Luohua Bio Launches Over 10 Proprietary Organ-on-a-Chip Platforms, Cutting Drug Development Timelines by 30%

April 11,FDA Issues Statement,The plan is to gradually phase out traditional animal testing requirements for antibodies and other drugs, replacing them with AI-based computational models, laboratory-cultured organoids, organ-on-a-chip systems, and real-world data.Enhancing the efficacy of drug safety testing, accelerating the assessment process, and reducing R&D costs, ultimately lowering the prices of innovative drugs. This initiative is regarded as a historic paradigm shift in drug development.

Organoids are three-dimensional (3D) structural tissue analogs with defined spatial architecture and multiple cell types, generated through in vitro 3D culture of adult stem cells or pluripotent stem cells. Compared with traditional two-dimensional (2D) cell culture models, 3D organoids better recapitulate complex structures and functions, thereby providing more precise and reliable experimental models for disease research and clinical diagnosis and treatment.

However, the organoid construction process involves not only cellular differentiation, self-organization, and spatially constrained lineage specification, but also requires precise control over specific cell culture conditions and biological factors, resulting in limited reproducibility and engineering scalability. Consequently, organ-on-a-chip platforms, which incorporate greater biomimetic and engineering principles, have emerged.

Organ-on-a-chip/organoid-on-a-chip technology is an emerging field resulting from the integration of microfluidics and organoids, encompassing multiple disciplines including physics, chemistry, biology, materials science, engineering, and microelectromechanical systems (MEMS). In simple terms, organ-on-a-chip builds upon traditional organoid culture by utilizingCore Microfluidic Chip Platform Achieves Reverse Biomimetics, high-throughput cultivation and precise regulation of complex physiological environments (such as microenvironments, tissue interfaces, etc.), thereby achievingApplications such as dynamic continuous monitoring, integration of multiple biological functions into a single system, and high-throughput drug screening。

In May 2019, a research team from the University of Science and Technology of China initiated the establishment of Anhui Luohua Biotechnology Co., Ltd. (hereinafter referred to as “Luohua Biotech”) in the High-Tech Zone of Hefei City. Over the past six years since its inception, Luohua Biotech has been dedicated to the development of organ-on-a-chip technology, having launched more than 10 types of organ chips and related supporting products, inScientific Research, Regenerative Medicine, Disease Model Construction, Personalized Treatment Plans, Traditional Chinese Medicine R&D, and Medical Aesthetics-Related Fieldsproviding advanced products and technical services in fields such as.

“Engineering is the most prominent feature of organ-on-a-chip technology. Only by achieving engineering and productization can organ-on-a-chip systems truly supplement and replace animal models in the future.”Dr. Miao Chunguang, Founder and CEO of Luohua Biotechnology, emphasized that from a technical perspective, organoids follow a biological pathway to form “cell clusters” with certain tissue and organ characteristics; whereas organ-on-a-chip is a multidisciplinary field of bioengineering that cultivates miniature human organs in vitro using microfluidic cell culture devices.

This micro-scale cell culture device centers on a microfluidic chip to establish multiple cell culture compartments that mimic human tissue and organ environments. These compartments are further interconnected via a biomimetic circulatory system, forming a platform with controllable microenvironments that enables the in vitro realization of key organ functions.Furthermore, organ-on-a-chip devices can incorporate multiple “organs” to form a microphysiological system (MPS), enabling the in vitro construction of complex physiological models—such as drug metabolism and inter-organ interactions—for practical applications in areas including drug metabolism.

Miao Chunguang, who has a background in mechanics, was first exposed to organ-on-a-chip technology while pursuing his Ph.D. at the University of Science and Technology of China. Captivated by its innovation and potential, he embarked on an in-depth exploration and research journey in this field. Miao pointed out, “Organ-on-a-chip technology deeply integrates multiple engineering disciplines, including bioengineering, materials engineering, and mechanics, spanning from chip design, fabrication, and packaging to later-stage perfusion devices and biomimetic mechanism studies. For instance, the technical systems employed for chip development and fabrication, such as soft lithography or computer numerical control (CNC) machining, represent critical engineering challenges. However, traditional biology and biomedical education severely lack training in mathematics, physics, chemistry, and engineering.”

Therefore, in 2019, Miao Chunguang founded Luohua Biotechnology and gradually built a team of scientists with interdisciplinary backgrounds in medicine and engineering:The R&D team led by the University of Science and Technology of China possesses interdisciplinary expertise in mechanics, tissue engineering, materials science, and biology, which is fully aligned with the organ-on-a-chip development framework.Among them, Professor Luo Tianzhi, a doctoral supervisor at the University of Science and Technology of China (USTC) who has long been engaged in biomechanics research at Johns Hopkins University, serves as Chief Scientist; Professor Ding Weiping, a doctoral supervisor at USTC with many years of experience in organoids/organ-on-a-chip, biomaterials, and biosensors, serves as Chief Technology Officer.

