PH009-1

PH009-1 is a novel, fourth-generation small molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed by Suzhou Puhe Biopharma. It is designed to overcome resistance mutations in EGFR-mutant non-small cell lung cancer (NSCLC), including the challenging C797S mutation as well as T790M and common activating mutations such as exon 19 deletion and L858R. Preclinical studies demonstrate that PH009-1 exhibits potent inhibitory activity against single, double, and triple EGFR mutations with high selectivity for mutant over wild-type EGFR. The compound shows strong anti-tumor efficacy in various mouse models of EGFR-mutant NSCLC, including those harboring multiple resistance mutations. Additionally, it has demonstrated good brain penetration potential and a favorable safety profile with low off-target risk in preclinical testing. Clinical development is ongoing to evaluate its safety, pharmacokinetics, and preliminary anti-tumor activity in patients with locally advanced or metastatic NSCLC harboring EGFR mutations[2][5][7].

Other names

PH009-1 tabletsPH-009-1 tabletsPH 009-1 tablets