Home Preclinical Animal Testing Platforms Are in High Demand as Biopharma Parks Across China Rush to Secure Strategic Partnerships

Preclinical Animal Testing Platforms Are in High Demand as Biopharma Parks Across China Rush to Secure Strategic Partnerships

May 26, 2023 08:00 CST Updated 08:00

3“The number of industrial parks visiting for inspections has increased significantly since the beginning of the month,” said the head of an animal testing institution, speaking to VCBeat. His institution primarily uses large laboratory animals, such as minipigs and beagles, to help innovative medical device companies complete preclinical safety evaluations. It recently received investment from a park-based fund in a coastal region and is about to establish a new branch there.

 

The executive stated that as regulatory frameworks continue to be refined, the previously fragmented landscape of animal testing services is being replaced by large-scale, standardized service providers. Coupled with the entry of incremental innovative medical devices into a critical phase of product compliance, which has driven rapid market demand expansion, experimental animal platforms have demonstrated unprecedented commercial value.

 

A business development executive at a biomedical industrial park also told VCBeat that in March, the park’s fund completed an investment in a non-human primate experimental animal platform based in Beijing. The latter will be entrusted with managing the animal experimentation facility funded and constructed by the park. “We decided to hand over the platform’s operations to a specialized commercial team,” he stated. “On one hand, this will provide more efficient R&D outsourcing services to companies within the park; on the other hand, we hope that relatively mature experimental animal platform companies can aggregate resources across the upstream and downstream of the industry chain, thereby activating the park’s R&D ecosystem.”

 

Across more biopharmaceutical industrial parks in China, experimental animal platforms—once the overlooked final piece of the R&D ecosystem—are now being eagerly introduced or even accelerated through independent development. For instance, in February, Cyagen Biosciences settled into Guangdong Medical Valley and established a strategic partnership to build a public technical service platform for gene therapy drug screening. Meanwhile, the Bio-Work accelerator’s experimental animal platform, located in the Yichuang Gaoke Innovation Technology Park, obtained its “Laboratory Animal Use License.” In another example, a fund in Nanshan District, Shenzhen, invested in an axenic mouse company, filling the gap in the region for a headquarters dedicated to high-end experimental animals.

 

For a time, experimental animal platforms have become highly sought-after scarce resources in the upstream segment of the biopharmaceutical industry.


Experimental Animal Platforms Snatched Up


Direct investment is the simplest and most common approach for industrial parks to compete for laboratory animal platform resources. Between March and April alone, funds from biomedical industrial parks in Shanghai, Suzhou, Hainan, and other regions successively acquired stakes in leading laboratory animal platforms across various specialized sectors.

 

In March, Meifengli Medical, based in Jiangsu Province, completed its latest round of financing, with a total transaction value reaching hundreds of millions of yuan. The company specializes in providing outsourced preclinical animal testing services and serves numerous star innovative medical device enterprises in the Yangtze River Delta region. Since its establishment, Meifengli has conducted preclinical animal studies for over 300 innovative medical device products, many of which are first-of-their-kind in China. More than ten of these products have passed the review process through the National Medical Products Administration’s (NMPA) Innovative Medical Device Approval Channel, gaining recognition and establishing collaborative partnerships with national drug regulatory authorities, multiple provincial medical device testing institutes, and professional testing organizations.

 

According to data from Tianyancha, Taizhou Rongjianda, an investment institution that publicly invested in Meifengli Medical during previous financing rounds, is a professional investment firm controlled by Taizhou Medical City. The funds raised by Meifengli Medical in its latest round will be used to advance the operation of its preclinical GLP laboratory platform in Suzhou and the construction of its Phase II preclinical experimental platform in Taizhou, reflecting the close interaction between the experimental animal platform and the industrial park.

 

In April, Dingtai Pharma, also based in Jiangsu Province, announced the completion of its Series C financing. The investor roster for this round included not only star institutions in the healthcare investment sector such as Legend Capital, Honghui Fund, and Hillhouse Ventures, but also Lingang Science and Technology Innovation Investment. Bolstered by this new round of funding, Dingtai Pharma will continue to deepen its expertise in specialized therapeutic areas, provide non-clinical data with greater clinical value, and accelerate its international expansion by enabling integrated preclinical-to-clinical development of drugs in ophthalmology, central nervous system (CNS) disorders, and metabolic diseases.

