Home Asia Regenerative Medicine Files Prospectus to Advance Bioengineered Organs for High-Quality Life Extension

Asia Regenerative Medicine Files Prospectus to Advance Bioengineered Organs for High-Quality Life Extension

Aug 25, 2019 08:00 CST Updated 08:00
AR

Biological Artificial Organ Developer

Throughout history, across all cultures and eras, humanity’s pursuit of longevity has never ceased; nevertheless, human lifespan expectations have yet to be fully satisfied. Historical records indicate that during primitive society, the average human life expectancy was merely 15 years. In April 2019, the World Health Organization released the World Health Statistics 2019, which showed that the global average life expectancy had reached 72 years.


What is preventing humans from extending their lifespan? And what is driving the continuous increase in human longevity? Can the 150-year lifespan proposed by Silicon Valley scientists ultimately be realized, just like other scientific predictions that have come true one by one?


According to statistics from the World Health Organization, disease, hunger, and environmental pollution are significant factors affecting life expectancy. Advances in modern medicine have enabled humans to understand the transmission pathways of diseases at a microscopic level, thereby effectively controlling them. In particular, cancer therapies that have emerged in recent years are gradually overcoming major diseases that threaten human longevity, offering hope for extending human lifespan.


Medicine emerged to combat disease, and even in today’s era of advanced medical science, disease remains a major factor affecting human survival and development. Currently, scientists are continuously conducting research and exploration to find the “ultimate weapon” against disease.


Regenerative medicine represents one such important avenue of exploration. Regenerative medicine involves the creation of living, functional tissues, with the goal of repairing or replacing tissues or organs that have lost function due to aging, disease, injury, or congenital defects. By substituting damaged tissues and organs with engineered tissues or organs, regenerative medicine aims to extend lifespan and improve health outcomes.


In fact, regenerative medicine has long been integrated into our daily lives; “dental fillings” represent an ancient clinical application of this field. In recent years, modern regenerative medicine has seen the successive emergence of artificial skin, bone substitutes, artificial joints, prosthetic heart valves, and synthetic blood vessels. This demonstrates that regenerative medicine is advancing in depth across scientific research, translational development, and clinical application within the medical sector.


Regenerative medicine has evolved for over three decades since 1984, experiencing phases of emergence, decline, and renewed flourishing. The invention of two groundbreaking biotechnologies—induced pluripotent stem (iPS) cell culture and organ-on-a-chip technology—between 2006 and 2007 marked milestone achievements. Together with organ transplantation, these advancements have significantly accelerated the development and clinical application of regenerative medicine across various medical fields.


The International Foundation for Regenerative Medicine has explicitly designated tissue engineering as a subdiscipline of regenerative medicine. In China, research in tissue regeneration and related fields has been flourishing in recent years, with many universities, hospitals, research institutions, and enterprises already engaged in this area. Currently, the strategies being explored in the field of regenerative medicine encompass three aspects:


1. Replace damaged tissue by transplanting cell suspensions or aggregates;

2. Implantation of bioartificial tissues or organs produced in the laboratory to replace natural tissues;

3. Induce regeneration of damaged tissues through pharmacological interventions.


In the second strategy, Shenzhen Huayuan Regenerative Medicine Co., Ltd. (Asia Regenerative Medicine, abbreviated as AR), which has just won the Shenzhen division of the Alibaba Global Entrepreneurship Competition (Hong Kong Jumpstarter) and qualified for the Top 40 competition among eight major global innovation cities to be held in Hong Kong next February, has already made early arrangements in the field of large organ manufacturing.


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(AR Wins the Shenzhen Division of the Alibaba Global Entrepreneurship Competition (Hong Kong Jumpstarter))


Mr. Zheng Lixin, founder of Huayuan, stated: “Huayuan is a cell preparation company, a biomaterial synthesis company, and an organ synthesis company. At this stage, Huayuan is solely an R&D company, as it will take another 3–5 years for our products to transition from the laboratory to clinical applications and the market. In the future, we aspire for Huayuan to become a world-class large-organ factory capable of mass-producing major organs, thereby providing patients with more treatment options.”


Three sectors possess “2.5 experience points,” with the field of regenerative medicine selected for its forward-looking vision


In 1985, Mr. Zheng Lixin was sent by the Chinese government to Canada for graduate studies. After earning dual master’s degrees from the University of Toronto and the Ivey Business School at Western University, he spent approximately ten years working in marketing, R&D, and management within Fortune 500 pharmaceutical companies. He served as Vice President at companies such as Sino-American SmithKline (SAS), Glaxo Wellcome UK, and Jiangzhong Pharmaceutical. He refers to this phase as his “Healthcare Enterprise Management Experience 1.0.”


Over the following decade, he engaged in healthcare investments, investing in nearly 100 companies and cultivating several leading enterprises in China’s healthcare industry. He refers to this phase as his “Healthcare Industry Investment Experience 1.0.”


