Changchun Hi-Tech (000661.SZ): GenSci 128 tablets new drug clinical trial application approved by US FDA

Zhitong Finance App News, Changchun Hi-Tech (000661.SZ) issued an announcement. Recently, the company's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”), received approval from the US Food and Drug Administration (hereinafter referred to as “FDA”) to conduct clinical trials with GenSci 128 tablets.

According to reports, TP53 is the most commonly mutated gene in human cancer. The p53 protein encoded by the TP53 gene acts as a transcription factor and has the function of suppressing tumors. Mutations in the tp53 gene cause p53 protein to become inactive, which is a critical step in tumor development. Among them, TP53Y220C mutations account for about 1.8% of TP53 mutations. There are no clinically approved treatments to target TP53Y220C mutations, and there are still unmet medical needs for patients with TP53Y220C mutations who have failed standard treatment.

The company GenScI128 tablets are a class 1 new therapeutic chemical. It is a selective reactivator for TP53Y220C mutations. It aims to selectively bind to the pocket of the TP53Y220C mutant protein, thereby restoring the normal conformation of the TP53Y220C mutant protein, increasing stability, and restoring the function of transcription and tumor suppression. Preclinical data shows that GenSci 128 tablets have good efficacy and safety. GenSci 128 tablets are registered as a new drug in the US and are intended to be used to treat locally advanced or metastatic solid tumors with TP53Y220C mutations. The new drug clinical trial application has been approved by the FDA. Jinsai Pharmaceutical will carry out related follow-up multi-center clinical trials in an orderly manner in accordance with relevant FDA requirements and laws and regulations.