TRANSTHERA-B(02617): The phase II clinical trial of Tenofovir combined with Fluvisil to treat HR-positive/HER2-negative or low-expressing relapsed or metastatic breast cancer that has failed previous treatments has been approved for initiation.

TRANSTHERA-B (02617) announced that its core product, Tinengotinib (TT-00420), in combination with fluorovis group, has obtained clinical implied approval from the China National Medical Products Administration for the phase II clinical trial in patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative or low expression (HER2-) recurrent or metastatic breast cancer who have failed prior treatment, on September 10, 2025. This trial is an open-label, multicenter, phase II clinical study conducted in China to evaluate the safety, efficacy, and pharmacokinetics of Tinengotinib tablets in combination with fluorovis group injections in patients with HR+/HER2- recurrent or metastatic breast cancer who have failed prior treatment. Early clinical research results of Tinengotinib have shown promising clinical outcomes in HR+/HER2- breast cancer patients who have undergone various treatments such as endocrine therapy, CDK4/6 inhibitor therapy, and chemotherapy. Preclinical results indicate a pharmacological synergy between Tinengotinib and fluorovis group in targeting endocrine therapy-resistant breast cancer cells. Therefore, the clinical treatment strategy of Tinengotinib in combination with fluorovis group may bring new breakthroughs in the treatment of this type of breast cancer patients.