Hisun Pharm: Innovative drug HSK3486 receives FDA approval for marketing application acceptance.

date
03/08/2025
Hycor Corporation Announcement: On July 30, 2025, the company received an acceptance notification from the U.S. Food and Drug Administration (FDA). According to relevant FDA regulations, after review, the new drug application for HSK3486 meets the requirements for drug registration and has been accepted for review. HSK3486 is a newly developed type 1 intravenous anesthetic drug with independent intellectual property rights. It was approved for marketing domestically in December 2020 and has obtained drug registration certificates for indications such as "sedation and anesthesia during non-tracheal intubation surgery/procedure," "induction and maintenance of general anesthesia," and "sedation during intensive care." HSK3486 received FDA IND application approval in January 2021, exempting it from phase II trials in the U.S. and allowing it to directly enter phase III clinical trials. Clinical research results both domestically and internationally show that HSK3486 has a fast onset, quick recovery, high success rate in anesthesia, more stable blood pressure control, and significantly reduced incidence of adverse reactions such as hypotension, respiratory depression, and injection pain. Both patients and doctors are more satisfied with it. The company completed all clinical studies in 2024, engaged in Pre-NDA communication with the FDA, reached an agreement on the application content, obtained FDA approval for NDA submission, and recently received acceptance of the marketing approval application.