SINO BIOPHARM (01177): Fourth generation EGFR inhibitor "TQB3002" granted permission for clinical trials in the United States.

SINO BIOPHARM (01177) announced that its independently developed fourth-generation EGFR inhibitor "TQB3002" has officially received approval for clinical trial application (IND) from the US Food and Drug Administration (FDA) and will soon start Phase I clinical trials. The epidermal growth factor receptor (EGFR) is one of the most frequently mutated genes. EGFR is also the main driving gene in non-small cell lung cancer, with mutation rates as high as 40%-50% in East Asian populations and 10%-20% in Western populations. TQB3002 competitively binds to the ATP site of the intracellular tyrosine kinase binding domain, inhibiting the activity of related tyrosine kinases and intracellular phosphorylation processes, thereby inhibiting downstream signal transduction of EGFR and ultimately leading to tumor cell death. Currently, first, second, and third-generation EGFR inhibitors are widely used in clinical practice, with each generation of drugs developed to address the resistance issues of the previous generation. Based on this, the group has developed an oral small molecule fourth-generation EGFR inhibitor, TQB3002. Preclinical studies have shown that TQB3002 can inhibit the kinase activity of EGFR single mutations (EGFRd746-750 and EGFR L858R), as well as EGFR double mutations (EGFRd746-750/T790M and EGFR L858R/T790M). TQB3002 showed strong inhibitory activity in EGFR single, double, and triple mutant cell lines. In EGFR single, double, and triple mutant in vivo models, TQB3002 effectively inhibited tumor growth in a dose-dependent manner and showed good tolerability. At the same time, TQB3002 has good safety and high clinical development value. The group will continue to focus on innovative research and accelerate the clinical development of TQB3002, while actively exploring overseas markets and expanding its international presence.