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pp-072

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
FDA, EU GMP
Comments
Indication: Advanced or metastatic solid tumors harboring EGFR or HER2 mutations or amplification, including patient populations that have progressed after standard targeted therapies. Clinical stage: Phase I clinical development (EU, US). Modality: Small molecule (oral) Mechanism / Target: Irreversible covalent pan-ERBB inhibitor targeting EGFR and HER2 mutations, including hard-to-treat variants and resistance mechanisms. Route / form: Oral tablets Differentiation: Next-generation covalent ERBB inhibitor engineered to overcome resistance to earlier EGFR/HER2 TKIs; designed for enhanced potency against mutant receptors while reducing off-target effects on wild-type EGFR, supporting a more precise and better-tolerated treatment option for genetically defined tumors.
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.

 

 

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