双环毒素偶联物的全球市场 - 临床试验，独自平台，市场机会(2025年)

全球双环毒素偶联物市场亮点 - 临床试验、专有平台及市场机会 (2025) 报告

• 全球及地区洞察
• 双环毒素偶联物专有平台概览
• 双环毒素偶联物研究及市场趋势（依适应症划分）
• 双环毒素偶联物临床管线（依公司、适应症及分期划分）
• 未来商业机遇
• 竞争格局

对双环毒素偶联物的需求及本报告的意义

对更安全、更有效、更有针对性的抗癌疗法的需求日益增长，这推动了新疗法的药物研发。双环毒素偶联物 (BTC) 代表了新一代标靶治疗药物，其特征是精准度高、药物动力学良好、肿瘤穿透性强。 BTC 结合了双环肽的亲和力和化疗药物的细胞毒性有效载荷，旨在发挥高效的抗癌活性，同时最大限度地降低全身毒性。

本报告的发布意义非凡，正值双环毒素偶联物领域从早期临床前景向坚实成果迈进之际。儘管该领域仍处于起步阶段，但临床进展、监管审批和研究投入的步伐正在加快。本分析全面概述了双环毒素偶联物目前的科学、临床和商业发展状况，为利益相关者提供了对这一快速发展领域的重要见解，该领域有可能重塑肿瘤学及其他领域的未来。

报告包含临床试验洞察

本报告详细总结了正在进行的双环毒素偶联物临床试验，并概述了关键早期和中期候选治疗药物的开发。由Bicycle Therapeutics公司开发的三种双环毒素偶联物——BT1718、BT5528和泽来奈克肽培维多汀（Zele，BT8009）——目前正在进行早期和晚期临床试验。这些试验针对多种实体瘤中的多种肿瘤相关抗原，包括MT1-MMP、EphA2和Nectin-4。

本报告记录了这些试验的重要讯息，包括临床试验阶段、地理位置、申办机构和正在研究的适应症。报告也总结了迄今为止的关键试验结果。这些数据清晰准确地描绘了双环毒素偶联物的临床进展和监管潜力。

技术平台、合作与协议

Bicycle Therapeutics 专有的 Bicycle® 平台构成了双环毒素偶联物开发的技术基础。我们的化学合成胜肽技术能够产生与 MMAE 和 DM1 等细胞毒素偶联的小型、高选择性结合物。这产生了一类介于生物製剂和小分子之间的治疗药物，可增强深层肿瘤渗透并促进清除。

合作是我们方法的核心。透过与英国癌症研究中心 (Cancer Research UK) 的新合作，BT1718 已进入由英国癌症研究中心赞助和资助的 1/2 期临床试验。此外，我们也参与了美国食品药物管理局 (FDA) 的癌症管理和临床研究实践 (CDRP)。

活跃于双环毒素偶联物研发的主要公司

目前，Bicycle Therapeutics 是唯一一家积极进行双环毒素偶联物临床阶段研发的公司。 Bicycle Therapeutics 成立于英国剑桥，是该领域的全球领导者，拥有一系列针对多种肿瘤的双环毒素偶联物产品组合。公司持续开发第一代、第二代和第三代双环毒素偶联物，体现了其致力于推进此类新型疗法的承诺。透过全球临床试验以及与大西洋和太平洋地区监管机构的互动，Bicycle Therapeutics 正在全球阐明双环毒素偶联物的未来方向和潜力。

一份关于双环毒素偶联物领域未来发展方向的报告

本报告显示，双环毒素偶联物是精准肿瘤学领域一个重要的新兴类别，在某些适应症上可能与抗体偶联药物（ADC）相媲美甚至超越ADC。快速通道和CDRP认定等监管方面的关注反映出机构对双环毒素偶联物日益增长的兴趣。联合疗法的临床疗效表明，双环毒素偶联物可能很快就会成为第一线癌症治疗方案中不可或缺的一部分。

随着进一步发展，双环毒素偶联物平台的应用范围可能超越肿瘤学，在传染病和其他需要靶向有效载荷递送的疾病领域展现出良好的前景。本文概述的双环毒素偶联物领域的发展清晰地展现了其获得监管部门认可、扩大应用范围和广泛行业应用的途径。

