TYK Medicines, Inc. (Stock Code: 2410) announced that the National Medical Products Administration’s Center for Drug Evaluation has accepted its New Drug Application for Asandeutertinib (TY-9591). According to official information, this deuterated analog of osimertinib shows high bioavailability and enhanced brain penetration.

Asandeutertinib (TY-9591) is intended for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutation, including those with CNS metastases. Previous clinical data indicate significant intracranial and systemic response rates that may address unmet clinical needs.

The acceptance of the application signifies the start of the review process but does not guarantee future approval. As with all pharmaceutical R&D, the final outcome is subject to further evaluation and regulatory decisions by the National Medical Products Administration.