CS231295 is a brain-penetrant, selective Aurora B inhibitor with global patent protection, independently developed by the Company using its AI + chemical genomics technology platform.
Malignant brain tumors and brain metastases remain major challenges in oncology, and there is a significant unmet need for novel anticancer therapies capable of penetrating the blood-brain barrier.CS231295 selectively inhibits Aurora B kinase, which is overexpressed in tumors. It induces synthetic lethality in RB1‑deficient and other treatment‑resistant tumors. Its strong blood-brain barrier penetration may provide a significant therapeutic advantage in the treatment of primary brain tumors and brain metastases.CS231295 also exhibits broad-spectrum antitumor activity by inhibiting tumor angiogenesis and modulating the tumor microenvironment, with potential for combination therapy with chemotherapy, targeted therapies, and immunotherapies with diverse mechanisms of action.
The Phase I clinical trial of CS231295 in China is progressing smoothly, with preliminary efficacy signals observed in patients with glioblastoma. The U.S. Phase I clinical trial has also completed first-patient dosing.
• In May 2025, the Phase I clinical trial of CS231295 in China enrolled its first patient.
• In July 2025, the U.S. FDA approved the clinical trial application for CS231295.
• In July 2026, the first patient was dosed in the U.S. Phase I clinical trial of CS231295.