目录

第1章 双环毒素偶联物的简介

• 概要
• 历史与演进

第2章 双环毒素偶联物- 作用机制

第3章 全球双环毒素偶联物的调查与市场趋势(各适应症)

• 癌症
• 病毒性疾病

第4章 双环毒素偶联物- 独家平台

第5章 二环式毒素复合体的临床试验概要

• 各企业
• 各适应症
• 场所
• 各相

第6章 企业，适应症，各相的全球二环式毒素复合体的临床实验平台

• 第一/二阶段
• 第三阶段

第7章 全球双环毒素偶联物的现在及未来市场趋势与展望

• 目前市场趋势，开发，临床试验的评估
• 未来的商业化的机会

第8章 全球双环毒素偶联物的研究和各地区市场趋势

• 美国
• 欧洲联盟
• 英国

第9章 全球双环毒素偶联物市场动态

• 推动市场要素和商业机会
• 市场课题与阻碍因素

第10章 竞争情形

• Bicycle Therapeutics

Global Bicycle Toxin Conjugates Clinical Trials, Proprietary Platforms & Market Opportunity Insight 2025 Report Highlights:

• Global & Regional Trends Insight
• Bicycle Toxin Conjugates Proprietary Platforms Overview
• Bicycle Toxin Conjugates Research & Market Trends By Indication
• Bicyclic Toxin Conjugates Clinical Pipeline By Company, Indication & Phase
• Future Commercialization Opportunity
• Competitive Landscape

Need for Bicycle Toxin Conjugates & Why This Report?

The increasing need for safer, more effective, and highly targeted anticancer therapies has driven pharmaceutical discovery towards new therapeutic modalities. Bicycle Toxin Conjugates (BTCs) are a new generation of targeted therapies possessing a distinctive blend of precision, favorable pharmacokinetics, and tumor penetration. Combining the binding affinity of bicyclic peptides and the cytotoxic payloads of chemotherapy drugs, BTCs are engineered to provide highly effective anti-cancer activity with reduced systemic toxicity.

This report is timely and critical as the bicycle toxin conjugates space transitions from initial clinical promise to solid achievements. While the area remains in its infancy, the velocity of clinical advancement, regulatory acceptance, and research investment is increasing. This analysis provides an all-encompassing perspective on where bicycle toxin conjugates are scientifically, clinically, and commercially now and gives stakeholders critical insight into a fast-developing area that can reshape future benchmarks in oncology and beyond.

Clinical Trials Insight Included In Report

The report offers an in-depth summary of the ongoing bicycle toxin conjugates clinical trial landscape, outlining the development of major therapeutic candidates through early- and mid-stage studies. Three bicycle toxin conjugates created by Bicycle Therapeutics, namely BT1718, BT5528, and zelenectide pevedotin (Zele, BT8009), are being studied in early and late-stage clinical trials. These trials are directed against several tumor-associated antigens, MT1-MMP, EphA2, and Nectin-4, in a variety of solid tumors.

This report records notable information on these trials, such as trial phases, geographical regions, sponsoring organizations, and indications being researched. It also summarizes key trial results to date; this data offer a clear, precise view of bicycle toxin conjugates clinical progress and regulatory promise

Technology Platforms, Collaborations and Agreements

Bicycle Therapeutics' proprietary Bicycle(R) platform constitutes the technological underpinning of bicycle toxin conjugates development. The chemically synthesized peptide technology allows small, highly selective binding agents to be generated coupled with cytotoxins such as MMAE and DM1. This results in a class of therapies that are intermediate between biologics and small molecules, showing enhanced deep tumor penetration and accelerated clearance.

Cooperative action is at the core of the firm's approach. A new collaboration with Cancer Research UK has brought BT1718 to Phase 1/2 trials, with CRUK sponsoring and funding the trial. Furthermore, the firm's engagement in the FDA's CMC Development and Readiness Pilot (CDRP).

Major Companies Active In R&D of Bicycle-Toxin Conjugates

Currently, Bicycle Therapeutics is the only company actively working on bicycle toxin conjugates at a clinical stage. Established in Cambridge, UK, the company is the global leader in this area with a portfolio of bicycle toxin conjugates addressing a variety of tumors. Its continued development of first-, second-, and third-generation bicycle toxin conjugates reflects its focus on advancing this new class of therapy. Through global trials and regulatory interaction on both Atlantic sides, Bicycle Therapeutics is outlining the future direction and potential of bicycle toxin conjugates worldwide.

