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生物製劑分子標靶治療學

市場調查報告書

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1831558

CD276標靶治療藥全球市場:臨床試驗和市場機會(2026年)

Global CD276 Targeted Therapies Clinical Trials & Market Opportunity Insight 2026

出版日期: 2025年10月01日 | 出版商:

KuicK Research | 英文 140 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

全球CD276標靶治療市場：臨床試驗與市場機會（2026年）報告結果與亮點

預計首個CD276療法將於2028年獲得批准
按地區和適應症劃分的CD276標靶治療發展趨勢
預計未來五年內全球將獲準的CD276標靶治療
臨床試驗中的CD276標靶治療：超過30種療法
參與CD276標靶治療開發的18家公司的洞察
CD276標靶治療孤兒藥與優先審評
CD276標靶治療全球臨床試驗：依公司、適應症及階段

CD276標靶治療腫瘤學研發管線發展勢頭強勁

CD276 (B7-H3) 已成為免疫腫瘤學領域最令人振奮的下一代標靶之一。它在多種實體瘤中均一過表達，而在正常組織中表達極低，使其成為精準醫療的理想標靶。隨著業界從第一代檢查點抑制劑轉向更具腫瘤特異性的策略轉型，CD276 在全球藥物研發管線的發展步伐日益加快。

本報告重點介紹了新興的 CD276 標靶治療市場。本報告考察了 CD276 標靶治療市場，重點介紹了關鍵臨床項目、關鍵商業合作以及推動該領域創新的技術。雖然本報告未提供詳細的臨床試驗結果或數據，但本報告重點介紹了關鍵策略方向以及正在改變這一快速崛起領域的新興公司。

本報告包含 CD276 標靶治療臨床試驗的深入分析

CD276 標靶治療產品線持續成長，重點在於抗體藥物偶聯物 (ADC)、嵌合抗原受體-T 細胞療法和雙特異性抗體。多個候選藥物正處於中後期臨床試驗階段，針對難治性癌症，例如小細胞肺癌 (SCLC)、轉移性去勢抗性前列腺癌 (mCRPC)、神經膠質瘤和頭頸癌。

例如，第一三共和默克的 ADC 藥物 ifinatamab deruxtecan 目前正處於 III 期開發階段，使用拓樸異構酶 I 有效載荷治療多種 SCLC 階段。同時，BrainChild Bio 正在將其 CD276 靶向 CAR-T 細胞療法推進到兒童腦腫瘤的關鍵臨床試驗階段，並且已經獲得監管部門的批准。這些項目以及其他項目代表著該標靶正向更成熟的臨床驗證過渡。

合作夥伴關係與協定

這種日益增長的商業信心也體現在新的授權協議和策略合作夥伴關係中。許多跨國製藥公司正在簽署利潤豐厚的合同，以確保獲得CD276靶向ADC的權益，尤其是在早期臨床結果顯示腫瘤緩解強勁且安全性可耐受的情況下。

一個典型的例子是明輝藥業與齊魯製藥於2024年簽署的價值超過2億美元的MHB-088C全球權益協議。該協議並非針對大中華區，而是在該藥物獲得多項FDA（美國食品藥物管理局）認證後達成的，這表明許可正在推動進入西方世界的市場。在其他地區，處於開發階段的公司正在本地授權 CD276 資產，利用當地臨床試驗基礎設施和監管靈活性。

技術平台協助進步

ADC 技術的進步是 CD276 領域進展的關鍵。新一代連接系統與高活性、可活化腫瘤的有效載荷的整合，正在提高特異性並降低脫靶毒性。 DXd 和 SuperTopoi™ 專有平台已在許多一線候選藥物中發揮重要作用，支持早期臨床試驗中實現持久療效。

雙特異性形式（例如 IDE034）將 CD276 與 PTK7 等其他腫瘤標記相結合，目前也正在探索中，以提高對具有複雜抗原譜的腫瘤的靶向性。這些組合旨在擴大治療窗口並延緩或規避抗藥性機制。

主要公司積極參與 CD276 標靶療法的研發

CD276 已吸引多家大型早期生技公司的大量投資，這些公司的研發管線涵蓋臨床前和 III 期階段。主要參與者既包括成熟的腫瘤學巨頭，也包括規模較小、創新且專注於平台的公司。其中許多公司正在客製化 CD276 項目，以針對高需求癌症和兒童癌症，從而有可能加快監管審批。

例如，BrainChild Bio 的 CD276 CAR-T 細胞療法 BCB-276 在短短一年內就獲得了 RMAT 認證和突破性療法資格認定。這表明 FDA 對該標靶的治療潛力日益濃厚，尤其是在瀰漫性內在性海綿狀膠質瘤 (DIPG) 等尚無核准治療方法的疾病中。

報告揭示CD276標靶治療的未來方向

雖然最初的重點仍然放在癌症上，但學術界對CD276作為非癌症疾病（尤其是自體免疫疾病和發炎性疾病）的一個因素的興趣日益濃厚。雖然非癌症適應症尚未進入臨床試驗階段，但臨床前研究表明，CD276的免疫調節活性未來可能與其他疾病有關。

本報告對這一趨勢進行了前瞻性分析，密切關注不斷發展的生物標記資訊、臨床試驗設計和新型聯合療法將如何塑造下一波CD276靶向治療浪潮。隨著新機制的闡明和技術平台的成熟，該標靶的治療和商業潛力將不斷提升。

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

簡介目錄圖表

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.

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

簡介目錄圖表

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