TYK MEDICINES-B (02410.HK): Dovatinib mesylate tablets (TY-9591) granted conditional approval as first-line treatment for EGFR-mutant NSCLC with CNS metastases

NewTimeSpace · 2026/08/27 21:55 · By Xuran Lin

NewTimeSpace News: On 27 August 2026, TYK MEDICINES-B (02410.HK) announced that its self-developed next-generation EGFR-TKI dovatinib mesylate tablets (TY-9591) have been granted conditional NMPA approval for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR 19del or L858R mutations with CNS metastases; the drug is a differentiated deuterated innovation derived from osimertinib, and the Company has initiated multiple monotherapy and combination studies around the product.

NewTimeSpace News: On 27 August 2026, TYK Medicines, Inc (stock code: 02410) voluntarily announced that its self-developed next-generation EGFR-TKI innovative drug, dovatinib mesylate tablets (TY-9591 tablets), has been granted conditional approval for marketing by the National Medical Products Administration (NMPA), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, with central nervous system (CNS) metastases.

According to the announcement, dovatinib mesylate tablets are a next-generation highly selective, irreversible oral EGFR-TKI, being a differentiated deuterated innovative product derived from osimertinib. Through unique structural optimization, the drug effectively reduces the generation of toxic metabolites and possesses superior pharmacokinetic characteristics, demonstrating outstanding clinical efficacy and safety advantages in patients with EGFR 19del and L858R sensitive mutations with brain metastases. The Company has established multiple monotherapy and combination therapy clinical studies around the product, comprehensively covering various segment indications of advanced NSCLC.

The announcement contains a warning statement that the Company cannot guarantee the eventual successful commercialization of dovatinib mesylate tablets, and shareholders and prospective investors should exercise caution when dealing in the Company's shares.

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