Drug intelligence / Profile preview

pruvonertinib

Development stage
Phase 3
Lead developer
Suzhou Puhe Biopharma
Modality
Small Molecules
Administration
Oral
01

Overview

Pruvonertinib (YK-029A) is an orally bioavailable, third-generation small molecule tyrosine kinase inhibitor (TKI) developed by Suzhou Puhe Pharmaceutical Technology Co., Ltd. It is specifically designed to be a mutant-selective and wild-type sparing inhibitor of the epidermal growth factor receptor (EGFR). Its primary targets include EGFR exon 20 insertion mutations and the T790M resistance mutation, which are significant drivers in non-small cell lung cancer (NSCLC). Pruvonertinib is currently undergoing Phase 3 clinical evaluation (NCT05767892) as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, comparing its efficacy and safety against standard platinum-based chemotherapy. The drug has been granted Breakthrough Therapy Designation (BTD) in China for this indication.

Other names
pruvonertinibYK-029AYK029AYK 029A
02

Targets

EGFR ex20ins (Epidermal growth factor receptor exon 20 mutant)EGFR T790M (Epidermal growth factor receptor T790M mutant)

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