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癌症分子标靶治疗学

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1394201

Claudin 18.2 标靶治疗全球市场：市场机会与临床试验考量（2028）

Global Claudin 18.2 Targeted Therapy Market Opportunity & Clinical Trials Insight 2028

出版日期: 2023年12月12日 | 出版商:

KuicK Research | 英文 220 Pages | 商品交期: 最快1-2个工作天内

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简介目录图表

本报告分析结果及摘要

首款 Claudin 18.2 标靶抗体将于 2024 年上半年上市
Claudin 18.2标靶药物进入临床试验：超过60种药物
当前全球Claudin 18.2标靶药物的市场趋势及动向
Claudin 18.2标靶药物临床试验资讯：依公司、适应症、阶段
Claudin 18.2 深入了解治疗开发的技术与临床平台
Claudin 18.2 标靶治疗开发方法：CAR T 细胞疗法、双特异性抗体和抗体药物偶联物

癌症的生物标记有很多，其中许多被用作精准医学的标靶。在各种有前景的癌蛋白中，Claudin 18 (CLDN18) 已成为非常有前景的治疗选择。 CLDN18的变异体CLDN18.2的出现引起了特别关注。 CLDN18.2具有独特的表达模式并且主要存在于胃黏膜中。这种变异因其与某些恶性肿瘤的相关性而引起人们的关注。随着 CLDN18 治疗潜力研究的进展，其对製药领域的影响将会扩大，有可能彻底改变多种癌症的治疗。

CLDN18是一种与上皮细胞紧密连接密切相关的蛋白质，最近因其作为治疗标靶的潜力而备受关注。 CLDN18的主要优点之一是它在多种肿瘤中表达，包括胰腺癌、胃癌和肺癌。这种选择性表达使其成为精准医学的有吸引力的靶标，从而能够创建保护健康组织同时破坏恶性组织的标靶药物。因此，CLDN18在多种恶性肿瘤中的过度表现为癌症医学领域提供了独特的机会。

此外，利用CLDN18.2作为癌症治疗标靶在降低抗药性方面也有希望。透过专门针对导致癌症的精确蛋白质，抗药性机制不太可能形成，治疗也更有效。因此，CLDN18和CLDN18.2的潜力不容忽视。

Zolvetuximab 是一种针对 CLDN18 的一流研究型单株抗体，正在开发作为 CLDN18.2 阳性、HER2 阴性胃癌或胃食道交界癌患者的一线治疗药物。 2023年7月，zolvetuximab开发商安斯泰来製药宣布，FDA已批准zolvetuximab的生物製品许可申请（BLA），并授予优先审查权。如果获得批准，zolvetuximab 将成为美国第一个针对 CLDN18.2 的抗癌药物。此外，安斯泰来已在日本、欧洲和中国申请佐维妥昔单抗的批准。该药物正在针对胃癌、胃食道连接部腺癌和胰腺腺癌的多项后期临床试验中进行评估。

除了zolvetuximab等抗体外，针对CLDN18.2的嵌合抗原受体T细胞（CAR-T）疗法也在开发中。这些基于细胞的疗法代表了对抗表达 CLDN18.2 的癌症的前沿方法。 CAR-T疗法对来自捐赠者或患者的T细胞进行基因改造，以识别和攻击癌细胞，当应用于表达CLDN18.2的癌症时，该疗法可以带来很多期待。例如，青岛大学医院对9名患者进行了一项研究，评估iPD-1-Claudin 18.2-CAR-T疗法XKDCT086治疗表达Claudin 18.2的复发或难治性胃癌的安全性和耐受性。我们正在与参与者进行临床试验。这种新方法不仅凸显了Claudin18.2作为治疗标靶的适用性，也凸显了精准医学在癌症治疗中的发展。

针对 CLDN18.2 的疗法也有助于个人化癌症治疗的发展。根据患者 CLDN18.2 水平量身定制的治疗可能会显着改善治疗结果。此外，针对 CLDN18 或 CLDN18.2 的疗法与现有疗法合併使用时可能能够提高疗效。例如，CLDN18标靶疗法和免疫疗法的结合是一种强大的癌症治疗策略，需要进一步研究。

