TYK Medicines (2410) H2 2025 earnings summary

Executive summary

• Annual loss narrowed 21.1% YoY to RMB305.972m, while R&D spending rose 3.7% to RMB244.064m as TY-9591 advanced toward commercialization.

• TY-9591’s brain-metastasis NDA was accepted for priority review in February 2026; the pipeline includes 10 drug candidates across clinical and preclinical stages.

Financial highlights

• Revenue was RMB107k, cost of sales RMB93k and gross profit RMB14k in 2025.

• Loss before tax and total comprehensive loss were RMB305.972m, down from RMB387.928m in 2024; loss attributable to parent owners was RMB299.768m.

• R&D costs rose 3.7% YoY to RMB244.064m, primarily on TY-9591 milestone payments; administrative expenses fell 27.6% to RMB78.478m, mainly on lower listing expenses.

• Other income and gains rose to RMB37.609m from RMB30.542m, including a RMB4.921m subsidiary-disposal gain; finance costs increased 16.4% to RMB14.916m.

• Basic and diluted loss per share improved to RMB0.80 from RMB1.15.

Outlook and guidance

• TY-9591 Phase III enrollment for EGFR L858R lung cancer is expected to finish in Q4 2026, with NDA submission targeted for 2028; combination Phase III trials are planned for H2 2026.

• TY-9591’s Phase II brain-metastasis study completed preliminary data cleansing and analysis in Q4 2025; confirmatory-study discussions with CDE took place in Q1 2026.

• The first TY-1054 clinical-trial site is expected to open in Q1 2026; CDK4 IND submission is expected in June 2027, and GLP-1 IND-enabling studies are expected by end-2026.

• Phase I factory production lines are expected to obtain GMP compliance certification and be ready for production in 2026; planned annual capacity is 150m tablets or capsules.

• Strategy prioritizes continued internal R&D, AI-enabled drug discovery, external commercialization partnerships and phased development of an independent sales and marketing system.