Huayi Regeneration Files IPO Prospectus: Building a World-Class Organoid Biobank to Advance Precision Medicine and Drug Discovery in China

In 2013, Hans Clevers co-founded HUB, an organoid technology incubator company, dedicated to developing patient-derived organoid biobanks for subsequent related research.

In an ideal organoid biobank, a large number of organoids can be readily accessed for targeted expansion and cryopreservation, thereby facilitating focused scientific research or serving downstream clients such as pharmaceutical companies. However, the establishment of biobanks has always been a time-consuming and capital-intensive endeavor, and organoid biobanks face the same challenges.

How Should Organoid Biobanks Be Established in China?Recently, VCBeat’s New Medicine channel interviewed Dr. Tian Jun, CEO of Huayi Regenerative Medicine. Founded in Guangzhou in 2019, Huayi Regenerative Medicine aims to establish a world-class biobank of organoid big data. Leveraging its extensive organoid sample resources and high-throughput drug screening platform, the company is dedicated to advancing the application and translation of organoid technology in precision medicine, drug development, research models, and regenerative medicine.

Since organoid bank samples can be derived directly from patients’ diseased tissues, they provide drug sensitivity data for drug development research, thereby facilitating personalized medication and regenerative medicine studies. Consequently, many organoid-related companies in China have incorporated biobanking into their business models.

However, establishing an organoid biobank is a project whose return on investment is difficult to measure using market-oriented standards. Nearly a decade has passed since the founding of HUB, yet the construction of high-quality organoid models remains complex and costly. Furthermore, the demands and standards for organoid models differ among academic research institutions, clinical settings, and pharmaceutical companies.Some investors have bluntly stated: the models in certain organoid banks fall far short of application-ready standards, often prioritizing scale over quality, with no relevant quality control standards in place.

High-quality organoid library samples will facilitate the establishment of high-throughput drug screening platforms and promote the translational application of organoid technology in precision medicine, drug development, research models, and even regenerative medicine. Huayi Regenerative Medicine has recognized this potential and understands the importance of creating a world-class big data biobank for organoids.

Dr. Tian Jun, the Company’s CEO, is the former CEO of Dade Behring China and the former CEO of the Diagnostics Division of DKSH China. He holds a Ph.D. in Molecular Biology from the Icahn School of Medicine at Mount Sinai in the United States and an MBA from the University of Chicago. With over 20 years of extensive experience in the biomedical industry, Dr. Tian was also a co-founder of Suzhou Boyuan Medical Technology Co., Ltd. prior to establishing Huayi Regenerative Medicine.

Another key figure instrumental in the company’s establishment is Academician Chen Yeguang, Chief Scientific Advisor. As an academician of the Chinese Academy of Sciences and President of the Chinese Society for Cell Biology, Academician Chen is among the earliest scholars in China to engage in organoid research. He has accumulated nearly a decade of technical expertise in the field, including the culture of human gastrointestinal organoids, research on special small molecules to promote organoid survival, studies on using human intestinal tumor organoids for cancer therapy, investigations into the metabolic functions of organoids derived from different segments of the human intestine, and the development of human lung organoid models for SARS-CoV-2 infection.

Observing the development of the organoid industry abroad, Academician Chen believes that China urgently needs to establish its own world-class organoid bank.Dr. Tian Jun also believes that, given the domestic environment and the large population base in China, establishing a localized, high-quality organoid biobank clearly offers advantages, though this requires substantial investment: “The translation and application of organoid technology is highly challenging; without a strong foundation in science, technology, and research, it is unlikely to be executed effectively. First, a comprehensive technical system must be established, covering every step from tissue and cell sampling and isolation to organoid culture. Second, after the organoid biobank is established, multi-omics approaches—such as high-throughput sequencing and single-cell sequencing—should be employed to build a big data repository of organoid samples. This data, combined with drug sensitivity screening results, can help identify molecular biomarkers relevant to disease diagnosis and treatment, which are then validated using organoid models. This endeavor not only demands the practical application of cutting-edge technologies but also necessitates the involvement of more institutions interested in technological innovation to foster joint development.”

In addition, the scientific advisory team of Huayi Regeneration includes Academician Pei Gang (member of the Chinese Academy of Sciences, The World Academy of Sciences, and the German National Academy of Sciences Leopoldina), Academician Rao Zihe (member of the Chinese Academy of Sciences, The World Academy of Sciences, and the International Eurasian Academy of Sciences), Academician Meng Anming (member of the Chinese Academy of Sciences and The World Academy of Sciences), and Academician Song Erwei (member of the Chinese Academy of Sciences).

With such a team configuration, Huayi Regeneration’s organoid bank primarily targets research institutions initially. As translational medicine advances rapidly and the academic community increasingly recognizes the importance of biological resources, research and academic institutions require biobanks to facilitate large-sample validation and accelerate translational research.

For organoid banks, scientific research collaboration serves as an excellent starting point and breakthrough.By collaborating with universities, hospitals, and other research institutions to develop organoid models for common or rare diseases, we can facilitate the exploration of pathological mechanisms, broaden research perspectives, enhance awareness of the significant potential value of organoids, and promote their subsequent industrial application.

Currently, the company has successively entered into strategic cooperation agreements with Grade A tertiary hospitals, including Guangdong Provincial People's Hospital, Sun Yat-sen University Cancer Center, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, The Seventh Affiliated Hospital of Sun Yat-sen University, Harbin Medical University Cancer Hospital, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Nanchang University, and The Second Affiliated Hospital of Nanchang University, through industry-academia-research strategic partnerships.

