B7-H3

Satya Bio Report | Updated February 2, 2026

Curated Database - Investment-grade data, manually verified (Last updated: 2026-01-29)
$5.8B
Committed Capital
4
Phase 3 Assets
2
BTD Designations
42
Active Trials
23
Curated Assets

Investment Metrics

$5.8B
Committed
(upfront + equity)
$25.5B
Total Potential
(w/ milestones)
4
Phase 3 Assets
2
BTD Designations
4
Deals Tracked
Largest Deal: Ifinatamab deruxtecan — $5.5B committed to Merck ($22.0B potential with milestones)

Investment Thesis

B7-H3 is the leading next-gen ADC target with $22B Merck deal and limited normal tissue expression
Key Investment Points:
  • Ideal ADC target: High tumor expression, minimal normal tissue expression
  • Merck mega-deal: $22B collaboration with Daiichi Sankyo for I-DXd
  • Multiple modalities: ADCs, CAR-T, bispecifics, radioconjugates all in development
  • Best clinical data: 52% ORR in ES-SCLC with ifinatamab deruxtecan
  • Regulatory momentum: BTD and ODD designations for lead programs
Market Opportunity:
Total: $80B+ oncology biologics market
Target: $5-10B peak revenue potential for best-in-class B7-H3 ADC
Population: Broad applicability: SCLC, NSCLC, prostate, breast, pediatric tumors
Key Catalysts:
• Ifinatamab deruxtecan: TROPION-Lung08 Phase 3 readout (NSCLC) (H2 2025)
• Ifinatamab deruxtecan: Potential accelerated approval in ES-SCLC (2025)
• Omburtamab: BLA decision for omburtamab (CNS tumors) (2024)

Efficacy Comparison

Head-to-head comparison of clinical efficacy data across development programs (sorted by placebo-adjusted response)

Drug Trial Dose Endpoint Result Placebo Δ vs Placebo Population Source
HS-20093 (GSK) Phase 1/2 Dose escalation ORR 75% 0% 75% ★ All patients WCLC 2023
Ifinatamab deruxtecan (DS-7300) Phase 1/2 8 mg/kg Q3W ORR 52% 0% 52% All patients ASCO 2024

★ = Best-in-class result | Purple = biomarker-selected population

Competitive Differentiation

Strategic positioning and key differentiators for each development program

Drug Strategy Dosing Biomarker Half-Life Beyond Lead Indication
Ifinatamab deruxtecan Platform leader 8-16 mg/kg Q3W IV No ~6 days Pan-solid tumor
HS-20093 Fast follower TBD No TBD Solid tumors

Key Risks

Risk Severity Mitigation
Competition from other ADC targets (TROP2, HER3, etc.) Medium B7-H3 expression is broader and more consistent than alternatives
Merck/Daiichi dominance may crowd out other players High Differentiation through indication focus or modality

Trials by Phase

Phase 1
44
Phase 1/2
12
Not Applicable
5
Phase 2
8
Phase 3
2
Phase 2/3
1

Top Sponsors

SponsorTrialsType
MacroGenics 10 Industry
UNC Lineberger Comprehensive Cancer Center 5 Academic
PersonGen BioTherapeutics (Suzhou) Co., Ltd. 4 Industry
Hansoh BioMedical R&D Company 4 Industry
Peking University People's Hospital 3 Academic
St. Jude Children's Research Hospital 3 Academic
Daiichi Sankyo 3 Industry
DualityBio Inc. 2 Industry
Shenzhen Geno-Immune Medical Institute 2 Academic
Stanford University 2 Academic

Competitive Landscape: B7-H3 Assets (23)

