TransThera gains NMPA clearance to launch Phase II study of TT-00973 plus firmonertinib in EGFR-mutant NSCLC

Bulletin Express07-10

TransThera Sciences (Nanjing), Inc. (TransThera, HKEX: 02617) has secured National Medical Products Administration approval, dated 10 July 2026, to initiate a multi-centre, open-label Phase II trial evaluating TT-00973 tablets combined with firmonertinib mesylate in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR-sensitive mutations.

TT-00973 is TransThera’s internally developed dual AXL/FLT3 inhibitor designed to block AXL-driven tumour survival, metastasis and drug resistance. Phase I data completed by 31 December 2025 showed the candidate was well tolerated and demonstrated preliminary antitumour activity in solid-tumour patients.

The upcoming study follows a clinical collaboration and drug-supply agreement signed in May 2026 between TransThera and Shanghai Allist Pharmaceuticals, the developer of the third-generation EGFR inhibitor firmonertinib. Positive Phase II outcomes could lead the partners to explore a Phase III programme for the combination regimen.

In accordance with Hong Kong Listing Rule 18A.08(3), TransThera emphasised that there is no guarantee the investigational therapy will ultimately achieve successful development or commercialisation.

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