首页 > 市场调查报告书 > 製药

癌症分子标靶治疗学

市场调查报告书

商品编码

1763117

全球 CD123 标靶治疗市场：市场趋势、临床试验、技术平台、未来展望 (2025)

Global CD123 Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025

出版日期: 2025年07月01日 | 出版商:

KuicK Research | 英文 100 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录图表

报告重点：

研究方法
全球 CD123 标靶治疗市场分析
全球 CD123 标靶治疗发展趋势（依适应症划分）
已核准的 CD123 标靶治疗药物：1 个
正在进行临床试验的 CD123 标靶治疗药物：10+ 个
最高开发阶段：II 期
公司、国家、适应症和阶段划分的 CD123 标靶治疗临床试验洞察
CD123 标靶治疗开发技术平台

CD123 标靶治疗市场受 Elzolis (Tagraxofusp) 药物获批的推动，CD123 疗法的应用范围已从罕见的母细胞性浆细胞样树突状细胞瘤 (BPDCN) 扩展到更广泛的血液系统癌症领域。 Elzonris 是一种与 IL-3 融合的截短型白喉毒素，是 2018 年底核准的首个 CD123 标靶药物。该药物的获批为 CD123 作为标靶实体开创了先例，但其应用主要限于少数 BPDCN 患者。

目前的重点是利用该平台治疗更常见和更致命的癌症，例如急性髓系白血病 (AML) 和骨髓增生异常综合征 (MDS)。目前正在研究将 Tagraxofusp 与去甲基化药物和维奈克拉联合使用，目标是基于分子进化的深化反应和克服抗药性。这些初步结果凸显了CD123疗法超越罕见疾病适应症，进入更广泛癌症领域的潜力。

几家大型製药公司正在重塑投资格局。艾伯维在收购ImmunoGen后，又收购了pivekimab sunirine。 pivekimab是一种高效的靶向CD123的抗体-药物偶联物，于2020年获得孤儿药和突破性疗法认定，用于治疗BPDCN和其他表达CD123的恶性肿瘤。同时，Innate Pharma正与赛诺菲共同开发IPH6101/SAR443579，这是一款一流的三功能NK细胞衔接剂，可同时结合CD123、NKp46和CD16受体。这种新颖的机制可实现高效的NK细胞募集并产生良好的安全讯号，復发或难治性患者的早期和长期完全缓解证实了这一点。急性骨髓性白血病 (AML)。

除了淋巴细胞介导疗法外，开发人员还专注于先进的工程方法以提高选择性。 Innate 的 ANKET® 平台增强了 IPH6101 的功能，使其能够活化 NK 细胞发挥抗白血病作用，同时最大限度地减少细胞因子的释放。同时，生技公司正在研究具有安全开关和亲和力调节功能的 CAR-T 构建体，以区分癌细胞和健康祖细胞，这项策略的灵感来自 CD123 的常见表达。

私人资本注入进一步推动了创新。 AvenCell 疗法公司于 2024 年 10 月完成 1.12 亿美元的 B 轮融资，显示投资者对其可编程、可切换的 CD123 CAR 平台充满信心。 AvenCell 的抗体药物偶联物采用外部控制分子切换 CAR-T 作用的控制方案，可能为剂量限制性毒性带来解决方案，并有望实现真正的个人化免疫疗法。

然而随着细胞疗法的进步，非细胞疗法也正在取得进展。采用不同连接体、有效载荷和双特异性抗体设计的双特异性抗体和抗体-药物偶联物已显示出更高的耐受性和靶向活性。这些改进旨在维持正常的造血功能，同时提高治疗指数。这些改进是第二代CD123标靶药物，旨在限制脱靶效应，例如细胞激素释放和毛细血管渗漏。

适应症扩展也推动了市场发展动能。由于CD123过度表现见于多种血液系统癌症，包括AML、MDS、高风险MDS和毛细胞白血病，该子公司正致力于开发适应症驱动和适应性临床计画。 CD123平台在更广泛的治疗领域备受青睐。

