HK Stock Movement | TYK MEDICINES-B (02410) Rises Over 5% in Early Trading as Company Prepares Conditional NDA Submission for TY-9591

Stock News12-12

TYK MEDICINES-B (02410) surged more than 5% in early trading, and as of press time, it was up 3.73% at HK$13.35, with a turnover of HK$21.546 million.

The company's EGFR-targeted high-selective small-molecule inhibitor, TY-9591 (Aidotinib), garnered significant attention at the World Conference on Lung Cancer in September this year due to its pivotal Phase II clinical trial results for non-small cell lung cancer (NSCLC) with brain metastases.

TYK MEDICINES-B completed patient enrollment (224 cases) for conditional approval eligibility in November 2024 and submitted a pre-NDA application in April 2025. The company plans to formally file the conditional New Drug Application (NDA) in Q4 2025.

During its interim results briefing, the company stated it is currently preparing the NDA submission for TY-9591 as a first-line treatment for EGFR-mutated lung cancer with brain metastases. Additionally, a registrational Phase III clinical trial for TY-9591 monotherapy is underway in China, targeting EGFR L858R-mutated locally advanced (Stage IIIb–IV) or metastatic NSCLC as a first-line therapy.

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