Miao Chunguang’s explorations and the founding of Anhui Luohua Biotechnology Co., Ltd. coincided with the rising momentum behind organ-on-a-chip technology. In 2011, the United States launched the “Microphysiological Systems” program, elevating the development and application of organ-on-a-chip technology to the level of national strategy. In 2021, China’s Ministry of Science and Technology included “organoid-based malignant tumor disease models” among the first batch of key special projects initiated under the National Key Research and Development Program during the 14th Five-Year Plan period, stipulating that “when suitable animal models are unavailable to meet experimental needs, alternative models such as organoids may be used for testing.” In 2022, the U.S. House of Representatives passed the FDA Modernization Act 2.0 (amending the Federal Food, Drug, and Cosmetic Act), formally incorporating organ-on-a-chip and microphysiological systems as alternative models within an independent non-clinical drug evaluation framework into the legislation.

From the perspective of industrial development, Luohua Biotechnology has adopted a dual-track strategy: clinical applications of organoids and the establishment of an organ-on-a-chip platform.

In the early exploratory phase, the R&D team initially focused on collaborating with clinical partners in the field of tumor organoids. Compared to traditional 2D cell lines used in experimental applications, tumor organoids possess an unparalleled 3D heterogeneous structure that can “inherit” the patient’s tumor phenotype. Furthermore, tumor organoids circumvent the species-specific differences inherent in animal models, significantly reducing experimental costs and timelines while enhancing clinical concordance. This makes them suitable for guiding personalized medication strategies for cancer patients in clinical settings.

The 2022 “Expert Consensus on the Clinical Application of Organoid Drug Sensitivity Testing to Guide Precision Oncology” states that tumor organoids derived directly from patient tumor tissues have been confirmed to maintain high concordance with the histopathological features, molecular characteristics, and drug sensitivity profiles of the patients’ tumors. Due to their high accuracy in predicting therapeutic efficacy based on drug sensitivity, they can be utilized for drug sensitivity testing of most chemotherapy and targeted therapy agents.

During this phase, the team at Anhui Luohua Biotechnology Co., Ltd. accumulated extensive clinical R&D experience and gradually strengthened its talent pool in the fields of biology and medical laboratory science. In 2021, the Luohua Medical Laboratory officially obtained accreditation as a third-party testing provider, becomingOne of the earliest biotechnology companies in China to provide organoid-based drug sensitivity testing for clinical applications.To date, Anhui Luohua Biotechnology Co., Ltd. has completed drug sensitivity testing for nearly 10,000 cancer patients and may further explore overseas markets in the future.

Furthermore, Luohua Biotechnology launchesOne-stop, end-to-end technical support for organoid culture, along with配套 culture media kits and low-attachment culture plates. Our self-developed organoid culture media cover liver, brain, stomach, colorectal, breast, and other tissues. The human brain organoid culture medium is a pioneering product in China, boasting a high success rate in organoid model establishment.

Unlike clinical medication and precision diagnosis and treatment, the development of organ-on-a-chip technology in drug R&D demands higher standards. Miao Chunguang pointed out, “The clinical stage requires precise feedback within a short timeframe and involves relatively qualitative comparisons to rank and select optimal drugs and treatment regimens; therefore, low-throughput organoids can meet these needs. However, as organoid technology matures and begins to be applied in pharmaceutical companies’ R&D and screening processes, high throughput, standardization, and automation have become essential requirements for further development.”

In principle, for organ-on-a-chip technology to become an independent non-clinical experimental evaluation system,The key lies in its ability to enable high-throughput, highly biomimetic 3D models with microenvironments, thereby addressing the limitations of traditional drug development evaluation.: 2D cell culture struggles to simulate the tissue microenvironment and lacks dynamic in vivo-like conditions; animal models are costly, and real-time monitoring of drug-cell interactions is difficult in animal tumor models; conventional 3D models fail to replicate the microenvironment of physiological systems characterized by multi-structural, multi-scale, and multi-component features; furthermore, there is insufficient evaluation of efficacy in emerging therapies such as cell and gene therapy and immunotherapy, as well as in specialized applications including drugs for neurological diseases, tumor vasculature, and the tumor microenvironment.

Building on over a decade of dedicated R&D, the team at Anhui Luohua Biotechnology Co., Ltd. has independently developed systematic solutions—including organ-on-a-chip automation equipment such as culture media materials, 3D cell culture plates, portable CO2 transport boxes, and live-cell workstations—adhering to industrial logic. This effort has established a fully localized platform covering the entire workflow from “sample–chip–equipment–data.”

Currently, Luohua Biotechnology has independently established an organoid biobank comprising over 2,000 samples of tumor tissues and normal tissues, covering more than 10 common clinical cancer types and over 30 subtypes.Meanwhile, we have independently developed a variety of chip models, including full-thickness skin chips, lung chips, liver chips, intestine chips, kidney chips, tumor chips, and high-throughput chips, which can simulate the three-dimensional structures and functions of human organs.