在这些趋势的推动下，精准肿瘤学技术正在促进更聪明的开发。能够测量CD123抗原密度并表征患者特异性表达谱的精细诊断方法为临床试验提供资讯。入组和疗效预测。这种精准策略降低了开发风险，并有助于定位更有效的疗法。

简而言之，CD123 标靶治疗市场正在经历革命性的变化。在早期临床验证的支持下，以及如今战略性製药合作、尖端平台、广泛的投资者支持和多样化适应症的推动下，该类别正从狭窄的 BPDCN 领域扩展到血液学领域。随着先进疗法的不断成熟和联合治疗策略的实现，CD123 将成为下一代标靶肿瘤治疗的支柱。

本报告提供全球CD123标靶治疗药市场相关调查，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。

Research Methodology
Global CD123 Targeting Therapies Market Analysis
Global CD123 Targeting Therapies Development Trends By Indication
Approved CD123 Targeting Therapies: 1
CD123 Targeting Therapies In Clinical Trials: > 10 Therapies
Highest Phase Of Development: Phase-II
CD123 Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase
CD123 Targeting Therapies Development Technology Platforms

The market for CD123 directed therapies, anchored by the approval of Elzonris (tagraxofusp erzs), is undergoing a vibrant transition into the broader space of hematologic cancers beyond the rare indication of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). Elzonris, a truncated diphtheria toxin fused to IL 3, was the first CD123 directed agent approved in late 2018. Its approval set a precedent for CD123 as a targetable entity, but its use has largely been limited to a minor cohort of patients with BPDCN.

Focus is now shifting to using this foundation to treat more common and deadly cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Tagraxofusp is being investigated in combination with hypomethylating agents and venetoclax, with the goal of enhancing depth of response and overcoming resistance based on molecular evolution. These initial results highlight the ability of CD123 therapies to break into the wider oncology space beyond orphan indications.

Several pharma giants are reshaping the investment scene. AbbVie, following its ImmunoGen acquisition, took over pivekimab sunirine, a highly effective CD123 targeting antibody drug conjugate that has received orphan drug and Breakthrough Therapy designations in 2020 to treat BPDCN and other CD123 expressing malignancies. Innate Pharma, on the other hand, is developing IPH6101/SAR443579, a trifunctional NK cell engager of first-in-class type that binds CD123, NKp46, and CD16 receptors simultaneously, with Sanofi as a collaborator. This new mechanism provides highly effective NK cell recruitment and good safety signals, demonstrated by early long-lasting complete remissions in patients with relapsed or refractory AML.

Expanding beyond lymphocyte mediated treatments, developers are focusing on sophisticated engineering to enhance selectivity. Innate's ANKET(R) platform powers IPH6101, activating NK cells to generate anti-leukemic actions with minimal cytokine release, a possible means to avoid some of the toxicity linked with CD3 based treatments. At the same time, biotech companies are investigating CAR T constructs with safety switches and affinity tuning to distinguish between cancerous and healthy progenitor cells, a strategy conceived from shared expression of CD123.

Private capital infusion drives innovation even further. October 2024's Series B funding of US$ 112 million for AvenCell therapeutics is an indicator of investors' confidence in programmable, switchable CD123 CAR platforms. AvenCell's antibody drug conjugates style control scheme, in which external regulator molecules will switch CAR T action, has the potential to bring a solution to dose limiting toxicities, trending towards truly individualized immunotherapies.

While cell therapies improve, non-cellular modalities make inroads. Bispecific and antibody drug conjugates modalities, designed with altered linkers, payloads, or bi-specificity, are showing enhanced tolerability and targeted activity. Such improvements intend to maintain normal hematopoiesis while enhancing therapeutic indices. These engineered forms are second generation CD123 targeting agents intended to limit off-target activities, including cytokine release and capillary leak.

Market momentum is also fueled by expanding indications. CD123 overexpression is seen in various hematologic cancers, including AML, MDS, high-risk MDS, and hairy cell leukemia, leading subsidiaries to develop adaptable clinical programs that can pivot indications. The variety increases return potential for developers, and CD123 platforms are coveted across a broader therapeutic spectrum.