23 assets tracked • 4 deals worth $5.8B • 4 in Phase 3

By Modality

ADC10 ($5.8B)
mAb3
Bispecific3
Radioconjugate1
CAR-T6

By Phase

Filed1
Phase 33
Phase 26
Phase 1/21
Phase 112

By Owner Type

Big Pharma2
Chinese Biotech9
Biotech8
Academic4

Regulatory Designations

BTD2
ODD8
PRIME1
Fast Track4
Ifinatamab deruxtecan
DS-7300, I-DXd, DS-7300a
Phase 3 Active
ADC Topoisomerase I inhibitor (DXd/deruxtecan payload)
Daiichi Sankyo (Big Pharma) + Merck
Lead: ES-SCLC (Extensive-Stage Small Cell Lung Cancer)
$5.5B committed to Merck
• $4.0B upfront + $1.5B equity
• Up to $16.5B in milestones
• Total potential: $22.0B
52% ORR in ES-SCLC; 26% ORR in heavily pretreated solid tumors (ASCO 2024)
Risvutatug rezetecan
HS-20093, GSK4428859
Phase 3 Active
ADC Topoisomerase I inhibitor payload
Hansoh Pharma (Chinese Biotech) + GSK
Lead: ES-SCLC
$85M committed to GSK
• $85M upfront
• Up to $1.5B in milestones
• Total potential: $1.6B
75% ORR in ES-SCLC 2L+ (WCLC 2023); durable responses
YL201
YL201
Phase 2 Active
ADC Topoisomerase I inhibitor (proprietary payload)
MediLink Therapeutics (Chinese Biotech)
Lead: ES-SCLC
61% ORR in ES-SCLC; 80.6% DCR (ASCO 2024)
DB-1311
DB-1311, BNT324
Phase 1/2 Active
ADC Topoisomerase I inhibitor payload
DualityBio (Chinese Biotech) + BioNTech
Lead: Solid tumors
$170M committed to BioNTech
• $170M upfront
• Up to $1.5B in milestones
• Total potential: $1.7B
Early clinical; BioNTech validation
MHB088C
MHB088C
Phase 2 Active
ADC ADC with undisclosed payload
Minghui Pharmaceuticals (Chinese Biotech) + Qilu Pharmaceutical
Lead: Solid tumors
$6M committed to Qilu Pharmaceutical
• $6M upfront
• Up to $179M in milestones
• Total potential: $185M
Vobramitamab duocarmazine
MGC018
Phase 2 Active
ADC Duocarmazine DNA alkylating payload
MacroGenics (Biotech)
Lead: mCRPC (Metastatic Castration-Resistant Prostate Cancer)
40% PSA50 response rate in mCRPC; differentiated prostate focus
BA3011
BA3011, CAB-B7-H3-ADC
Phase 2 Active
ADC Conditionally Active Biologic (CAB) with MMAE payload
BioAtla (Biotech)
Lead: Solid tumors
CAB technology enables tumor-selective activation
JS203
JS203
Phase 1 Active
ADC ADC with proprietary payload
Junshi Biosciences (Chinese Biotech)
Lead: Solid tumors
SHR-3680
SHR-3680
Phase 1 Active
ADC
Hengrui Medicine (Chinese Biotech)
Lead: Solid tumors
Enoblituzumab
MGA271
Phase 2 Active
mAb Fc-enhanced humanized IgG1 monoclonal antibody
MacroGenics (Biotech)
Lead: HNSCC (Head and Neck Squamous Cell Carcinoma)
Fc-enhanced for ADCC; combination with retifanlimab (PD-1)
TQB2103
TQB2103
Phase 1 Active
mAb
Chia Tai Tianqing (Chinese Biotech)
Lead: Solid tumors
MGD024
MGD024
Phase 1 Active
Bispecific DART (Dual-Affinity Re-Targeting) B7-H3 x CD3 bispecific
MacroGenics (Biotech)
Lead: Solid tumors
Orlotamab
MGD009
Phase 1 On Hold
Bispecific DART B7-H3 x CD3 bispecific (first-gen)
MacroGenics (Biotech)
Lead: Solid tumors
PT217
PT217
Phase 1 Active
Bispecific B7-H3 x 4-1BB bispecific antibody
Phanes Therapeutics (Biotech)
Lead: Solid tumors
Omburtamab
8H9, Burtomab
Filed Active
Radioconjugate Iodine-131 labeled monoclonal antibody (radioimmunotherapy)
Y-mAbs Therapeutics (Biotech)
Lead: CNS/leptomeningeal metastases from neuroblastoma
BLA filed Oct 2022; PDUFA extended; Phase 3 for DIPG
4SCAR-276
4SCAR-276
Phase 1 Active
CAR-T 4th generation CAR-T targeting B7-H3
Stanford University (Academic)
Lead: Pediatric solid tumors
SCRI-CARB7H3
SCRI-CARB7H3
Phase 1 Active
CAR-T CAR-T for CNS tumors with intrathecal delivery
Seattle Children's Research Institute (Academic)
Lead: Medulloblastoma
Intrathecal delivery for CNS penetration
TAA06
TAA06
Phase 1 Active
CAR-T Autologous B7-H3 CAR-T
PersonGen BioTherapeutics (Chinese Biotech)
Lead: Solid tumors
LM-302
LM-302
Phase 1 Active
CAR-T Autologous B7-H3 CAR-T
Legend Biotech (Chinese Biotech)
Lead: Solid tumors
B7-H3 CAR-T (NCI)
NCI-B7H3-CAR
Phase 1 Active
CAR-T NCI-developed B7-H3 CAR-T
National Cancer Institute (Academic)
Lead: Pediatric solid tumors
C7R-GD2/B7-H3 CAR-T
C7R-GD2-B7H3
Phase 1 Active
CAR-T Dual-targeting CAR-T (GD2 + B7-H3) with C7R cytokine support
Baylor College of Medicine (Academic)
Lead: Neuroblastoma
DS-7300 + Pembrolizumab
I-DXd + Keytruda
Phase 3 Active
ADC B7-H3 ADC + PD-1 combination
Daiichi Sankyo (Big Pharma) + Merck
Lead: NSCLC
Pivotal combination study in lung cancer
Enoblituzumab + Retifanlimab
MGA271 + INCMGA00012
Phase 2 Active
mAb B7-H3 mAb + PD-1 combination
MacroGenics (Biotech)
Lead: HNSCC