 

In April, Lingfu Biotechnology, based in Beijing, completed an A2 financing round of nearly RMB 100 million. The lead investor was SDIC Venture Capital, with follow-on investments from Hainan Rongzhi Venture Capital and Sanya Yazhou Bay Venture Capital. This marks the second consecutive investment by Sanya Yazhou Bay Venture Capital in the company. Previously, Lingfu Biotechnology had completed multiple financing rounds, raising hundreds of millions of yuan in total and attracting several professional investment institutions, including Legend Capital and Puhua Capital. It is understood that Lingfu Biotechnology is a research service provider committed to integrating three core businesses: the full industry chain of laboratory animal resources, the full industry chain of animal model technologies, and high-value-added innovative scientific research services. The company primarily serves the development of drug targets for source innovation and the screening and validation of drug molecules by establishing a development platform for complex disease animal models. With the introduction of this new round of financing, Lingfu Biotechnology will strengthen its domestic and international layout of non-human primate (NHP) resource bases and the construction of experimental facilities related to brain science and nervous system disease models, while continuously improving its high-quality laboratory animal resources and high-value-added model technology industry chain.

 

During the COVID-19 pandemic, severe supply-demand imbalances led to the emergence of exorbitantly priced experimental non-human primates and specialized disease model mice. From a long-term industry perspective, the sudden surge in the cost of laboratory animals not only caused shock but also reshaped perceptions of preclinical research. As a fundamental element of innovative R&D, the laboratory animal industry has received the attention it deserves.


Experimental Animals Are the Foundation of Scientific Research


Experimental animals are known as "living reagents" and represent a unique class of life science tools.

 

Laboratory animals refer to animals that are bred under controlled conditions, with defined microbial status, clear genetic backgrounds, or known origins, and are used for scientific research, teaching, the evaluation of biological products or pharmaceuticals, and other scientific experiments. Various types of animals, including mammals, birds, and amphibians, can serve as laboratory animals.

 

The global laboratory animal industry has developed for nearly a century, establishing a vast supply and management system. Although ethical considerations regarding animal welfare dictate an overall trend toward minimizing the number of animals used and replacing higher-order species with lower-order ones, laboratory animals remain an indispensable component of life science research as a product of phased scientific and technological advancement. Typically, the degree of their standardization determines, to a certain extent, whether experimental results are scientific, credible, and reproducible. According to statistics from *Nature* and *Science*, papers involving animal models account for 35%–45% of publications.

 

Based on the level of microbial control, laboratory animals are classified into categories such as conventional animals, clean animals, specific pathogen-free (SPF) animals, gnotobiotic animals, and germ-free animals. Different types of animal experiments require different categories of laboratory animals.

 

For example, conventional animals are the primary type of experimental animals used in early-stage safety evaluation studies for innovative medical devices at the current stage. They represent the category of experimental animals with the lowest requirements for microbial and parasitic control, housed in open systems, and free from major zoonotic pathogens and highly contagious animal disease agents as specified by quality standards. In contrast, germ-free animals represent the highest level of microbial control among experimental animals; they are completely free of all parasites, do not exist in nature, and must be bred through artificial methods. The most commonly used animals in new drug development are Specific Pathogen-Free (SPF) animals. SPF animals are offspring of germ-free animals and require a longer breeding cycle. This is precisely why there was previously a situation in the model mouse market where demand existed but supply was unavailable.

 

Research on laboratory animal resources has long been a key focus in developed countries overseas. In the United States, the government has invested substantial funds to establish national-level laboratory animal resource and technical service institutions for various species, including rodents, non-human primates, aquatic animals, and invertebrates. Tens of thousands of distinct strains of laboratory animals have been successively developed to meet diverse scientific experimental needs, thereby accelerating innovation and progress in life sciences in the U.S. As a major consumer of laboratory animals, China ranks second only to the United States in production volume. It routinely utilizes genetic engineering models and disease animal models encompassing 30 species and 2,000 strains, including mice, rats, guinea pigs, rabbits, dogs, and certain primates.

 

In China, the laboratory animal industry is currently transitioning from the previous extensive model of self-production and self-sales to a standardized model characterized by marketization and high-tech industrialization. Since the 12th Five-Year Plan period, China has established eight national laboratory animal resource repositories, which preserve 810 breeds and strains of laboratory animals and more than 32,000 sets of biological characteristic data across 14 animal categories. “The market is gradually concentrating toward leading enterprises with higher levels of standardization,” pointed out a practitioner in the laboratory animal platform sector.

 

However, overall, China still lacks a long-term mechanism for the preservation, sharing, and research and development of laboratory animal resources, with overseas companies accounting for more than 30% of the conventional laboratory animal market.


