TRANSTHERA-B (02617) has reached clinical cooperation and drug supply agreement with Shanghai Allist Pharmaceuticals Co., Ltd.

TRANSTHERA-B(02617) announced that the company has reached a clinical cooperation and drug supply agreement with Shanghai Allist Pharmaceuticals Co., Ltd. Both parties will collaborate on a multicenter, open-label phase II study to evaluate the safety and efficacy of TT-00973-MS tablets in combination with gefitinib mesylate in patients with locally advanced or metastatic non-small cell lung cancer with EGFR-sensitive mutations. According to the agreement, Transthera-B as the sponsor of this clinical trial will be responsible for the operation and expenses of the trial. Shanghai Allist Pharmaceuticals Co., Ltd. will provide gefitinib mesylate tablets required for the trial free of charge. Based on the results of this trial, both parties will explore further opportunities for collaboration on a phase III clinical trial of TT-00973-MS tablets in combination with gefitinib mesylate. TT-00973 is a novel AXL/FLT3 dual-target inhibitor developed by Transthera-B. AXL kinase is a key factor in cancer survival, metastasis, and drug resistance, with abnormal activation of AXL signaling being associated with poor prognosis in various cancers. TT-00973 can effectively interfere with the activation of AXL in tumor cells and has shown effective anti-tumor activity in a xenograft mouse model with AXL overexpression. As of December 31, 2025, the company has completed a phase I clinical trial, with good tolerability of TT-00973 and observed clinical efficacy in some solid tumor patients. Gefitinib mesylate is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). Clinical studies have shown that gefitinib has broad efficacy against various EGFR mutations, with indications for first-line treatment, EGFR exon 20 insertion mutation NSCLC first and second-line treatment, and EGFR PACC mutation NSCLC first-line treatment being included in the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) list of breakthrough therapies. The indication for EGFR exon 20 insertion mutation NSCLC first-line treatment has also received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA).