长春高新技术产业（集团）股份有限公司 关于子公司GenSci128片新药临床试验申请 获得美国食品药品监督管理局批准的公告

Core Viewpoint - The company has received FDA approval for clinical trials of GenSci128 tablets, a targeted therapy for patients with TP53 Y220C mutation in advanced or metastatic solid tumors [1][2]. Group 1: Drug Information - Product Name: GenSci128 tablets - Application: Clinical trial approval in the US - Acceptance Number: IND 174059 - Applicant: Changchun JinSai Pharmaceutical Co., Ltd. - Approval Conclusion: Permission granted for clinical trials in the US - Indication: Local advanced or metastatic solid tumors with TP53 Y220C mutation [1]. Group 2: Drug Mechanism and Development - GenSci128 is a class 1 new chemical drug designed as a selective reactivator for TP53 Y220C mutation, aiming to restore the normal conformation and function of the mutated protein [2]. - Preclinical data indicates that GenSci128 has good efficacy and safety [2]. - The drug has also been approved for clinical trials in China for the same indication [2]. Group 3: Company Impact - Successful progress in clinical trials could help the company expand its business structure, optimize product offerings, and enhance core competitiveness [3]. - The company will actively promote the research and development of this project and comply with disclosure obligations regarding project progress [4].