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Why is Cipepofol named 3486? How much more effective is it, and what clinical benefits does it offer? How did Haiscoo get its name? Where does the confidence in “China, for the world” come from... On June 22, Xinhua Net published a in-depth report titled “Domestic anesthetic drug ‘skips levels’ and receives FDA approval in the US; after fifteen years, Haiscoo enters the top tier of innovative drugs”, with a total of 2608 words. The original text is now reprinted for readers.

On May 30, 2026, CYPSEDO, a class 1 intravenous anesthesia innovative drug developed by Haisco Medicine Group, officially received approval for marketing from the U.S. Food and Drug Administration (FDA). This is the first independently developed intravenous anesthesia drug in China to receive FDA approval, and also the first FDA-approved product in the non-tumor field for Chinese innovative drugs.

For over thirty years, the global intravenous anesthesia market has been dominated by propofol. Now, a Chinese molecule has rewritten this history.

3,488 times of "trial and error" and the birth of a molecule

“Hengpofen has a code name in China—HSK3486.”

Recently, Dou Ying, the deputy general manager of R&D at Hisco Pharmaceutical Group, said at a media conference, "We tested and screened thousands of innovative compounds, and finally selected our 3486th compound. This is the later compound, cyclobiphenol.

In 2012, Haisco was listed on the Shenzhen Stock Exchange. That same year, in response to the national policy promoting innovative drugs, the company made a far-reaching strategic decision: shifting from generic drugs to research and development of innovative drugs.

Wu Nan, the deputy general manager of Hisicor Pharmaceutical Group, recalled: “At that time, we brought in a large number of scientific researchers from home and abroad, and officially entered the ‘high-cost’ new drug research and development model.”

Cyclopentolate is the first molecule approved after SeaScience's transformation. At that time, domestic pharmaceutical companies were focusing on the oncology field, and anesthetics were not seen as promising due to their low pricing and high clinical barriers. However, the research and development team decided to persevere—starting from the molecular structure of propofol, introducing chiral cyclopropyl groups, and going through tens of thousands of screenings.

Dou Ying said, “The structure of propofol is very simple, but the more simple a compound is, the more difficult it is to make innovations. Over the past 30 years, the industry has mainly made improvements at the formulation or prodrug level, but no breakthroughs have been achieved at the molecular level. After introducing the chiral cyclopropyl group, the binding force of cyclophenol with the GABA receptor has increased significantly, and its pharmacological activity is about 5 times that of propofol.”

What does a 5-fold increase in drug efficacy mean? Professor Zuo Yunxia, an expert in anesthesia, chief physician at the Anesthesia and Surgery Center of West China Hospital of Sichuan University, and a doctoral supervisor, said: “It retains the advantages of propofol while overcoming its disadvantages.”

Zuo Yunxia explained that only one-fifth of the dose is needed to achieve the same anesthetic effect, the load on the lipid carrier decreases, and the incidence of injection pain is only one-tenth of propofol. "In addition, cyclopropanol has a wider therapeutic index than propofol, less respiratory depression, and a higher safety margin.

From the project initiation in 2012 to its approval in China in 2020, Enpofol has gone through eight years. In recent years, Haisco's research and development investment has never been less than 1 billion yuan per year.

How “Chinese data” can get through the FDA’s doors

After ringponol was approved for marketing in China in December 2020, a bold idea began to form—to bring it to the US market.

In 2021, Hisicor submitted a request to the FDA: Can it bypass the US Phase I and II clinical trials and directly enter the critical Phase III stage, based on domestic Phase I, II, and III data as well as early Australian data?

This is the first time an innovative intravenous anesthesia drug from China has passed the FDA review, with no prior experience to draw from.

“At that time, everyone was under great pressure,” Wu Nan said. “We wanted to prove that China’s data quality and research and development capabilities can fully meet international standards.”

The FDA, known for its strict standards, approved the application after a series of reviews.

This breakthrough is by no means accidental.

Professor Yang Mengchang, director of the Clinical Trial Center at Sichuan Provincial People's Hospital, revealed a key detail: During the phase II clinical trial of cyclopentolate, the team found that there might be statistical deviations in blood pressure data. The statistical protocol required measuring blood pressure every 5 minutes, but in reality, measurements were taken every minute. The data indicate that the effect of cyclopentolate on the circulatory system may be better than that of propofol.

“I reached out to the research team and persuaded them to conduct animal experiments on vascular ring tension,” Yang Mengchang said. “Both with and without vascular endothelial cells, cringopanol has a significantly better effect on vascular tension than propofol.”