BTD Breakthrough Therapy   ODD Orphan Drug   PRIME EU Priority   FT Fast Track

Clinical Trials (72)

NCT IDTitlePhaseStatusSponsorEnrollmentStart
NCT07181473 A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors Phase 1 Recruiting Phrontline Biopharma 200 2025-08-25
NCT05276609 ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors Phase 1 Unknown Shanghai Hansoh Biomedical Co., Ltd 177 2021-11-28
NCT05914116 A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors Phase 1/2 Recruiting DualityBio Inc. 862 2023-08-17
NCT05562024 TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma Phase 1 Recruiting PersonGen BioTherapeutics (Suzhou) Co., Ltd. 24 2022-12-30
NCT04432649 Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276 Phase 1/2 Unknown Shenzhen Geno-Immune Medical Institute 100 2020-06-01
NCT05142189 Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer Phase 1 Recruiting BioNTech SE 280 2022-06-17
NCT04670068 Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian Phase 1 Recruiting UNC Lineberger Comprehensive Cancer Center 4 2021-01-27
NCT06347068 Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells Phase 1 Recruiting UNC Lineberger Comprehensive Cancer Center 42 2024-06-27
NCT05942456 Soluble B7-H3 as a Biomarker for Osteosarcoma Not Applicable Recruiting Peking University People's Hospital 200 2023-06-05
NCT06018363 Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection Phase 1/2 Recruiting Dushu Lake Hospital Affiliated to Soochow University 25 2023-06-01
NCT06305299 Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells Phase 1 Recruiting UNC Lineberger Comprehensive Cancer Center 27 2024-07-29
NCT07268053 A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases Phase 1 Not yet recruiting Nader Sanai 15 2026-01
NCT02628535 Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1 Terminated MacroGenics 67 2015-09
NCT05064306 131I-omburtamab for the Treatment of Central Nervous System/Leptomeningeal Neoplasms in Children and Young Adults Not Applicable Unknown Memorial Sloan Kettering Cancer Center - -
NCT05474378 B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme Phase 1 Recruiting Stanford University 39 2022-07-12
NCT03729596 MGC018 With or Without MGA012 in Advanced Solid Tumors Phase 1/2 Terminated MacroGenics 143 2018-11-21
NCT06052423 ARTEMIS-007: HS-20093 in Patients With Extensive Stage Small Cell Lung Cancer Phase 2 Withdrawn Hansoh BioMedical R&D Company - 2024-11-30
NCT06912152 MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors Phase 1 Recruiting Zhejiang University 12 2025-05-12
NCT06112704 HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors Phase 2 Recruiting Hansoh BioMedical R&D Company 220 2024-02-06
NCT05366179 Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc Phase 1 Recruiting UNC Lineberger Comprehensive Cancer Center 36 2022-09-02
NCT06778603 B7-H3 NIR Imaging for Osteosarcoma Surgery Phase 1/2 Recruiting Peking University People's Hospital 32 2024-01-01
NCT07099898 A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) Phase 3 Recruiting GlaxoSmithKline 300 2025-08-11
NCT05241392 Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma Phase 1 Recruiting Beijing Tiantan Hospital 30 2022-01-27
NCT05768880 Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors Phase 1 Recruiting Seattle Children's Hospital 72 2023-05-05
NCT05515185 B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors Phase 1 Unknown The First People's Hospital of Lianyungang 30 2022-09-09
NCT07172958 Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE) Phase 1 Recruiting Children's National Research Institute 18 2026-01-27
