CD276标靶治疗药全球市场:临床试验和市场机会(2026年)

全球CD276标靶治疗市场：临床试验与市场机会（2026年）报告结果与亮点

• 预计首个CD276疗法将于2028年获得批准
• 按地区和适应症划分的CD276标靶治疗发展趋势
• 预计未来五年内全球将获准的CD276标靶治疗
• 临床试验中的CD276标靶治疗：超过30种疗法
• 参与CD276标靶治疗开发的18家公司的洞察
• CD276标靶治疗孤儿药与优先审评
• CD276标靶治疗全球临床试验：依公司、适应症及阶段

CD276标靶治疗肿瘤学研发管线发展势头强劲

CD276 (B7-H3) 已成为免疫肿瘤学领域最令人振奋的下一代标靶之一。它在多种实体瘤中均一过表达，而在正常组织中表达极低，使其成为精准医疗的理想标靶。随着业界从第一代检查点抑制剂转向更具肿瘤特异性的策略转型，CD276 在全球药物研发管线的发展步伐日益加快。

本报告重点介绍了新兴的 CD276 标靶治疗市场。本报告考察了 CD276 标靶治疗市场，重点介绍了关键临床项目、关键商业合作以及推动该领域创新的技术。虽然本报告未提供详细的临床试验结果或数据，但本报告重点介绍了关键策略方向以及正在改变这一快速崛起领域的新兴公司。

本报告包​​含 CD276 标靶治疗临床试验的深入分析

CD276 标靶治疗产品线持续成长，重点在于抗体药物偶联物 (ADC)、嵌合抗原受体-T 细胞疗法和双特异性抗体。多个候选药物正处于中后期临床试验阶段，针对难治性癌症，例如小细胞肺癌 (SCLC)、转移性去势抗性前列腺癌 (mCRPC)、神经胶质瘤和头颈癌。

例如，第一三共和默克的 ADC 药物 ifinatamab deruxtecan 目前正处于 III 期开发阶段，使用拓朴异构酶 I 有效载荷治疗多种 SCLC 阶段。同时，BrainChild Bio 正在将其 CD276 靶向 CAR-T 细胞疗法推进到儿童脑肿瘤的关键临床试验阶段，并且已经获得监管部门的批准。这些项目以及其他项目代表着该标靶正向更成熟的临床验证过渡。

合作伙伴关係与协定

这种日益增长的商业信心也体现在新的授权协议和策略合作伙伴关係中。许多跨国製药公司正在签署利润丰厚的合同，以确保获得CD276靶向ADC的权益，尤其是在早期临床结果显示肿瘤缓解强劲且安全性可耐受的情况下。

一个典型的例子是明辉药业与齐鲁製药于2024年签署的价值超过2亿美元的MHB-088C全球权益协议。该协议并非针对大中华区，而是在该药物获得多项FDA（美国食品药物管理局）认证后达成的，这表明许可正在推动进入西方世界的市场。在其他地区，处于开发阶段的公司正在本地授权 CD276 资产，利用当地临床试验基础设施和监管灵活性。

技术平台协助进步

ADC 技术的进步是 CD276 领域进展的关键。新一代连接系统与高活性、可活化肿瘤的有效载荷的整合，正在提高特异性并降低脱靶毒性。 DXd 和 SuperTopoi™ 专有平台已在许多一线候选药物中发挥重要作用，支持早期临床试验中实现持久疗效。

双特异性形式（例如 IDE034）将 CD276 与 PTK7 等其他肿瘤标记相结合，目前也正在探索中，以提高对具有复杂抗原谱的肿瘤的靶向性。这些组合旨在扩大治疗窗口并延缓或规避抗药性机制。

主要公司积极参与 CD276 标靶疗法的研发

CD276 已吸引多家大型早期生技公司的大量投资，这些公司的研发管线涵盖临床前和 III 期阶段。主要参与者既包括成熟的肿瘤学巨头，也包括规模较小、创新且专注于平台的公司。其中许多公司正在客製化 CD276 项目，以针对高需求癌症和儿童癌症，从而有可能加快监管审批。

例如，BrainChild Bio 的 CD276 CAR-T 细胞疗法 BCB-276 在短短一年内就获得了 RMAT 认证和突破性疗法资格认定。这表明 FDA 对该标靶的治疗潜力日益浓厚，尤其是在瀰漫性内在性海绵状胶质瘤 (DIPG) 等尚无核准治疗方法的疾病中。