Technologically, Huayi Regeneration leverages the advantages of the Echo650 acoustic liquid handling platform to simultaneously achieve micro-droplet transfer at levels as low as 2.5 nL in 384-well or 1536-well plates, thereby better meeting the needs of high-throughput drug screening for organoids. Meanwhile, Huayi Regeneration has developed various organoid co-culture models, including those involving immune cells, cancer-associated fibroblasts, stromal cells, and microbes, which significantly expands the range of drugs available for organoid-based drug sensitivity testing.

“Translating organoid technology from development to clinical application requires a step-by-step, scientifically validated process. We are collaborating with several top-tier Grade A tertiary hospitals in Guangzhou through industry-academia-research partnerships to generate more compelling clinical trial data, while simultaneously promoting its adoption across major cities in the Guangdong-Hong Kong-Macao Greater Bay Area,” said Dr. Tian Jun.

To accelerate the expansion of hospital partnership channels, Huayi Regenerative Medicine has also secured strategic investment from KingMed Diagnostics. It is reported that KingMed Diagnostics processes over 12 million pathology specimens annually and serves more than 23,000 medical institutions. The company is currently developing a big data biobank and seeking partners across various disease areas and diagnostic and therapeutic fields.

By leveraging nationwide platforms such as KingMed Diagnostics, Huayi Regenerative Medicine complements these partners in hospital resources and market coverage through its own technological and R&D strengths.

Policy incentives also serve as a significant external driver for the development of organoid startups. Guangdong Province has long been at the forefront of precision medicine in China. Huayi Regeneration, based in Guangzhou, has closely followed local government guidance. The 14th Five-Year Plan for the Development of Strategic Emerging Industries in Guangzhou specifically highlights the goal of establishing an internationally leading precision medicine center. The plan actively supports pilot programs for Laboratory Developed Tests (LDTs) and conditionally permits LDT projects to be promoted for clinical use. It also supports the inclusion of testing products in the medical insurance reimbursement list. These measures represent substantial benefits for the advancement of organoid technology.

For patients with rare genetic diseases and cancer, precision medicine empowered by organoid technology can transform disease treatment. Examples include obtaining intestinal tissue from patients with cystic fibrosis to culture organoids for in vitro drug testing, as well as extracting tumor tissue from patients with intermediate-to-advanced stage cancers for 3D culture that simulates the in vivo tumor microenvironment, enabling personalized screening of drug sensitivity.

The resulting data can also be fed back to the Organoid Big Data Center, providing research institutions and hospitals with scientific services such as clinical omics data analysis.

However, a major factor contributing to clinical hesitation regarding the application of organoid technology is the lack of high-quality clinical trial data and expert consensus on its use in precision medicine. For various tumors, authoritative guidelines such as those from the National Comprehensive Cancer Network (NCCN) and the Chinese Society of Clinical Oncology (CSCO) provide corresponding diagnostic and therapeutic approaches and standards based on pathology, molecular subtyping, and staging. The issuance of guidelines by NCCN, CSCO, and other organizations is generally grounded in data from large-scale randomized controlled trials (RCTs). Therefore, advancing organoid technology into clinical practice requires the accumulation of substantial evidence from clinical trials.

If the application of organoid technology can establish relevant standards, thereby facilitating its inclusion in clinical practice guidelines and even reimbursement coverage, it will gain greater recognition among downstream clients, paving the way for broader and more diversified commercialization pathways.

In September this year, two domestic group standards for organoids co-developed by Huayi Regenerative Medicine—“Human Intestinal Organoids” and “Human Colorectal Cancer Organoids”—were simultaneously released. These standards cover key quality attributes such as ethics-related requirements, technical specifications, and testing methods for organoids, providing standardized descriptions for key biomarkers and quality control. The issuance of these two standards has laid the foundation for the standardization and industrialization of China’s organoid industry.

Another major issue in the construction of large-scale organoid biobanks is regulatory compliance. Human-derived organoids possess unique, complex, and sensitive characteristics, posing potential ethical risks during their collection and use.

Huayi Regenerative Medicine places great emphasis on regulatory compliance in biobank establishment. As a type of biobank, the success of an organoid bank in achieving its goals of research, application, and translation requires substantial financial investment, policy support, as well as strong commitment and sustained efforts from all stakeholders.

It is reported that the company’s samples are currently derived primarily from patient tumor tissues, and informed consent forms are signed with patients prior to sample collection to ensure the legality of the sample sources.

Meanwhile, in light of the commercial application trends in organoid research, ethical assessments and judgments regarding commercial value or benefit distribution should also be conducted. Huayi Regenerative Medicine stated that it is exploring collaboration models more beneficial to patients who are the source of the organoids.

“Engaging in organoid research and translating it into practical applications is highly meaningful. Organoids represent a cutting-edge, innovative technology, and their applications in fields such as precision medicine and drug development have been continuously advancing in recent years, making this an opportune time for us to embark on industrialization.”

It is reported that Huayi Regenerative Medicine will intensify its efforts in the field of precision medicine next year, aiming to surpass RMB 20 million in revenue. Over the next three to five years, the company will continue to advance the development of its organoid biobank. Building on this foundation, it will establish organoid models for various tumors, including those of the stomach, intestine, breast, liver, lung, pancreas, prostate, and bladder. Additionally, Huayi Regenerative Medicine will collaborate with biopharmaceutical companies specializing in adeno-associated viruses (AAV), lipid nanoparticles, and oncolytic viruses to explore the development of innovative drugs and therapeutic approaches.