pp-070.1 Tablets
Dossier type
US CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
FDA
Comments
Indication: Advanced or metastatic solid tumors with HER2 or HER3 abnormalities, including HER2-amplified or HER2-mutated cancers that have progressed on standard HER2-directed therapies.
Clinical stage: Phase I/II clinical development.
Modality: Small molecule (oral)
Mechanism / Target: Irreversible covalent inhibitor of HER2 and HER3 signaling, designed to suppress downstream proliferative pathways in tumors dependent on HER2/HER3 activation.
Route / form: Oral tablets
Differentiation: A next-generation covalent HER2/HER3 inhibitor with potential to overcome resistance to existing HER2-targeted treatments; offers precision activity in HER2-altered tumors and may address patients who no longer respond to antibody-based HER2 therapies.
Manufacturer #38605
A research-driven pharma company developing therapies across oncology and other major diseases. It advances innovative medicines through global R&D and strategic alliances. The organization emphasizes high-quality manufacturing and patient impact.