Haisco Pharmaceutical Group (002653.SZ): Hydroxytyrosol injection has obtained FDA market approval.

Haisco Pharmaceutical Group (002653.SZ) announced that its wholly-owned subsidiary, Haisco USA Pharmaceuticals Inc., received notification of FDA approval for the listing of its independently developed Cipepofol Injection (trade name: Sishuning, English name: CYPSEDO) in the United States for adult general anesthesia induction. Cipepofol Injection is a new type of intravenous anesthetic developed independently by the company with proprietary intellectual property rights, and is a GABAA receptor agonist. The product was approved for listing in China in December 2020 and has since been approved for multiple indications, including "sedation and anesthesia during non-tracheal intubation surgery/operation," "induction and maintenance of general anesthesia," "sedation during critical care," and "induction and maintenance of general anesthesia in children/adolescents," with a steadily growing market share. In terms of internationalization, Cipepofol Injection obtained FDA IND approval in 2021 and entered directly into crucial Phase III clinical trials in the United States. After completing all clinical studies, its New Drug Application (NDA) was accepted by the FDA in July 2025 and was recently granted FDA approval for listing. Results from several crucial Phase III clinical trials overseas have shown that Cipepofol Injection has clinical advantages over Propofol Injection in terms of rapid onset of action for general anesthesia induction, quick postoperative recovery, and stability of blood pressure and lower injection pain incidence.