三重特异性抗体的全球市场:临床试验，贸易快速审批的现状，技术平台与市场机会的展望(2025年)

三特异性抗体市场已成为生物製药领域一个前景光明且充满活力的领域，这主要得益于多特异性抗体研究的持续进步。单株抗体和双特异性抗体的成功为三特异性抗体的开发奠定了基础，三特异性抗体是免疫疗法的下一个创新。这些三特异性抗体针对三种不同的抗原，与单株抗体或双特异性抗体相比增强了其治疗潜力。儘管尚未有三特异性抗体获得批准，但有几种候选抗体正处于后期开发阶段，一些已进入 II/III 期临床试验，这表明在不久的将来有可能获得批准。

目前，许多公司，无论大小，都专注于三特异性抗体的开发，经常与其他组织合作以共享资源和专业知识。例如，2025 年 1 月，AbbVie 与 Simcere Zaiming 签署了一份许可选择权协议，以开发针对 GPRC5D、BCMA 和 CD3 的人源化三特异性抗体 SIM0500。该抗体目前正在美国和中国对復发或难治性多发性骨髓瘤（MM）患者进行 I 期临床试验。根据协议，先声再明将从艾伯维获得一笔预付款以及潜在的里程碑费用和选择权费用（取决于专案的成功程度），总额高达 10.55 亿美元。

三特异性抗体已显示出良好的临床前结果，其效果通常优于传统疗法。一个值得注意的例子是 ISB 2001，由 Ichnos Glenmark Innovation 开发的 BCMA/CD38/CD3 三特异性抗体。在人类细胞系中对杨森的 Tekbairi 和百时美施贵宝的 alnuctamab 候选药物等双特异性抗体进行测试时，ISB 2001 杀死癌细胞的有效性提高了 20 到 260 倍。此外，ISB 2001 在消除多发性骨髓瘤患者肿瘤方面已被证明优于 Tekbairi。在动物模型中，低剂量的 ISB 2001 完全消除了所有八隻小鼠的肿瘤，而 Tecvayli 仅抑制了 30.8% 的肿瘤生长。这些令人鼓舞的结果凸显了三特异性抗体与现有疗法相比增强的治疗潜力。

三特异性抗体的新临床试验不断涌现，提高了其在癌症治疗及其他领域应用的期望。例如，2025年3月，基石药业宣布其新型PD-1/VEGF/CTLA-4三特异性抗体CS2009的国际多中心I期临床试验中首例患者成功给药。初步报告显示没有输液反应或其他不良事件，进一步证明了这种先进疗法的安全性。随着这些临床试验的进展，三特异性抗体的市场预计将扩大，为癌症和其他对常规治疗有抗药性的疾病患者提供新的选择。

儘管前景乐观，但三特异性抗体的开发面临若干挑战。製造的复杂性和精确针对多种抗原的需要是主要障碍。开发有效且可扩展的製造流程对于三特异性抗体疗法的成功至关重要。此外，监管挑战（特别是在安全性和有效性数据方面）可能会减缓这些创新疗法的批准进程。

然而，由于对更有针对性和更有效的癌症治疗的需求不断增加，以及抗体工程和生产技术的进步等因素，三特异性抗体市场持续成长。随着双特异性抗体研究的成功数量不断增加，以及越来越多的临床试验证明三特异性抗体的潜力，我们预计会看到对该市场的进一步投资和兴趣。因此，三特异性抗体市场预计将在未来几年经历显着成长，更多的研究合作、临床试验和潜在的市场批准将为这种有前景的新型治疗方法铺平道路。

本报告提供全球三重特异性抗体市场相关调查，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。

目录

第1章 标靶治疗的三重特异性抗体

第2章 三重特异性抗体- 目前临床开发与未来的商业化的展望

• 目前市场开拓情势
• 未来市场商业化预测

第3章 各地区的三重特异性抗体临床及市场开拓趋势分析

• 美国
• 中国
• EU
• 英国
• 日本
• 澳洲

第4章 三重特异性抗体的治疗的临床倾向，各适应症

• 癌症
  • 乳癌
  • 大肠癌症
  • 肺癌症
  • 脑瘤
  • 多发性骨髓瘤
  • 淋巴瘤
  • 白血病
• 病毒感染
• 眼科疾病
• 自体免疫疾病及发炎性疾病

