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pp-086

Tablets

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA, China
Comments
Indication: Advanced or metastatic solid tumors characterized by ROS1 or ALK alterations, including non–small cell lung cancer (NSCLC); additional exploration in tumors with FAK-driven resistance or invasive phenotypes. Clinical stage: Phase I/II clinical development in patients with ROS1-positive or ALK-positive malignancies, including populations resistant or intolerant to prior TKIs. Modality: Small-molecule tyrosine-kinase inhibitor Mechanism / Target: Potent, selective inhibitor of ROS1, ALK, and FAK designed to overcome kinase-domain mutations and resistance mechanisms while suppressing tumor proliferation, survival pathways, and metastatic signaling. Route / form: Oral formulation Differentiation: Multi-target inhibition strategy addressing both oncogenic drivers (ROS1/ALK) and FAK-mediated resistance pathways; potential to treat patients who have relapsed on earlier-generation TKIs; preclinical and early clinical data support activity against resistance mutations and invasive tumor behavior.
Manufacturer #38620

A global, clinical-stage biopharmaceutical company discovering, developing and commercializing small-molecule therapies addressing unmet needs in hematological cancers and other serious diseases. It advances programs through international registrational trials with strategic development and partnership goals. The organization integrates R&D and global expansion efforts.
 

 

 

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