微芯生物: 关于CS231295临床试验申请获得FDA批准的公告

Group 1 - The core announcement is that Shenzhen MicuRx Biopharma Co., Ltd. has received FDA approval for its clinical trial application for CS231295, aimed at treating advanced solid tumors [1][2] - CS231295 is a selective Aurora B inhibitor that targets tumor-specific overexpression of Aurora B kinase, potentially providing treatment advantages for primary or metastatic brain tumors due to its ability to penetrate the blood-brain barrier [2] - This drug is unique as there are currently no similar drugs in clinical trial stages globally, indicating a potential first-mover advantage in the market [2] Group 2 - The clinical trial application was submitted under IND 176942, specifically for advanced solid tumors, and the FDA has approved the trial to proceed as per the submitted protocol [1] - The company will actively advance the research and development of this project and will fulfill its information disclosure obligations in accordance with relevant regulations [3]