Backed by these trends, precision oncology technologies facilitate smarter development. Sophisticated diagnostics measuring CD123 antigen density and characterizing patient-specific expression profiles inform trial enrollment and response prediction. This precision strategy de-risks development and facilitates more effective therapeutic positioning.

In short, the CD123 targeted therapy market is at a period of revolutionary change. Tethered by early clinical validation, now boosted by strategic pharma engagement, cutting edge platforms, expansive investor support, and indication diversification, this category is evolving from a narrow BPDCN niche to expanding hematologic reach. As advanced therapies continue to mature and combination strategies are realized, CD123 is set to be an anchor pillar in next generation targeted oncology.

1. RESEARCH METHODOLOGY

2. Introduction To CD123 Targeting Therapies

2.1 Introduction
2.2 History & Evolution

3. Scientific & Biological Insight

3.1 Structure, Biology & Significance Of CD123 (IL-3Ra)
3.2 Rationale For Targeting CD123
3.3 CD123 As Biomarker

4. Therapeutic Approaches Targeting CD123

4.1 Fusion Proteins
4.2 Antibodies
4.3 Antibody Drug Conjugates
4.4 Cell Therapies
4.5 Therapeutic Peptides

5. Global CD123 Targeting Therapies Development Trends By Indication

5.1 Leukemia
5.2 Blastic Plasmacytoid Dendritic Cell Neoplasm
5.3 Myeloproliferative Neoplasms
5.4 Other Indications

6. CD123 Targeting Therapies Development Technology Platforms

7. Global CD123 Targeting Therapies Market Analysis

7.1 Current Market Scenario
7.2 Future Market Opportunity

8. Elzonris Clinical & Commercial Insight

8.1 Overview
8.2 Pricing & Dosage
8.3 Coverage & Reimbursement Scenario

9. CD123 Targeting Therapies Clinical Trials Overview

9.1 By Company
9.2 By Country
9.3 By Indication
9.4 By Phase
9.5 By Priority Status

10. Global CD123 Targeting Therapies Clinical Pipeline Overview By Company, Country, Indication & Phase

10.1 Preclinical
10.2 Phase I
10.3 Phase I/II
10.4 Phase II

11. Marketed CD123 Targeting Therapy Clinical Insight

12. Global CD123 Targeting Therapies Market Dynamics

12.1 Market Drivers & Opportunities
12.2 Market Challenges & Restraints

13. Competitive Landscape

13.1 AbbVie
13.2 Affimed
13.3 Aptevo Therapeutics
13.4 Arcellx
13.5 AstraZeneca
13.6 AvenCell Therapeutics
13.7 CSL Limited
13.8 Essen Biotech
13.9 Innate Pharma
13.10 Lava Therapeutics
13.11 Macrogenics
13.12 Molecular Partners
13.13 Stemline Therapeutics
13.14 Vincerx Pharma

