By Fineline Cube 
On July 31, 2025, the investigational new drug (IND) application for Shenzhen Chipscreen Biosciences Co., Ltd.’s (SHA: 688321) next-generation brain-penetrant Aurora B selective inhibitor, CS231295 tablets, was approved by the U.S. FDA for the treatment of advanced solid tumors. This marks a significant milestone in the development of innovative therapies for challenging oncological conditions.
Mechanism of Action and Development
CS231295 represents a next-generation brain-penetrant Aurora B selective inhibitor discovered by Chipscreen following years of dedicated research. It precisely targets the Aurora B kinase, which is overexpressed in tumors, inducing a synthetic lethal effect that directly addresses the genetic vulnerabilities of refractory tumors, including those with RB1 deletion.
Therapeutic Advantages and Broad-Spectrum Activity
The compound’s exceptional ability to cross the blood-brain barrier provides a significant therapeutic advantage against primary brain tumors and brain metastases. Additionally, CS231295 demonstrates broad-spectrum antitumor activity, improving the tumor microenvironment and offering potential solutions for various tumor types with similar genetic defects and the global challenge of tumor brain metastasis.
Global Innovation and Clinical Progress
Currently, no other drug with a similar design has entered the clinical trial stage worldwide. The FDA’s approval of the IND application for CS231295 underscores its novel mechanism and potential impact on cancer treatment, particularly for patients with advanced solid tumors and brain metastases.-Fineline Info & Tech