第5章 企业，国家，适应症，各相的世界三重特异性抗体临床试验的洞察

• 研究
• 前临床
• 第一阶段
• 第一/二阶段
• 第二/三阶段

第6章 全球三重特异性抗体市场动态

• 市场促进因素
• 市场课题

第7章 三重特异性抗体市场最近的趋势:联盟，收购，合作，投资

第8章 对成长中的三重特异性抗体的组合方法

• 免疫疗法
• 放射治疗

第9章 被三重特异性抗体的前导的开发使用了的平台

第10章 竞争情形

• Antibody Studio
• BeiGene
• Beijing Mabworks Biotech
• Biocytogen Pharmaceuticals
• Candid Therapeutics
• Chimagen Biosciences
• Chiome Bioscience
• Chugai Pharmaceutical
• Eluminex Biosciences
• Genor Biopharma
• Harpoon Therapeutics
• Ichnos Glenmark Innovation
• KisoJi Biotechnology
• L and L Biopharma
• Lyvgen Biopharma
• Numab
• OPKO Health
• Sanofi
• Shine-On
• Zymeworks

Global Trispecific Antibodies Clinical Trials, Fast Track Status, Technology Platforms & Market Opportunity Outlook 2025 Report Findings & Highlights:

• First Trispecific Antibody Commercial Approval Expected By 2028
• Currently More Than 50 Trispecific Antibodies Are Under Clinical Trials
• Report Includes Clinical Trials Insight On More Than 50 Trispecific Antibodies By Company, Country, Indication & Phase
• China & USA Dominating Trispecific Antibody Research
• Highest Phase Of Development: Phase II/III
• Insight On Platforms Used For Pioneering Trispecific Antibody By Companies
• Trispecific Antibodies Therapeutic Clinical Tends By Region & Indications
• Insight On 20 Key Companies Developing Trispecific Antibodies

The trispecific antibody market has emerged as a promising and dynamic field in biopharmaceuticals, driven largely by ongoing advancements in multispecific antibody research. The success of monoclonal and bispecific antibodies has laid the foundation for the development of trispecific antibodies, a next-generation innovation in immunotherapy. These trispecific antibodies target three distinct antigens, enhancing their therapeutic potential in comparison to their monoclonal and bispecific counterparts. While none of the trispecific antibodies have yet gained approval, several candidates are in advanced stages of development, with some in Phase II/III clinical trials, indicating a potential for approval in the near future.

Many companies, both large and small, are now focusing their efforts on the development of trispecific antibodies, often collaborating with other organizations to pool resources and expertise. For instance, in January 2025, AbbVie and Simcere Zaiming entered into an option-to-license agreement for the development of SIM0500, a humanized trispecific antibody targeting GPRC5D, BCMA, and CD3. This antibody is currently undergoing Phase I clinical trials in the US and China for patients with relapsed or refractory multiple myeloma (MM). Under the agreement, Simcere Zaiming stands to receive an upfront payment from AbbVie, in addition to milestone payments and option fees that could total up to US$ 1.055 Billion, depending on the success of the program.

Trispecific antibodies have demonstrated promising preclinical results, often outperforming traditional therapies. A notable example is ISB 2001, a BCMA/CD38/CD3 trispecific antibody developed by Ichnos Glenmark Innovation. When tested against bispecific antibodies like Janssen's Tecvayli and Bristol Myers Squibb's candidate alnuctamab in human cell lines, ISB 2001 showed a 20- to 260-fold stronger cancer-killing potency. Furthermore, ISB 2001 proved superior to Tecvayli in its ability to eliminate tumors from multiple myeloma patients. In animal models, ISB 2001 completely eradicated tumors in all eight mice treated with a low dose, whereas Tecvayli showed limited efficacy, with only a 30.8% tumor growth inhibition. These promising results highlight the enhanced therapeutic potential of trispecific antibodies in comparison to existing therapies.

