三特異性抗體的全球市場：臨床試驗與市場前景（2024）

在過去的幾十年裡，隨著單一特異性和雙特異性抗體等抗體藥物發現治療的出現，免疫治療領域的藍圖被認為是未來主義的。在 FDA 批准第一個單株抗體利妥昔單抗用於治療非何傑金氏淋巴瘤患者後，這項研究得到了推動。儘管單特異性抗體取得了巨大成功，但它們也存在許多缺陷，例如僅針對一種類型的抗原並且對治療的抗藥性增加，使得很難使用針對體內多種抗原或外來入侵者的治療。發展。近年來，三特異性抗體因其同時靶向三種抗原的能力而成為有前景的治療靶標，使其成為乾預各種疾病的潛在遊戲規則改變者。

迄今為止，市面上還沒有三特異性抗體，但未來幾年內可能會有少量三特異性抗體獲得批准。三特異性抗體可以同時結合三種不同的抗原，提高靶向腫瘤細胞的精確度和有效性。

目前有超過 50 種三特異性抗體正在進行臨床前和臨床試驗，用於治療癌症、傳染病、眼科疾病等。然而，研究人員相信，三特異性抗體的臨床開發將在未來幾年迅速推進，擴展到自體免疫疾病等新的治療領域。隨著我們對三特異性抗體的瞭解不斷加深，作用機制和蛋白質工程的創新將會加速，針對精確疾病生物學和分子機制的三特異性構建體的非常規設計也將加速。

本報告檢視了全球三特異性抗體市場，並提供了市場概況，包括藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司的競爭格局。

目錄

第1章 三特異性抗體作為標靶治療

第2章 三特異性抗體的臨床進展及未來商業化前景

第3章 三特異性抗體臨床及市場發展趨勢分析

• 美國
• 中國
• EU
• 英國
• 日本
• 澳大利亞

第4章 三特異性抗體的治療臨床趨勢（依適應症）

• 癌症
• 病毒感染
• 眼病

第5章 全球三特異性抗體臨床試驗概況

• 依國家
• 相別
• 依公司
• 依指示
• 依患者細分

第6章 依公司、國家、適應症和階段分析全球三特異性抗體臨床試驗。

• 研究
• 臨床前
• 第一階段
• 一期/二期

第7章 三特異性抗體市場動態

• 市場驅動力
• 市場課題

第8章 三特異性抗體市場的最新趨勢：聯盟、收購、合作與投資

第9章 不斷發展的三特異性抗體組合方法

第10章 用於開拓三特異性抗體開發的平台

第11章 競爭格局

• AbbVie
• Antibody Studio
• Beijing Mabworks Biotech
• Biocytogen Pharmaceuticals
• Chimagen Biosciences
• Chiome Bioscience
• Genor Biopharma
• GT Biopharma
• Harpoon Therapeutics
• Ichnos Sciences
• KisoJi Biotechnology
• L and L Biopharma
• Lyvgen Biopharma
• Numab
• OPKO Health
• Sanofi
• Sichuan Baili Pharmaceuticals
• TG ImmunoPharma

Global Trispecific Antibodies Clinical Trials & Market Outlook 2024 Report Highlights:

• Trispecific Antibodies In Clinical Trials: > 50 Antibodies
• Majority Of Antibodies Developed For Multiple Myeloma: 8 Antibodies
• Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
• Platforms Used For Pioneering Trispecific Antibody
• China Dominating Trispecific Antibodies Clinical Trials: >20 Antibodies
• Competitive Landscape: Insight On 18 Companies

The blueprint in the domain of immunotherapy has perceived futuristic with the advent of antibody founded therapy, like monospecific and bispecific antibodies, in the past decenniums. The investigation has picked up its gait after the FDA approval of the first monoclonal antibody, rituximab, for the management of patients suffering from non-Hodgkin's lymphoma. Albeit, the monospecific antibodies have demonstrated gigantic triumph, there comes a number of pitfalls, such as their ability to target only one type of antigens as well as increased therapy resistance, urges the need to develop more therapies that will target more than one antigen or foreign foe inside the person's body. In the recent years, trispecific antibody has emerged as a promising therapeutic target due to its plausibility in targeting 3 antigens at the same time, making it a game changer candidate for intervention in various ailments.