In terms of scientific research, he rates his experience at 0.5. Zheng Lixin stated, “Although I received some research training and developed engineering competencies during my undergraduate studies in China and my graduate studies abroad, my experience still falls short compared to that of scientists, warranting only a 0.5 rating. Therefore, in the areas of healthcare enterprise management, medical investment, and scientific research, if others have a score of 3.0 while I have only 2.5, I make it a point to attend every industry academic conference to intensively strengthen my scientific knowledge.”


Leveraging his accumulation in these three areas, along with forward-looking investment experience and insight, Zheng Lixin aims to identify entrepreneurial opportunities for disruptive innovations that may emerge in the future healthcare industry. During his tenure in healthcare investment, he has encountered a wide variety of conventional technologies and has invested multiple times in projects related to organ repair and fabrication.


Based on years of due diligence conducted on dozens of international laboratories and companies, he has confirmed that regenerative medicine is a technology with immense disruptive potential in clinical practice, capable of fundamentally transforming many current treatment modalities. Zheng Lixin offered a vivid analogy: “If pharmacological treatment is akin to patching a tire, then regenerative medicine is like replacing the tire entirely, thereby freeing patients from reliance on any single chemical drug or device with limited functionality.”


Before committing to the manufacture of large artificial organs, Zheng Lixin’s team had been involved in multiple projects, including dentures, dental implants, artificial dural patches, intraocular lenses, artificial lacrimal glands, synthetic blood vessels, skin membrane regeneration, and artificial joints, thereby accumulating industrial resources and experience in human organ repair and reconstruction. However, it was only two years ago that he firmly resolved to venture into the field of regenerative large organs.


At that time, Zheng Lixin observed a globally leading experimental team in human major organ regeneration at a Harvard Medical School laboratory in the United States. They were the first to utilize decellularization technology to enable a bioengineered mouse heart to beat under electrical stimulation.


The application of cell technology, bioscaffold technology, and clinical transplantation techniques to the regeneration of major human organs was profoundly striking to Zheng Lixin. He immediately recognized that regenerating and transplanting major organs could help patients extend their lifespan and enjoy a higher quality of life, holding greater clinical significance and value compared to his previous work in repairing teeth, joints, and other structures.


At that moment, he felt the entrepreneurial opportunity he had been seeking had arrived. Regeneration and transplantation of major organs represent a revolution in disease treatment. Therefore, two years ago, he abandoned the pursuit of other medical market opportunities and founded Huayuan (AR), dedicating himself to a single mission: the repair and reconstruction of human major organs.


Four Major Teams Join Forces to Prepare for Large Organ Regeneration and Transplantation


The advancement of medical technology relies heavily on expert-level talent, particularly in the repair and regeneration of major human organs, which encompasses multiple disciplines such as adult cell isolation, stem cell differentiation, and tissue engineering scaffolds. Therefore, the repair and regeneration of major human organs require multidisciplinary experts with extensive experience, including specialists in stem cells, biomaterials, immunology, and clinical practice.


In addition to Mr. Zheng Lixin, the initial founding team of Huayuan included Professor Xin, a lung transplant expert from the University of Hong Kong who has participated in over 100 lung transplant procedures. Experts who later joined the founding team include: Chief Physician Professor Qiu, who has specialized in kidney transplantation for nearly 20 years and has served as the lead surgeon in more than 800 various types of kidney transplant surgeries; Dr. Zhang Lei, an islet cell and immunology expert who has received the Young Investigator Award from the American Society of Transplantation and the Scientific Achievement Award from The Transplantation Society; and Professor Wu from the National Engineering Research Center for Tissue Restoration and Reconstruction at South China University of Technology, who has long been engaged in research on the application of medical polymer materials in human tissue repair and regeneration.


This lineup also encompasses young and middle-aged scientists from the Greater Bay Area. In addition to the founding team, AR boasts a team of nearly 20 PhDs and Master’s degree holders from industry and research institutions, as well as an advisory board composed of 10 contracted professors. These talents have continuously joined AR throughout its development, working together toward the goal of large-organ repair and regeneration. Zheng Lixin stated, “AR continues to sincerely invite like-minded experts and outstanding talents to join the company in achieving this exciting vision.”


Most members of the company’s operations team are alumni of prestigious institutions such as Sun Yat-sen University, Peking University, Harvard University, the Chinese Academy of Sciences, Jinan University, and Cheung Kong Graduate School of Business. The R&D team is led by Dr. Zhang Lei, Dr. Guo Jinshu, and Dr. Wu Zhipeng, who conduct research in the fields of cell and immunology technologies, materials science, and transplantation technologies, respectively.


Currently, the team has established R&D laboratories in Shenzhen and Guangzhou, respectively. Zheng Lixin revealed, “AR is building a more advanced GMP-grade laboratory in Shenzhen, which is expected to become operational by mid-September. Additionally, the team will expand to around 30 members by the end of the year.”


