BEBT-109 is a highly active pan-mutant EGFR inhibitor independently developed by the company. The BEBT-109 program is currently in a Phase III clinical trial agreed to by the CDE in September 2023 for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Distinguishing itself from the first-approved third-generation EGFR inhibitor osimertinib, BEBT-109 increases the in vivo maximum blood concentration (Cmax) and appropriately shortens the half-life of covalent irreversible EGFR inhibitors. This overcomes the deficiency of osimertinib's metabolite inhibiting wild-type EGFR and allows for higher drug doses and exposure, enhancing product efficacy with a higher safety profile. Moreover, both preclinical and clinical research indicate that BEBT-109 not only exhibits high inhibitory activity against common EGFR mutations and the T790M resistance mutation but also demonstrates potent inhibitory activity against rare mutations, including EGFR exon 20 insertion mutations. The results of the clinical Phase I and Phase II trials demonstrated the safety and preliminary efficacy of the product. With the widespread use of third-generation EGFR inhibitors in first- and second-line treatment regimens for NSCLC, patients progressing after third-generation EGFR-TKI treatment lack effective standard therapeutic options. The potential market for BEBT-109 in combination with BEBT-908 for the treatment of advanced NSCLC after disease progression on third-generation EGFR-TKI therapy is substantial. Currently, this trial is in Phase Ib/II clinical trials.
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