BeijingJune 1, 2026 /PRNewswire/ — On May 30, Ciprofol Injection (hereinafter referred to as “Ciprofol”), a Class 1 innovative intravenous anesthetic independently developed by Haisco Pharmaceutical Group, officially received marketing approval from the U.S. Food and Drug Administration (FDA) for the induction of general anesthesia in adults. Ciprofol thus becomes China’s first original innovative intravenous anesthetic to go global.
For a long time, clinical pain points such as injection pain and respiratory depression caused by intravenous anesthesia have been challenges that the global pharmaceutical research field has been striving to overcome. Ciprofol is China’s first independently developed Class 1 intravenous anesthetic innovation with global independent intellectual property rights, addressing long-standing unmet clinical needs.
The research and development journey of Ciprofol dates back to 2012. Following the strategy of “innovation” and “internationalization,” the R&D team at Haisco Pharmaceutical Group refined the molecular structure by introducing a chiral cyclopropyl group. After over a thousand screenings and safety evaluations, they successfully developed a Class 1 new drug with favorable characteristics in terms of efficacy and safety.
On December 11, 2020, Ciprofol was officially approved for marketing by the National Medical Products Administration (NMPA) of China. Subsequently, multiple indications were approved, including induction of general anesthesia, fiberoptic bronchoscopy, and sedation during intensive care. In September 2025, the dosage and administration for induction and maintenance of general anesthesia in children and adolescents were approved, further expanding its clinical application scenarios.
Clinical study results from both domestic and international sources indicate that while retaining advantages such as rapid onset and complete recovery, Ciprofol significantly reduces the incidence of intraoperative respiratory depression and cardiovascular adverse reactions, as well as injection pain. With a lower risk of respiratory depression, more stable hemodynamic fluctuations, milder injection pain, and individualized care for elderly and pediatric patients, Ciprofol not only makes “comfortable treatment” more compassionate—directly addressing patients’ desire for “no pain” during anesthesia induction and reducing fear of surgery—but also greatly enhances the comfort and safety of the diagnosis and treatment process from both physiological and psychological perspectives, while significantly improving the accuracy and success rate of physicians’ procedures.
In China, Ciprofol has received continuous support from the “Major New Drug Development” National Science and Technology Major Project, has been included in the 14th Five-Year Plan higher education textbook, and is featured in over 20 guidelines and consensus documents, including the Chinese Society of Anesthesiologists’ “Clinical Practice Guidelines for the Use of Intravenous Anesthetics (2025 Edition)” and the Chinese Society of Anesthesiology’s “Chinese Clinical Practice Guidelines for Total Intravenous Anesthesia (2024 Edition).” It was included in the National Reimbursement Drug List in 2022, and as of May 2026, it has been used in over 3,300 medical institutions, benefiting more than 40 million patient visits.
Ciprofol received FDA approval to initiate clinical trials in 2021, bypassing Phase I and II in the U.S. to directly enter a pivotal Phase III study. All clinical research was completed in 2024, with superior results achieved in head-to-head comparisons against standard treatments. In July 2025, based on its outstanding innovation capabilities and solid clinical evidence, the New Drug Application (NDA) for Ciprofol was formally accepted by the U.S. FDA.
The successful FDA approval of Ciprofol is a strong testament to the global competitiveness of Chinese pharmaceutical companies. Leveraging the FDA approval of Ciprofol as an opportunity, Haisco is actively promoting its commercialization in the U.S. and other regions, providing high-quality solutions with China’s original innovative drugs to benefit more patients worldwide.
About Haisco
Attachment: Background Information on Ciprofol
I. Published SCI Papers with Impact Factor > 6
- Ni T, Zhou X, Wu S, et al. Hemodynamic Impact of Cipepofol vs Propofol During Anesthesia Induction in Patients With Severe Aortic Stenosis: A Randomized Clinical Trial. JAMA Surg. 2025;14.9(IF).
- Yu Y, Deng J, Yin Y, et al. Ciprofol vs propofol for gastrointestinal endoscopy sedation: a systematic review and meta-analysis. Int J Surg. 2025;10.1(IF).
- He ZZ, Liang JY, Duan JX, et al. Ciprofol versus propofol sedation in ICU patients and norepinephrine requirements: a single-center prospective cohort study. Crit Care. 2025;9.3(IF).
- Gan TJ, Bertoch T, Habib AS, et al. Comparison of the efficacy of HSK3486 and propofol for induction of general anesthesia in adults: a multicenter, randomized, double-blind, controlled, phase 3 noninferiority trial. Anesthesiology. 2024;9.1(IF).
- Liu YJ, Peng Z, Liu S, et al. Efficacy and safety of ciprofol sedation in ICU patients undergoing mechanical ventilation: A multicenter, single-blind, randomized, noninferiority trial. Crit Care Med. 2023;8.3(IF).
- Liu YJ, Zuo LY, Li XY, et al. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care. 2024;7.8(IF).
