Chipscreen(SH:688321) 智通财经网·2025-07-31 09:02Core 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: Clinical Trial Approval - The FDA has granted permission for the Phase I clinical trial of CS231295, which targets advanced solid tumors [1] - The trial represents a significant step in the development of innovative cancer therapies [1] Group 2: Mechanism of Action - CS231295 is a selective AuroraB inhibitor that precisely targets tumor-specific overexpression of AuroraB kinase, inducing synthetic lethality by addressing RB1 gene vulnerabilities [1] - The compound demonstrates excellent blood-brain barrier penetration, providing a therapeutic advantage for primary or metastatic brain tumors [1] Group 3: Broader Implications - CS231295 also possesses broad-spectrum anti-tumor activity that can improve the tumor microenvironment [1] - The drug has the potential to offer new solutions for various tumor types with similar genetic defects and address the global challenge of tumor brain metastasis [1]