On June 1, Haisco Pharmaceutical Group issued a statement that its wholly-owned subsidiary, Haisco-USA Pharmaceuticals Inc., recently received approval from the U.S. Food and Drug Administration (FDA) for a new drug application. The Class 1 intravenous anesthesia innovation drug—Cipepofol Injection (common name in English: Cipepofol Injection, commercial name in Chinese: Sishuning®, commercial name in English: CYPSEDO)—developed by Haisco Pharmaceutical Group, is approved for use in adult general anesthesia induction. As a result, Cipepofol becomes the first original innovation drug for intravenous anesthesia from China to enter international markets.

For a long time, clinical challenges such as injection pain and respiratory depression caused by intravenous anesthesia have been difficult problems that the global pharmaceutical research field has tried to overcome. Cepacol is China's first independently developed class I intravenous anesthetic innovation drug with global independent intellectual property rights, meeting long-unmet clinical needs.

The development process of cyclopellin can be traced back to 2012. Haisco Pharmaceutical Group carried out detailed molecular structure improvements in line with the "innovation" and "internationalization" strategies proposed by Mr. Wang Junmin, the group's founder and chairman. By introducing chiral cyclopropyl groups and undergoing over a thousand screenings and safety assessments, they finally developed a class I new drug that exhibits good characteristics in both efficacy and safety.

On December 11, 2020,环泊酚 was officially approved for market release by the National Medical Products Administration (NMPA). Subsequently, multiple indications such as general anesthesia induction, fiberoptic bronchoscopy, and sedation during intensive care were approved one after another; in September 2025, usage guidelines for general anesthesia induction and maintenance in children/youngsters were approved, further expanding clinical applications.

Clinical research results both in China and abroad indicate that cyclopelline significantly reduces intraoperative respiratory depression and cardiovascular side effects, as well as injection pain, while maintaining the advantages of rapid onset and complete recovery. With lower risks of respiratory depression, more stable blood flow fluctuations, less injection pain, and personalized care for elderly and pediatric patients, cyclopelline enhances "comfortable treatment" by directly meeting patients' desire for "no pain" during anesthesia induction and reducing fear of surgery. It significantly improves the comfort and safety of the treatment process both physically and mentally, while also greatly enhancing the accuracy and success rate of medical procedures.

In China,环泊酚 has received continuous support from the "Major New Drug Development" major scientific and technological project. It has been included in the 14th Five-Year Higher Education Planning textbooks and incorporated into more than 20 guidelines. This includes the "Clinical Practice Guidelines for Intravenous Anesthetics (2025 Edition)" by the Anesthesiology Society of the Chinese Medical Doctor Association, and the "Clinical Practice Guidelines for Total Intravenous Anesthesia in China (2024 Edition)" by the Anesthesiology Branch of the Chinese Medical Association. In 2022, it was included in the national medical insurance catalog. As of May 2026, over 3,300 medical institutions have used it, benefiting more than 40 million people.

Cyclobenzaprine was approved by the FDA for clinical trials in 2021. It is exempt from Phase I and II trials in the US and directly enters Phase III trials. All clinical studies will be completed by 2024, and it shows a favorable outcome compared to standard treatments in head-to-head trials. In July 2025, based on its excellent innovative capabilities and solid clinical evidence, the new drug application (NDA) for Cyclobenzaprine has been officially accepted by the US FDA.

Cyclobenzaprine has been approved for market release by the US FDA, which is a strong testament to the strength of Chinese pharmaceutical companies in international markets. Taking the FDA approval of Cyclobenzaprine as an opportunity, Haiscoo is actively promoting its commercialization in the US and other regions, offering high-quality innovative Chinese drugs to global patients.