Changchun Hi-Tech (000661.SZ): Gensci 122 tablet project obtained implied approval from the US FDA to apply for clinical trials of new drugs

Zhitongcaijing · 10/14 12:25

Zhitong Finance App News, Changchun Hi-Tech (000661.SZ) issued an announcement. According to the relevant rules of the US Food and Drug Administration (“FDA”), the company's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”), has obtained implied approval from the FDA to apply for clinical trials of new drugs.

According to reports, GenSci122 is a small-molecule KIF18A inhibitor with a novel structure independently developed by Jinsai Pharmaceutical. It is an effective selective KIF18A inhibitor, and has anti-tumor characteristics that are significantly different from other cell cycle and anti-mitotic drug targets.