製药公司已经认识到 CLDN18 巨大改变市场的潜力，并正在投入大量资金进行 CLDN18 研究。专门从事 CLDN18 的创投公司可能对寻求製药业前景的投资者有吸引力。致力于 CLDN18 疗法的小型製药公司也在製药市场上获得了关注。例如，KYM Biosciences于2023年2月宣布与全球製药巨头阿斯特捷利康签署针对CLDN18.2的抗体药物偶联物CMG901的全球授权协议。阿斯特捷利康将负责 CMG901 的全球研发、製造和商业化。根据协议，阿斯特捷利康将在交易完成后向 KYM 支付 6,300 万美元的预付款，并额外支付 11 亿美元用于进一步的研究和商业里程碑。

因此，CLDN18及其变异CLDN18.2是製药业尤其是癌症治疗领域的第一线希望。 CLDN18 存在于许多癌症中，研究和临床试验中令人鼓舞的结果继续凸显了其重要性。 CLDN18 作为治疗标靶具有诱人的潜力，可能会改变我们治疗癌症的方式。

Abpro Therapeutics
Antengene Corporation
Arovella Therapeutics
Astellas Pharma
AstraZeneca
Beijing Mabworks Biotech
BioNTech
Biotheus
CARsgen
Dragonboat Biopharmaceutical
Gracell Biotechnology
Harbour BioMed
Innovent Biologics
Integral Molecular
Klus Pharma
L and L Biopharma
LaNova Medicines Limited
Leap Therapeutics
Luye Pharma Group
Nanjing Bioheng Biotech
Nanjing KAEDI Biotech
NBE-Therapeutics
OriCell Therapeutics
Qilu Pharmaceutical
Shanghai Junshi Biosciences
Sparx Therapeutics
Tillead Therapeutics
TORL Biotherapeutics
Transcenta Holding
Zai Biopharmaceutical

简介目录图表

“Global Claudin 18.2 Targeted Therapy Market Opportunity & Clinical Trials Insight 2028” Report Findings & Highlights:

First Claudin 18.2 Targeting Antibody Commercial Launch By H1 2024
Claudin 18.2 Targeted Drugs In Clinical Trials: > 60 Drugs
Global Claudin 18.2 Current Market Trend & Developments
Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase
Insight On Technical & Clinical Platforms For Developing Claudin 18.2 Therapy
Claudin 18.2 Targeted Therapy Development Approaches: CAR T Cell Therapy, Bispecific Antibodies, Antibody Drug Conjugates

Cancer is marked by the presence of numerous biomarkers, many of which are being used as targets for precision medicine. Among the various promising cancer proteins, Claudin-18 (CLDN18) has become a compelling option with considerable therapeutic promise. Particular attention has been aroused by the emergence of CLDN18.2, a variation of CLDN18. The expression pattern of CLDN18.2 is distinct and it is mostly present in the gastric mucosa. This variant has gained prominence due to its association with certain malignancies. As investigations into the therapeutic potential of CLDN18 continue, its impact on the pharmaceutical domain is poised to be substantial, potentially revolutionizing the way we treat some cancers.

CLDN18, a protein that is largely linked with tight junctions in epithelial cells, has received a lot of interest recently because of its potential as a therapeutic target. One of its key advantages is that it is expressed in a variety of tumors, including pancreatic, gastric and lung cancers. Because of this selective expression, it is an appealing target for precision medicine, enabling the creation of targeted medicines that protect healthy tissues while destroying malignant tissues. Therefore, CLDN18 overexpression in diverse malignancies offers a unique opportunity in the realm of cancer pharmaceuticals.

In addition, the usage of CLDN18.2 as a cancer therapeutic target has also showed promise in terms of lowering drug resistance. Resistance mechanisms are less likely to develop when the exact protein responsible for the cancer is specifically targeted, boosting the effectiveness of treatment. Therefore, loaded with several benefits, the potential of CLDN18 and CLDN18.2 has not clearly not gone unnoticed by the pharmaceutical sector.

Zolbetuximab, a first-in-class investigational monoclonal antibody designed to target the CLDN18, is being developed for the first-line treatment of patients with gastric or gastroesophageal junction cancer that is CLDN18.2-positive HER2-negative. Astellas, the developer of Zolbetuximab, announced in July 2023 that the FDA had approved their biologics license application (BLA) for Zolbetuximab, also granting it a priority review. If approved, Zolbetuximab will become the first CLDN18.2-targetd drug to become available in the US for these patients. In addition, Astellas has also filed applications for Zolbetuximab approval in Japan, Europe and China. The drug is being evaluated in multiple late-phase clinical trials in gastric and gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma.