报告揭示CD276标靶治疗的未来方向

虽然最初的重点仍然放在癌症上，但学术界对CD276作为非癌症疾病（尤其是自体免疫疾病和发炎性疾病）的一个因素的兴趣日益浓厚。虽然非癌症适应症尚未进入临床试验阶段，但临床前研究表明，CD276的免疫调节活性未来可能与其他疾病有关。

本报告对这一趋势进行了前瞻性分析，密切关注不断发展的生物标记资讯、临床试验设计和新型联合疗法将如何塑造下一波CD276靶向治疗浪潮。随着新机制的阐明和技术平台的成熟，该标靶的治疗和商业潜力将不断提升。

目录

第1章 CD276标靶治疗的简介

第2章 把CD276作为标的临床方法

• CD276 单株抗体
• CD276 细胞疗法
• 多特异性抗体
• 小分子抑制剂
• 抗体药物偶联物

第3章 全球CD276标靶治疗市场展望

• 目前市场趋势与发展
• 未来市场机会

第4章 全球CD276抗体临床试验概要

• 各企业
• 各国
• 各适应症
• 各相
• 优先开发及罕见疾病各状态

第5章 各企业，各适应症，各相的CD276抗体的临床试验

• 研究
• 前临床
• 第一阶段
• 第一/二阶段
• 第二阶段
• 第三阶段
• 预註册

第6章 癌症的CD276理解

• CD276 在癌症中的多重作用
• 研究创新与临床进展

第7章 癌症治疗策略的CD276标靶化

• 标靶治疗
• 单剂疗法
• 联合治疗

第8章 癌症以外的领域的CD276所扮演的角色

• 自体免疫疾病及发炎性疾病
• 微生物感染疾病
• 代谢性疾病

第9章 全球CD276抑制剂市场动态

• 促进因素和机会
• 课题与阻碍因素

第10章 竞争情形

• Aleta Biotherapeutics
• Beijing Biocytogen
• Beijing Mabworks Biotech
• BoYuan RunSheng Pharma
• Daiichi Sankyo Company
• Elpis Biopharmaceuticals
• Fate Therapeutics
• Innate Pharma
• Invenra
• MacroGenics
• Minghui Pharmaceutical (Shanghai)
• Nanjing Kati Medical Technology
• PersonGen Biotherapeutics
• Radiopharm Ventures
• Shanghai Hansoh Biomedical
• Shattuck Labs
• TrueBinding
• TC BioPharm

Global CD276 Targeted Therapies Clinical Trials & Market Opportunity Insight 2026 Report Findings & Highlights:

• First CD276 Therapy Approval Expected By 2028
• CD276 Targeted Therapies Development Trends By Region & Indications
• Global CD276 Targeted Therapies Expected Drug Approvals Over Next 5 Years
• CD276 Targeted Therapies In Clinical Trials: > 30 Therapies
• Insight On 18 Companies Involved In Development of CD276 Targeted Therapies
• CD276 Targeted Therapies Orphan & Priority Status Review
• Global CD276 Targeted Therapies Clinical Trials By Company, Indication & Phase

CD276 Targeted Therapies: Momentum Builds Across Oncology Pipeline

CD276, or B7-H3, has become one of the most exciting next-generation targets in immuno-oncology. Its uniform overexpression across the broadest range of solid tumors, and negligible expression in normal tissue, renders it a highly desirable target for precision medicines. With the industry moving from first-generation checkpoint inhibitors towards more tumor-specific strategies, CD276 is picking up speed in drug development pipelines worldwide.

This report offers a targeted view of the emerging CD276 targeted therapeutics market. It identifies pivotal clinical programs, top commercial collaborations, and the technology driving innovation within this field. Although in-depth trial results and data are withheld for the full report, this snapshot delineates the major strategic directions and nascent players transforming this quickly emerging sector.

CD276 Targeted Therapy Clinical Trials Insight Included In the Report

The CD276 targeted therapy pipeline is growing consistently, with a deep focus on antibody-drug conjugates (ADCs), CAR T-cell treatments, and bispecific antibodies. Several candidates are in the mid- to late-stage clinical trials, and they are targeting difficult-to-treat cancers like small-cell lung cancer (SCLC), metastatic castration-resistant prostate cancer (mCRPC), gliomas, and head and neck cancers.