For Hisico, it is a difficult choice—to submit through the conventional route, or to restart a clinical trial to validate this finding?

Yang Mengchang said, “Haiscop finally chose the latter option. At that time, a phase I trial was restarted at Sichuan Provincial People’s Hospital, where continuous arterial blood pressure monitoring was conducted on healthy subjects to compare the effects of the two drugs head-to-head. It was found that the difference was very significant, and the effect of cyclopentolate on vascular ring tension is much less than that of propofol.”

The pursuit of high-quality research has laid a solid foundation for the subsequent FDA submission of cyclobutanol. “We have collected data for high-risk populations, allowing us to fully present the product’s value to US regulatory authorities,” Yang Mengchang said. “Most researchers in China were even more confident in the launch of cyclobutanol in the US than within our company.”

In 2024,环泊酚 completed all phase III clinical studies and showed superior results in head-to-head comparisons with standard treatments. In July 2025, its new drug application was accepted by the FDA.

What was even more surprising for the team was the Pre-NDA communication meeting—which took only 20 minutes in total. “The FDA didn’t raise any questions at all,” Wu Nan recalled.

Dou Ying summarized the three key experiences of环泊酚’s FDA review: “First, the international layout should be established in advance, with standards for both China and US applied from the project initiation stage; second, strengthen active communication with the FDA to ensure they fully understand the clinical value of the product; third, establish an international quality system to ensure all data are verifiable.”

From "only being treated politely" to "sitting in the main seat

Shortly after the approval of cyclobutanol, the core team at Haixike traveled to the US for an 11-day exchange, engaging in discussions with over 10 fund companies and multinational pharmaceutical firms.

“In the past, when we attended the annual industry summit of JPMorgan Chase in the US, Chinese assets were often treated merely politely,” Wu Nan said. “Previously, Chinese companies presented their research layouts and clinical data overseas, and the recipients usually only said politely that it was interesting. There weren’t many cases where there was actual follow-up progress.”

But this year is completely different. "Chinese assets have truly 'made it to the table' and taken a central position," Wu Nan pointed out. "Many executives of multinational pharmaceutical companies are learning Chinese, trying to understand China more deeply, and they speak highly of China's growth rate and resilience.

Hisicor's international expansion is also accelerating. After the approval of Enpofin, the company has successively signed authorization agreements for Nav1.8 inhibitors with AbbVie (total amount: $745 million), established a partnership with AirNexis via the NewCo model (a capital formation approach to take over specific drug assets for overseas research and development, production, and commercialization), and reached a strategic cooperation with Eli Lilly worth up to $3.054 billion in June 2026.

Yan Pangke, General Manager of Hisicore, said: “We always believe that innovation should be global in nature, and there are no boundaries for innovation. The ability to get Ringopol to the United States for FDA testing is one of our proudest achievements in research and development.”

Regarding overseas commercialization, Haisco is steadily and on schedule advancing the selection of partners, jointly promoting the development of环泊酚 for various indications in the United States, to benefit more patients worldwide.

Haisco moves into the top tier of global innovation

In 2025, Hisike's revenue reached 4.388 billion yuan, with four innovative drugs generating a year-on-year increase of over 50%. The research and development expenses accounted for 25% of the revenue. In the first quarter of 2026, the net profit attributable to the parent company was 550 million yuan, a 1090% increase from the previous year.

“The name of Haisco is a transliteration of ‘Health care’. It embodies the philosophy of ‘embracing all rivers and seeking wisdom eagerly’, while ‘Ke’ stands for ‘science-driven.’” Wu Nan said, “Now, Haisco possesses global intellectual property rights for all its products, whether they are licensed externally, listed overseas, or in the development stage domestically. All patents and all inventors are Chinese. Today, we can say with confidence that Haisco has achieved ‘In China, for global’.”

From research and development to market launch, and finally getting approval from the FDA, Haisco has gone through fifteen years. Yan Pangke attributed its success to three points: "First, acting in line with trends and keeping up with national development trends; second, combining the company's actual situation to make appropriate decisions; third, always adhering to innovation and internationalization strategies.

The significance of ringponol is far more than the success of a single product—it is the 10th innovative drug in China to receive FDA approval, and the first in non-tumor fields.

Zuo Yunxia said, "For a long time, the anesthetic drugs we use have mostly relied on imports. We hope that domestic companies can develop anesthetic products that are more suitable for Chinese people and also benefit all of humanity. Cephem is such a product.

[Responsibility editor: Wu Qilong] [End]