China-based Changchun High & New Technology Industries (Group) Inc., (SHE:000661) announced that its subsidiary Changchun GeneScience Pharmaceutical Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug GenSci128. This drug is indicated for the treatment of locally advanced or metastatic solid tumors harboring the TP53 Y220C mutation.

GenSci128 Mechanism and Preclinical Results
GenSci128 is a p53 Y220C activator that has demonstrated promising efficacy and safety in preclinical studies. TP53 is the most frequently mutated gene in human cancers, with the Y220C mutation accounting for approximately 1.8% of all TP53 mutations. Currently, there are no approved targeted therapies for this specific mutation, highlighting a significant area of unmet medical need.-Fineline Info & Tech