For instance, Ifinatamab Deruxtecan, Daiichi Sankyo and Merck's ADC drug, now has Phase 3 in extensive-stage SCLC using a topoisomerase I payload. In the meantime, BrainChild Bio is moving one of its CD276 targeted CAR T-cell therapies into a pivotal study for pediatric brain cancers, with regulatory nods already in hand. Such programs, and others like them, represent a turning towards more mature clinical confirmation of the target.

Collaborations & Agreements

This increased commercial confidence is also seen in new licensing agreements and strategic partnerships. A number of multinational pharmaceutical firms have entered into high value deals to secure rights to CD276 targeted ADCs, especially when initial clinical results have demonstrated robust tumor response and tolerable safety profiles.

A prime example is a global rights deal between Minghui Pharmaceutical and Qilu Pharmaceutical in 2024 for MHB-088C, worth more than US$ 200 million. The agreement is not for Greater China, and it followed the asset gaining multiple FDA designations, showing that licensing is serving to drive Western market entry. Elsewhere, development-stage firms have licensed CD276 assets regionally to access localized trial infrastructure and regulatory agility.

Technology Platforms Enabling Progress

Advances in ADC technology lie at the heart of progress in the CD276 area. The integration of next-generation linker systems and highly active, tumor-activated payloads is facilitating improved specificity and diminished off-target toxicity. DXd and SuperTopoi(TM) proprietary platforms have been prominently represented in a number of front-running candidates, underpinning sustained responses in early trials.

Some bispecific formats are also being explored, where CD276 is combined with a different tumor marker like PTK7, as in the instance of IDE034, providing improved targeting in tumors with intricate antigen profiles. These pairs are aimed at expanding the therapeutic window and possibly postpone or avoid mechanisms of resistance.

Major Companies Active In R&D For CD276 Targeted Therapies

Several big-cap and early-stage biotech players have significant investments in CD276, with pipelines ranging from preclinical through Phase 3. Leading players encompass both mature oncology giants and smaller, platform-focused innovators. A number of these companies are conditioning their CD276 programs for high-need cancers or pediatric opportunities, which leaves the door open to accelerated regulatory routes.

For instance, BrainChild Bio was awarded both RMAT and Breakthrough designations in a single year for its CD276 CAR T-cell therapy, BCB-276, indicating the FDA's increasing interest in the therapeutic potential of this target, especially in conditions such as diffuse intrinsic pontine glioma (DIPG) in which no approved treatment is available.

Report Suggesting Future Direction Of CD276 Targeted Therapies

Though the initial emphasis is still on cancer, there is initial academic interest in CD276 as a factor in non-oncologic illness, particularly autoimmune and inflammatory diseases. Although no indication in the non-cancer category has reached clinical trials, preclinical studies indicate that CD276's immunomodulatory activity may make it of relevance outside of oncology in the future.

The report provides a forward-looking view of this trend with a close watch on how changing biomarker information, trial designs, and novel combination approaches will inform the next wave of CD276 targeted treatments. As new mechanisms are understood and technology platforms reach maturity, the therapeutic and commercial potential of this target increases.

Table of Contents

1. Introduction To CD276 Targeted Therapy

2. Clinical Approaches To Target CD276

• 2.1 Monoclonal Antibodies Against CD276
• 2.2 Cell Therapy Against CD276
• 2.3 Multispecific Antibodies
• 2.4 Small Molecule Inhibitors
• 2.5 Antibody Drug Conjugates

3. Global CD276 Targeted Therapy Market Outlook

• 3.1 Current Market Trends & Developments
• 3.2 Future Market Opportunities

4. Global CD276 Antibody Clinical Trials Overview

• 4.1 By Company
• 4.2 By Country
• 4.3 By Indication
• 4.4 By Phase
• 4.5 By Priority Development & Orphan Status

5. Global CD276 Antibody Clinical Trials By Company, Indication & Phase

• 5.1 Research
• 5.2 Preclinical
• 5.3 Phase-I
• 5.4 Phase-I/II
• 5.5 Phase-II
• 5.6 Phase-III
• 5.7 Preregistration

6. Understanding CD276 In Cancer

• 6.1 Multifaceted Role Of CD276 In Cancer
• 6.2 Research Innovations & Clinical Progress

7. Targeting CD276 As A Strategy For Cancer Treatment

• 7.1 As Targeted Therapy
• 7.2 As Monotherapy
• 7.3 As Combination Therapy

8. Role Of CD276 Beyond Cancer

• 8.1 Autoimmune & Inflammatory Diseases
• 8.2 Microbial Infections
• 8.3 Metabolic Diseases

