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Country of origin : China
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pp-121

Capsules

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Comments
Indication: Acute graft-versus-host disease (aGVHD), including steroid-refractory cases in post-allogeneic hematopoietic stem cell transplant patients; potential expansion into fibrotic and inflammatory diseases (e.g., IPF, IBD in earlier research settings) Clinical stage: Phase 1 completed; Phase 1b ongoing in aGVHD patients (global development in early clinical stage) Modality: Small molecule Mechanism / Target: Selective RIPK1 (Receptor-interacting serine/threonine-protein kinase 1) inhibitor, blocking necroptosis signaling and downstream inflammatory cytokine release, reducing tissue damage and immune-mediated inflammation Route / form: Oral capsules Differentiation: First-in-class approach targeting regulated cell death (necroptosis) rather than broad immunosuppression; designed for selective control of inflammatory tissue injury in severe immune-mediated conditions with limited treatment options such as aGVHD; potential to expand into multiple high-unmet-need inflammatory diseases
Manufacturer #39107

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