NCT03198052 GPC3/Mesothelin/Claudin18.2/GUCY2C/B7-H3/PSCA/PSMA/MUC1/TGFβ/HER2/Lewis-Y/AXL/EGFR-CAR-T Cells Against Cancers Phase 1 Recruiting Second Affiliated Hospital of Guangzhou Medical University 30 2017-07-01
NCT05752877 Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma Not Applicable Recruiting Second Affiliated Hospital of Soochow University 12 2021-05-01
NCT04842812 Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors Phase 1 Recruiting Second Affiliated Hospital of Guangzhou Medical University 40 2021-01-01
NCT06646627 Clinical Trial of Autologous B7-H3 CAR T Cells in Reoccurent Platinum-resistant Ovarian Tumors Phase 1 Recruiting Stanford University 48 2024-11-11
NCT06454955 Study on B7-H3 Targeted Affibody Radioligand Probes for PET Imaging of Solid Tumors Phase 1 Recruiting Peking University Cancer Hospital & Institute 50 2024-01-01
NCT06500819 Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors Phase 1 Recruiting Crystal Mackall, MD 41 2024-07-11
NCT03406949 MGD009/MGA012 Combination in Relapsed/Refractory Cancer Phase 1 Completed MacroGenics 25 2018-02-27
NCT05835687 Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors Phase 1 Recruiting St. Jude Children's Research Hospital 48 2023-04-27
NCT06203210 A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer Phase 3 Recruiting Daiichi Sankyo 540 2024-05-21
NCT01918930 Tissue Procurement Substudy for Participants in Study CP-MGA271-01 Phase 1 Terminated MacroGenics 6 2013-07
NCT04185038 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors Phase 1 Recruiting Seattle Children's Hospital 90 2019-12-11
NCT07222735 Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas Phase 1 Recruiting St. Jude Children's Research Hospital 42 2025-12-05
NCT06825624 ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer Phase 1 Recruiting Hansoh BioMedical R&D Company 560 2024-10-03
NCT06158139 Autologous CAR-T Cells Targeting B7-H3 in PDAC Phase 1 Recruiting UNC Lineberger Comprehensive Cancer Center 27 2024-07-18
NCT04385173 Pilot Study of B7-H3 CAR-T in Treating Patients With Recurrent and Refractory Glioblastoma Phase 1 Unknown Second Affiliated Hospital, School of Medicine, Zhejiang University 12 2022-12-01
NCT02982941 Enoblituzumab (MGA271) in Children With B7-H3-expressing Solid Tumors Phase 1 Completed MacroGenics 25 2016-12
NCT02381314 Safety Study of Enoblituzumab (MGA271) in Combination With Ipilimumab in Refractory Cancer Phase 1 Completed MacroGenics 24 2015-03-26
NCT07189871 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors Phase 1/2 Recruiting Radiopharm Theranostics, Ltd 61 2026-02
NCT06953089 DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors Phase 2 Recruiting DualityBio Inc. 492 2025-07-18
NCT06372236 UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors Phase 1 Completed Peking University 10 2023-12-05
NCT04897321 B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR) Phase 1 Recruiting St. Jude Children's Research Hospital 32 2022-07-06
NCT05991583 A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors Phase 1/2 Recruiting SUNHO(China)BioPharmaceutical CO., Ltd. 25 2023-07-03
NCT05280470 Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Phase 2 Recruiting Daiichi Sankyo 187 2022-03-09
NCT04077866 B7-H3 CAR-T for Recurrent or Refractory Glioblastoma Phase 1/2 Unknown Second Affiliated Hospital, School of Medicine, Zhejiang University 40 2023-06-01

Showing 50 of 72 trials. Download Excel for complete data.

Publications (0)

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