Organ-on-a-chip technology involves constructing miniature, biofunctional artificial organs on microchips for applications in drug screening and precision medicine. As an emerging biochip technology that debuted in 2010, it has undergone more than a decade of rapid development, giving rise to several pioneering and transformative organ-on-a-chip companies worldwide.
Driven by their knowledge-intensive and highly innovative nature, companies spun out from the world’s top universities and research institutes have become the main players in this sector. For instance, Emulate was founded by Harvard University’s Wyss Institute, TissUse originated from the Technical University of Berlin in Germany, Hesperos was established at Cornell University in the United States, and Mimetas emerged from scholars and technology transfer efforts at Leiden University in the Netherlands, among others.
As early as 2012, the National Center for Advancing Translational Sciences (NCATS) of the U.S. National Institutes of Health (NIH), in collaboration with the FDA, forty international pharmaceutical companies, and DARPA, established the Microphysiological Systems Alliance. An initial investment of $140 million was allocated to advance organ-on-a-chip projects during Phase I. Following additional investments in Phases II and III, the total funding has exceeded $2 billion. Under this R&D and industrialization framework, supported by policy incentives and government funding, a cohort of organ-on-a-chip companies emerged, having successfully translated their research into applications with participation from leading academic institutions such as Harvard University, the Massachusetts Institute of Technology (MIT), and Columbia University.
Today, with joint support from Southeast University, the Jiangsu Industrial Technology Research Institute, and relevant industrial funds in Suzhou New District, Jiangsu Aiweide Biotechnology Co., Ltd. has emerged as a domestic organ-on-a-chip company incubated through government-university research collaboration. The company aligns with international standards, boasts over a decade of independent technological accumulation, and possesses in-depth familiarity with China’s policies and market landscape.
On November 11, 2021, Jiangsu Aiweide Biotechnology Co., Ltd. was established by the technical team from the Suzhou Medical Device Research Institute of Southeast University and the State Key Laboratory of Bioelectronics, with the support of the Jiangsu Industrial Technology Research Institute and the Suzhou New District. The company focuses on the research, development, and application of human organ-on-a-chip systems, along with supporting reagents, equipment, and software and hardware solutions.
This July, Jiangsu Aiweide Biotechnology Co., Ltd. completed its Pre-A financing round with a total transaction value of nearly RMB 100 million, marking one of the largest financing events in China’s organoid and organ-on-a-chip sector in recent years.
Today, on the first anniversary of the establishment of Aiweide, this article examines: how a laboratory engaged in cutting-edge scientific research achieves project commercialization and completes the “last mile” of industrial translation; and how Chinese enterprises, as developers of transformative new technologies, align with international standards.
Organ-on-a-Chip Translation in China: From the Lab to the Last Mile
From the past and present of Aiweide Biotechnology, and the formation of its team that integrates cutting-edge scientific technology with industrialization experience, one can see a microcosm of the trajectory of integration between scientific research and industry in China.
In 2010, Professor Gu Zhongze, Founder and Chief Scientist of Aiweide Biotechnology and Dean of the School of Biological Science and Medical Engineering at Southeast University, had already begun focusing on the field of organs and engaging in fundamental research in related areas, establishing technologies such as organ-on-a-chip fabrication and artificial intelligence integration.
Meanwhile, Dr. Sha Lifeng has just returned to Suzhou from Shenzhen to join Changguang Huayi (Suzhou) as Deputy General Manager. Previously, Dr. Sha primarily worked at Mindray in Shenzhen, where he participated in the development of China’s first fully automated clinical chemistry analyzer, led the software system architecture design for Mindray’s clinical chemistry analyzers, and contributed to the development of a series of core technologies for fully automated clinical chemistry analyzers. During his tenure at Changguang Huayi, he successively spearheaded the R&D and industrialization of multiple fully automated chemiluminescence immunoassay analyzers, accumulating extensive experience in the medical device sector.
Time flew to 2020, when Dr. Sha Lifeng and Dean Gu Zhongze met at an external promotion conference held by Southeast University, a meeting that ultimately led to a remarkable partnership. Dr. Sha was deeply moved by Dean Gu’s vision and passion for organ-on-a-chip technology, prompting him to dedicate himself to this field. He led his team in building a platform for the industrialization of organ-on-a-chip technology, bridging the “last mile” from research and development to practical application.
In addition, the company has two other key founding members.
Dr. Chen Zaozao, the company’s Chief Technology Officer (CTO), earned his bachelor’s degree from the Wu Jianxiong Honors College at Southeast University and his Ph.D. from the University of North Carolina at Chapel Hill in the United States. With over a decade of experience in organ-on-a-chip research and development in both China and the U.S., Dr. Chen served as an Associate Research Scientist at Columbia University prior to returning to China. He also acted as the technical lead for organ-on-a-chip research projects within the team of Professor Kam Leong, a member of three U.S. national academies. In late 2017, Dr. Chen returned to China to join Southeast University and its Suzhou Medical Device Research Institute, where he has been leading the R&D and industrialization of organ-on-a-chip technologies.
Mr. Ge Jianjun, the Chairman of the Company, is a graduate of the Youth Class at Wu Jianxiong College, Southeast University, and holds an MBA from Nanjing University. He served as the executive lead of the organ-on-a-chip team prior to the company’s establishment.
Finally, on November 11, 2021, Jiangsu Aiweide Biotechnology Co., Ltd. was officially established. The date, November 11, also symbolizes the company’s core spirit of striving for first place.
