TRANSTHERA-B (02617) announced that its core product Tinengotinib (TT-00420) in combination with fulvestrant for the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative or low-expressing (HER2-) recurrent or metastatic breast cancer following treatment failure has received clinical trial approval by default from China's National Medical Products Administration 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 combined with fulvestrant injection in patients with treatment-failed HR+/HER2- recurrent or metastatic breast cancer.

Early clinical research results indicate that Tinengotinib monotherapy demonstrates encouraging clinical effects in HR+/HER2- breast cancer patients who have experienced multiple treatments (such as endocrine therapy, CDK4/6 inhibitor therapy, and chemotherapy). Preclinical experimental results show that the combination of Tinengotinib and fulvestrant exhibits pharmacological synergistic effects against endocrine therapy-resistant breast cancer cells.

Therefore, the clinical treatment strategy of combining Tinengotinib with fulvestrant may potentially bring new breakthroughs in the treatment of such breast cancer patients.