타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 1개 · 임상 갱신 필요 1개
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 | nipocalimab (Imaavy, M281, nipocalimab-aahu) Johnson & Johnson / Janssen·FcRn 27 trials·t½ Supports q2w maintenance after loading |
|---|---|
Overview Program | Imaavy (nipocalimab) |
Overview Company | Johnson & Johnson / Janssen |
Overview Modality | ANTIBODY |
Overview Target | FcRn |
Overview Indication | Generalized myasthenia gravis (AChR or MuSK antibody-positive, age ≥12); warm autoimmune hemolytic anemia |
Overview Phase | APPROVED |
Overview Status | APPROVED |
Overview Content status | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established |
Overview Approval status | FDA approved |
Positioning Key differentiator | Continuous q2w maintenance after loading, MuSK coverage, and a wAIHA indication — not a CIDP or subcutaneous Hytrulo story. |
Positioning Known limitation | Non-IgG-mediated disease and incomplete FcRn occupancy. |
Positioning Development positioning | After or with steroids / conventional immunosuppressants per label |
MoA Mechanism | Occupies FcRn and blocks IgG recycling, lowering total and pathogenic IgG. Autoantibody titers fall while dosing continues and recover when it stops. |
MoA Biomarker | MG-ADL, QMG, AChR/MuSK serology; hemoglobin in wAIHA. |
PK/PD Half-life | Supports q2w maintenance after loading |
PK/PD Species | Total IgG reduction, MG-ADL, hemoglobin |
PK/PD Animal (cat.) | Human |
Toxicology Major finding | Infection risk tracks the reversible IgG drop. Infusion reactions and hypersensitivity are labeled; this is not B-cell depletion. |
Toxicology CRS | N/A |
Clinical Safety signal | Infection risk tracks the reversible IgG drop. Infusion reactions and hypersensitivity are labeled; this is not B-cell depletion. |
Clinical Program phase | APPROVED |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 1개 · 임상 갱신 필요 1개
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 | nipocalimab (Imaavy, M281, nipocalimab-aahu) Johnson & Johnson / Janssen·FcRn 27 trials·t½ Supports q2w maintenance after loading |
|---|---|
Overview Program | Imaavy (nipocalimab) |
Overview Company | Johnson & Johnson / Janssen |
Overview Modality | ANTIBODY |
Overview Target | FcRn |
Overview Indication | Generalized myasthenia gravis (AChR or MuSK antibody-positive, age ≥12); warm autoimmune hemolytic anemia |
Overview Phase | APPROVED |
Overview Status | APPROVED |
Overview Content status | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established |
Overview Approval status | FDA approved |
Positioning Key differentiator | Continuous q2w maintenance after loading, MuSK coverage, and a wAIHA indication — not a CIDP or subcutaneous Hytrulo story. |
Positioning Known limitation | Non-IgG-mediated disease and incomplete FcRn occupancy. |
Positioning Development positioning | After or with steroids / conventional immunosuppressants per label |
MoA Mechanism | Occupies FcRn and blocks IgG recycling, lowering total and pathogenic IgG. Autoantibody titers fall while dosing continues and recover when it stops. |
MoA Biomarker | MG-ADL, QMG, AChR/MuSK serology; hemoglobin in wAIHA. |
PK/PD Half-life | Supports q2w maintenance after loading |
PK/PD Species | Total IgG reduction, MG-ADL, hemoglobin |
PK/PD Animal (cat.) | Human |
Toxicology Major finding | Infection risk tracks the reversible IgG drop. Infusion reactions and hypersensitivity are labeled; this is not B-cell depletion. |
Toxicology CRS | N/A |
Clinical Safety signal | Infection risk tracks the reversible IgG drop. Infusion reactions and hypersensitivity are labeled; this is not B-cell depletion. |
Clinical Program phase | APPROVED |
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