New clinical trials for trispecific antibodies continue to emerge, further solidifying their promise in cancer treatment and beyond. For instance, in March 2025, CStone Pharmaceuticals announced the successful dosing of the first patient in a global multicenter Phase I clinical trial of CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody. Early reports indicate that no infusion reactions or other adverse events were observed, providing further evidence of the safety profile of these advanced therapeutics. As these trials progress, the market for trispecific antibodies will likely expand, offering new options for patients with cancer and other conditions that have proven resistant to conventional therapies.

Despite the optimistic outlook, there are several challenges facing the development of trispecific antibodies. The complexity of manufacturing and the need for precise targeting of multiple antigens are among the key hurdles. The development of effective and scalable manufacturing processes will be crucial to ensuring the success of trispecific antibody therapies. Additionally, regulatory challenges, particularly in terms of safety and efficacy data, may slow the path to approval for these innovative treatments.

Regardless, the market for trispecific antibodies continues to grow due to factors such as the growing demand for more targeted and effective cancer therapies, as well as advancements in antibody engineering and production technologies. The increasing success of bispecific antibodies, combined with the growing number of clinical trials demonstrating the potential of trispecifics, is likely to drive further investment and interest in this market. As a result, the trispecific antibody market is expected to see significant growth in the coming years, with more collaborations, clinical trials, and potentially, market approvals paving the way for this promising new class of therapeutics.

Table of Contents

1. Trispecific Antibody As Targeted Therapy

2. Trispecific Antibody - Current Clinical Development & Future Commercialization Outlook

• 2.1 Current Market Development Scenario
• 2.2 Future Market Commercialization Outlook

3. Trispecific Antibody Clinical & Market Development Trend Analysis By Region

• 3.1 US
• 3.2 China
• 3.3 EU
• 3.4 UK
• 3.5 Japan
• 3.6 Australia

4. Trispecific Antibodies Therapeutic Clinical Tends By Indications

• 4.1 Cancer
  • 4.1.1 Breast Cancer
  • 4.1.2 Colorectal Cancer
  • 4.1.3 Lung Cancer
  • 4.1.4 Brain Cancer
  • 4.1.5 Multiple Myeloma
  • 4.1.6 Lymphoma
  • 4.1.7 Leukemia
• 4.2 Viral Infections
• 4.3 Ophthalmic Diseases
• 4.4 Autoimmune & Inflammatory Diseases

5. Global Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

• 5.1 Research
• 5.2 Preclinical
• 5.3 Phase I
• 5.4 Phase I/II
• 5.5 Phase II/III

6. Global Trispecific Antibody Market Dynamics

• 6.1 Market Drivers
• 6.2 Market Challenges

7. Recent Trends In Trispecific Antibody Market: Partnerships, Acquisitions, Collaboration, & Investments

8. Combinations Approaches For Bourgeoning Trispecific Antibody

• 8.1 Immunotherapy
• 8.2 Radiotherapy

9. Platforms Used For Pioneering Trispecific Antibody

• 9.1 Chugai Pharmaceutical - Dual-Ig Platform
• 9.2 Ichnos Sciences - BEAT Platform
• 9.3 Mab Works - Multispecific Antibody Platform
• 9.4 Molecular Partners - DARPin Platform
• 9.5 Merus - Triclonics Platform
• 9.6 Purple Biotech - Tribody Antibody Platform
• 9.7 Shine-On BioMedical - Trispecific T Cell Engager Antibody
• 9.8 Simcere Zaiming - T-Cell Engager Polyspecific Antibody Technology Platform
• 9.9 Tavotek Biotherapeutics - TavoSelect & TavoPrecise Platforms
• 9.10 Zymeworks - Azymetric

