According to the relevant rules of the U.S. Food and Drug Administration (hereinafter referred to as "FDA"), Changchun Hi-Tech Industrial (Group) Co. (hereinafter referred to as "GenSci") will carry out Phase I clinical trials in the United States for GenSci125 for injection (IND No. 168162), and the relevant information is hereby announced as follows:

The Company had issued the ''Announcement on the Approval of the Application for Clinical Trial of GenSci125 for Injection by the Controlling Subsidiary'' (Announcement No. 2023-096) on December 15, 2023, obtaining the ''Notification of Approval for Clinical Trial of Drugs'' by the State Drug Administration of the PRC in respect of the project of GenSci125 for injection and agreeing to carry out the clinical trial.

On December 15, 2023, GenSci obtained the IND confirmation letter from FDA. According to the requirements of the letter, there is an implied license period of 30 days after the receipt of the letter. At present, the end of the implied license period has been reached, and human clinical trial research can be started. GenSci will carry out the subsequent clinical trials in an orderly manner in accordance with the relevant requirements of the FDA. GenSci focuses on R&D and innovation, and steadily advances its strategic layout in the fields of women's health and assisted reproduction. Progesterone is commonly used and necessary for maintaining pregnancy. GenSci125 for injection is independently developed by GenSci, and is the first weekly long-acting progesterone for injection approved by FDA for clinical research, which can significantly reduce the number of times of clinical dosing compared with the short-acting progesterone for injection, and provide patients with a better choice of medication.

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