China's Cipepofol Becomes First Chinese-Developed Anesthetic to Receive FDA Approval
核心洞察
Cipepofol (CYPSEDO (搜索)), developed by Haisco Pharmaceutical Group (搜索), has become the first China-originated innovative intravenous anesthetic to receive U.S. FDA marketing approval.
Clinical studies demonstrate that Cipepofol significantly reduces injection pain (搜索), respiratory depression (搜索), and cardiovascular adverse reactions compared to standard anesthetics while maintaining rapid onset and complete recovery.
The drug has already benefited over 40 million patient visits across 3,300 medical institutions in China and is incorporated into more than 20 clinical guidelines.
Cipepofol (CYPSEDO (搜索)) Injection, a Class 1 innovative intravenous anesthetic independently developed by Haisco Pharmaceutical Group (搜索), has officially received marketing approval from the U.S. Food and Drug Administration (搜索), marking a historic milestone as the first China-originated innovative intravenous anesthetic to enter the global market. This achievement represents a significant breakthrough for Chinese pharmaceutical innovation in addressing longstanding clinical challenges in anesthesia.
Addressing Persistent Clinical Challenges
Intravenous anesthetics serve as the cornerstone of clinical surgeries and intensive care, yet for decades, persistent challenges such as injection pain (搜索) and respiratory depression (搜索) have remained obstacles that the global pharmaceutical research community has strived to overcome. Cipepofol was specifically designed to address these unmet medical needs through innovative molecular engineering.
The development of Cipepofol began in 2012, with Haisco's R&D team tackling 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.
Superior Clinical Performance
Results from clinical studies conducted both domestically and internationally showed that Cipepofol significantly reduced the incidence of intraoperative respiratory depression (搜索) and cardiovascular adverse reactions, as well as injection pain (搜索), while retaining the advantages of rapid onset and complete recovery. The drug demonstrates lower risk of respiratory depression, more stable hemodynamics, milder injection pain, and provides individualized care for elderly and pediatric patients.
These improvements substantially enhance 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. The drug directly addresses patients' desire for pain-free anesthesia induction and reduces their fear of surgery.
Regulatory Journey and Clinical Adoption
Cipepofol received initial marketing approval from China's National Medical Products Administration (搜索) (NMPA) in December 2020. The drug's indications have since expanded to include sedation and anesthesia in non-tracheal intubation surgeries/procedures, induction and maintenance of general anesthesia, and sedation during mechanical ventilation in intensive care units. In September 2025, approval was further expanded to include induction and maintenance of general anesthesia in children and adolescents.
The internationalization journey exemplifies 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 head-to-head comparisons against the standard of care. The New Drug Application was formally accepted by the U.S. FDA in July 2025.
Widespread Clinical Integration
As of May 2026, Cipepofol has been incorporated into the recommendations of over 20 guidelines and consensus documents and included in textbooks for higher education under China's 14th Five-Year Plan. The drug has been added to the National Reimbursement Drug List and adopted by over 3,300 medical institutions, cumulatively benefiting more than 40 million patient visits.
Global Expansion Strategy
Seizing the opportunity presented by FDA approval, Haisco is actively advancing commercialization in the United States and other regions through collaborations. The company plans to consider initiating a marketing authorization application in Europe at an appropriate time, delivering high-quality solutions originating from Chinese innovative drugs to benefit more global patients.
The successful FDA marketing approval stands as a powerful testament to the overseas capabilities of Chinese pharmaceutical enterprises and marks a significant milestone in the global expansion of Chinese pharmaceutical innovation.