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2026.6.1 Wu Nan, Haisco: The Strong Competence Behind the US FDA’s “skip-stage approval” for cyclopelline

“The development of innovative drugs is a very ‘long-lasting confession’,” Wu Nan said. “It takes over ten years from project initiation to market launch for each molecule. The company has a strong belief—we must invest the most resources into research and development.” And this ‘long-lasting confession’ is now facing a period of intensive returns. Haisco expects at least one new drug to be approved each year on average, and the revenue from innovative drugs will account for more than 50% of total income by 2026.

From a firm shift toward innovation in 2012, to spending over 1 billion yuan on research and development each year, to the approval of the self-developed Class 1 intravenous anesthesia drug c环泊酚 by the US FDA for clinical trials, and the rapid advancement towards overseas market entry—Hisicor has spent nearly fifteen years transforming from a traditional generic drug company into a top innovator in Chinese innovative drugs.Recently, Wu Nan, the deputy general manager of Hisco Pharmaceutical Group, appeared on the "Facing the Leaders" program on Shanghai Securities News to share the company's development history, innovation commitments, and thoughts on its international strategy. She said that the research and development of innovative drugs is a "long-lasting confession" that requires time, patience, and great faith.

Innovation is not a slogan, but a strategic choice

Haisco is founded in 2000 and went public on the Shenzhen Stock Exchange in 2012. It was in that year that Haisco Group made a strategic shift: transitioning from generic drugs to innovative drugs.

“At that time, we established our own innovation research institute and brought in many scientific researchers from home and abroad. We began to adopt the new drug development model that requires a lot of funding,” Wu Nan recalled.

Behind this transformation is the company's deep understanding of industry trends—only innovation and internationalization can enable the enterprise to go further.

Over the past five years, Haiscoi's annual R & D investment has never been less than 1 billion yuan. Even during the "cold winter" period in the pharmaceutical industry, the company has continued to invest heavily in R & D. In 2024, the R & D investment accounted for approximately 25% of its operating income, far exceeding the industry average.

“The development of innovative drugs is a very ‘long-lasting confession’,” Wu Nan said. “It takes over ten years for each molecule to go from project initiation to market launch. The company has a strong belief—we must invest the most resources into research and development.” And this ‘long-lasting confession’ is now facing a period of intensive returns. Haisco expects at least one new drug to be approved each year on average, and by 2026, the revenue from innovative drugs will account for more than 50% of total revenue.

As of now, Hisicor has launched four innovative drugs of category 1, all of which have been included in the national medical insurance catalog.

Among them, the cibopanol injection approved for market in December 2020 is China’s first independently developed Class I intravenous anesthesia innovation drug with global proprietary rights. In China, it has been approved for sedation and anesthesia during non-tracheal intubation procedures/operations, induction and maintenance of general anesthesia, and sedation during mechanical ventilation during intensive care. In September 2025, it was approved to be extended to induction and maintenance of general anesthesia in children/youngsters.

Cyclopentolate breaks the over thirty-year market monopoly of imported propofol, and due to its outstanding advantages in addressing clinical issues such as injection pain and respiratory depression, it has been recommended by more than 20 guidelines, and was included in the "14th Five-Year Plan" textbooks for general higher education in Anesthesiology.

In 2021, perbolone participated in its first medical insurance negotiation. In 2022, it was successfully included in the national medical insurance list. Currently, over 3,300 medical institutions use it, benefiting more than 40 million people.

Henopolone goes to market: “Chinese data” impresses the FDA

Among the four launched 1-class innovative drugs, Cilobol is undoubtedly one of the most iconic products. It is China's first original innovative drug for intravenous anesthesia to enter international markets. After being approved by the FDA for clinical trials in 2021, Cilobol is exempt from phases I and II in the US and directly enters phase III.

“We used the domestic Phase I, II, and III data, along with early data from Australia, to directly communicate with the FDA and ask if we could skip Phase I and II and go straight to Phase III,” Wu Nan recalled. “What was inspiring is that the FDA agreed.”

