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生物製剂分子标靶治疗学

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1531956

TROP2抗体的全球市场:临床试验相关洞察(2029年)

Global TROP2 Antibody Market & Clinical Trials Insight 2029

出版日期: 2024年08月01日 | 出版商:

KuicK Research | 英文 200 Pages | 商品交期: 最快1-2个工作天内

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简介目录图表

TROP2（滋养层细胞表面抗原2）最近作为癌症治疗的标靶引起了人们的关注，因为它在乳腺癌、肺癌和尿路上皮癌等各种上皮癌中过度表达。这种膜蛋白对于细胞增殖和生存至关重要，使其成为创新疗法的有吸引力的目标，特别是抗体药物偶联物（ADC），它构成了开发管道的主要部分。针对 TROP2- 的治疗正在迅速发展，人们对使用这种生物标记进行更有效的癌症治疗越来越感兴趣。

目前，Trodelvy（sacituzumab govitecan）是唯一核准的针对 TROP2 的药物。它由Immunomedics（现为吉利德科学公司的一部分）开发，于2020年4月获得FDA批准用于治疗三阴性乳癌，并于2021年4月扩大到包括尿路上皮癌。截至 2024 年 8 月，Trodelvy 在约 50 个国家获得批准。 Trodelvy 的商业成功体现在其强劲的销售成长。 2024年上半年销售额较2023年同期激增超过30%，主要是由于二线转移性三阴性乳癌和先前治疗的HR+/HER2转移性乳癌需求增加推动，销售额超过6亿美元。

Datapotamab deruxtecan 是由第一三共和阿斯特捷利康开发的另一种有前景的针对 TROP2 的研究药物，在多种实体瘤的试验中显示出积极的结果。 2024年上半年，FDA和EMA都接受了针对非鳞状非小细胞肺癌和HR阳性、HER2阴性乳癌的生物製品许可申请（BLA）和行销授权申请（MAA）。这项进展凸显了人们对 TROP2 作为治疗标靶日益增长的兴趣，并表明更多的治疗方法可能很快就会获得批准。

针对 TROP2 的疗法主要以抗体药物偶联物 (ADC) 为特征。 ADC 有效地将单株抗体的特异性与有效的细胞毒性药物结合。这种策略有利于将化疗直接且精确地递送至癌细胞，从而减少全身副作用。 ADC 在 TROP2 标靶治疗方面处于领先地位，但其他创新方法也在研究中。这包括基于 RNA 的细胞疗法，重点是改变 TROP2 表达并利用免疫系统攻击表达 TROP2 的癌细胞。

围绕 TROP2 疗法的竞争环境正在迅速发展，目前正在进行大量临床试验。默克、豪森生物医疗、BiOneCure Therapeutics、Bio-Thera Solutions、Biohaven Therapeutics 和上海復旦张江生物製药等着名製药和生物技术公司都在这一领域进行了大量投资。这种日益激烈的竞争可以促进创新并加速为患者推出新疗法。

本报告提供全球TROP2抗体市场相关调查，提供市场概要，以及药物趋势，临床试验趋势，各地区趋势，及加入此市场的主要企业竞争情形等资讯。

Abion Bio
Amunix
Aptamer Sciences
Arbele
Aston Science
AstraZeneca
Beijing Biocytogen
BiOneCure Therapeutics
Biosion
Bio-Thera Solutions
Daiichi Sankyo Company
Hangzhou DAC Biotech
Innovent Biologics
Janux Therapeutics
LegoChem Biosciences
Merck
Molecular Templates
OBI Pharma
Peak Bio
Radiopharm Theranostics
Shanghai Henlius Biotech
Suzhou GeneQuantum Healthcare

简介目录图表

Global TROP2 Antibody Market & Clinical Trials Insight 2029 Report Offering:

Global TROP2 Antibody Market Opportunity: > USD 3 Billion
Global & Regional Market Insight
Approved Drug Annual & Quarterly Sales By Region
Approved Drug Dosage & Pricing Insight
TROP2 Antibodies In Clinical Trials: > 45 Drugs
TROP2 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
Combination Approaches for TROP2 Antibody

TROP2 (trophoblast cell surface antigen 2) has recently gained prominence as target for cancer therapies due to its overexpression in a range of epithelial cancers, such as breast, lung, and urothelial cancers. This membrane protein, crucial for cell growth and survival, presents an appealing target for innovative treatments, especially antibody-drug conjugates (ADCs), which dominate the development pipeline. The landscape for TROP2- targeted therapies has experienced rapid evolution, marked by significant advancements and growing interest in harnessing this biomarker for more effective cancer treatment.

