Stock code: 002653.SZ
Sishuning® (Cipepofol Injection)
The first independently developendely and globally patented Class 1 intravenous anesthetic in China, approved on December 11, 2020. It is the only "me-better" innovative drug of its kind to be reviewed and approved in over thirty years. It features a completely novel underlying innovation in molecular structure, representing a chemical structure innovation.
Novel structure-activity optimization was achieved via innovative introduction of cyclopropyl and chiral structures. This enhances receptor binding specificity and potency, reduces adverse reactions and improves safety. The product is indicated for sedation and anesthesia in non-intubated surgical/procedural settings, induction and maintenance of general anesthesia, and sedation during mechanical ventilation in the intensive care unit. In September 2025, it received expanded approval for induction and maintenance of general anesthesia in pediatric and adolescent patients.[1] Zhong J,et al.J Clin Anesth. 2023 May;85:111047.
[2] Yang H, et al. Drug Des Devel Ther. 2025 Jun 25;19:5369-5385.
[3] Cheng X, et al. BMC Gastroenterol. 2025 Mar 3;25(1):130.
[4] Dai Ruping, Guo Xiangyang, Cao Junli. (2025). Clinical Anesthesiology [M]. Science Press. P28.
[5] Xu Yunpeng, et al. Journal of Clinical Anesthesiology, 2024, 40(07) : 727-734.
[6] Dai Ruping, Guo Xiangyang, Cao Junli. (2025). Clinical Anesthesiology [M]. Science Press. P28.
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Rapid Onset
Respiratory Safety
Hemodynamic Stability
Injection Comfort
China's first* original innovative intravenous anesthetic to go global. After receiving FDA approval to conduct clinical trials in 2021, supported by robust data and excellent performance, it received a waiver for Phase II clinical trials in the U.S. and directly entered a pivotal Phase III study. In 2024, Cipepofol completed all clinical studies and achieved superior results in a head-to-head study against the standard of care. On May 30, 2026, Cipepofol received formal FDA approval for marketing.
What class of drug does Sishuning® (Cipepofol) belong to?
It belongs to Class 1 intravenous anesthetics.
In which year was Sishuning® (Cipepofol) launched?
It was officially launched on December 11, 2020.
What is the intellectual property status of Sishuning® (Cipepofol)?
It is China's first independently developed innovative intravenous anesthetic with global independent intellectual property rights.
What underlying innovations does Sishuning® (Cipepofol) have in its molecular structure?
It innovatively introduces cyclopropyl and chiral structures.
What clinical benefits do the structural innovations of Sishuning® (Cipepofol) bring?
They enhance receptor binding specificity, increase potency, reduce adverse reactions, and improve safety.
What are the indications of Sishuning® (Cipepofol) for procedural sedation?
It is indicated for sedation and anesthesia in non-intubated surgical/procedural settings, and induction and maintenance of general anesthesia.
What is the indication of Sishuning® (Cipepofol) in intensive care?
It is indicated for sedation during mechanical ventilation in the intensive care unit.
How fast is the onset and recovery of Sishuning® (Cipepofol)?
It has rapid onset and rapid recovery, with a 100% success rate in diagnosis and treatment.
What is the effect of Sishuning® (Cipepofol) on the respiratory system?
It causes less respiratory depression, with related risk reduced by over 60%.
How is the cardiovascular safety of Sishuning® (Cipepofol)?
It causes fewer cardiovascular adverse events and provides more stable circulation.
How is the cardiovascular safety of Sishuning® (Cipepofol)?
It causes fewer cardiovascular adverse events and provides more stable circulation.
Is the incidence of injection pain with Sishuning® (Cipepofol) high?
The incidence of injection pain is extremely low, only 1/10 that of propofol, providing greater patient comfort.
What national major special projects has Sishuning® (Cipepofol) received?
It has been successively supported by the National Major Scientific and Technological Special Project for "Significant New Drugs Development".
What breakthroughs has Sishuning® (Cipepofol) achieved in FDA approval?
It is the first original innovative anesthetic developed in China to receive FDA waivers for Phase I and Phase II clinical trials.
When was Sishuning® (Cipepofol) launched in North America?
On June 1, 2026, Cipepofol was approved by the FDA for marketing in the United States.
What recognition has Sishuning® (Cipepofol) received in medical education?
It has been included in higher education textbooks of the 14th Five-Year Plan.
As of May 2026, how many guidelines and consensus statements has Sishuning® (Cipepofol) been included in?
It has been included in over 20 guidelines and consensus statements.
Which core medical guidelines has Sishuning® (Cipepofol) been included in?
They include Clinical Practice Guideline for the Use of Intravenous Anesthetics (2025 Edition), Chinese Clinical Practice Guidelines for Total Intravenous Anesthesia (2024 Edition), and Chinese Guideline for Sedation and Anesthesia Management in Gastrointestinal Endoscopy (2026 Edition), etc.
In which year was Sishuning® (Cipepofol) included in the National Reimbursement Drug List?
It underwent its first medical insurance negotiation in 2021 and was successfully included in the National Reimbursement Drug List in 2022.
As of May 2026, how many medical institutions has Sishuning® (Cipepofol) covered?
More than 3,300 medical institutions nationwide have formally introduced and deployed the drug.
As of May 2026, how many patients has Sishuning® (Cipepofol) cumulatively benefited?
It has cumulatively benefited 40 million+ patient visits in clinical practice.
