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pp-071.2

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
EU GMP
Comments
Indication: Advanced or metastatic non-small cell lung cancer harboring EGFR mutations, including patients who have developed resistance to earlier-generation EGFR TKIs (e.g., C797S and other acquired mutations). Clinical stage: Phase I/II clinical development. Modality: Small molecule (oral) Mechanism / Target: Mutant-selective EGFR tyrosine kinase inhibitor designed to inhibit a broad spectrum of activating and resistance EGFR mutations while sparing wild-type EGFR. Route / form: Oral tablets Differentiation: Fourth-generation EGFR inhibitor engineered to overcome key resistance mechanisms (including C797S), with selective inhibition expected to improve tolerability; aims to address unmet need in patients who progress after osimertinib and other standard EGFR-TKI 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.

 

 

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