Currently, only one drug targeting TROP2 has been approved, namely Trodelvy (sacituzumab govitecan). Developed by Immunomedics (now part of Gilead Sciences), it received FDA approval in April 2020 for triple negative breast cancer and had its indication expanded to urothelial cancer in April 2021. As of August 2024, Trodelvy is approved in around 50 countries. Trodelvy's commercial success is evident from its significant sales growth. In the first half of 2024, sales jumped over 30% to surpass USD 600 million compared to the same period in 2023, driven mainly by increased demand for treatments in second-line metastatic triple-negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.

Datopotamab deruxtecan, another promising investigational TROP2-targeting drug developed by Daiichi Sankyo and AstraZeneca, has shown positive results in trials for various solid cancers. In the first half of 2024, both the FDA and EMA accepted applications for its Biologics License Application (BLA) and Marketing Authorization Application (MAA) for treating non-squamous non-small cell lung cancer and HR-positive, HER2-negative breast cancer. This progress highlights the growing interest in TROP2 as a therapeutic target and suggests the potential for more approved treatments soon.

The landscape of TROP2-targeted therapies is primarily characterized by antibody-drug conjugates (ADCs), which effectively merge the specificity of monoclonal antibodies with potent cytotoxic agents. This strategy facilitates the precise delivery of chemotherapy directly to cancer cells, thereby reducing systemic side effects. Although ADCs lead the way in TROP2-targeted therapies, other innovative methods are also under investigation. These include RNA-based therapies and cell therapies, which focus on altering TROP2 expression or leveraging the immune system to attack cancer cells that express TROP2.

The competitive environment surrounding TROP2 therapies is rapidly evolving, with a multitude of clinical trials currently in progress. Prominent pharmaceutical and biotechnology companies, such as Merck, Hansoh BioMedical, BiOneCure Therapeutics, Bio-Thera Solutions, Biohaven Therapeutics, and Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, are making significant investments in this area. This heightened competition is fostering innovation and may expedite the introduction of new treatment alternatives for patients.

Notably, China is leading the TROP2 therapeutic landscape, showcasing a significant number of clinical trials and participating companies, with the US closely trailing behind. This development underscores the increasing significance of the Chinese biopharmaceutical sector and its commitment to pioneering cancer treatments. The international scope of TROP2 research and development indicates that patients around the globe may soon have access to these innovative therapies.

As the field progresses, several key factors will be crucial for advancing TROP2-targeted therapies. Extensive long-term data on the efficacy and safety of both approved and experimental treatments will be essential for integrating these therapies into standard protocols and achieving broader acceptance. Identifying biomarkers for patient stratification will be critical to enhance treatment outcomes and ensure therapies are administered to those most likely to benefit. Additionally, understanding resistance mechanisms to TROP2-targeted therapies will be vital for developing strategies to mitigate or prevent resistance, potentially through combination therapies or next-generation agents.

The rapid development of therapies targeting TROP2 marks a notable progression in the field of precision oncology. As additional data is gathered from ongoing clinical trials and the practical application of approved treatments, the comprehensive potential of TROP2 targeting in cancer management will become more evident. The achievements observed to date indicate that TROP2-targeted therapies could assume a more prominent position in the treatment of diverse epithelial cancers, thereby enhancing outcomes for patients who have few treatment alternatives.

