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SISHUNING® (Cinophorol Injection)

Cipepofol Injection

SISHUNING® (Cinophorol Injection)

Drug Introduction

The first independently developed 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.

References

[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 Ru Ping, Guo Xiang Yang, Cao Jun Li. (2025). Clinical Anesthesiology[M]. Science Press. P28.

[5] Xu Yunpeng, et al. Journal of Clinical Anesthesiology, 2024, 40(07): 727-734.

[6] Dai Ru Ping, Guo Xiang Yang, Cao Jun Li. (2025). Clinical Anesthesiology [M]. Science Press. P28.

Download prescribing information

SISHUNING® (Cinophorol Injection)

Rapid onset

Rapid onset and rapid recovery, with 100% success rate in diagnosis and treatment[1]

Respiratory safety

Significantly less respiratory depression, with risk reduced by over 60%[2-3]

Stable circulation

Fewer cardiovascular adverse events, providing more stable circulation[4]

Comfortable injection

Greater comfort, with injection pain incidence only 1/10 that of Propofol[5]

U.S. FDA Waiver for Expedited Review

Cipepofol is also 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, Ciprofol received formal FDA approval for marketing.

In China, CYPSEDO (cipepofol) has been successively supported by the National Major Scientific and Technological Special Project for "Significant New Drugs Development". It is included in higher education textbooks of the 14th Five-Year Plan[6] and over 20 clinical guidelines and consensus statements, such as Clinical Practice Guideline for the Use of Intravenous Anesthetics (2025) issued by the Chinese Association of Anesthesiologists and Chinese Clinical Practice Guidelines for Total Intravenous Anesthesia (2024) released by Chinese Society of Anesthesiology. It was listed in the National Medical Insurance Catalog in 2022. To date, the drug is now available in more than 3300 medical institutions, cumulatively benefiting over 40 million patients.

U.S. FDA Waiver for Expedited Review

U.S. FDA Waiver for Expedited Review

Frequently Asked Questions

Common Questions and Answers

SISHUNING® (Cinophorol Injection)Common Questions and Answers

Q

What class of drug is Sisuning® (cyproterone) belonging to?

A

Belongs to class 1 intravenous anesthetics.

Q

In which year was Sisuning® (cyproterol) launched?

A

It was officially launched on December 11, 2020.

Q

What is the intellectual property status of Sisuning® (cyproterone)?

A

It is the first venous anesthesia innovative drug in China developed independently and possessing global independent intellectual property rights.

Q

What are the underlying innovations in the molecular structure of Sisuning® (cyprodiphen)?

A

Innovative cyclopropyl and chiral structures were introduced.

Q

What clinical benefits does the structural innovation of Sisuning® (cyprodiphen) bring?

A

Enhanced the receptor binding specificity, increased efficacy, reduced adverse reactions, and improved safety.

Q

What are the indications for Sisunin® (ciclopirimol) in surgical sedation?

A

Indicated for sedation and anesthesia, general anesthesia induction and maintenance in non-tracheal intubation procedures/operations.

Q

What are the indications of Sisuning® (cicloram) in critical care?

A

Indicated for sedation during mechanical ventilation in intensive care.

Q

How quickly is Sisuning® (cyproterol) effective and how quickly does it help you wake up?

A

It takes effect quickly, wakes up promptly, and has a 100% success rate for treatment.

Q

How does Sisuning® (ciclopirox) affect the patient's respiratory system?

A

There is less respiratory depression, and the associated risk can be reduced by more than 60%.

Q

What is the safety profile of Sisuning® (cyproterol) for cardiovascular health?

A

Fewer adverse cardiovascular events, more stable circulation.

Q

What is the safety profile of Sisuning® (cyproterol) for cardiovascular health?

A

Fewer cardiovascular adverse events occur, and the circulation is more stable.

Q

Is the probability of injection pain with Sisuning® (ciclopirox) high?

A

The incidence of injection pain is extremely low, only 1/10 of propofol, making the patients more comfortable.

Q

What national-level major projects has Sishuning® (ciclopirimol) received?

A

Received continuous support from the "Major New Drug Development" major scientific and technological project.

Q

What breakthroughs have there been in the FDA approval of Sisunin® (cyproterone)?

A

It is the first indigenous research anesthetic innovation drug in phase I and II clinical trials that has been exempted by the FDA.

Q

When is Sisunin® (ciclopirox) launched in North America?

A

On June 1, 2026,Cipepofol was approved by the FDA for market entry in the United States.

Q

What recognition has SiShuNing® (Cinophorol) received in the medical education field?

A

It has been included in the 14-21 educational planning textbooks.

Q

As of May 2026, how many guidelines have adopted Sishuning® (cibopanol)?

A

It has been included in the consensus of over 20 guidelines.

Q

Which key medical guidelines have included Sisunin® (ciclopirimol)?

A

Including the "Clinical Practice Guidelines for Intravenous Anesthetic Use (2025 Edition)", the "Chinese Clinical Practice Guidelines for Intravenous Anesthesia (2024 Edition)", and the "Chinese Guidelines for Sedation and Anesthesia Management in Digestive Endoscopy (2026 Edition)".

Q

In which year was Sisuning® (cyproterol) included in the national medical insurance?

A

In 2021, the first medical insurance negotiation was carried out, and in 2022, it was successfully included in the national medical insurance list.

Q

As of May 2026, how many medical institutions does Sishuning® (cyproterol) cover?

A

More than 3,300 medical institutions across the country have officially adopted and utilized these systems.

Q

As of May 2026, how many patients have been benefited by Sishuning® (ciclopiroperazine)?

A

The clinical program has benefited over 40 million people.