TYK MEDICINES-B(02410): The National Medical Products Administration has conditionally approved the marketing application for Dihydroartemisinin Mesylate Tablets (TY-9591 Tablets).

TYK MEDICINES-B (02410) announced that its independently developed new generation EGFR-TKI innovative drug, Dihydroxylatinib Maleate Tablets (TY-9591), has received conditional approval for marketing from the National Medical Products Administration (NMPA) of China. The indication is for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, accompanied by central nervous system (CNS) metastases. Dihydroxylatinib Maleate Tablets are a new generation, highly selective, irreversible oral EGFR-TKI independently developed by the company, representing a differentiated deuterated innovative product compared to Osimertinib. The drug is designed with a unique structural optimization that effectively reduces the generation of toxic metabolites and exhibits superior pharmacokinetic characteristics, demonstrating outstanding clinical efficacy and safety advantages in lung cancer patients with EGFR 19del and L858R sensitive mutation with brain metastases. Currently, the company is conducting multiple clinical studies of monotherapy and combination therapy related to this product, covering various sub-indications for advanced non-small cell lung cancer comprehensively.