Shenzhen Chipscreen Biosciences Co., Ltd. announced that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors. This significant milestone marks a key step forward in the global development strategy for CS231295.
Addressing Critical Unmet Medical Need
Malignant tumors remain one of the leading causes of death worldwide. Despite continuous advancements in clinical treatments and efficacy, most cancers remain incurable. Drug resistance, recurrence, and metastasis pose significant threats to long-term patient survival. In particular, due to the presence of the blood-brain barrier, primary brain tumors and brain metastases not only pose a severe danger to life but also serve as natural barriers to effective drug therapy. Thus, developing novel brain-penetrant anti-cancer drugs has become a pressing challenge and a key research focus.
Novel Mechanism of Action
CS231295 is a next-generation brain-penetrant Aurora B selective inhibitor discovered through years of mechanism-based research by Chipscreen Biosciences. On one hand, it precisely inhibits tumor-specifically overexpressed Aurora B kinase to induce synthetic lethality, directly targeting the genetic vulnerability of hard-to-treat cancers such as those with RB1 deletion. On the other hand, due to its strong blood-brain barrier permeability, it shows significant therapeutic potential for both primary and metastatic brain tumors.
Furthermore, this molecule also exhibits broad-spectrum anti-tumor activity, which improves the tumor microenvironment. It is expected to provide a novel solution for tumors with similar genetic defects and the global challenge of brain metastases. Currently, there is no similar compound with this design that has entered clinical trials globally.
Combination Therapy Potential
With its unique mechanism and chemical structure, CS231295 demonstrates synergistic effects when combined with chemotherapy, targeted therapy, and cancer immunotherapy. In preclinical studies, CS231295 has shown remarkable pharmacodynamic activity, ideal pharmacokinetic properties, and a favorable safety profile.
Clinical Development Progress
Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in China in May 2025, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development. The FDA's IND approval will further accelerate the initiation and implementation of its clinical research in the United States.
Company Background
Chipscreen Biosciences is an innovation-driven pharmaceutical company dedicated to developing globally competitive pipelines of first- and best-in-class original drugs. As a pioneer in China's original drug innovation space, the company upholds the mission of "Innovation, Safety, Efficacy, China-Origin". The company has successfully developed multiple first-in-class and best-in-class novel drugs. Two of its drugs covering six indications have been launched globally.
The company maintains a diversified innovation pipeline across five major areas: oncology, metabolic diseases, autoimmune disorders, central nervous system diseases, and antivirals. As one of the first national "Innovative Drug Incubation Bases" and a certified National High-Tech Enterprise, Chipscreen has independently undertaken numerous national-level projects, including the "Major New Drug Innovation" initiative, and has filed over 700 patent applications globally, with more than 200 granted.
Chipscreen Biosciences (USA) Ltd., founded in April 2021 and headquartered in New Jersey, is committed to advancing the clinical development of the company's innovative drugs globally. The U.S. subsidiary has built a U.S.-based R&D platform to accelerate the clinical translation and global registration of drug candidates, including CS231295.