Regarding the advisory team, Zheng Lixin stated, “We have established connections with universities, research institutions, and hospitals across multiple countries and regions, including Harvard University in the United States, the University of Toronto in Canada, and The Chinese University of Hong Kong. Our advisory team provides guidance on our technical roadmap and shares cutting-edge insights, while also engaging in collaborative R&D efforts.”


In terms of industrial layout, collaboration, and operations, Zheng Lixin is also the most proactive member of the team. He previously owned and operated a publicly listed company with over 10,000 employees, making him well-equipped to manage the startup Huayuan (AR). The industry team also includes Ms. Li Jun, who has over 10 years of experience in investment within the medical industry chain and financial management for industrial enterprises. She previously served as a senior financial executive at two Hong Kong-listed healthcare companies, bringing extensive management expertise. Zheng Lixin stated, “The industry team is primarily responsible for integrating industrial resources, managing company operations, and providing logistical support to partner institutions and laboratories.”

 

Ongoing Projects: Implantable Bioartificial Pancreas and Kidney


In May this year, Bank of America released a report stating that technologies aimed at delaying death will become one of the hottest investment sectors in the next decade. The value of this market has already reached $110 billion, and it is projected to grow to $600 billion by 2025.


Regenerative medicine has overcome challenges such as insufficient donor sources, fundamentally addressing the repair of tissue and organ defects and functional reconstruction, thereby offering significant advantages.


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(Schematic Diagram of the Principles of Large Organ Regeneration)


AR’s current research projects include implantable bioartificial pancreas and implantable bioartificial kidney, aiming to address diabetes and end-stage renal disease (ESRD; including kidney failure and uremia). These two areas have been prioritized because there is a vast population of patients with diabetes yet no effective cure, while 99% of ESRD patients currently rely on passive maintenance therapy—dialysis. Dialysis causes significant suffering for patients and imposes an enormous financial burden on families and the nation. Only 1% of patients are able to receive a suitable kidney for effective transplantation. The severe shortage of kidney donors represents a critical unmet need for patients with end-stage renal disease.


Regarding patients with diabetes, according to the latest statistics from China's National Health Commission, the number of diabetic patients in China exceeded 114 million in 2017, with a prevalence rate as high as 10.9%, accounting for approximately 27% of the global total. China has become the country with the largest diabetic population worldwide.


According to IDF projections, if no interventions are implemented, the number of diabetes patients in China will rise to 154 million by 2040. In 2015, healthcare expenditures for diabetes in China reached $51 billion. Patients require lifelong medication, blood glucose monitoring, or multiple daily insulin injections; however, due to extremely low control rates, 1.3 million people died from diabetes and its complications in 2015. There is an urgent need to identify more effective curative treatments for patients.


For patients with end-stage renal disease (ESRD), undergoing dialysis three times a week for four hours per session significantly reduces their quality of life and imposes substantial financial burden, with an average survival time of only 5 to 10 years. While kidney transplantation offers a potentially curative option, it faces two major challenges: a severe shortage of donors and the risk that many recipients die from infections during immunosuppressive therapy or develop malignancies post-transplantation. This current situation has led both patients and hospitals to eagerly await the emergence of other effective treatment modalities. Statistics show that in 2018, approximately 11,000 kidney transplants were performed in China, which is negligible compared to the 3 million patients with severe kidney disease.


Zheng Lixin told VCBeat, “Over the past year and a half, AR has designed a series of organ products and established an organ regeneration R&D platform. We are accelerating research and development through independent experiments and collaborative efforts with other institutions.” In addition to R&D at its Shenzhen laboratory, AR is concurrently conducting research on biomaterial scaffolds, primary cell isolation, and stem cell differentiation in collaboration with several universities in South China. AR plans to advance its artificial pancreas project into clinical trials within three years, with market entry expected in approximately five to six years. For the artificial kidney, the timeline is estimated at seven to ten years. However, AR will not remain revenue-free during this period; it will adopt a strategy of “developing products and continuously upgrading and optimizing them” to generate income that supports scientific research.


Since its establishment, Huayuan’s founding shareholders have invested tens of millions of yuan. On August 20 this year, AR (Huayuan Regenerative Medicine) successfully qualified for the Alibaba Global Finals in Hong Kong scheduled for next February. This will enable AR to connect with hundreds of funds on Hong Kong’s international capital stage, laying a solid foundation for its first official external financing round.


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AR Secures a Spot in the Hong Kong Finals of the Alibaba Global Entrepreneurs Competition


Although research on regenerative medicine for major organs is still in its early stages in China, its future prospects are undoubtedly bright. To conclude, we quote Academician Wu Zuze of the Chinese Academy of Sciences: “While we cannot halt the aging process, we can slow it down by treating chronic diseases.” In this regard, we must strengthen basic research on key technologies such as regenerative medicine, standardize and accelerate the clinical application of cutting-edge biomedical technologies, and improve the level of clinical care. This holds significant importance for national economic development and the realization of the “Healthy China” initiative.