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微芯生物:CS231295临床试验申请获FDA受理

Core Viewpoint - Micron Biomedical (688321.SH) announced that its wholly-owned subsidiary, Micron Biomedical Technology (USA) Co., Ltd., received a written response from the FDA, indicating that the clinical trial application for its self-developed drug CS231295 for advanced solid tumors has been accepted by the FDA [1] Group 1 - The drug CS231295 is a selective Aurora B inhibitor that may provide new solutions for various types of tumors and brain metastases with similar genetic defects [1] - Currently, there are no similar designed drugs entering the clinical trial phase globally [1] - The application is for a new drug clinical trial, and if the FDA does not respond within 30 days of submission or provides consent to proceed within that timeframe, the company can commence clinical trials as per the submitted plan [1]