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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.
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