Hisun Pharmaceuticals announced that it received a notice of acceptance from the U.S. Food and Drug Administration (FDA) on July 30, 2025. Following review, the New Drug Application (NDA) for HSK3486 (Propofol Injection) was determined to meet the relevant drug registration requirements in accordance with FDA regulations and has been accepted. HSK3486 (Propofol Injection, Sishuning) is a brand-new, Class 1 intravenous anesthetic drug developed by the company with independent intellectual property rights. It was approved for marketing in China in December 2020 and has received drug registration certificates in China for the indications of "sedation and anesthesia for non-intubated surgeries/procedures," "induction and maintenance of general anesthesia," and "sedation during intensive care." HSK3486 received FDA approval of its IND application in January 2021, waiving Phase II in the United States and directly entering pivotal Phase III clinical trials. Clinical studies both domestically and internationally have demonstrated that HSK3486 has a rapid onset of action, rapid recovery, high anesthesia success rate, more stable blood pressure control, significantly reduced incidence of adverse reactions such as hypotension, respiratory depression, and injection pain, and improved patient and physician satisfaction. The company completed all clinical studies in 2024 and completed Pre-NDA communication with the FDA, reached an agreement on the content of the application, obtained FDA's consent to submit the NDA application, and recently received acceptance of the marketing authorization application.