타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 2개 · 임상 갱신 필요 2개 · Data Tier에서 열림
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 | |
|---|---|---|
Overview Program | Herceptin (trastuzumab) | Ziihera (zanidatamab) |
Overview Company | Roche / Genentech | Jazz Pharmaceuticals / Zymeworks |
Overview Modality | ANTIBODY | ANTIBODY |
Overview Target | HER2 | HER2 (biparatopic) |
Overview Indication | HER2+ breast cancer, HER2+ gastric/GEJ adenocarcinoma | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved |
Positioning Key differentiator | novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRT | 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). |
Positioning Known limitation | resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomes | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. |
Positioning Development positioning | — | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy |
MoA Mechanism | Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2. | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. |
MoA Biomarker | HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines). | 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+. |
Toxicology Species | Rat | — |
Toxicology Major finding | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Toxicology CRS | N/A | N/A |
Clinical Safety signal | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
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: 2개 · 임상 갱신 필요 2개 · Data Tier에서 열림
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 | |
|---|---|---|
Overview Program | Herceptin (trastuzumab) | Ziihera (zanidatamab) |
Overview Company | Roche / Genentech | Jazz Pharmaceuticals / Zymeworks |
Overview Modality | ANTIBODY | ANTIBODY |
Overview Target | HER2 | HER2 (biparatopic) |
Overview Indication | HER2+ breast cancer, HER2+ gastric/GEJ adenocarcinoma | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved |
Positioning Key differentiator | novel bifunctional chelator (2E-C-NETA) for applications in 177 Lu-based TRT | 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). |
Positioning Known limitation | resistance to trastuzumab-based targeted therapy and limited intratumoral antibody penetration continue to restrict clinical outcomes | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. |
Positioning Development positioning | — | 1L GEA with fluoropyrimidine-platinum ± Tevimbra; 2L+ BTC monotherapy |
MoA Mechanism | Trastuzumab binds domain IV of HER2, inhibiting ligand-independent HER2 signaling, mediating ADCC via Fcγ receptors, and inducing internalization/degradation of HER2. | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. |
MoA Biomarker | HER2 IHC 3+ or ISH amplified (ASCO/CAP guidelines). | 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+. |
Toxicology Species | Rat | — |
Toxicology Major finding | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Toxicology CRS | N/A | N/A |
Clinical Safety signal | Cardiotoxicity (LVEF decline, CHF risk especially with anthracyclines); infusion reactions; myelosuppression in combos. | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
Preclinical Animal (cat.) | Mouse, In vitro | — |
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