Apart from antibodies like Zolbetuximab, chimeric antigen receptor T-cell (CAR-T) therapies targeting CLDN18.2 are also under development. These cell-based therapies represent a cutting-edge approach to combating cancers that express CLDN18.2 CAR-T therapy involves the genetic modification of donor or patient-derived T cells to recognize and attack cancer cells, and when applied to CLDN18.2-expressing cancers, the therapy holds great promise. For instance, the Affiliated Hospital of Qingdao University is conducting a clinical trial with 9 participants to assess the safety and tolerability of iPD-1-Claudin18.2-CAR-T therapy, XKDCT086, in recurrent or refractory gastric cancer expressing Claudin18.2. This novel approach not only highlights the adaptability of Claudin18.2 as a therapeutic target but also underscores the evolving nature of precision medicine in the treatment of cancer.

CLDN18.2-targeted therapies have also aided the growth of personalized therapies in cancer treatment. Treatments customized to the patient's CLDN18.2 levels could improve treatment outcomes significantly. In addition, therapies that target CLDN18 or CLDN18.2 can potentially be used in combination with current therapies to boost their efficacy. For instance, pairing CLDN18-targeted therapies with immunotherapies represents a powerful cancer treatment strategy that requires further investigation.

Pharmaceutical companies are heavily spending on CLDN18 research, realizing its market upheaval potential. CLDN18-focussed ventures may be appealing to investors looking for prospects in the pharmaceutical sector. Small pharmaceutical companies working on CLDN18-targeting therapies are also becoming more visible in the pharmaceutical market. KYM Biosciences, for example, announced a global license agreement with global pharma giant AstraZeneca in February 2023 for its CLDN18.2 targeting antibody-drug conjugate CMG901, the first of its kind. AstraZeneca will be responsible for the global research, development, manufacturing and commercialization of CMG901. According to the agreement, AstraZeneca will pay KYM an upfront payment of US$ 63 million upon closing of the transaction, as well as another US$ 1.1 billion on further research and sales-related milestones.

Therefore, CLDN18 and its variant CLDN18.2 are a ray of hope in the pharmaceutical industry, especially cancer therapy. Its prevalence in numerous cancers as well as encouraging outcomes from research investigations and clinical trials have continuously highlighted its importance. CLDN18 has a fascinating potential as a therapeutic target and could potentially alter the way we approach cancer therapy.

1. Claudin 18.2 Therapy - New Epoch For Cancer Treatment

2. Introduction To Claudin 18.2 Therapy

2.1. Understanding Claudin 18.2 Proteins
2.2. Chronicle & Development of Claudin 18.2 Therapy

3. Need For Claudin 18.2 Targeted Therapy

4. Research Advancement Targeting Claudin 18.2 For Cancer Immunotherapy

4.1. Monoclonal Antibody Therapy
4.2. Bispecific Antibody
4.3. CAR T Cell Therapy
4.4. Antibody Drug Conjugate

5. Claudin 18.2 Therapy In Gastric & Pancreatic Cancer: Clinical Trends & Innovations

5.1. Gastric Cancer
5.2. Pancreatic Cancer

6. Global Claudin 18.2 Current Market Trend & Developments

6.1. Current Market Development Outlook
6.2. Future Market Outlook

7. Claudin 18.2 Therapy Trend Analysis By Region

7.1. US
7.2. China
7.3. Europe
7.4. UK
7.5. Japan
7.6. Australia
7.7. South Korea

8. Global Claudin 18.2 Drugs Clinical Trials Overview

8.1. By Company
8.2. By Country
8.3. By Therapy Class
8.4. By Indication
8.5. By Patient Segment
8.6. By Phase

9. Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase

9.1. Research
9.2. Preclinical
9.3. Phase-I
9.4. Phase-I/II
9.5. Phase-II
9.6. Preregistration

10. Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

11. Global Claudin 18.2 Therapy Market Dynamics

11.1. Market Drivers
11.2. Market Challenges

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. Biotheus
12.9. CARsgen
12.10. Dragonboat Biopharmaceutical
12.11. Gracell Biotechnology
12.12. Harbour BioMed
12.13. Innovent Biologics
12.14. Integral Molecular
12.15. Klus Pharma
12.16. L and L Biopharma
12.17. LaNova Medicines Limited
12.18. Leap Therapeutics
12.19. Luye Pharma Group
12.20. Nanjing Bioheng Biotech
12.21. Nanjing KAEDI Biotech
12.22. NBE-Therapeutics
12.23. OriCell Therapeutics
12.24. Qilu Pharmaceutical
12.25. Shanghai Junshi Biosciences
12.26. Sparx Therapeutics
12.27. Tillead Therapeutics
12.28. TORL Biotherapeutics
12.29. Transcenta Holding
12.30. Zai Biopharmaceutical