简介目录图表

List of Figures

Figure 2-1: Evolution of CD123-Targeted Therapies
Figure 3-1: CD123 - Expression Levels Across Cell Types
Figure 3-2: CD123 - Expression In Normal vs. Malignant Stem Cells
Figure 3-3: CD123 Targeted Therapies - Overview
Figure 3-4: CD123 As Biomarker For Patient Stratification
Figure 4-1: CD123 Targeting Fusion Protein - Structure
Figure 4-2: CD123 Fusion Proteins - Mechanism Of Action
Figure 4-3: CD123 Targeting Antibodies - Mechanism Of Action
Figure 4-4: CD123 Targeting ADCs - Structure & Mechanism Of Action
Figure 4-5: CD123 CAR T Cells
Figure 4-6: Therapeutic Peptides - Mechanism of Action
Figure 5-1: Leukemia - CD123 Driven Signaling Pathway
Figure 5-2: CD123 - Expression Across Leukemia Subtypes
Figure 5-3: AFM28-101 Phase 1 (NCT05817058) Trial - Study Initiation & Completion Year
Figure 5-4: Vibecotamab Phase 2 (NCT05285813) Trial - Study Initiation & Completion Year
Figure 5-5: CART123 Phase 1 (NCT03766126) Trial - Study Initiation & Completion Year
Figure 5-6: VNC-943-101 Phase 1 (NCT06034275) Trial - Study Initiation & Completion Year
Figure 5-7: CP-MGD024-01 Phase 1 (NCT05362773) Trial - Study Initiation & Completion Year
Figure 5-8: TAGVEN Phase 2 (NCT07007052) Trial - Study Initiation & Completion Year
Figure 5-9: Tagraxofusp Phase 2 (NCT04216524) Trial - Study Initiation & Completion Year
Figure 5-10: IMGN632-0801 Phase 1/2 (NCT03386513) Trial - Study Initiation & Completion Year
Figure 5-11: UHKT-CAR123-01 Early Phase 1 (NCT06765876) Trial - Study Initiation & Completion Year
Figure 5-12: PBC065 Phase 1 (NCT06690827) Trial - Study Initiation & Completion Year
Figure 5-13: STUDY00160238 Phase 1 (NCT06414681) Trial - Study Initiation & Completion Year
Figure 5-14: HSR210434 Phase 1 (NCT05233618) Trial - Study Initiation & Completion Year
Figure 5-15: Tagraxofusp Phase 1/2 (NCT05038592) Trial - Study Initiation & Completion Year
Figure 5-16: IMGN632-0801 Phase 1/2 (NCT03386513) Trial - Study Initiation & Completion Year
Figure 5-17: Flotetuzumab Phase 1 (NCT04681105) Trial - Study Initiation & Completion Year
Figure 6-1: ICE Platform - Affimed
Figure 6-2: ADAPTIR - Aptevo Therapeutics
Figure 6-3: ARC-SparX - Arcellx
Figure 6-4: Universal Targeting Platform - AvenCell
Figure 6-5: ANKET - Innate Pharma
Figure 6-6: GAMMABODY(R) Platform - LAVA Therapeutics
Figure 6-7: GAMMABODY(R) Platform Mechanism - LAVA Therapeutics
Figure 6-8: DART Platform - MacroGenics
Figure 6-9: VersAptx - Vincerx Pharma
Figure 7-1: CD123 Targeted Therapy Market - Future Opportunities
Figure 8-1: Elzonris - Price Per Vial By Region (US$), July'2025
Figure 9-1: Global - CD123 Targeting Therapy Clinical Pipeline By Company (Number Of Therapies), 2025
Figure 9-2: Global - CD123 Targeting Therapy Clinical Pipeline By Country (Number Of Therapies), 2025
Figure 9-3: Global - CD123 Targeting Therapy Clinical Pipeline By Indication (Number Of Therapies), 2025
Figure 9-4: Global - CD123 Targeting Therapy Clinical Pipeline By Phase (Number Of Therapies), 2025
Figure 9-5: Global - CD123 Targeting Therapy Clinical Pipeline By Priority Status (Number Of Therapies), 2025
Figure 12-1: CD123 Targeted Therapy Market - Drivers & Opportunities
Figure 12-2: CD123 Targeted Therapy Market - Challenges & Restraints

List of Tables

Table 8-1: Elzonris - Recommended Dosage Modifications
Table 8-2: Elzonris - CLS Management Guidelines

02-2729-4219

+886-2-2729-4219

License/价格

全球 CD123 标靶治疗市场：市场趋势、临床试验、技术平台、未来展望 (2025)

Global CD123 Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025

目录

第1章调查手法

第2章 CD123标靶治疗药的简介

第3章科学性·生物学的洞察

第4章把CD123作为标的治疗方法

第5章全球CD123标靶治疗药的开发趋势，各适应症

第6章 CD123标靶治疗药的开发技术平台

第7章全球CD123标靶治疗药市场分析

第8章 Elzonris临床及商业性洞察

第9章 CD123标靶治疗药的临床试验概要

第10章 CD123标靶治疗药的世界临床实验平台概要(企业，国家，适应症，各相)

第11章已上市CD123标靶治疗药的临床性洞察

第12章全球CD123标靶治疗药市场动态

第13章竞争情形