Jiangsu Aiweide Biotechnology Co., Ltd. has achieved significant milestones in its organ-on-a-chip technology. First, the company has established a mature system for tumor-related organoid culture and analysis, complemented by an automated operation and evaluation platform. Second, its cardiac organoid culture technology has reached an internationally leading level, with organoids capable of beating continuously for 150 days, making them suitable for modeling diseases such as heart failure and ventricular hypertrophy, as well as for drug screening. Third, in the realm of skin-on-a-chip, the company has developed epidermal, dermal, and full-thickness skin models, which have demonstrated promising efficacy in applications related to whitening, anti-aging, and spot removal; these models have passed OECD testing and have been included in the public notice for national standard project initiation. Fourth, the company has developed a high-content imaging system specifically for organ-on-a-chip and organoid platforms, leveraging intelligent algorithms to analyze organoid growth, development, and response trends following drug administration.
“The most fundamental aspect of industrialization is to solve practical problems,” said Sha Lifeng. “Organ-on-a-chip technology not only requires robust technical capabilities but also demands in-depth collaboration with hospitals, pharmaceutical companies, and other stakeholders. It is difficult to develop products that are truly accepted or satisfactory to the market by working in isolation.”
During its corporatization process, Jiangsu Aiweide Biotechnology Co., Ltd. received R&D cooperation funding support from the Suzhou High-Tech Zone and the Jiangsu Industrial Technology Research Institute. Meanwhile, the founding team recognized that competition in the organoid and organ-on-a-chip sectors had intensified by 2021, necessitating an acceleration of external fundraising efforts. External investors had shown interest in Aiweide at an early stage. Ultimately, the company officially announced this July the completion of its Pre-A financing round, raising nearly RMB 100 million, marking one of the largest financing events in China’s organoid and organ-on-a-chip field in recent years.
Developing Organ-on-a-Chip Technology Requires Anchoring to International Standards
The concept of organ-on-a-chip originated in Europe and the United States. In 2011, the U.S. National Institutes of Health (NIH) and the Food and Drug Administration (FDA) elevated organ-on-a-chip technology to the level of national strategy for the first time. Subsequently, European countries also increased their investment in this field, leading to the establishment of organ-on-a-chip consortia in both the United States and Europe.
This year has witnessed new milestone developments in the organ-on-a-chip field, such as the FDA’s approval of the first new drug (NCT04658472) to enter clinical trials based on preclinical data derived from “organ-on-a-chip” studies, and the unanimous passage of the FDA Modernization Act 2.0 by the U.S. Congress, which advances drug screening from traditional animal models to novel in vitro models and imposes higher regulatory standards.
Globally, organizations such as the International Microphysiological Systems Society (iMPSS), headquartered in the United States, have emerged this year to promote industry standardization. Professor Gu Zhongze is one of the 16 founding board members of the organization and the only Chinese national serving on the board.
Chen Zaizao emphasized, “In the organ-on-a-chip industry, it is crucial to stand alongside international peers and engage in discussions on the same stage, where having a voice is of utmost importance.”
Equipped with an international perspective, the team at Jiangsu Aiweide Biotechnology Co., Ltd. has anchored itself to the most cutting-edge standards from the outset, positioning itself to compete on a global scale.
Amidst Fierce Competition, Chinese Companies Must Secure a Foothold
Shali Feng stated that he hopes Jiangsu Aiweide Biotechnology Co., Ltd. can become the leading enterprise in China’s organ-on-a-chip sector, which, in terms of mission and strategic planning, is distinct from companies focused on organoids or drug development.
Jiangsu Aiweide Biotechnology Co., Ltd. has long been committed to collaborating with organ-on-a-chip manufacturers, aiming to jointly establish standards and facilitate the smoother development of organ-on-a-chip technology. This year, Professor Gu Zhongze established the Branch Committee on Organoids and Organs-on-Chips under the Chinese Society for Biological Engineering and serves as its Chairman. The General Technical Requirements for Skin-on-a-Chip, led by Professor Gu Zhongze’s team, has also been publicly listed as a proposed national standard project.
Aiweide not only aligns with internationally leading organ-on-a-chip concepts but also possesses independently developed intellectual property rights. It has established a comprehensive organ-on-a-chip technology system encompassing chip fabrication, biomaterials, tissue engineering, microfluidics, detection instruments, and intelligent analysis. Currently, Aiweide has collaborated with more than 20 universities and research institutes as well as 10 hospitals. Its organ-on-a-chip platforms and systems have been tested and utilized by several prominent domestic pharmaceutical companies, including Hengrui Medicine, Chia Tai Tianqing Pharmaceutical Group, Simcere Pharmaceutical Group, and Qilu Pharmaceutical. Furthermore, an organ-on-a-chip-based efficacy evaluation for a drug candidate conducted in partnership with a major pharmaceutical company has already been submitted for Pre-IND application.
Amid the fragmented landscape of organoids and organ-on-a-chip technologies, China needs to secure its own place, a goal that will be achieved through the joint efforts of Jiangsu Aiweide Biotechnology Co., Ltd. and other companies in the organoid and organ-on-a-chip sectors. Dr. Sha Lifeng holds long-term aspirations for the company’s vision: “The current landscape of the organ-on-a-chip industry closely resembles that of the sequencing industry a decade ago. We hope that Aiweide will ultimately become the Illumina of the organ-on-a-chip field.”