pp-162 Tablets
Dossier type
CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA
Comments
Indication: ROS1-positive NSCLC (1L and 2L+, including after crizotinib or entrectinib); NTRK-positive solid tumours
Clinical stage: FDA approved June 2025 (Ibtrozi); post-approval Phase 3 expansion ongoing
Modality: Small molecule
Mechanism / Target: Next-generation ROS1/NTRK1/2/3 kinase inhibitor — CNS-penetrant; active against G2032R and other solvent-front mutations causing resistance to crizotinib/lorlatinib
Route / form: Oral tablet (once daily)
Differentiation: CNS penetration for brain metastases; overcomes resistance to 1G/2G ROS1 inhibitors; covers NTRK fusions; once-daily oral; broader mutation coverage than entrectinib
Manufacturer #39189
Oncology company with an FDA-approved ROS1/NTRK inhibitor and next-generation solid tumour pipeline. Focuses on CNS-penetrant kinase inhibitors for molecularly defined lung and other cancers. Wholly owned US/global development with China territory licensed to Innovent Biologics.
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