Core Viewpoint - The company, ZhiJie AnKang-B, 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 Phase II clinical trial for Tinengotinib combined with Fulvestrant has been granted clinical implicit approval by the National Medical Products Administration of China on September 10, 2025 [1] - This trial is an open-label, multi-center study aimed at evaluating the safety, efficacy, and pharmacokinetics of the combination treatment in patients with HR+/HER2- recurrent or metastatic breast cancer [1] Group 2: Early Research Results - 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, indicating a potential breakthrough in treatment strategies for these patients [1]
药捷安康-B(02617)：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