Core Insights - The FDA has granted fast track designation to Tinengotinib (TT-00420) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) [1][2] - mCRPC is a significant cause of mortality in prostate cancer patients, with global incidence projected to rise from 180,500 cases in 2019 to 209,300 cases in 2024 due to aging populations [1] - Tinengotinib is a multi-target kinase inhibitor in Phase III trials, showing potential efficacy in treating various solid tumors [1][2] Company Developments - Tinengotinib is the first and only drug with clinical efficacy evidence targeting both FGFR and JAK pathways for mCRPC [2] - In early-phase clinical trials, Tinengotinib demonstrated an overall response rate (ORR) of 46% and a disease control rate (DCR) of 85%, with over 90% of patients experiencing tumor volume reduction [2] - The successful fast track designation for Tinengotinib highlights the company's efficient clinical and regulatory execution capabilities [2]
药捷安康-B(02617.HK)：替恩戈替尼(TT-00420)被授予治疗MCRPC快速通道认证