TYK MEDICINES-B (02410) has announced that its independently developed next-generation EGFR-TKI innovative drug, Duxenaitinib Mesylate Tablets (TY-9591), has received conditional marketing approval from China's National Medical Products Administration (NMPA).

The approved indication covers first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions (19DEL) or exon 21 (L858R) substitution mutations, accompanied by central nervous system (CNS) metastases.

Duxenaitinib Mesylate Tablets represent a novel, highly selective, irreversible oral EGFR-TKI independently developed by the company, positioned as a differentiated deuterated innovation of osimertinib. Through unique structural optimization, the drug effectively reduces the generation of toxic metabolites while demonstrating superior pharmacokinetic properties, showcasing remarkable clinical efficacy and safety advantages in lung cancer patients with brain metastases carrying EGFR 19del and L858R sensitive mutations.

The company has already established a comprehensive clinical development program around this product, encompassing multiple monotherapy and combination therapy studies that extensively cover various niche indications within advanced non-small cell lung cancer.