“For example, the vascularized tumor-on-a-chip we developed—an in vitro physiological model with abundant capillaries—can simulate the microenvironment of angiogenesis and its inhibition around tumors. In the future, it will serve as a clinical alternative model for tumor-related anti-angiogenic drugs,” emphasized Miao Chunguang.Especially in the field of novel biologics such as cell and gene therapy and immunotherapy, organ-on-a-chip technology will fill the gap in relevant product guidelines.Moreover, liver and kidney organ-on-a-chip platforms have a wide range of applications, spanning drug toxicity testing and the development of therapeutics for various liver- and kidney-related diseases.

Meanwhile, Anhui Luohua Biotechnology Co., Ltd. has launchedMultiple Proprietary Intelligent Devices and Detection Systems, including microfluidic chip ancillary equipment (such as intelligent culture and observation systems for multi-organ chips), sample processing equipment (liquid handling systems, automated incubators, automatic centrifuges, automated robotic arms, etc.), and high-end detection equipment (cell counters, microplate readers, high-content imaging systems, etc.), which can support single-unit or fully automated operations for high-throughput experiments, significantly reducing R&D costs.

More practically, the application of organ-on-a-chip technology can minimize the cost and timeline of new drug development.“Time is the most critical cost in drug development. Whether for innovative drugs or biosimilars, first-to-market products enjoy significant first-mover advantages in terms of market potential and share.”By integrating AI algorithms, Anhui Luohua Biotechnology Co., Ltd. has launched an intelligent multi-organ-on-a-chip culture and observation system capable of consolidating experimental data from multi-organ chips to intelligently predict drug toxicity, metabolic pathways, and efficacy, thereby helping to shorten the new drug development cycle by more than 30%.

In March this year, Luohua Biotechnology and a China Time-Honored BrandMa Yinglong Pharmaceutical Health Research InstituteThe partnership will foster in-depth collaboration across multiple perspectives, including innovative drug R&D, the broader health industry, and consumer product development. Built upon Anhui Luohua Biotechnology’s skin-on-a-chip technology, this cooperation leverages various skin models—such as epidermal, full-thickness, and vascularized skin constructs—tailored for diverse applications. These models simulate the physiological environment and inflammatory responses of human skin, enabling precise safety and efficacy evaluations for cosmetics and traditional Chinese medicine products.

“Through the application of skin-on-a-chip technology in the development of cosmetics, traditional Chinese medicine, and functional products, we can observe distinct advantages. By constructing tissue interfaces layer by layer, organ-on-a-chip systems establish an integrated microphysiological environment, enabling the observation and experimental recording of functional units such as active transport, passive transport, and basement membrane reconstruction. This capability is unattainable in organoids and previous experimental models,” said Miao Chunguang.

The disruptive impact of the novel experimental models and data lies in establishing a more precise, efficient, and multidimensional evaluation system and standard paradigm.Taking the collaboration with Ma Yinglong Pharmaceutical as an example, based on Luohua Biotechnology’s skin-on-a-chip platform, Ma Yinglong will provide a series of its drugs with anti-inflammatory potential to closely observe their effects on cellular behavior and the release of inflammatory mediators in simulated inflammatory environments. Furthermore, both parties aim to establish a more precise and efficient evaluation system for assessing the anti-inflammatory efficacy of pharmaceuticals.

The Iteration of Organ-on-a-Chip Technology: A Key Interface for the Future-Oriented Innovative Transformation of Traditional Chinese Medicine Enterprises. Miao Chunguang stated, “Traditional Chinese medicine enterprises have shown greater acceptance and enthusiasm for organ-on-a-chip technology than for innovative drugs.”In addition to the Ma Yinglong Research Institute, Luohua Biotechnology has also established R&D collaborations with several time-honored large-scale traditional Chinese medicine enterprises, multiple universities of traditional Chinese medicine, and research centers, includingQilu Pharmaceutical, Pien Tze Huangetc.

“Animal models are the gold standard for Western medicine, partly due to their potent effects, clear mechanisms of action, and the wide variety of available animal models. However, traditional Chinese medicine (TCM) emphasizes holistic and long-term effects. Given the current data requirements for innovative TCM drugs and the limited applicability of existing animal models, there is an urgent need in R&D for alternative models to be used in toxicology, efficacy, and pathology studies.”

Meanwhile, Anhui Luohua Biotechnology Co., Ltd. is developingMultiple pathological model chips to explore the possibility of connecting multiple single-organ chips in series,Advancing practices in pharmacokinetics, such as the three-layer glomerular filtration mechanism in hyperuricemia.The team has developed a serial model of six organs using intelligent devices.Following the order of blood circulation, organ chips are interconnected via microvasculature to establish a lung–heart–liver–other organs axis.

At the end of the interview, Miao Chunguang stated, “The future of organ-on-a-chip technology lies in high throughput and cost-effectiveness. High throughput signifies a comprehensive reduction in efficiency costs, while cost-effectiveness points to the accelerated expansion of application scenarios and potential in the global market.” As a domestically produced organ-on-a-chip solution, Anhui Luohua Biotechnology has already, during the R&D phase,Aligned with global market standards, products such as culture media are compatible with leading global life sciences equipment manufacturers like Revvity, potentially further expanding direct sales and distribution channels both domestically and internationally., capitalizing on the global trend of the FDA’s “mandatory substitution” policy in clinical drug development.