타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 5개 · 임상 갱신 필요 5개
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials | zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab) Astellas·CLDN18.2 (claudin-18.2) 26 trials | sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy) Gilead / Immunomedics·TROP2 242 trials | tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr) BeOne Medicines·PD-1 213 trials·t½ ~20 days class range | |
|---|---|---|---|---|---|
Overview Program | Ziihera (zanidatamab) | Vyloy (zolbetuximab) | Trodelvy (sacituzumab govitecan-hziy) | Tevimbra (tislelizumab) | Kadcyla (ado-trastuzumab emtansine) |
Overview Company | Jazz Pharmaceuticals / Zymeworks | Astellas | Gilead / Immunomedics | BeOne Medicines | Roche / Genentech |
Overview Modality | ANTIBODY | ANTIBODY | ADC | ANTIBODY | ADC |
Overview Target | HER2 (biparatopic) | CLDN18.2 (claudin-18.2) | TROP2 | PD-1 | HER2 |
Overview Indication | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer | CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma | TNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label. | Esophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and chemotherapy | HER2+ breast cancer |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra). | Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality. | Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors. | Not a Keytruda substitute. The 2026 GEA label is a HER2-selected triplet with zanidatamab, not a PD-L1-unselected 1L PD-1 row. | Stable linker, DAR ~3.5 |
Positioning Known limitation | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. | CLDN18.2 heterogeneity and loss under treatment pressure. | TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux. | Antigen-presentation loss, alternate checkpoints, immunosuppressive TME. | HER2 downregulation, lysosomal trapping, and efflux; superseded in 2L HER2+ mBC by trastuzumab deruxtecan (DESTINY-Breast03). |
Positioning Development positioning | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy | 1L with fluoropyrimidine and platinum chemotherapy | Regimen-specific; includes 1L TNBC indications from June 2026 | 1L–2L gastroesophageal, regimen-dependent | 2L |
Technology Payload | — | — | SN-38 (topoisomerase I inhibitor) | — | DM1 (maytansine derivative) |
Technology Linker | — | — | Hydrolyzable CL2A, DAR ~7.6 | — | Non-cleavable stable thioether MCC |
Technology DAR | — | — | DAR 7.6 | — | — |
MoA Mechanism | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. | Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. | Anti-TROP2 antibody binds and internalizes; the hydrolyzable linker releases SN-38 both intracellularly and in the tumor microenvironment, inhibiting topoisomerase I and causing lethal DNA double-strand breaks. | Binds PD-1 on T cells, blocking PD-L1/PD-L2 engagement and restoring antitumor T-cell activity. Fc silencing is intended to avoid macrophage-mediated T-cell clearance. | Ado-trastuzumab emtansine (T-DM1) binds HER2 on tumor cells, is internalized, and MMAE is released after lysosomal degradation of the antibody in the non-cleavable SMCC linker system. MMAE disrupts microtubules, causing G2/M arrest and apoptosis. |
MoA Biomarker | GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+. | CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining. | TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label. | PD-L1 and tumor type on older labels; HER2 IHC/ISH when given with Ziihera. | HER2 overexpression/amplification (IHC 3+ or ISH+ per label). |
PK/PD Half-life | — | — | — | ~20 days class range | — |
PK/PD Species | — | — | — | OS/PFS, radiographic response | — |
PK/PD Animal (cat.) | — | — | — | Human | — |
Toxicology Species | — | — | Cynomolgus monkey, Hamster | — | Cynomolgus monkey, Rat |
Toxicology Animal (cat.) | — | — | — | — | NHP |
Toxicology Major finding | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Thrombocytopenia, hepatotoxicity |
Toxicology CRS | N/A | N/A | N/A | N/A | Minimal |
Clinical Safety signal | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Thrombocytopenia, hepatotoxicity |
Clinical Selected reported efficacy | — | — | ORR 50% | — | — |
Clinical Reported ORR | — | — | 50% vs 47% (chemotherapy) | — | — |
Clinical Reported PFS | — | — | 9.7 months vs 6.9 months (chemotherapy) | — | — |
Clinical Reported OS | — | — | Immature in FDA approval analysis | — | — |
Clinical Result source | — | — | FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299) | — | — |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | — | No active/completed counts |
Clinical Trial ref | — | — | NCT05382299 | — | — |
Preclinical Animal (cat.) | — | — | Mouse | — | In vitro |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 5개 · 임상 갱신 필요 5개
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials | zolbetuximab (Vyloy, IMAB362, zolbetuximab-clzb, claudiximab) Astellas·CLDN18.2 (claudin-18.2) 26 trials | sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy) Gilead / Immunomedics·TROP2 242 trials | tislelizumab (Tevimbra, BGB-A317, tislelizumab-jsgr) BeOne Medicines·PD-1 213 trials·t½ ~20 days class range | |
|---|---|---|---|---|---|