1. Introduction to TROP2 Targeting Therapy Market

1.1 Overview
1.2 TROP2 Targeting Therapeutics Mechanism
1.3 TROP2 Ideal Clinical Biomarker for Cancer

2. TROP2 Targeted Antibodies Ongoing Clinical Trials Insight

2.1 By Company
2.2 By Country
2.3 By Patient Segment
2.4 By Phase
2.5 By Priority Status

3. Global TROP2 Antibody Market Outlook

3.1 Current Market Scenario
3.2 Future Market Opportunities

4. Trodelvy (Sacituzumab Govitecan) - First Approved TROP2 Targeting Antibody

4.1 Overview
4.2 Approval, Patent & Exclusivity

5. Trodelvy (Sacituzumab Govitecan) - Commercial Insight

5.1 Dosage & Price Analysis
5.2 Sales Analysis (2020 - 2024)

6. Unveiling TROP2 Therapeutic Frontiers Market Trend By Region

6.1 US
6.2 China
6.3 Australia
6.4 South Korea
6.5 Europe
6.6 Taiwan
6.7 Japan

7. Global TROP2 Targeting Antibodies Market by Cancer

7.1 Breast Cancer
7.2 Lung Cancer
7.3 Gastric Cancer
7.4 Urothelial Cancer
7.5 Ovarian Cancer

8. TROP2 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

8.1 Research
8.2 Preclinical
8.3 Phase I
8.4 Phase I/II
8.5 Phase II
8.6 Phase III
8.7 Preregistration

9. Marketed TROP2 Antibody Clinical Insight

10. Combination Approaches for TROP2 Antibody

11. Competitive Landscape

11.1 Abion Bio
11.2 Amunix
11.3 Aptamer Sciences
11.4 Arbele
11.5 Aston Science
11.6 AstraZeneca
11.7 Beijing Biocytogen
11.8 BiOneCure Therapeutics
11.9 Biosion
11.10 Bio-Thera Solutions
11.11 Daiichi Sankyo Company
11.12 Hangzhou DAC Biotech
11.13 Innovent Biologics
11.14 Janux Therapeutics
11.15 LegoChem Biosciences
11.16 Merck
11.17 Molecular Templates
11.18 OBI Pharma
11.19 Peak Bio
11.20 Radiopharm Theranostics
11.21 Shanghai Henlius Biotech
11.22 Suzhou GeneQuantum Healthcare

简介目录图表

List of Figures

Figure 1-1: Evolution of TROP2 Targeting Therapeutics
Figure 1-2: TROP2 Stimulated Effectors, Biomarker & Pathways
Figure 1-3: TROP2 Regulated Oncogenic Cell Signaling Pathways
Figure 1-4: General Mechanism of TROP2 Targeting Therapy
Figure 1-5: Trodelvy - Mechanism of Action
Figure 1-6: Frequency of TROP2 Expression by Cancer Type (%)
Figure 1-7: Role of TROP2 in Cancer
Figure 2-1: Global -TROP2 Antibodies Clinical Pipeline By Company, 2024 - 2029
Figure 2-2: Global -TROP2 Antibodies Clinical Pipeline By Country, 2024 - 2029
Figure 2-3: Global -TROP2 Antibodies Clinical Pipeline By Patient Segment, 2024 - 2029
Figure 2-4: Global -TROP2 Antibodies Clinical Pipeline By Phase, 2024 - 2029
Figure 2-5: Global -TROP2 Antibodies Clinical Pipeline By Priority Status, 2024 - 2029
Figure 3-1: Global - TROP2 Antibody Market (US$ Million), 2020-2024
Figure 3-2: Global - TROP2 Antibody Market (US$ Million), Q1 - Q2'2024
Figure 3-3: Global - TROP2 Antibody Market by Region (US$ Million), H1'2024
Figure 3-4: Global - TROP2 Antibody Market by Region (%), H1'2024
Figure 3-5: Phase 3 - Key TROP2 Drugs & Companies
Figure 3-6: Gilead Secures Investment From Abingworth To Fund Trodelvy Trials
Figure 3-7: Future TROP2 Market
Figure 3-8: Global - TROP2 Antibodies Market (US$ Million), 2024-2029
Figure 4-1: Trodelvy - FDA Approval Year by Indication
Figure 4-2: Trodelvy - Patent Expiration Year by Region
Figure 4-3: Trodelvy - Approval Year by Region
Figure 4-4: Trodelvy - FDA Orphan Designation Year by Indication
Figure 5-1: US - Price of 180mg Vial of Trodelvy Intravenous Powder (US$), August'2024
Figure 5-2: EU - Price of 180mg & 200mg Vials of Trodelvy Intravenous Powder (US$), August'2024
Figure 5-3: Global - Trodelvy Sales (US$ Million), 2020-2024
Figure 5-4: Global - Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-5: Regional -Trodelvy Sales by Region (US$ Million), H1'2024
Figure 5-6: Trodelvy Sales by Region (%), H1'2024
Figure 5-7: US -Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-8: Europe - Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-9: ROW - Trodelvy Sales (US$ Million), Q1 - Q2'2024
Figure 5-10: US -Trodelvy Sales (US$ Million), 2021-2024
Figure 5-11: Europe - Trodelvy Sales (US$ Million), 2021-2024
Figure 5-12: ROW - Trodelvy Sales (US$ Million), 2021-2024
Figure 5-13: Global - Trodelvy Sales (US$ Million), Q1- Q4'2023
Figure 5-14: Trodelvy - Sales By Region (US$ Million), 2023
Figure 5-15: Trodelvy - Sales By Region (%), 2023
Figure 5-16: US - Trodelvy Sales (US$ Million), Q1 - Q4'2023
Figure 5-17: Europe - Trodelvy Sales (US$ Million), Q1 - Q4'2023
Figure 5-18: ROW - Trodelvy Sales (US$ Million), Q1 - Q4'2023
Figure 6-1: China TROP2 - Key Players & Drugs
Figure 6-2: FDA018-ADC Phase III Study (NCT06519370) - Initiation & Completion Year
Figure 6-3: SHR-A1921 Phase III Study (NCT06394492) - Initiation & Completion Year
Figure 6-4: FZ-AD004 Phase I Study (NCT05914545) - Initiation & Completion Year
Figure 6-5: Trodelvy - TGA Priority Review for HR+/HER2 Metastatic Breast Cancer
Figure 6-6: MT-302 Phase I Study (NCT05969041) - Initiation & Completion Year
Figure 6-7: Radiopharm Theranostics & Lantheus Holdings Agreement
Figure 6-8: South Korea - Key TROP2 Companies
Figure 6-9: LegoChem Biosciences (LCB) & Johnson & Johnson Collaboration
Figure 6-10: LCB84 with an Anti-PD-1 Antibody Phase I/II Study (NCT05941507) - Initiation & Completion Year
Figure 6-11: Dato-DXd Received two EMA marketing authorization applications (MAAs)
Figure 6-12: DB-1305/BNT325 Phase I/II Study (NCT05438329) - Initiation & Completion Year
Figure 6-13: Mediterranea TROP2 antibody, Hu-2G10
Figure 6-14: OBI Pharma TROP2 Therapy Pipeline
Figure 6-15: OBI-992 Phase I/II Study (NCT06480240) - Initiation & Completion Year
Figure 6-16: Dato-DXd & Durvalumab Phase III Study (NCT06112379) - Initiation & Completion Year
Figure 7-1: Breast Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-2: Lung Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-3: TROPION-Lung01 Phase 3 Study - Initiation & Completion Year
Figure 7-4: EVOKE-01 Phase 3 Study - Initiation & Completion Year
Figure 7-5: EVOKE-03 Phase 3 Study - Initiation & Completion Year
Figure 7-6: EVOKE-02 Phase 2 Study - Initiation & Completion Year
Figure 7-7: Gastrointestinal Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-8: MK-2870-015 Phase 3 Study - Initiation & Completion Year
Figure 7-9: MK-3475-06C Phase 1/2 Study - Initiation & Completion Year
Figure 7-10: KL264-01 Phase 1/2 Study - Initiation & Completion Year
Figure 7-11: Urothelial Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-12: Urothelial Cancer - Estimated & Projected Cases, 2022 & 2030
Figure 7-13: BNT-325 (NCT05438329) Phase 1/2 Study - Initiation & Completion Year
Figure 10-1: TROP2 Antibodies Combinations

