China's Original Innovative Drug Cipepofol Approved for Marketing by the U.S. FDA

PR Newswire

BEIJING, June 1, 2026

BEIJING, June 1, 2026 /PRNewswire/ -- 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.

About Haisco

Haisco is an international pharmaceutical enterprise integrating research and development, manufacturing, and sales (Stock Code: 002653.SZ). Focusing on therapeutic areas such as anesthesia and analgesia, chronic metabolic diseases, respiratory and autoimmune diseases, neurological systems, and oncology, the company adheres to an innovation and globalization strategy. With the vision of "striving to become the most trusted international pharmaceutical enterprise", it aims to meet unmet clinical needs and care for patients worldwide. Currently, Haisco Pharmaceutical Group has established a series of diversified R&D pipelines with independent intellectual property rights, covering small-molecule innovative drugs, biologics, and high-end generics. Multiple projects are in the clinical development stage, and several innovative drugs have been commercialized, providing diversified innovative product solutions globally.

Appendix: Background Information on CYPSEDO (cipepofol)

I. Published SCI Papers Related to CYPSEDO (cipepofol) with Impact Factor >6

  1. 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).
  2. 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).
  3. 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).
  4. 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).
  5. 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).
  6. 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).
  7. 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).
  8. 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).
  9. 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).
  10. 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 Where CYPSEDO (cipepofol) Was Presented

  1. ISAP 31st Annual Meeting - 2022 - Poster
  2. WCA - 2024- Lecture & LBA ePoster & ePoster
  3. ESA Annual Meeting - 2024 - ePoster
  4. JSA Annual Meeting - 2024 - Poster
  5. ASA Annual Meeting - 2025 - Oral & ePoster
  6. ESICM LIVES - 2024 - Poster
  7. ESA Annual Meeting - 2025 - Lecture & ePoster
  8. SCCM Critical Care Congress - 2025 - Poster
  9. ESICM LIVES - 2025 - Oral & Poster
  10. AACA Annual Meeting - 2025 -  Lecture
  11. ESA Annual Meeting - 2026 - ePoster

III. Clinical Guidelines and Consensus Statements Incorporating CYPSEDO (cipepofol)

  1. Expert Consensus on Sedation/Anesthesia for Bronchoscopy (2020 Edition), 2020, Chinese Society of Anesthesiology
  2. Chinese Expert Consensus on Sedation/Anesthesia for Digestive Endoscopy (2020 Edition), 2020, Anesthesia Collaborative Group of the Chinese Society of Digestive Endoscopy
  3. Guidelines for Anesthesia in Ambulatory Surgery (2023 Edition), 2023, Chinese Society of Anesthesiology
  4. Expert Consensus on Out-of-Operating Room Anesthesia/Sedation in Elderly Patients (2023 Edition), 2023, Journal of Clinical Anesthesiology
  5. Guidance on Sedation and Anesthesia Protocols for Diagnostic and Therapeutic Procedures (2023 Edition), 2023, Chinese Society of Anesthesiology
  6. Expert Consensus on Analgesia and Sedation in Patients with Severe Neurological Diseases (2023 Edition), 2023, Expert Group on Analgesia and Sedation for Severe Neurological Diseases
  7. Diagnostic and Therapeutic Process for Analgesia and Sedation in Adult Critically Ill Patients, 2023, Chinese Journal of Critical Care Medicine (Electronic Edition)
  8. Expert Consensus on Data Elements and Definitions for Analgesia and Sedation in Adult Critically Ill Patients (2023 Edition), 2023, Expert Group on Data Elements and Definitions for Analgesia and Sedation in Adult Critically Ill Patients
  9. Expert Consensus on Post-Intensive Care Management (2023 Edition), 2023, Chinese Society of Critical Care Medicine
  10. Standards for Diagnosis and Treatment of Non-Neonatal Tetanus (2024 Edition), 2024, General Office of the National Health Commission
  11. Chinese Clinical Practice Guidelines for Total Intravenous Anesthesia (2024 Edition), 2024, Chinese Society of Anesthesiology
  12. Chinese clinical practice guidelines for total intravenous anaesthesia:a systematic review and expert consensus-based recommendations，2025，e Chinese Society of Anaesthesiology of the Chinese Medical Association.
  13. Expert Consensus on Medication 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
  14. Expert Recommendations for Out-of-Operating Room Anesthesia/Sedation in Patients with Obesity, 2025, Task Force on "Expert Recommendations for Out-of-Operating Room Anesthesia/Sedation in Patients with Obesity"
  15. Expert Consensus on Anesthesia Management for ERCP (2025), 2025, Chinese Society of Digestive Endoscopy, Anesthesiology Branch of Chinese Geriatrics Society
  16. Expert Consensus on the Use of Intravenous Anesthetics for Refractory Insomnia Disorder, 2025, Psychiatric Health Branch of Sichuan Preventive Medicine Association, Sleep Medicine Committee of Sichuan Geriatrics Society
  17. Emergency Expert Consensus on Diagnosis and Treatment of Sepsis-Associated Encephalopathy in the Elderly, 2025, Emergency Medicine Branch of Chinese Medical Association, Emergency Branch of Chinese Geriatrics Society, Emergency Medicine Branch of Beijing Medical Association
  18. Expert Consensus on Analgesia, Sedation, and Delirium Management in Adult Patients Receiving Extracorporeal Membrane Oxygenation (2025 Edition), 2025, Extracorporeal Life Support Committee of Chinese Medical Doctor Association, Chinese Society of Anesthesiology
  19. Expert Consensus on the Application of Drug-Induced Sleep Endoscopy in the Diagnosis and Treatment of Obstructive Sleep Apnea (2025 Edition), 2025, Sleep Breathing Disorders Working Committee of the Respiratory Physician Branch of Chinese Medical Doctor Association
  20. Clinical Practice Guideline for the Use of Intravenous Anesthetics (2025 Edition), 2025, Anesthesiologist Branch of Chinese Medical Doctor Association
  21. Chinese Guidelines for Sedation and Anesthesia Management During Digestive Endoscopy (2026 Edition), 2026, Chinese Society of Digestive Endoscopy / Chinese Society of Anesthesiology

 

Cision View original content:https://www.prnewswire.com/news-releases/chinas-original-innovative-drug-cipepofol-approved-for-marketing-by-the-us-fda-302786857.html

SOURCE Haisco