Changchun High-Tech's GenSci128 receives FDA clinical trial nod

Changchun High & New Technology Industry Group (SZSE:000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with clinical trials for GenSci128 tablets. GenSci128 is a new Class 1 drug intended for the treatment of locally advanced or metastatic solid tumors carrying the TP53 Y220C mutation. This mutation, found in approximately 1.8% of TP53 mutations, currently lacks targeted therapies, addressing an unmet medical need. Jinsai Pharmaceutical will initiate multi-center clinical trials in accordance with FDA requirements, building on existing trials already approved in China. The company says this progress will broaden its business structure, optimizing product lines, and boosting core competitiveness, but also cautions investors about uncertainties during clinical trials.