Behind this breakthrough is the years of careful preparation by the Hisisco research team—including translation and proofreading of all domestic research, repeated communication with the FDA, and an extreme focus on data quality.

“At that time, everyone was under great pressure, as this was a major event in the field of innovative drugs using intravenous anesthesia in China. We wanted to prove that the quality of data and research and development capabilities in China are capable of meeting international standards.” In 2024,环泊酚 completed all clinical studies and achieved favorable results compared to standard treatments. The marketing application is currently under review by the FDA, and if approved, it will be available in the United States.

“This is not only a milestone for HiSilicon, but also represents the strength and attitude created by China,” Wu Nan said.

Cycloheximide is merely a glimpse of SeaTech's international expansion strategy.

In recent years, the company has continuously promoted internationalization through various methods such as external licensing, collaborative development, and overseas clinical studies. In 2021, it licensed FTP637 for autoimmune diseases to the American company Alumis, which went public on NASDAQ using this molecule. In 2023, it licensed HSK31858 for respiratory disease treatment to the Italian Chiesi Group. At the beginning of 2026, it reached a cooperation worth over $1 billion with American AirNexis under the "NewCo" model. In April this year, it licensed Nav1.8 inhibitors to the global pharmaceutical giant AbbVie, with a total transaction value reaching up to $745 million.

“When choosing partners, we focus on two things: first, whether the other party has strong clinical management capabilities; second, whether they truly value our research and are willing to work together,” Wu Nan said.

Haisco Co. receives milestone payments for almost every transaction on time, which indirectly proves the quality and credibility of its research and development projects.

Haisco is also a reflection of China's international expansion in innovative medicine. In the first quarter of 2026, the total value of related transactions in China reached $61.4 billion, a 30% increase year-on-year. The number of license-out transactions accounted for 16% of the global total, and the global value of Chinese innovative drug assets is gradually gaining recognition in the international market.

From "small molecules" to more possibilities

In addition to the continuous implementation of international cooperation, Hisicor's innovation achievements in the domestic market are also accelerating.

Benzene Sulfonic Chlorogabalin Capsules are the world’s first third-generation calcium ion channel modulator that does not require titration, and also the first Class 1 new drug in China approved for diabetic peripheral neuropathy pain. The globally first bi-weekly long-acting oral hypoglycemic drug, copaglitide tablets, was launched in China. As of May 2026, it has been available at over 6,000 medical institutions, benefiting more than 350,000 patients. The Anruikefen Injection approved in May 2025 is the world’s first highly selective peripheral K receptor agonist with an analgesic indication. It participated in the first medical insurance negotiation that year and was successfully included in the national medical insurance drug list in 2026. It has already been widely implemented at over 300 medical institutions...

Under the drive of the 2.0 strategy, Hisisco continuously upgrades its research and development system. In 2025, the group launched the “Sail Plan” aimed at further promoting early varieties into overseas clinical trials, and daring to conduct “head-to-head” comparisons with leading therapies.

At the same time, Haisco has expanded from traditional small-molecule advantages into emerging technology platforms such as large molecules and small nucleic acids. It has also established an in-situ CAR-T (In vivo CAR-T) drug research and development platform with low immunogenicity and efficient targeted delivery, achieving a strategic leap in diversified technology platforms.

According to Haisco, the four new drugs that have been launched, as well as HSK31858 and HSK39297 which are in phase III clinical trials, are expected to reach or exceed 1 billion yuan in domestic sales at peak. The commercialization potential for early clinical projects is also very broad.

        Through a continuously deepening R&D system, Haisco has established a differentiated strategy in core areas such as anesthesia CNS, autoimmunity, respiration, and chronic diseases. There are more than five products under development in each area, creating a product portfolio with depth and resilience.

“We do not blindly chase popular trends, but focus on deep cultivation in areas we truly understand,” Wu Nan said. “In a noisy world, we do quiet things. Innovation drug research and development require perseverance and belief.” This belief has supported Hisilbo’s nearly fifteen-year journey of innovation transformation, and is also pushing this Chinese innovative pharmaceutical company onto a broader global stage.

Note: The text is from the Shanghai Securities News.