Haisco-USA：CYPSEDO Cipepofol Injection approved for marketing by the U.S. FDA.
On June 1, Haisco Pharmaceutical Group announced that its wholly-owned subsidiary, Haisco-USA Pharmaceuticals Inc., recently received a marketing approval notification from the U.S. Food and Drug Administration (FDA). The New Drug Application (NDA) for Cipepofol Injection (Cipepofol Injection, CYPSEDO), a Class 1 innovative intravenous anesthetic independently developed by Haisco Pharmaceutical Group, has been approved in the United States for the induction of general anesthesia in adults. With this approval, Cipepofol has become an original innovative intravenous anesthetic drug of global reach.
Domestic and international clinical study results show that Cipepofol significantly reduces the incidence of intraoperative respiratory depression and cardiovascular adverse reactions, as well as decreases injection pain, while retaining the advantages of rapid onset and complete recovery. With a lower risk of respiratory depression, more stable hemodynamic fluctuations, milder injection pain, and individualized care for elderly and pediatric patients, Cipepofol not only makes “comfortable treatment” more compassionate—directly responding to patients’ expectations of being “pain-free” and reducing their fear of surgery during anesthesia induction—but also greatly enhances the comfort and safety of the diagnostic and treatment process from both physiological and psychological perspectives. At the same time, it significantly improves the accuracy and success rate of physicians’ diagnoses and treatments.
In 2021, Cipepofol received FDA approval to initiate clinical trials in the United States, where it was exempted from Phase I and Phase II clinical trials and proceeded directly into the pivotal Phase III clinical trial. All clinical studies were completed in 2024, and Cipepofol achieved superior results in head-to-head comparisons with standard of care. In July 2025, based on its exceptional innovation capabilities and robust clinical evidence, the New Drug Application (NDA) for Cipepofol was formally accepted for review by the U.S. FDA.
The successful approval of Cipepofol by the U.S. FDA is a strong testament to the global market entry capabilities of Chinese pharmaceutical companies. Haisco stated that it will take the FDA approval of Cipepofol as an opportunity to actively promote its commercialization in the United States and other regions, providing high-quality solutions with China-originated innovative drugs to the world and benefiting more patients globally.
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