Shares of TYK MEDICINES-B (ASX: 02410) surged more than 15% during the trading session. At the time of writing, the stock was up 12.68% to HK$7.82, with a turnover of HK$49.356 million.

Positive Clinical Trial Outcomes

A research report from Guohai Securities noted that Edotinib has demonstrated superior efficacy compared to Osimertinib in a head-to-head study involving NSCLC patients with brain metastases. The report highlighted that third-generation EGFR-TKI drugs still have limitations in their ability to penetrate and inhibit brain metastatic lesions. Edotinib is a differentiated deuterated innovative product based on Osimertinib.

Key Data from ESAONA Study

At the 2026 ASCO conference, the company presented interim analysis results from the ESAONA study, which evaluated Edotinib as a first-line treatment for EGFR-mutant NSCLC patients with brain metastases. The data showed an intracranial objective response rate of 95.5% for Edotinib versus 79.6% for Osimertinib. The intracranial progression-free survival was not reached for Edotinib, compared to 17.51 months for Osimertinib, with a hazard ratio of 0.46. The report indicated that all predefined patient subgroups derived significant benefit from Edotinib treatment.

Commercialization Timeline for TY-9591

The brokerage further stated that the company anticipates its third-generation EGFR-TKI drug, TY-9591, will be launched in the third quarter of 2026. In December 2025, the company submitted a conditional marketing application for its core product, TY-9591, for the first-line treatment of EGFR-mutant lung cancer with brain metastases. Following the priority review process, approval is expected in Q3 2026.

Additional Clinical Development Plans

Additionally, patient enrollment is ongoing for a clinical study of TY-9591 as a first-line treatment for locally advanced or metastatic lung cancer with the EGFR L858R mutation. Full patient enrollment is projected to be completed by the fourth quarter of 2026, with a New Drug Application submission anticipated in 2028. For the indication of EGFR-mutant advanced or metastatic lung cancer, a Phase 3 clinical trial for TY-9591 is scheduled to commence in the second half of 2026.