A Historic Breakthrough for Chinese Medicine
On June 1, 2026, Haisco Pharmaceutical Group announced a landmark achievement: the company’s independently developed Class 1 innovative intravenous anesthetic drug, Cipepofol Injection (trade name: 思舒宁® in Chinese, CYPSEDO in English), received marketing approval from the U.S. Food and Drug Administration (FDA) for use in adult general anesthesia induction. This marks the first time a Chinese original intravenous anesthetic drug has successfully entered the international market, representing a significant milestone in China’s pharmaceutical innovation journey.
Chinese hospitals have adopted Cipepofol across more than 3,300 medical institutions, benefiting over 40 million patients. (Photo: Marcus Lenk / Pexels)
The approval came through Haisco’s U.S. subsidiary, Haisco-USA Pharmaceuticals Inc., after a rigorous review process that demonstrated the drug’s safety and efficacy profile. Cipepofol’s journey from a concept in a Chinese laboratory to FDA approval embodies the growing capabilities of China’s pharmaceutical industry in developing world-class innovative medicines.
14 Years of Innovation: The Journey of Cipepofol
The story of Cipepofol began in 2012, when Haisco’s research team embarked on an ambitious project following the company’s “Innovation” and “Internationalization” strategy. The goal was clear: develop a next-generation intravenous anesthetic that would improve upon existing options while meeting the highest international standards.
Chinese pharmaceutical research has made significant strides in developing innovative drugs that meet international standards. (Photo: Artem Podrez / Pexels)
The development process involved meticulous molecular structure optimization. The research team introduced a chiral cyclopropyl group into the molecular design, a modification that required over a thousand rounds of screening and safety validation. This precision engineering approach ultimately yielded a compound with superior pharmacological properties—maintaining the rapid onset and complete recovery characteristics essential for anesthesia while significantly reducing adverse effects.
Key Development Milestones
| Year | Milestone |
|---|---|
| 2012 | Research and development initiated |
| 2020 | Received marketing approval from China’s National Medical Products Administration (NMPA) |
| 2021 | FDA approved clinical trials in the United States |
| 2024 | Completed all clinical studies with superior results |
| 2025 | New Drug Application (NDA) accepted by FDA |
| 2026 | FDA marketing approval granted |
Clinical Advantages: Why Cipepofol Matters
Clinical studies conducted both in China and internationally have demonstrated Cipepofol’s significant advantages over existing intravenous anesthetics. The drug preserves the desirable characteristics of rapid onset and complete awakening while offering several important improvements:
Reduced Respiratory Depression
One of the most critical advantages of Cipepofol is its lower risk of respiratory depression during surgery. This complication, which can be life-threatening, occurs less frequently with Cipepofol compared to traditional anesthetics, making procedures safer for patients.
Stable Hemodynamic Profile
The drug causes more stable blood pressure and heart rate fluctuations during anesthesia induction and maintenance. This stability is particularly important for patients with cardiovascular conditions and elderly patients who may be more vulnerable to hemodynamic instability.
Minimal Injection Pain
Unlike some intravenous anesthetics that cause significant pain upon injection, Cipepofol produces minimal injection discomfort, improving patient experience during anesthesia induction.
Specialized Patient Care
The drug’s favorable safety profile makes it particularly suitable for vulnerable populations, including elderly patients and children. In September 2025, approval was granted for use in children and adolescents for general anesthesia induction and maintenance, expanding its clinical applications significantly.
Domestic Impact: Serving 40 Million Patients
Since its approval in China in December 2020, Cipepofol has rapidly become an important tool in the anesthesiologist’s armamentarium. The drug has been adopted by over 3,300 medical institutions across China and has benefited more than 40 million patients. This widespread adoption reflects the medical community’s recognition of its clinical value.