简介目录图表

List of Figures

Figure 2-1: Function of Claudin 18.2 Protein
Figure 2-2: Functional Classification of the Claudin Family Proteins
Figure 2-3: Dichotomous Role of Claudin 18.2 Protein in Cancer
Figure 2-4: Claudin 18 Isoforms
Figure 3-1: Global - Gastric Cancer Incidences & Deaths (Million), 2020
Figure 4-1: Therapeutic Approach for Claudin 18.2 protein
Figure 4-2: mAb - Mode of Action
Figure 4-3: Claudin 18.2 - Novel Monoclonal Antibodies in Clinical Research
Figure 4-4: Advantage of Bispecific Antibodies
Figure 4-5: PT886 - Phanes Therapeutics Development Vista
Figure 4-6: Q-1802 Phase I/II Study - Initiation & Completion Year
Figure 4-7: QLS31905 Phase I/II Study - Initiation & Completion Year
Figure 4-8: ASP2138 - Astellas Pharma
Figure 4-9: CARsgen Pharmaceuticals Collaboration - Fudan & Peking University for CT041 & CT048
Figure 4-10: Immunofoco - Pipeline for Claudin 18.2 Therapy
Figure 4-11: NCT06084286 Phase I Study - Initiation & Completion Year
Figure 4-12: SKB315 - Clinical Trial & Collaboration Overview
Figure 4-13: RC118 Phase I/I Study - Initiation & Completion Year
Figure 4-14: Claudin 18.2 -ADCs Candidates
Figure 5-1: Upregulation of Claudin 18.2 in Gastric Cancer
Figure 5-2: HEC-016 Phase I Study - Initiation & Completion Year
Figure 5-3: Structure & Mode of Action for TJ-CD4B
Figure 5-4: Osemitamab Phase I/II Study - Initiation & Completion Year
Figure 5-5: LY011 Phase I/II Study - Initiation & Completion Year
Figure 5-6: SOT102 Phase I Study - Initiation & Completion Year
Figure 5-7: KD-496 Phase I Study - Initiation & Completion Year
Figure 5-8: SPX-101 Phase I Study - Initiation & Completion Year
Figure 5-9: Zolbetuximab Phase II Study - Initiation & Completion Year
Figure 6-1: Companies involved in Clinical Trial for Claudin 18.2 Therapy
Figure 6-2: Global - Claudin 18.2 Target Therapy Market (US Million), 2024 - 2028
Figure 6-3: Aspects Determining the Future of Claudin 18.2 Therapy
Figure 7-1: TAC101-CLAUDIN 18.2 Phase I Study - Initiation & Completion Year
Figure 7-2: Triumvira Immunologics - Pipeline for Claudin 18.2 Therapies
Figure 7-3: TORL-2-307 Phase I Study - Initiation & Completion Year
Figure 7-4: Aspects Influencing the Claudin 18.2 Therapy in US
Figure 7-5: China - Major Candidates in Clinical Trial
Figure 7-6: LM302 Phase II Study - Initiation & Completion Year
Figure 7-7: Strategic Collaboration Between LaNova & Turning Point
Figure 7-8: TQB2103 Phase I Study - Initiation & Completion Year
Figure 7-9: CARsgen Therapeutics Pipeline for Claudin 18.2
Figure 7-10: CT041 Phase II Study - Initiation & Completion Year
Figure 7-11: NCT06084286 Phase I Study - Initiation & Completion Year
Figure 7-12: SOT102 Phase I/II Study - Initiation & Completion Year
Figure 7-13: AZD0901 Phase II Study - Initiation & Completion Year
Figure 7-14: AZD0901 Phase II Study - Initiation & Completion Year
Figure 7-15: CMG901 - Partnership Between AstraZeneca & KYM Bioscience
Figure 7-16: Zolbetuximab - Reasons for Approval of Biologics License Application & Priority Designations
Figure 7-17: SPOTLIGHT Phase III Study - Initiation & Completion Year
Figure 7-18: GLOW Phase III Study - Initiation & Completion Year
Figure 7-19: ASP2138 Phase I Study - Initiation & Completion Year
Figure 7-20: Collaboration of SparX Group & Arovella Therapeutics for Claudin 18.2 iNKT cell therapy
Figure 7-21: ATG-022 Phase I Study - Initiation & Completion Year
Figure 8-1: Global - Claudin 18.2 Drugs Clinical Trials by Company (Numbers), 2023 till 2028
Figure 8-2: Global - Claudin 18.2 Drugs Clinical Trials by Country (Numbers), 2023 till 2028
Figure 8-3: Global - Claudin 18.2 Drugs Clinical Trials by Therapy Class (Numbers), 2023 till 2028
Figure 8-4: Global - Claudin 18.2 Drugs Clinical Trials by Indication (Numbers), 2023 till 2028
Figure 8-5: Global - Claudin 18.2 Drugs Clinical Trials by Patient Segment(Numbers), 2023 till 2028(Numbers), 2023 till 2028
Figure 8-6: Global - Claudin 18.2 Drugs Clinical Trials by Phase (Numbers), 2023 till 2028
Figure 10-1: CARsgen Pharmaceuticals - CycloCAR platform
Figure 10-2: LaNova - LX-ADC™ Platform
Figure 10-3: Phanes Therapeutics - PACbody
Figure 10-4: Phanes Therapeutics - SPECpair
Figure 11 1: Market Drivers for Claudin 18.2 Therapy
Figure 11 2: Market Challenges for Claudin 18.2 Therapy

