床趨勢與創新

• 胃腸道癌症
• 婦科癌症
• 肺癌

第十章：全球 Claudin 18.2標靶治療市場概況

• 市場驅動因素與機遇
• 市場挑戰與策略解決方案

第11章 Claudin 18.2標靶療法的技術與臨床平台

第12章：競爭格局

• 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