Chinese medical institutions have embraced Cipepofol for its superior safety profile and clinical efficacy. (Photo: RDNE Stock project / Pexels)
The drug has been included in more than 20 clinical guidelines and consensus statements, including:
- Chinese Society of Anesthesiology’s “Clinical Practice Guidelines for Total Intravenous Anesthesia (2024 Edition)”
- Chinese Medical Doctor Association Anesthesiology Branch’s “Clinical Practice Guidelines for Intravenous Anesthetics (2025 Edition)”
Cipepofol has also been included in China’s National Medical Insurance Catalog, making it more accessible and affordable for patients. The drug’s multiple approved indications include:
- General anesthesia induction
- Fiberoptic bronchoscopy sedation
- Intensive care unit sedation
- Pediatric and adolescent general anesthesia induction and maintenance
Going Global: FDA Approval Process
The path to FDA approval demonstrated both the quality of Cipepofol and the efficiency of the regulatory process. In 2021, the FDA granted permission to conduct clinical trials in the United States. Notably, based on the comprehensive data from Chinese clinical studies and the drug’s established safety profile, the FDA waived Phase I and Phase II trials, allowing Cipepofol to proceed directly to a pivotal Phase III clinical trial.
Chinese pharmaceutical companies are increasingly capable of conducting world-class drug discovery research and navigating complex international regulatory pathways. (Photo: www.kaboompics.com / Pexels)
The Phase III trial was completed in 2024, with Cipepofol demonstrating superior results in head-to-head comparison with standard treatment. These results provided strong evidence for the drug’s efficacy and safety in the U.S. patient population. In July 2025, the FDA formally accepted the New Drug Application (NDA), and after thorough review, granted marketing approval on June 1, 2026.
This streamlined approval pathway reflects the FDA’s recognition of the quality and reliability of the clinical data generated during the Chinese development program, as well as the drug’s innovative nature and potential to address unmet medical needs.
Significance for China’s Pharmaceutical Industry
Cipepofol’s FDA approval represents more than just a commercial milestone—it symbolizes the maturation of China’s pharmaceutical innovation ecosystem. For decades, China’s pharmaceutical industry was primarily known for manufacturing generic drugs. The development and international approval of Cipepofol demonstrates that Chinese companies can successfully:
- Conduct world-class drug discovery research
- Navigate complex international regulatory pathways
- Generate clinical data that meets the highest global standards
- Compete in the innovative pharmaceutical market
Haisco’s success with Cipepofol provides a blueprint for other Chinese pharmaceutical companies pursuing international markets. It demonstrates that with sustained investment in research and development, rigorous clinical trial conduct, and strategic regulatory planning, Chinese innovative drugs can achieve global recognition and acceptance.
Comparison: Cipepofol vs. Propofol
| Feature | Propofol | Cipepofol |
|---|---|---|
| Origin | Developed in 1970s (UK) | Developed in 2010s (China) |
| Respiratory depression risk | Standard | Lower |
| Injection pain | Common | Minimal |
| Hemodynamic stability | Standard | More stable |
| Pediatric approval | Limited | Approved (2025) |
| Markets | Global | China, USA (FDA approved) |
Future Outlook: Bringing Chinese Innovation to the World
With FDA approval secured, Haisco is now positioned to commercialize Cipepofol in the United States and other international markets. The company has stated its commitment to leveraging this approval as a foundation for expanding global access to Chinese original innovative medicines.
The success of Cipepofol opens doors for broader recognition of Chinese pharmaceutical innovation. As more Chinese-developed drugs demonstrate safety and efficacy in international markets, regulatory agencies worldwide may increasingly recognize and accept Chinese clinical trial data, potentially accelerating the global introduction of future Chinese innovative medicines.
For patients worldwide, Cipepofol’s approval means access to a new option for safer, more comfortable anesthesia experiences. For China’s pharmaceutical industry, it represents a validation of years of investment in innovation and a promise of more breakthroughs to come.
Implications for International Patients
For international patients considering treatment in China, Cipepofol’s approval highlights the quality of pharmaceutical innovation available in Chinese hospitals. The drug is already used in over 3,300 Chinese medical institutions, offering patients access to cutting-edge anesthesia technology.
Key Considerations for Patients
- Availability: Cipepofol is widely available in major Chinese hospitals
- Safety profile: Lower risk of respiratory depression and injection pain
- Cost: Included in China’s National Medical Insurance Catalog, making it cost-effective
- Pediatric use: Approved for children and adolescents since September 2025
Sources
- Xinhua News: Haisco Class 1 Innovative Intravenous Anesthetic Cipepofol Receives FDA Approval
- Haisco Pharmaceutical Group Official Website
- U.S. Food and Drug Administration
- China National Medical Products Administration
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Patients should consult qualified healthcare professionals for personalized medical guidance. Cipepofol availability may vary by institution and regulatory status.