微芯生物:CS231295临床试验申请获FDA批准

Core Viewpoint - Microchip Biotech (688321.SH) announced that its wholly-owned subsidiary, Microchip Biotech (USA) Co., received a notification from the FDA on July 31, allowing the company to initiate a Phase I clinical trial for its self-developed CS231295 to treat advanced solid tumors [1] Group 1 - CS231295 is a selective AuroraB inhibitor that precisely targets tumor-specific overexpression of AuroraB kinase, inducing synthetic lethality and directly addressing RB1 gene vulnerabilities [1] - The compound demonstrates significant therapeutic advantages for primary or metastatic brain tumors due to its good blood-brain barrier penetration capability [1] - CS231295 also possesses broad-spectrum anti-tumor activity that improves the tumor microenvironment, potentially offering new solutions for various tumor types with similar genetic defects and addressing the global challenge of tumor brain metastasis [1]