List of Tables

Table 2-1: Subfamilies of Claudin involved in Different Types of Cancer Formation
Table 4-1: Monoclonal Antibody Approaches Targeting Claudin 18.2 Protein
Table 4-2: Bispecific Antibody Approaches Targeting Claudin 18.2 Protein
Table 4-3: CAR-T Therapy Approaches Targeting Claudin 18.2 Protein
Table 4-4: Antibody Drug Conjugate Approaches Targeting Claudin 18.2 Protein
Table 5-1: Gastric Cancer - Ongoing Clinical Trials For Claudin 18.2 Therapy
Table 7-2: US - Ongoing Clinical Trial for Claudin 18.2 Therapy
Table 7-1: China - Ongoing Clinical Trials for Claudin 18.2 Therapy
Table 7-3: EU - Ongoing Clinical Trial for Claudin 18.2 Therapy
Table 7-5: UK- Ongoing Clinical Trial for Claudin 18.2 Therapy
Table 7-4: Japan - Ongoing Clinical Trial for Claudin 18.2
Table 7-6: Australia - Ongoing Clinical Trial for Claudin 18.2
Table 7-7: South Korea - Ongoing Clinical Trial for Claudin 18.2

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License/价格

Claudin 18.2 标靶治疗全球市场：市场机会与临床试验考量（2028）

Global Claudin 18.2 Targeted Therapy Market Opportunity & Clinical Trials Insight 2028

目录

第 1 章 Claudin 18.2 治疗 - 癌症治疗的新时代

第 2 章 Claudin 18.2 治疗概论

第 3 章 Claudin 18.2 标靶治疗的必要性

第 4 章癌症免疫治疗中针对 Claudin 18.2 的分析进展

第 5 章 Claudin 18.2 治疗胃癌和胰臟癌：临床趋势与创新

第 6 章全球 Claudin 18.2 市场：当前趋势与动向

第 7 章 Claudin 18.2 治疗趋势分析：依地区

第 8 章全球Claudin 18.2药物临床试验概述

第 9 章 Claudin 18.2药物在全球的临床试验：依公司、依适应症、阶段

第 10 章开发先进的Claudin 18.2疗法的技术与临床平台

第 11 章全球 Claudin 18.2 治疗市场动态

第 12 章竞争态势

Table of Contents

1. Claudin 18.2 Therapy - New Epoch For Cancer Treatment

2. Introduction To Claudin 18.2 Therapy

3. Need For Claudin 18.2 Targeted Therapy

4. Research Advancement Targeting Claudin 18.2 For Cancer Immunotherapy

5. Claudin 18.2 Therapy In Gastric & Pancreatic Cancer: Clinical Trends & Innovations

6. Global Claudin 18.2 Current Market Trend & Developments

7. Claudin 18.2 Therapy Trend Analysis By Region

8. Global Claudin 18.2 Drugs Clinical Trials Overview

9. Global Claudin 18.2 Drugs Clinical Trials By Company, Indication & Phase

10. Technical & Clinical Platforms For Developing Advanced Claudin 18.2 Therapy

11. Global Claudin 18.2 Therapy Market Dynamics

12. Competitive Landscape

List of Figures

List of Tables