Haisco Pharmaceutical Group Co. Ltd (002653.SZ), a Chinese pharmaceutical company, on Monday announced approval from the U.S. Food and Drug Administration (FDA) for Cipepofol, an intravenous anesthetic.
Cipepofol is a Class 1 intravenous anesthetic previously approved in 2020 by the Chinese National Medical Products Administration (NMPA) for sedation and anesthetic in non-tracheal intubation surgeries or procedures.
Under development since 2021, clinical studies suggest that Cipepofol reduced respiratory depression and injection pain and stabilized hemodynamic parameters for patients undergoing anesthesia for surgery and/or invasive procedures.
In 2021, a pivotal Phase 3 clinical trial was initiated in the U.S. The study determined that Cipepofol showed improvement over standard-of-care anesthetics upon its conclusion in 2024, and a new drug application (NDA) was submitted to the FDA.
The company has stated intentions to apply for marketing authorization in Europe as well.
002653.SZ closed Monday on the Shenzhen Stock Exchange at CNY 50.13, down 2.79%.
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