Report Suggesting Future Direction Of Bicycle-Toxin Conjugates Segment

This report identifies bicycle toxin conjugates as an essential up-and-coming category in precision oncology with the potential to either match or even outperform ADCs in some indications. Regulatory interest, including Fast Track and CDRP designation, reflects increasing institutional interest in bicycle toxin conjugates. Clinical efficacy in combination therapies implies bicycle toxin conjugates may become an integral part of front-line cancer regimens within a short while.

As it continues to develop, the bicycle toxin conjugates platform can also be utilized outside of oncology, with promise in infectious disease and other indications that call for targeted payload delivery. The development of the bicycle toxin conjugates segment, as illustrated here, clearly shows a path toward regulatory acceptance, expanded application, and increased industry uptake.

Table of Contents

1. Introduction To Bicycle Toxin Conjugates

• 1.1 Overview
• 1.2 History & Evolution

2. Bicycle Toxin Conjugates - Mechanism Of Action

3. Global Bicycle Toxin Conjugates Research & Market Trends By Indication

• 3.1 Cancer
• 3.2 Viral Diseases

4. Bicycle Toxin Conjugates - Proprietary Platforms

5. Global Bicyclic Toxin Conjugates Clinical Trials Overview

• 5.1 By Company
• 5.2 By Indication
• 5.3 By Location
• 5.4 By Phase

6. Global Bicyclic Toxin Conjugates Clinical Pipeline By Company, Indication & Phase

• 6.1 Phase-I/II
• 6.2 Phase-III

7. Global Bicycle Toxin Conjugates Current & Future Market Trends Outlook

• 7.1 Current Market Trends, Developments & Clinical Trials Assessment
• 7.2 Future Commercialization Opportunity

8. Global Bicycle Toxin Conjugates Research & Market Trends By Region

• 8.1 US
• 8.2 EU
• 8.3 UK

9. Global Bicycle Toxin Conjugates Market Dynamics

• 9.1 Market Drivers & Commercial Opportunities
• 9.2 Market Challenges & Restraints

10. Competitive Landscape

• 10.1 Bicycle Therapeutics

List of Figures

• Figure 1-1: Bicycle Toxin Conjugate - Structure
• Figure 2-1: Bicycle Toxin Conjugates - Mechanism Of Action
• Figure 3-1: Zelenectide Pevedotin - Structure
• Figure 3-2: Duravelo-1 Phase 1/2 (NCT04561362) Study - Initiation & Completion Year
• Figure 3-3: Duravelo-2 Phase 2/3 (NCT06225596) Study - Initiation & Completion Year
• Figure 3-4: Duravelo-3 Phase 2 (NCT06840483) Study - Initiation & Completion Year
• Figure 3-5: Duravelo-4 Phase 2 (NCT06933329) Study - Initiation & Completion Year
• Figure 3-6: BT5528 - Structure
• Figure 3-7: BT5528-100 Phase 1/2 Study - Initiation & Completion Year
• Figure 3-8: BT1718 - Structure
• Figure 4-1: Bicycles - Advantages
• Figure 4-2: Bicycles - Key Properties
• Figure 5-1: Global - Bicyclic Toxin Conjugates Clinical Trials By Company (Number), 2025
• Figure 5-2: Global - Bicyclic Toxin Conjugates Clinical Trials By Indication (Number), 2025
• Figure 5-3: Global - Bicyclic Toxin Conjugates Clinical Trials By Location (Number), 2025
• Figure 5-4: Global - Bicyclic Toxin Conjugates Clinical Trials By Phase (Number), 2025
• Figure 7-1: Global Bicycle Toxin Conjugates Market - Future Opportunities
• Figure 9-1: Bicycle Toxin Conjugates Market - Drivers & Opportunities
• Figure 9-2: Bicycle Toxin Conjugates Market - Challenges & Restraints

List of Tables

• Table 8-1: US - Ongoing Clinical Trials for Bicycle Toxin Conjugates
• Table 8-2: EU - Ongoing Clinical Trials for Bicycle Toxin Conjugates
• Table 8-3: UK - Ongoing Clinical Trials for Bicycle Toxin Conjugates