List of Tables

Table 5-1: Trodelvy - Dose Modifications for Adverse Reactions
Table 6-1: US - Some Clinical Trials Assessing TROP2 Targeting Therapies
Table 6-2: China - Ongoing Clinical Trial for TROP2 Therapies
Table 6-3: SKB264 (MK-2870) - NMPA Designations, Indications & Year Insight
Table 6-4: Preclinical TROP2 Candidates Development in China
Table 6-5: Australia - Ongoing Clinical Trial for TROP2 Therapies
Table 6-6: South Korea - Ongoing Clinical Trial for TROP2 Therapies
Table 6-7: Europe - Ongoing Clinical Trial for TROP2 Therapies
Table 6-8: Taiwan - Ongoing Clinical Trial for TROP2 Therapies
Table 6-9: Japan - Ongoing Clinical Trial for TROP2 Therapies
Table 7-1: Breast Cancer - TROP2 ADC under Review
Table 7-2: Breast Cancer - Some TROP2 Targeted Candidates in Development
Table 7-3: Lung Cancer - TROP2 ADC under Review
Table 7-4: Lung Cancer - Some TROP2 Targeted Candidates in Development
Table 7-5: Gastric Cancer - Some TROP2 Targeted Candidates in Development
Table 7-6: Urothelial Cancer -Key TROP2 Targeted Candidates in Development
Table 7-7: Urothelial Cancer - Key TROP2 Targeted Candidates in Development
Table 10-1: Ongoing Preclinical & Clinical trials for Combination of TROP2 Therapy

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TROP2抗体的全球市场:临床试验相关洞察(2029年)

Global TROP2 Antibody Market & Clinical Trials Insight 2029

目录

第1章 TROP2标靶治疗市场简介

第2章 TROP2抗体进行中的临床试验的洞察

第3章全球TROP2抗体市场预测

第4章 Trodelvy (sacituzumab govitecan)- 第一次已批准TROP2抗体

第5章 Trodelvy (sacituzumab govitecan)- 商业性洞察

第6章 TROP2治疗的最前线市场趋势，各地区

第7章全球TROP2抗体市场，癌症

第8章 TROP2抗体的临床试验的洞察(企业，国家，适应症，各相)

第9章市售TROP2抗体的临床性洞察

第10章 TROP2抗体的组合方法

第11章竞争情形