TRANSTHERA-B(02617): TT-00973 combined with gefitinib mesylate is approved to conduct a Phase II clinical trial in China for the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations.

TRANSTHERA-B (02617) announces that the Phase II clinical trial of the company's product TT-00973 in combination with gefitinib mesylate for the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations has been approved by the National Medical Products Administration (NMPA) on July 10, 2026. This trial is a multicenter, open-label Phase II study to evaluate the safety and efficacy of TT-00973 in combination with gefitinib mesylate for patients with EGFR-sensitive mutations in locally advanced or metastatic non-small cell lung cancer. TT-00973 is a novel AXL/FLT3 dual-target inhibitor developed by the company. AXL kinase is a key factor in cancer cell survival, metastasis, and resistance, and abnormal activation of AXL signaling is associated with poor prognosis in multiple cancers. TT-00973 can effectively interfere with the activation of AXL in tumor cells and has shown significant anti-tumor activity in preclinical models overexpressing AXL. As of December 31, 2025, the company has completed Phase I clinical trials, demonstrating good tolerability of TT-00973 and observed clinical efficacy in some solid tumor patients. In May 2026, the company entered into a clinical cooperation and drug supply agreement with Shanghai Allist Pharmaceuticals Co., Ltd. to jointly conduct the Phase II study of TT-00973 in combination with gefitinib mesylate for patients with EGFR-sensitive mutations in locally advanced or metastatic non-small cell lung cancer. Based on the results of this clinical trial, the two companies will explore opportunities for further cooperation in conducting Phase III clinical trials of TT-00973 in combination with gefitinib mesylate.