TRANSTHERA-B (02617) has announced a clinical collaboration and drug supply agreement with Shanghai Allist Pharmaceuticals Co.,Ltd. (Shanghai Allist Pharmaceuticals). The two companies will jointly advance a multicenter, open-label Phase II study. This study is designed to evaluate the safety and efficacy of TT-00973-MS tablets in combination with almonertinib mesylate tablets for the treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR-sensitive mutations. Under the terms of the agreement, TRANSTHERA-B will act as the sponsor of this clinical trial, responsible for its operations and costs. Shanghai Allist Pharmaceuticals will provide the almonertinib mesylate tablets required for the trial free of charge. Based on the results of this clinical trial, both parties will explore opportunities for further collaboration on a Phase III clinical trial for the combination of TT-00973-MS tablets and almonertinib mesylate tablets.
TT-00973 is a novel AXL/FLT3 dual-target inhibitor independently developed by TRANSTHERA-B. The AXL kinase is a key factor in cancer survival, metastasis, and drug resistance. Abnormal activation of AXL signaling is associated with poor prognosis in various cancers. TT-00973 can effectively interfere with the activation of AXL in tumor cells and has demonstrated potent anti-tumor activity in mouse xenograft models with AXL overexpression. As of December 31, 2025, the company has completed a Phase I clinical trial, where TT-00973 showed favorable tolerability, and clinical efficacy was observed in some patients with solid tumors.
Almonertinib mesylate tablet is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). Clinical research results indicate that almonertinib exhibits broad efficacy against various EGFR mutations. Its first-line treatment indication for NSCLC with EGFR exon 20 insertion mutations has been included in the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) Breakthrough Therapy Designation list. This same first-line treatment indication for NSCLC with EGFR exon 20 insertion mutations has also received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA).
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