Announcement on Subsidiary's STSP-0601 Injection Obtaining US FDA Clinical Trial Approval

Announcement on Subsidiary's STSP-0601 Injection Obtaining US FDA Clinical Trial Approval

The company and all members of the board of directors guarantee the truthfulness, accuracy, and completeness of the information disclosed, and are free from any false records, misleading statements, or major omissions.

Recently, Sinovant (Beijing) Pharmaceutical Co., Ltd. (hereinafter referred to as "Sinovant" or "the Company") subsidiary Jiangsu Beijierui Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as "Beijierui") received an official letter from the US Food and Drug Administration (FDA) (Study May Proceed Letter), agreeing to conduct clinical trials for STSP-0601 for the treatment of bleeding in patients with hemophilia A or B with inhibitors. The relevant situation is hereby announced as follows:

I. Basic Information

1. Drug Name: STSP-0601

2. Application Type/Number: IND172958

3. Indication: On-demand treatment for bleeding in patients with hemophilia A or B with inhibitors

4. Applicant: Jiangsu Beijierui Bio-Pharmaceutical Co., Ltd.

5. Main Content of the Letter: FDA agrees to conduct clinical trials for STSP-0601 for the treatment of bleeding in patients with hemophilia A or B with inhibitors.

II. Other Related Information