Exclusive Interview with Bao Ji from West China Hospital: Why Is Domestic Translation of a Breakthrough Bioartificial Liver System Stuck in Regulatory Limbo While Heading for Overseas Launch?

“Looking ahead, we hope the project will achieve success both domestically and internationally.”Researcher Bao Ji, West China Hospital of Sichuan UniversityHe remarked as the interview was drawing to a close.

It is reported that the “Whole Blood Perfusion Bioartificial Liver System“This project represents one of the first batches of patents from China to be licensed to a top-tier international medical institution—the Mayo Clinic.”

In the future, technology transfer efforts will focus on three key areas: first, collaborating with Mayo Clinic to facilitate the regulatory approval and market launch of the bio-artificial liver product in the United States; second, establishing close partnerships with domestic investors to ensure the project aligns more closely with local requirements; and third, jointly exploring global markets with Mayo Clinic.

But while the vision is ideal, reality is stark. In fact, such expectations are destined to require a long journey ahead. Recently, Bao Ji was invited to participate in the 2022 Second High-Value Patent Project Selection in the Biomedical Field, andVCBeat Orange BureauTogether, drawing on the team’s research and translation of the “Whole Blood Perfusion Bioartificial Liver System” project, they discussed their stories across two distinct phases and reflected on how to overcome key challenges in translating scientific achievements into practical applications.

"Significantly reducing patient wait times, this is a technology that has impressed international peers."

The liver belongs to the Wood element, symbolizing vitality. Within the human body, the liver is characterized by its functions of promoting free flow and maintaining harmony. Its 10 billion hepatocytes clear toxins and waste from the blood daily, thereby regulating the circulation of Qi throughout the body.

The liver is resilient, with powerful regenerative capacity and high tolerance; it will not tell you it is tired until the very last moment. However, as a country with a high burden of liver disease, China has up to 200 million patients.The effective treatment rate for patients with end-stage liver disease is less than 5%., most patients lost the race against death. This is primarily due to the scarcity of donor livers for transplantation, which fails to meet clinical demand; many patients died on the eve of dawn while waiting for a donor liver.

Seeing the Dilemma, Breaking the Dilemma: Bao Ji Hopes to DevelopA Device Capable of Extending the Waiting Time for Liver Patients, driven by such passion and ideals, he devoted himself wholeheartedly to research on bioartificial livers during his studies in the United States.

Upon returning to China, Bao Ji not only replicated the U.S. technology but also made further advancements: first, he improved the cell separation process to enhance separation efficiency; second, he modified the cell culture process to extend cell survival time in vitro; and third, he redesigned the bioreactor to optimize its internal structure and accommodate a larger number of cells.

After extensive efforts, the “Whole Blood Perfusion Bioartificial Liver System” achieved a disruptive technological breakthrough:First, the quantity of primary hepatocytes reached 20 billion; second, the culture efficiency of liver organoids increased by 100-fold, with a detoxification efficiency exceeding 90%; third, the bioreactor was capable of supporting therapeutic durations of up to 24 hours.

Meanwhile, this technology has also attracted the world’s number one-rankedCollaborate with Mayo Clinic for Technology Transfer。

It is reported that in 2019, West China Hospital of Sichuan Universityin the form of a RMB 5 million payment and a 20% royalty on net revenue, and signed a patent assignment agreement with the Mayo Clinic in the United States for bioartificial liver-related technologies, marking the first batch of patents exported by medical institutions in mainland China to the world-renowned Mayo Clinic.

Recalling that technology transfer experience, Bao Ji still describes it as a bittersweet journey. The pain stemmed from the differences in patent drafting practices between the two countries and a lack of negotiation experience, which made the entire process fraught with difficulties. The joy, however, came from gaining Mayo Clinic’s endorsement for the technology, which significantly boosted its visibility both domestically and internationally and markedly enhanced its industry influence.

However, this technology inDomestic TranslationYet such joy is rare. It is understood that, at present, technology translationStill stuck in the approval stage., has not been clearly categorized, which undoubtedly increases post-investment risk and causes many investors to hesitate.

Difficult approval is merely one manifestation of the bottlenecks in achievement transformation.

This is largely due to the gap created by differences, as divergent translational mindsets between China and other countries have led to inconsistencies in progress.

Regarding the translation of scientific research achievements, Bao Ji stated that there are mainly two difficulties: one isThe interdisciplinary integration and configuration in China are not as well-developed as those in the United States.Specifically, the team lacked support and input from specialized technical professionals when developing hardware facilities, whereas U.S. teams typically comprise multidisciplinary talent spanning biomedical engineering, mechanical manufacturing, and computer programming.

The other isFunding IssuesIn the United States, innovation translation is primarily market-driven; products prioritize therapeutic efficacy before addressing economic considerations. Consequently, the U.S. is willing to provide ample funding to support the development of innovative therapeutic technologies.

However, in China, research funding remains tight. On one hand, due to the domestic environment, even after securing national grants, researchers typically receive only hundreds of thousands to a few million RMB, lacking sustained financial support for R&D efforts. On the other hand, the publication-driven research orientation also hinders the development of translational research.

To this end,Sichuan University and West China Hospital Actively Support the Team’s R&D Efforts. First, the team received substantial funding support for its research projects, particularly in areas involving industrial translation; second, the hospital covered all personnel costs associated with the research; and finally, the team was provided with a favorable research environment, including well-equipped laboratories and state-of-the-art instruments.

Regarding the approval of medical technologies, China’s regulatory framework is relatively rigid, though new pathways do exist. Bao Ji revealed that his team is currently working on industrial upgrading of this technology and securing new patents. When developing clinically viable products, both the university and the hospital will engage in communications related to the approval process.

Despite numerous challenges, investors remain optimistic about Bao Ji’s team and the “Whole Blood Perfusion Bioartificial Liver System” project.

It is reported that Bao Ji’s teamHave partnered with investors.“He is an investor with a sense of mission,” commented Bao Ji. Coming from a traditional industry background, this investor prioritizes technological R&D above all else. Within the scope of his capacity to provide support, he fully collaborates with the team’s research and development efforts, facilitating the translation of technology into clinical practice so that more people can benefit.

Although the primary focus of R&D personnel is not on final profitability, once investors provide funding to support research efforts, business operations naturally become part of the consideration. As a result, R&D teams will, to some extent, adjust their development mindset by prioritizing the creation of cost-effective products to help investors maintain the company’s normal operations.

"In fact, collaboration with investors is a long-term process,"Honesty is the most important principle we must adhere to."It is understood that before formally collaborating with investors, Bao Ji provided a thorough and detailed introduction of the project and product positioning to the investors, clarified the purpose of the collaboration, enabled the investors to understand the team's needs, and accurately assess whether both parties could work together."

So, in addition to candor, Bao Ji also highlighted three key points during the process of external engagement:

First, researchers needUnderstanding Clinical and Market Needs, unlike the innovation-driven approach of traditional scientific research, technology transfer requires a problem-oriented approach to identify application scenarios for the technology; secondly,Regulate Mindset, industrial translation requires broader thinking and the ability to withstand greater pressure; a positive mindset is essential for maintaining rational thinking; thirdly,Team Collaboration, enabling more people to participate and address their own shortcomings in the business sector.

“Where the water ends, sit and watch the clouds rise.” The translation of scientific research is a long journey, requiring travelers to think, correct, and act. On this path, Bao Ji and his team have been forging ahead with their original intentions.