Overview Program | Ziihera (zanidatamab) | Vyloy (zolbetuximab) | Trodelvy (sacituzumab govitecan-hziy) | Tevimbra (tislelizumab) | Kadcyla (ado-trastuzumab emtansine) |
Overview Company | Jazz Pharmaceuticals / Zymeworks | Astellas | Gilead / Immunomedics | BeOne Medicines | Roche / Genentech |
Overview Modality | ANTIBODY | ANTIBODY | ADC | ANTIBODY | ADC |
Overview Target | HER2 (biparatopic) | CLDN18.2 (claudin-18.2) | TROP2 | PD-1 | HER2 |
Overview Indication | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer | CLDN18.2-positive HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma | TNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label. | Esophageal squamous cell carcinoma, gastric/GEJ adenocarcinoma, and first-line HER2-positive GEA with zanidatamab and chemotherapy | HER2+ breast cancer |
Overview Phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core | Curated Core | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved | FDA approved | FDA approved | FDA approved |
Positioning Key differentiator | Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra). | Exploits a tight-junction protein that only becomes accessible after malignant transformation, creating tumor selectivity without a novel modality. | Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors. | Not a Keytruda substitute. The 2026 GEA label is a HER2-selected triplet with zanidatamab, not a PD-L1-unselected 1L PD-1 row. | Stable linker, DAR ~3.5 |
Positioning Known limitation | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. | CLDN18.2 heterogeneity and loss under treatment pressure. | TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux. | Antigen-presentation loss, alternate checkpoints, immunosuppressive TME. | HER2 downregulation, lysosomal trapping, and efflux; superseded in 2L HER2+ mBC by trastuzumab deruxtecan (DESTINY-Breast03). |
Positioning Development positioning | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy | 1L with fluoropyrimidine and platinum chemotherapy | Regimen-specific; includes 1L TNBC indications from June 2026 | 1L–2L gastroesophageal, regimen-dependent | 2L |
Technology Payload | — | — | SN-38 (topoisomerase I inhibitor) | — | DM1 (maytansine derivative) |
Technology Linker | — | — | Hydrolyzable CL2A, DAR ~7.6 | — | Non-cleavable stable thioether MCC |
Technology DAR | — | — | DAR 7.6 | — | — |
MoA Mechanism | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. | Binds CLDN18.2 on gastric tumor cells and kills them through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. | Anti-TROP2 antibody binds and internalizes; the hydrolyzable linker releases SN-38 both intracellularly and in the tumor microenvironment, inhibiting topoisomerase I and causing lethal DNA double-strand breaks. | Binds PD-1 on T cells, blocking PD-L1/PD-L2 engagement and restoring antitumor T-cell activity. Fc silencing is intended to avoid macrophage-mediated T-cell clearance. | Ado-trastuzumab emtansine (T-DM1) binds HER2 on tumor cells, is internalized, and MMAE is released after lysosomal degradation of the antibody in the non-cleavable SMCC linker system. MMAE disrupts microtubules, causing G2/M arrest and apoptosis. |
MoA Biomarker | GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+. | CLDN18.2 IHC with ≥75% of tumor cells at moderate-to-strong membranous staining. | TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label. | PD-L1 and tumor type on older labels; HER2 IHC/ISH when given with Ziihera. | HER2 overexpression/amplification (IHC 3+ or ISH+ per label). |
PK/PD Half-life | — | — | — | ~20 days class range | — |
PK/PD Species | — | — | — | OS/PFS, radiographic response | — |
PK/PD Animal (cat.) | — | — | — | Human | — |
Toxicology Species | — | — | Cynomolgus monkey, Hamster | — | Cynomolgus monkey, Rat |
Toxicology Animal (cat.) | — | — | — | — | NHP |
Toxicology Major finding | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Thrombocytopenia, hepatotoxicity |
Toxicology CRS | N/A | N/A | N/A | N/A | Minimal |
Clinical Safety signal | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. | Nausea and vomiting are frequent and often infusion-related, requiring rate adjustment and antiemetics. Hypoalbuminemia, appetite loss, and hypersensitivity also occur. | Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common. | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and infusion-related reactions. Allogeneic transplant complications are labeled. | Thrombocytopenia, hepatotoxicity |
Clinical Selected reported efficacy | — | — | ORR 50% | — | — |
Clinical Reported ORR | — | — | 50% vs 47% (chemotherapy) | — | — |
Clinical Reported PFS | — | — | 9.7 months vs 6.9 months (chemotherapy) | — | — |
Clinical Reported OS | — | — | Immature in FDA approval analysis | — | — |
Clinical Result source | — | — | FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299) | — | — |
Clinical Program phase | APPROVED | APPROVED | APPROVED | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts | No active/completed counts | — | No active/completed counts |
Clinical Trial ref | — | — | NCT05382299 | — | — |
Preclinical Animal (cat.) | — | — | Mouse | — | In vitro |
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