9. Global CD276 Inhibitors Market Dynamics

• 9.1 Drivers & Opportunities
• 9.2 Challenges & Restraints

10. Competitive Landscape

• 10.1 Aleta Biotherapeutics
• 10.2 Beijing Biocytogen
• 10.3 Beijing Mabworks Biotech
• 10.4 BoYuan RunSheng Pharma
• 10.5 Daiichi Sankyo Company
• 10.6 Elpis Biopharmaceuticals
• 10.7 Fate Therapeutics
• 10.8 Innate Pharma
• 10.9 Invenra
• 10.10 MacroGenics
• 10.11 Minghui Pharmaceutical (Shanghai)
• 10.12 Nanjing Kati Medical Technology
• 10.13 PersonGen Biotherapeutics
• 10.14 Radiopharm Ventures
• 10.15 Shanghai Hansoh Biomedical
• 10.16 Shattuck Labs
• 10.17 TrueBinding
• 10.18 TC BioPharm

List of Figures

• Figure 1-1: CD276 - Mechanism Of Immune Suppression
• Figure 1-2: CD276: Impact On Immune Cells
• Figure 1-3: CD276 - Role In Non-Oncological Diseases
• Figure 2-1: CD276 - Targeting With Monoclonal Antibodies
• Figure 2-2: Challenges In Developing CD276 Blocking mAbs
• Figure 2-3: CD276-Targeted CAR-T Cells - Mechanism Of Action
• Figure 2-4: Targeting CD276 - CAR-T Cell Design
• Figure 2-5: Gene Editing Strategies To Improve CD276 CAR-T Cell Persistence
• Figure 2-6: Bispecific Antibodies Targeting CD276
• Figure 2-7: Technical University of Darmstadt - Trispecific Antibody Targeting CD276
• Figure 2-8: Small Molecule Inhibitors Targeting CD276 - Mechanism Of Action
• Figure 2-9: Small Molecule Inhibitor - Design & Development Process
• Figure 2-10: CD276 Antibody Drug Conjugate - Schematic
• Figure 2-11: CD276-Targeted Antibody Drug Conjugates - Mechanism Of Action
• Figure 3-1: CD276 Targeted Therapy Market - Future Opportunities
• Figure 4-1: Global - Number Of CD276 Antibodies In Clinical Pipeline By Company, 2025 Till 2026
• Figure 4-2: Global - Number Of CD276 Antibodies In Clinical Pipeline By Country, 2025 Till 2026
• Figure 4-3: Global - Number Of CD276 Antibodies In Clinical Pipeline By Indication, 2025 Till 2026
• Figure 4-4: Global - CD276 Antibody Clinical Pipeline By Phase, 2025 Till 2026
• Figure 4-5: Global - CD276 Antibody Designation By Priority Development & Orphan Status, 2025 Till 2026
• Figure 6-1: Cancer - CD276 Mediated Signaling Pathways
• Figure 6-2: IDeate-Lung01 Phase 2 (NCT05280470) Study - Initiation & Completion Year
• Figure 6-3: CP-MGC026-01 Phase 1 (NCT06242470) Study - Initiation & Completion Year
• Figure 6-4: BrainChild-03 Phase 1 (NCT04185038) Study - Initiation & Completion Year
• Figure 6-5: DB-1311-O-1001 Phase 1/2 (NCT05914116) Study - Initiation & Completion Year
• Figure 6-6: BNT324-01 Phase 2 (NCT06892548) Study - Initiation & Completion Year
• Figure 6-7: DB-1311-201 Phase 2 (NCT06953089) Study - Initiation & Completion Year
• Figure 6-8: BetaBart-US-101 Phase 1/2 (NCT07189871) Study - Initiation & Completion Year
• Figure 8-1: Autoimmune & Inflammatory Diseases - Dual Immunomodulatory Role Of CD276
• Figure 8-2: Type 1 Diabetes - CD276 As Biomarker For Early Detection
• Figure 8-3: Ankylosing Spondylitis - Epigenetic Regulation Of CD276
• Figure 8-4: Infection - Dual Role Of CD276
• Figure 8-5: Infectious Diseases - Challenges In CD276-Targeted Therapies
• Figure 8-6: CD276 - Role In Adipose Tissue & Metabolic Homeostasis
• Figure 9-1: Global CD276 Inhibitors Market - Drivers & Opportunities
• Figure 9-2: Global CD276 Inhibitors Market - Challenges & Strategic Solutions

List of Tables

• Table 2-1: CAR-T vs. CAR-NK Cells Targeting CD276