10. Competitive Landscape

• 10.1 Antibody Studio
• 10.2 BeiGene
• 10.3 Beijing Mabworks Biotech
• 10.4 Biocytogen Pharmaceuticals
• 10.5 Candid Therapeutics
• 10.6 Chimagen Biosciences
• 10.7 Chiome Bioscience
• 10.8 Chugai Pharmaceutical
• 10.9 Eluminex Biosciences
• 10.10 Genor Biopharma
• 10.11 Harpoon Therapeutics
• 10.12 Ichnos Glenmark Innovation
• 10.13 KisoJi Biotechnology
• 10.14 L and L Biopharma
• 10.15 Lyvgen Biopharma
• 10.16 Numab
• 10.17 OPKO Health
• 10.18 Sanofi
• 10.19 Shine-On
• 10.20 Zymeworks

List of Figures

• Figure 1-1: Trispecific Antibody As Targeted Therapy
• Figure 2-1: Strategies To Develop Next Generation Trispecific Antibody
• Figure 2-2: Aspects Influencing Future Of Trispecific Antibody
• Figure 3-1: POTENTIA Phase 1 (NCT04839991) Study - Initiation & Completion Year
• Figure 3-2: SAL101JG Phase 1 Study (NCT05735366) - Initiation & Completion Year
• Figure 4-1: NM32-2668 Phase 1 Study (NCT06299163) - Initiation & Completion Year
• Figure 4-2: MK-6070-001/HPN328-4001 Phase 1/2 (NCT04471727) Study - Initiation & Completion Year
• Figure 4-3: MK-6070-002 Phase 1/2 MK-6070-002 (NCT06780137) Study - Initiation & Completion Year
• Figure 4-4: GB263T-FIH001 Phase 1/2 Study (NCT05332574) - Initiation & Completion Year
• Figure 4-5: SIM0500-101 Phase 1 (NCT06375044) Study - Initiation & Completion Year
• Figure 4-6: ISB 2001-101 Phase 1 (NCT05862012) Study - Initiation & Completion Year
• Figure 4-7: CR109234 Phase 1 (NCT05652335) Study - Initiation & Completion Year
• Figure 4-8: JNJ-79635322 Phase 1 (NCT06768489) Study - Initiation & Completion Year
• Figure 4-9: Multiple Myeloma - Trispecific Antibodies With Regulatory Designations
• Figure 4-10: CPIT565A12101 Phase 1 (NCT05397496) Study - Initiation & Completion Year
• Figure 4-11: CR109174 Phase 1 (NCT05424822) Study - Initiation & Completion Year
• Figure 4-12: JNJ-80948543 Phase 2 (NCT06660563) Study - Initiation & Completion Year
• Figure 4-13: JNJ-80948543 Phase 1 (NCT06139406) Study - Initiation & Completion Year
• Figure 4-14: AZD5492 Phase 1/2 (NCT06542250) Study - Initiation & Completion Year
• Figure 4-15: Restoret - Structure
• Figure 4-16: BRUNELLO Phase 2/3 (NCT06571045) Study - Initiation & Completion Year
• Figure 4-17: Ophthalmic Diseases - Eluminex Ophthalmics Trispecific Antibody Candidates
• Figure 4-18: CPIT565B12101 Phase 1 (NCT06335979) Study - Initiation & Completion Year

Figure 6-1 : Trispecific Antibody - Market Drivers

• Figure 6-2: Trispecific Antibody - Market Challenges
• Figure 9-1: Chugai Pharmaceutical - Dual-Ig Platform
• Figure 9-2: Mab Works - Multispecific Antibody Platform
• Figure 9-3: DARPin Platform - Molecular Partners
• Figure 9-4: Merus - Triclonics Platform
• Figure 9-5: Purple Biotech - Tribody Antibody Platform
• Figure 9-6: Shine-On BioMedical - Trispecific T Cell Engager Antibody
• Figure 9-7: Zymeworks Azymetric

List of Tables

• Table 3-1: US - Ongoing Clinical Trials For Trispecific Antibodies
• Table 3-2: EU - Ongoing Clinical Trials For Trispecific Antibodies
• Table 3-3: Australia -Ongoing Clinical Trials For Trispecific Antibodies