Qianhui Bio's Pioneering Combination Bioartificial Liver Therapy Receives Clinical Trial Approval and Files for IPO

In the field of liver failure treatment, bioartificial liver technology has been one of the most prominent technologies in recent years.

This technology offers the advantages of being unconstrained by plasma limitations and having minimal side effects. By utilizing substances secreted by hepatocytes in vitro, it accelerates the repair process of diseased livers in vivo, thereby achieving patient cure.

As a specialist in hepatobiliary and pancreatic surgery,Professor Gao Yi, Executive Director of the Translational Medicine Center at Zhujiang Hospital of Southern Medical University, has been dedicated to research on artificial livers for over two decades. As early as 2006, he led his team in presiding over and undertaking a major project under the National “11th Five-Year” 863 Program for Science and Technology Development: “Research and Development of Human Cell-Based Hybrid Bioartificial Liver.”, and successfully developed the world's first prototype of a hybrid bioartificial liver.

In 2011, Professor Gao Yi established Qianhui Biotechnology to begin commercializing this technology. Since its inception, Qianhui Biotechnology has won numerous prestigious awards in the medical field, including the top prize at the National Disruptive Technology Innovation Competition organized by the Ministry of Science and Technology in 2023.

From a technical perspective, bioartificial livers place cultured hepatocytes in an extracorporeal bioreactor and use an extracorporeal circulation device to direct the patient’s blood or plasma through the reactor, enabling material exchange with the hepatocytes; this exchange can occur via a semipermeable membrane or through direct contact.

Among these, hepatocyte sources are key to treating patients with liver failure. Differences in hepatic function among cells from various sources directly determine the functional potential of bioartificial livers. An ideal hepatocyte source must meet three major requirements: superior hepatic function, sufficient quantity, and high safety.

In the development and utilization of hepatocyte-derived sources,Guangdong Qianhui Biotechnology Co., Ltd. is progressively establishing a comprehensive and refined strategic framework to address the urgent need of patients with liver failure for ideal hepatocyte sources.

Professor Gao Yi emphasized to VCBeat that screening cells suitable for patients is the top priority of the team’s work.

Therefore, when screening liver cells, the team cannot rely solely on normal physiological standards but must consider the specific cell types required based on the actual needs of patients with liver failure. Targeting different stages of disease progression, Guangdong Qianhui Biotechnology Co., Ltd. proposes a stratified treatment approach using different cell types. When liver function is still preserved, stem cells are primarily selected to suppress inflammation and promote regeneration; whereas after liver function is lost, hepatocytes are employed for treatment.

From a safety perspective, to avoid the potential risks associated with multi-gene editing technologies, the team opted for the safer and more reliable chemical reprogramming technique to establish the immortalized hepatocyte cell line HepGL, which serves as the source cell line.

In terms of supply assurance, Qianhui Biotechnology has also established fully automated hepatocyte production equipment, capable of producing one batch of cells within ten days. Professor Gao Yi stated, “In the future, Qianhui Biotechnology will expand its production scale to 200 units of equipment, with a production base covering an area of 3,000 square meters, aiming to produce ten to twenty batches of cells per day.”

As another core component of bioartificial livers, the ideal bioreactor plays a crucial role. It must not only fully harness the functional capabilities of hepatocyte sources but also ensure patient safety during treatment. Professor Gao Yi stated, “Liver functions are complex and diverse, primarily encompassing excretion, detoxification, and biosynthesis. Although excretory function can be achieved through conventional hemodialysis techniques, existing bioartificial liver technologies remain insufficient in addressing detoxification and metabolic functions, which rely mainly on the effective activity of cells within the bioartificial liver.”

Based on an in-depth understanding of liver function,Qianhui Biotechnology ingeniously integrates biotechnology with non-biological technologies, successfully developing the first hybrid bioartificial liver therapy device. This system employs a plasma molecular adsorption system as the non-biological component and a fiber-scaffold bioreactor as the biological component to achieve absorption and detoxification.

Specifically, a high-density hepatocyte culture system is constructed by combining fibrous scaffold carriers with an oxygenation system, enabling the three-dimensional culture of 10^9–10^10 clinical-grade hepatocytes with robust functionality to build a hybrid bioartificial liver. Furthermore, the bioreactor can monitor pH, temperature, and dissolved oxygen levels, while automatically supplying carbon dioxide and oxygen to maintain a stable culture environment. The culture medium is vertically transported via a magnetic impeller and flows down the outer wall from the top like a “waterfall,” thereby preventing bubble-induced cell damage.

It is worth noting that experimental studies on the treatment of liver failure in large animals have confirmed that, compared with conventional therapy,Survival Rate with Combined Bioartificial Liver Therapy Increased from 17% to 87.5%, which can effectively suppress systemic inflammatory responses, holds promise for providing a new life-saving therapeutic regimen for patients with liver failure.

