Cipepofol (CYPSEDO) Injection (hereinafter "Cipepofol"), a Class 1 innovative intravenous anesthetic independently developed by Haisco Pharmaceutical Group, has officially received marketing approval from the U.S. Food and Drug Administration (FDA), becoming the first China-originated innovative intravenous anesthetic to enter the global market. This milestone marks the moment a China-originated innovative drug, backed by outstanding breakthroughs and robust clinical evidence, has officially opened the door to the global high-standard pharmaceutical market and secured its entry ticket.

Intravenous anesthetics are the cornerstone of clinical surgeries and intensive care. For decades, clinical challenges associated with intravenous anesthesia—such as injection pain and respiratory depression—have remained persistent obstacles that the global pharmaceutical research community has strived to overcome.

Cipepofol (Chinese trade name: Sishuning) is China's first independently developed Class 1 innovative intravenous anesthetic with global independent intellectual property rights. It has been approved in China for sedation and anesthesia in non-tracheal intubation surgeries/procedures, induction and maintenance of general anesthesia, and sedation during mechanical ventilation in the intensive care unit. In September 2025, its approval was further expanded to include the induction and maintenance of general anesthesia in children and adolescents.

The development of Cipepofol dates back to 2012. Haisco's R&D team tackled numerous challenges to refine the molecular structure. By introducing a chiral cyclopropyl group and conducting thousands of screenings and safety evaluations, they successfully developed a Class 1 new drug that demonstrated favorable efficacy and safety profiles.

Results from clinical studies conducted both domestically and internationally showed that, while retaining the advantages of rapid onset and complete recovery, Cipepofol significantly reduced the incidence of intraoperative respiratory depression and cardiovascular adverse reactions, as well as injection pain. With a lower risk of respiratory depression, more stable hemodynamics, milder injection pain, and individualized care for elderly and pediatric patients, Cipepofol not only makes "comfortable treatment" more compassionate—directly addressing patients' desire for a pain-free anesthesia induction and reducing their fear of surgery—but also substantially enhances the comfort and safety of the diagnosis and treatment process on both physiological and psychological levels, while greatly improving the accuracy and success rate of physicians' diagnoses and treatments.

In December 2020, Cipepofol was officially approved for marketing by the National Medical Products Administration (NMPA), ushering in a new chapter in clinical comfortable anesthesia. Subsequently, multiple indications were approved in succession, including induction of general anesthesia, fiberoptic bronchoscopy, and sedation during intensive care. In September 2025, the dosage and administration for the induction and maintenance of general anesthesia in children and adolescents were approved, further broadening its clinical application scenarios.

As of May 2026, Cipepofol has been incorporated into the recommendations of over 20 guidelines and consensus documents, as well as into textbooks for higher education under China's 14th Five-Year Plan, and has been included in the National Reimbursement Drug List (NRDL). To date, it has been adopted by over 3,300 medical institutions, cumulatively benefiting more than 40 million patient visits.

The internationalization journey of Cipepofol epitomizes the shift from "Made in China" to "Innovated in China". After receiving FDA clearance to conduct clinical trials in 2021, Cipepofol was granted a waiver for Phase II trials in the United States and advanced directly to pivotal Phase III trials. All clinical studies were completed in 2024, yielding superior results in a head-to-head comparison against the standard of care. In July 2025, driven by its exceptional innovative strength and solid clinical evidence, the New Drug Application (NDA) for Cipepofol was formally accepted by the U.S. FDA.

The successful U.S. FDA marketing approval of Cipepofol (CYPSEDO) stands as a powerful testament to the overseas capabilities of Chinese pharmaceutical enterprises. Seizing the opportunity presented by the FDA approval of Cipepofol (CYPSEDO), Haisco is actively advancing its commercialization in the United States and other regions through collaborations. The company will also consider initiating a marketing authorization application in Europe at an appropriate time, delivering high-quality solutions originating from Chinese innovative drugs to the world and benefiting more global patients.