In a major milestone for China’s pharmaceutical industry, Cipepofol (marketed as CYPSEDO), an innovative intravenous anaesthetic developed by Haisco Pharmaceutical Group, has received marketing approval from the US Food and Drug Administration (FDA).
With this approval, Cipepofol becomes the first China-originated innovative intravenous anaesthetic to enter the global market.
A Class 1 innovative drug independently developed by Haisco, Cipepofol is designed to address long-standing challenges associated with intravenous anaesthesia, including injection pain and respiratory depression.
Clinical studies conducted in China and overseas have shown that Cipepofol can significantly reduce the incidence of intraoperative respiratory depression, cardiovascular adverse reactions and injection pain, while retaining the advantages of rapid onset and complete recovery.
Cipepofol was first approved by China’s National Medical Products Administration (NMPA) in December 2020 for sedation and anaesthesia during non-tracheal intubation procedures. Since then, its approved indications have expanded to include induction and maintenance of general anaesthesia, fibreoptic bronchoscopy, and sedation during mechanical ventilation in intensive care units. In September 2025, Chinese regulators further expanded its approval to include induction and maintenance of general anaesthesia in children and adolescents.
After receiving FDA clearance to begin clinical trials in 2021, Cipepofol was granted a waiver for Phase II trials in the United States and advanced directly into pivotal Phase III studies. The clinical programme was completed in 2024, with the drug reportedly delivering superior outcomes in head-to-head comparisons with the current standard of care.
In July 2025, Haisco’s New Drug Application (NDA) for Cipepofol was formally accepted by the US FDA, supported by strong clinical evidence and the drug’s innovative strength.
Following the FDA approval, Haisco said it is actively advancing the commercialization of Cipepofol in the United States and other international markets through strategic collaborations. The company is also considering filing for marketing authorization in Europe in the future.