To date, no trispecific antibody have been launched in the market; however, it is probable that handful of trispecific antibodies will be approved in the imminent years. Founded on the accomplishment of monospecific antibodies, healthcare professionals have developed trispecific antibody, which can simultaneously bind to three different antigens at the same time, enhancing the precision and effectiveness of targeting tumor cells; representing a groundbreaking innovation in the field of cancer immunotherapy.

At present, more than 50 trispecific antibodies are lately in the preclinical together with clinical studies for the treatment of cancer, infectious diseases, and eye diseases. Nevertheless, researchers believed that the clinical conduit of trispecific antibody is proposed to perceive swift development in the years ahead and will likely expand into additional therapeutic areas like autoimmune diseases, and beyond. As progression in trispecific antibody understanding, mode of action in addition to protein engineering innovations upsurges; simultaneously, the unconventional design of trispecific constructs tailored to precise disease biology and molecular mechanisms will expand.

Accompanied that, the presences of giant pharma companies, such as Roche/ Genentech, Chugai Pharmaceutical, Genor Biopharma, Johnson & Johnson, Merck, Gilead Sciences, Xencor, Numab Therapeutics others, signifies that the sector of trispecific antibodies will prosper further in the forthcoming years as the involvement of giant stakeholders aid to conduct multiple research studies.

Over and above, pharmaceutical companies as well as biotechnology corporations are progressively engaging in strategic collaborations, investments, in addition to acquisitions to influence corresponding expertise and resources in trispecific antibody development domain. These partnerships accelerate research and development, optimize clinical trial design, and enhance market penetration. For instance, in May 2024, Merck has acquired EyeBio with an investment of US$ 3 Billion in order to advance the sector of trispecific antibody. Furthermore, Gilead Science and Merus collaboration deal to discover novel antibody-based trispecific t-cell engagers in March 2024 is another such example.

For the treatment of cancer disorders, a diverse landscape of trispecific antibody candidates is currently under evaluation to treat solid tumors and hematological cancer diseases. However, in the recent years, scientists have expanded the clinical application of trispecific antibody beyond cancer and can be utilized to treat other indications such as eye disorders, viral infections and other, specifying novel avenue. Given their biological complexity as well as anticipated premium pricing, the segment of trispecific assets could feasibly generate multi billion-dollar peak sales in forthcoming years among successful programs.

Looking further ahead, the commercial global market of trispecific antibody is intensifying at a farfetched pace owing to the market drivers like the rising population, involvement of stakeholders, ongoing pre-clinical and clinical trials, augment in technological advancement in immunotherapies domain, rise in awareness for immuno oncology therapy, together with increase in investments and licensing deals. Presently, the US as well as China have become the front runner up in the segment of trispecific immuno therapy due to the rising research in addition to clinical trials.

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 Multiple Myeloma
  • 4.1.5 Lymphoma
  • 4.1.6 Leukemia
• 4.2 Viral Infections
• 4.3 Eye Diseases

5. Global Trispecific Antibodies Clinical Trials Overview

• 5.1 By Country
• 5.2 By Phase
• 5.3 By Company
• 5.4 By Indication
• 5.5 By Patient Segment

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

• 6.1 Research
• 6.2 Preclinical
• 6.3 Phase I
• 6.4 Phase I/II

7. Trispecific Antibody Market Dynamics

• 7.1 Market Drivers
• 7.2 Market Challenges

8. Recent Trends in Trispecific Antibody Market: Partnerships, Acquisitions, Collaboration, & Investments

9. Combinations Approaches for Bourgeoning Trispecific Antibody

• 9.1 Immunotherapy
• 9.2 Radiotherapy

10. Platforms Used For Pioneering Trispecific Antibody

• 10.1 Tavotek Biotherapeutics - TavoSelect Platform
• 10.2 Tavotek Biotherapeutics - TavoPrecise Platform
• 10.3 Purple Biotech - Tribody Antibody Platform
• 10.4 Simcere Zaiming's - T-Cell Engager Polyspecific Antibody Technology Platform
• 10.5 Ichnos Sciences - BEAT Platform
• 10.6 Molecular Partners - DARPin Platform
• 10.7 Merus - Triclonics Platform

