Changchun High-tech Industry (Group) Co., Ltd. (hereinafter referred to as "the Company") announces that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd. (hereinafter referred to as "JinSai Pharmaceutical"), has received the approval document from the U.S. Food and Drug Administration (FDA) for the clinical trial of GenSci145 tablets. The relevant information is as follows:
1. Basic Information of the Drug
- Product Name: GenSci145 tablets
- Application Matter: Clinical trial application in the U.S.
- Application Acceptance Number: IND 178181
- Applicant: Changchun JinSai Pharmaceutical Co., Ltd.
- Approval Conclusion: Approval granted for clinical trials in the U.S.
- Indication: Locally advanced or metastatic solid tumors with PIK3CA mutations