Not Just Laboratory Animals


“China’s laboratory animal industry is still in its nascent, early stages,” the head of the aforementioned animal experimentation platform repeatedly emphasized to VCBeat during the interview. Securing laboratory animal resources is not merely about possessing a richer diversity of germplasm and species; rather, it is a complex systems engineering endeavor. The most critical elements involve the participation of experienced professionals and the development of comprehensive technical capabilities, leveraging cutting-edge technologies to enhance the efficiency of laboratory animal breeding and utilization.

 

Data show that the number of laboratory animal practitioners in China has exceeded 300,000. However, when further broken down by different business segments, the existing talent pipeline falls far short of industry demands. As the scope of laboratory animal platform services continues to expand and become more specialized, distinct subfields have emerged, including model development, husbandry management, animal boarding, testing technologies, genetic technologies, and diagnostic reagents. Each of these areas imposes varying requirements on practitioners’ educational backgrounds and technical competencies.

 

Specifically, the specialized technologies involved in experimental animal platforms encompass the entire process, including experimental procedures, result evaluation, and the development of novel animal models. Practitioners must apply cutting-edge biotechnologies to animal experiments to maximize experimental efficiency and optimize animal welfare. Furthermore, standardized animal experimentation requires, to a certain extent, that industry teams transition from ordinary animal caretakers to animal specialists equipped with medical knowledge and technical skills.

 

First is the application of minimally invasive techniques in laboratory animals. In animal experiments, surgical procedures are indispensable. Typically, while conventional surgery affects the normal tissue structure and physiological functions of experimental animals, it also impacts non-target organs, causing unintended effects such as inflammatory responses, hemorrhage, trauma, and pain. These reactions can significantly interfere with experimental outcomes. With the continued application of minimally invasive techniques in the medical field, technologies such as endoscopy, laparoscopy, ultrasound guidance, and radiological intervention have been introduced into animal experiments to minimize the impact of surgery on the organism. This undoubtedly places higher demands on the operational skills of researchers; extensive surgical procedures previously performed by general technicians now require precise execution by professionals with specialized technical backgrounds.

 

Next are advanced detection technologies, including molecular-level laboratory tests and imaging examinations, which constitute the most critical aspect of animal experiments. In terms of laboratory testing, techniques such as bacterial culture, ELISA, immunofluorescence, immunoenzymatic assays, hemagglutination, and hemagglutination inhibition are commonly employed. With technological advancements, DNA detection technology has also been introduced as a tool for assessing the genetic quality of blood or certain tissues. Regarding imaging examinations, molecular imaging technologies have evolved from traditional imaging methods. These primarily include bioluminescence imaging (BLI) and fluorescence imaging (FMI). By labeling with luciferase genes and fluorescent reporter genes (such as GFP, RFP, Cyt, and dyes), and utilizing highly sensitive optical detection instruments, these techniques enable direct monitoring of cellular activities and biomolecular behaviors in living organisms.

 

Finally, there is the development of new animal models, including the construction of novel disease models and the exploration of alternatives among experimental animals of different taxonomic ranks. This involves cutting-edge gene-editing techniques, even base editing technologies. Since the biological activity of many biologics is associated with species and tissue specificity, safety evaluations cannot rely on conventional animals (such as rats and dogs) using standard toxicity study designs; instead, relevant species should be used. For example, in the quality testing of live attenuated polio vaccines, only primates can be employed because other animal species are insensitive to the virus. To address this, based on the characterization of the nucleic acid structure of the human poliovirus receptor (PVR) gene, scientists have established transgenic mice carrying the human PVR gene (Tg PVR mice) for neurovirulence testing of polio vaccines. The results showed that clinical observations were consistent with histopathological findings in these transgenic mice after vaccination with the vaccine virus. Moreover, the frequency of clinical symptoms in mice was significantly higher than that observed in monkeys during monkey trials, making them easier to monitor.

 

Of course, in addition to purely technical factors, the standardized development of China’s laboratory animal industry requires continuous improvement in external areas such as regulatory oversight and funding channels. For instance, to address issues of substandard and inconsistent quality in laboratory animals, China needs to refine its laws and regulations, strengthen the development of national standards, and enhance the construction of industry organizations and standardization systems. Furthermore, it is essential to establish stable funding channels by incorporating the preservation of laboratory animal resources, quality assurance, and big data platforms into the national science and technology infrastructure platform, thereby providing long-term and stable financial support to foster a virtuous cycle of continuous resource accumulation and expansion.

 

Resources on experimental animal platforms have become highly sought-after, which may increase experimental costs in the short term. However, in the long run, they are a key component in building an innovative ecosystem for biomedicine. We hope that, bolstered by the continuous influx of capital, China’s experimental animal industry will transition more rapidly toward efficient standardization.