11. Competitive Landscape

• 11.1 AbbVie
• 11.2 Antibody Studio
• 11.3 Beijing Mabworks Biotech
• 11.4 Biocytogen Pharmaceuticals
• 11.5 Chimagen Biosciences
• 11.6 Chiome Bioscience
• 11.7 Genor Biopharma
• 11.8 GT Biopharma
• 11.9 Harpoon Therapeutics
• 11.10 Ichnos Sciences
• 11.11 KisoJi Biotechnology
• 11.12 L and L Biopharma
• 11.13 Lyvgen Biopharma
• 11.14 Numab
• 11.15 OPKO Health
• 11.16 Sanofi
• 11.17 Sichuan Baili Pharmaceuticals
• 11.18 TG ImmunoPharma

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: CB307 Phase I Study (NCT04839991) - Initiation & Completion Year
• Figure 3-2: SAIL66 Phase I Study (NCT05735366) - Initiation & Completion Year
• Figure 4-1: BR115 Phase I Study (NCT06388902) - Initiation & Completion Year
• Figure 4-2: NM32-2668 Phase I Study (NCT06299163) - Initiation & Completion Year
• Figure 4-3: Trispecific Antibody Benefit to Treat Colorectal Cancer
• Figure 4-4: Chimagen Biosciences Pipeline
• Figure 4-5: HPN328 (MK-6070) with Atezolizumab Phase I/II Study (NCT04471727) - Initiation & Completion Year
• Figure 4-6: Genor Biopharma Pipeline
• Figure 4-7: GB263T Phase I/II Study (NCT05332574) - Initiation & Completion Year
• Figure 4-8: SIM0500 Phase I Study (NCT06375044) - Initiation & Completion Year
• Figure 4-9: JNJ-79635322 Phase I Study (NCT05652335) - Initiation & Completion Year
• Figure 4-10: MBS314 Phase I/II Study (NCT06232096) - Initiation & Completion Year
• Figure 4-11: Trispecific Antibodies FDA Designations
• Figure 4-12: HPN217 Phase I Study (NCT04184050) - Initiation & Completion Year
• Figure 4-13: PIT565 Phase I Study (NCT05397496) - Initiation & Completion Year
• Figure 4-14: JNJ-80948543 Phase I Study (NCT05424822) - Initiation & Completion Year
• Figure 4-15: 1A46/ BR110 Phase I/II Study (NCT05987605) - Initiation & Completion Year
• Figure 4-16: KL-HIV-Tri01 Phase I Study (NCT06117657) - Initiation & Completion Year
• Figure 4-17: Restoret (EYE103) - Tetravalent, Tri-Specific Antibody Binding Sites
• Figure 4-18: Restoret/ EYE103 Phase I/II Study (NCT05919693) - Initiation & Completion Year
• Figure 4-19: Eluminex Ophthalmics Clinical Trispecific Pipeline for Eye Ailments
• Figure 5-1: Global - Trispecific Antibodies Clinical Trials by Country, 2024
• Figure 5-2: Global - Trispecific Antibodies Clinical Trials by Phase, 2024
• Figure 5-3: Global - Trispecific Antibodies Clinical Trials by Company
• Figure 5-4: Global - Trispecific Antibodies Clinical Trials by Indication, 2024
• Figure 5-5: Global - Trispecific Antibodies Clinical Trials by Patient Segment, 2024

Figure 7-1 : Trispecific Antibody - Market Drivers

• Figure 7-2: Key Players in Trispecific Antibody Market
• Figure 7-3: Trispecific Antibody - Market Challenges
• Figure 9-1: JNJ-87801493 with JNJ-80948543 & JNJ-75348780 Phase I Study (NCT06139406) - Initiation & Completion Year
• Figure 9-2: Radiolabelled CB307/ 89Zr-CB307 Phase I Study (NCT05836623) - Initiation & Completion Year
• Figure 10-1: Purple Biotech - Tribody Antibody Platform
• Figure 10-2: DARPin Platform - Molecular Partners
• Figure 10-3: Merus - Triclonics Platform
• Figure 11-1: GT Biopharma - Clinical Pipeline

List of Tables

• Table 3-1: US -Ongoing Clinical Trials for Trispecific Antibodies (May'2024)
• Table 3-2: EU -Ongoing Clinical Trials for Trispecific Antibodies (May'2024)
• Table 3-3: Australia -Ongoing Clinical Trials for Trispecific Antibodies (May'2024)