Core Viewpoint - The company has received clinical approval for its core product, Tinengotinib, in combination with Fulvestrant, for the treatment of HR+/HER2- recurrent or metastatic breast cancer that has failed previous treatments [1] Group 1: Clinical Trial Details - The clinical trial is a Phase II, open-label, multi-center study conducted in China, evaluating the safety, efficacy, and pharmacokinetics of Tinengotinib combined with Fulvestrant in patients with HR+/HER2- breast cancer [1] - The trial received clinical implicit approval from the National Medical Products Administration of China on September 10, 2025 [1] Group 2: Early Research Findings - Early clinical research results indicate that Tinengotinib as a monotherapy shows promising clinical effects in HR+/HER2- breast cancer patients who have undergone multiple treatments, including endocrine therapy, CDK4/6 inhibitors, and chemotherapy [1] - Preclinical studies suggest that the combination of Tinengotinib and Fulvestrant exhibits pharmacological synergy against endocrine-resistant breast cancer cells [1] Group 3: Potential Impact - The clinical treatment strategy involving Tinengotinib and Fulvestrant may provide a new breakthrough in the treatment of breast cancer patients who have developed resistance to endocrine therapy [1]
药捷安康-B：替恩戈替尼联合氟维司群治疗经治失败的HR阳性╱HER2阴性或低表达的复发或转移性乳腺癌II期临床试验获批开展