By Fineline Cube 
China-based TYK Medicines, Inc. (HKG: 2410) announced the formal submission of a pre-NDA communication package to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its in-house developed asandeutertinib (TY-9591). This third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targets non-small cell lung cancer (NSCLC) brain metastasis.
Clinical Trial and Results
The submission is supported by positive outcomes from the TYKM1601202 study (ESAONA), a prospective, multicenter, randomized, active-controlled trial involving 224 treatment-naïve EGFRm+ NSCLC patients with measurable brain metastases. Asandeutertinib demonstrated significant superiority over osimertinib in intracranial objective response rate (primary endpoint assessed by IRC) and showed favorable safety and tolerability.-Fineline Info & Tech