- Qin LL, Ren L, Wan SL, et al. Design, synthesis, and evaluation of novel 2,6-disubstituted phenol derivatives as general anesthetics. J Med Chem. 2017;7.3(IF).
- Liang P, Dai M, Wang X, et al. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023;6.8(IF).
- Ding YY, Long YQ, Yang HT, et al. Efficacy and safety of ciprofol for general anaesthesia induction in elderly patients undergoing major noncardiac surgery: A randomised controlled pilot trial. Eur J Anaesthesiol. 2022;6.8(IF).
- Liu YJ, Yu XY, Zhu DM, et al. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J. 2022;6.1(IF).
II. International Academic Conferences Attended
- WCA – 2024- Lecture & LBA ePoster & ePoster
III. Guidelines and Consensus Documents Included
- “Expert Consensus on Sedation/Anesthesia for Bronchoscopy (2020 Edition)”, 2020, Chinese Society of Anesthesiology
- “Chinese Expert Consensus on Sedation/Anesthesia for Digestive Endoscopy (2020 Edition)”, 2020, Anesthesia Collaboration Group of Chinese Society of Digestive Endoscopy
- “Guidelines for Ambulatory Surgery Anesthesia (2023 Edition)”, 2023, Chinese Society of Anesthesiology
- “Expert Consensus on Out-of-Operating Room Anesthesia/Sedation for Elderly Patients (2023 Edition)”, 2023, Journal of Clinical Anesthesiology
- “Guidance on Sedation and Anesthesia for Diagnostic and Therapeutic Procedures (2023 Edition)”, 2023, Chinese Society of Anesthesiology
- “Expert Consensus on Analgesia and Sedation for Neurocritical Care Patients (2023 Edition)”, 2023, Expert Group on Analgesia and Sedation for Neurocritical Care Patients
- “Diagnosis and Treatment Process for Analgesia and Sedation in Adult Critical Care Patients”, 2023, Chinese Journal of Critical Care Medicine (Electronic Edition)
- “Expert Consensus on Data Elements and Definitions for Analgesia and Sedation in Adult Critical Care Patients (2023 Edition)”, 2023, Expert Group on Data Elements and Definitions for Analgesia and Sedation in Adult Critical Care Patients
- “Expert Consensus on Post-Intensive Care Management (2023 Edition)”, 2023, Chinese Society of Critical Care Medicine
- “Diagnosis and Treatment Standards for Non-Neonatal Tetanus (2024 Edition)”, 2024, National Health Commission of the People’s Republic of China
- “Chinese Clinical Practice Guidelines for Total Intravenous Anesthesia (2024 Edition)”, 2024, Chinese Society of Anesthesiology
- “Chinese clinical practice guidelines for total intravenous anaesthesia: a systematic review and expert consensus-based recommendations”, 2025, Chinese Society of Anaesthesiology of the Chinese Medical Association
- “Expert Consensus on Drug Adjustment During ECMO Support (2025)”, 2025, Critical Care Medicine Committee of China International Exchange and Promotive Association for Medical and Health Care, Hospital Pharmacy Committee of Chinese Pharmaceutical Association
- “Expert Recommendations on Out-of-Operating Room Anesthesia/Sedation for Obese Patients”, 2025, Working Group on Expert Recommendations for Out-of-Operating Room Anesthesia/Sedation in Obese Patients
- “Expert Consensus on Anesthesia Management for ERCP (2025)”, 2025, Chinese Society of Digestive Endoscopy, Anesthesiology Branch of Chinese Geriatrics Society
- “Expert Consensus on the Use of Intravenous Anesthetics for Refractory Insomnia”, 2025, Mental Health Branch of Sichuan Preventive Medicine Association, Sleep Medicine Committee of Sichuan Geriatrics Society
- “Emergency Expert Consensus on Diagnosis and Treatment of Sepsis-Associated Encephalopathy in the Elderly”, 2025, Chinese Society of Emergency Medicine, Emergency Branch of Chinese Geriatrics Society, Emergency Medicine Branch of Beijing Medical Association
- “Expert Consensus on Analgesia, Sedation, and Delirium Management in Adult Extracorporeal Membrane Oxygenation Patients (2025 Edition)”, 2025, Extracorporeal Life Support Committee of Chinese Medical Doctor Association, Chinese Society of Anesthesiology
- “Expert Consensus on the Application of Drug-Induced Sleep Endoscopy in the Diagnosis and Treatment of Obstructive Sleep Apnea (2025 Edition)”, 2025, Sleep Respiratory Disease Working Group of Respiratory Physician Branch of Chinese Medical Doctor Association
- “Clinical Practice Guidelines for the Use of Intravenous Anesthetics (2025 Edition)”, 2025, Chinese Society of Anesthesiologists
- “Chinese Guidelines for Sedation and Anesthesia Management in Digestive Endoscopy (2026 Edition)”, 2026, Chinese Society of Digestive Endoscopy / Chinese Society of Anesthesiology