In 2023, the drug-device combination product “Mesenchymal Stem Cells for Blood Purification,” independently developed by Qianhui Biotechnology and comprising a Class 1 therapeutic biological product (drug) and a Class III active medical device, successfully obtained clinical trial approval from the National Medical Products Administration (NMPA).

“Mesenchymal Stem Cells for Blood Purification” represents a therapeutic modality that is essentially a dialysis therapy based on live stem cells. The mesenchymal stem cells employed in this therapy are typically derived from infant umbilical cords. When these stem cells encounter plasma containing hepatitis viruses, they effectively purify the blood through paracrine mechanisms, thereby promoting hepatic regeneration and repair in patients.

Professor Gao Yi told VCBeat that more than 40 patients have been enrolled in the study.Based on preliminary clinical trial results, no serious complications or adverse events (including AEs) were reported in the safety assessment for any patients, confirming the reliability of the treatment in terms of safety.Regarding the efficacy assessment in clinical trials, current research has entered Phase II, with randomized controlled trials (RCTs) underway, in which the 28-day survival rate of patients has shown a significant improving trend.

Currently, no bioartificial liver products have been approved for market launch worldwide. In China, the regulatory pathway for approval in this field remains in a stage of exploration and development. At present, products containing natural cells can be registered through medical technology filing, while those involving gene editing or cellular modification can be submitted to the National Medical Products Administration (NMPA) as combination products of drugs and devices.

From the perspective of development trends in bioartificial liver technology, Professor Gao Yi maintains that national advancement in this field must encompass both related equipment and consumables, and that clinical treatment must be conducted on the basis of legally compliant devices and materials.

Based on this,Guangdong Qianhui Biotechnology Co., Ltd. has established seven product pipelines covering the entire value chain and multiple product specifications., including consumables and equipment for extracorporeal bioartificial liver support systems targeting acute liver failure, stem cell-related consumables, as well as therapeutic products for post-hepatectomy liver failure, implantable in vivo bioartificial liver devices, exosome-based therapies associated with stem cells, and products for the treatment of liver fibrosis.

Regarding its pipeline progress, in addition to the two pipelines that have recently received approval for clinical trials, Guangdong Qianhui Biotechnology Co., Ltd. is expected to advance three additional product pipelines to the Investigational New Drug (IND) application stage within the next one to two years.

To accelerate the advancement of its product pipeline, Qianhui Biotechnology is currently actively seeking financing. As a partner of Qianhui Biotechnology, Chen Yiqun from Shangjun Investment revealed to VCBeat that the team is actively preparing and promoting the establishment of a specialized medical technology fund to provide strong financial support for Qianhui Biotechnology.

The ultimate vision of clinical research is to achieve industrialization, enabling bioartificial livers to benefit more patients. However, the path to industrialization presents numerous challenges for bioartificial livers. Among these, treatment cost is a focal point of concern for both patients and the industry. As an innovative therapeutic product, the cost of bioartificial liver treatment directly impacts the financial burden on patients.

The cost of artificial liver support systems varies depending on the hospital tier and national pricing regulations. Typically, the initial treatment session costs between 10,000 and 20,000 yuan, with subsequent sessions costing approximately 5,000 yuan each.

For innovative enterprises, cell culture and supporting medical devices constitute the major portion of product costs. Professor Gao Yi stated that since the project’s inception, Qianhui Biotechnology has incorporated cost control into its considerations, covering multiple aspects such as cell screening, scalable manufacturing processes, and clinical accessibility. “Safety, efficacy, and low cost have always been the three core objectives pursued by Qianhui Biotechnology.”

Based on the current situation,Guangdong Qianhui Biotechnology Co., Ltd. has managed to control the production cost of its stem cell bioreactors within RMB 10,000, initially achieving the goals of low cost and accessibility.Furthermore, the team has not only achieved full localization of core components but also adopted the latest wireless passive detection technology for the online assessment of cellular functions.

Moving forward, Guangdong Qianhui Biotechnology Co., Ltd. will actively seek international cooperation to accelerate the industrialization of bio-artificial liver technology. It is reported that Professor Gao Yi’s team has signed a framework cooperation agreement with the Shumakov National Medical Research Center for Transplantology and Artificial Organs under the Ministry of Health of the Russian Federation. This agreement has been approved and confirmed by the Russian Ministry of Health.

The collaboration between the two parties encompasses the joint establishment of a Belt and Road Joint Laboratory for Regenerative Medicine and Artificial Organs, promoting the exchange of high-level talent, conducting collaborative research and technological development in the field of bioartificial livers, advancing the industrialization of key technology projects, and carrying out joint clinical trials and validation in regenerative medicine and artificial organs. With the continuous advancement of bioartificial liver technology, we believe that innovative enterprises represented by Guangdong Qianhui Biotechnology Co., Ltd. will lead the treatment of liver failure into a new stage of development, injecting fresh vitality and momentum into the industry.