Hebei Tech Files IPO Prospectus: Leveraging 6000+ Clinical Experts and Business Model Innovation to Break Through in High-Demand Preclinical Animal Testing Market

Since 2023, the laboratory animal platform, once the overlooked final piece of the R&D ecosystem, has been eagerly introduced by biopharmaceutical industrial parks across China, with some parks even accelerating its independent development. As a result, laboratory animal platforms have suddenly become a highly sought-after scarce resource in the upstream segment of the biopharmaceutical industry.

Laboratory animals, often referred to as “living reagents,” constitute a unique category of tools in life sciences. The term “laboratory animals” refers to animals that are bred under controlled conditions, with managed microbial flora, defined genetic backgrounds, or clear 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, forming a vast supply and management system. Despite considerations such as animal welfare, the overall trend in the structure of laboratory animals should be to minimize the number of animals used and replace higher-order animals with lower-order ones.However, as a product of the phased achievements in scientific and technological development, laboratory animals remain an indispensable and critical component of life science tools.。

Founded in 2009, Hebei Technology recognized the potential of this promising sector in its early stages, andBuilding a Scientific Research Service System on the Foundation of Animal Experiments。

Yang Ruhui, Technical Director at Hebei Technology, holds a Ph.D. in Pharmacology from China Pharmaceutical University and completed postdoctoral research. He has led or participated in seven national- and provincial/ministerial-level scientific research projects and holds more than 13 patents for inventions and utility models. During his doctoral studies, Mr. Yang specialized in pharmacodynamic testing and played a key role in numerous critical experiments for drug development.

Yang Ru recognized the immense potential of efficacy evaluation in new drug development. Driven by his foresight into this promising sector and his extensive accumulation of clinical research experience, Yang Ru became determined to launch a startup. Thus, Hebei Technology was established.

Initially, Hebei Technology served major scientific research projects at universities and hospitals,Accumulating animal experimentation experience step by step through participation in international-level research projects. In this process, the company has established various disease models, laying a solid foundation for subsequent business expansion. With the accumulation of experience, the company has graduallyExpanding into the Field of Drug Efficacy Evaluation, and has established partnerships with several well-known pharmaceutical companies, such as Huadong Medicine.

At that time, the demand for drug testing in China was still relatively simple, primarily consisting of basic testing needs; however, as time went on,Especially between 2013 and 2014, demand for animal studies and efficacy evaluation of new drugs began to grow rapidly., Hebei Technology seized the opportunity to settle in the Hangzhou Future Sci-Tech City Overseas High-Level Talent Entrepreneurship Park in 2012. In 2014, it was recognized as a high-tech enterprise by Hangzhou Municipality and approved to establish an SPF Animal Experiment Center, becoming a member unit of the Zhejiang Provincial Laboratory Animal Industry Association. Meanwhile, the company participated in establishing a quality management system compliant with ISO/IEC 17025, "General Requirements for the Competence of Testing and Calibration Laboratories." In 2016, Hebei Technology obtained CNAS accreditation.

Currently, Hebei Technology has established a first-class technical management team primarily composed of senior researchers, with over 50% holding master’s or doctoral degrees. The company has engaged in comprehensive collaborations with numerous domestic and international universities, research institutes, and pharmaceutical enterprises across various fields, including scientific research technical services and medical device product development.

It is worth noting that in the early days of animal experimentation in China, there was a scarcity of specialized professionals, particularly high-level veterinarians and surgical support experts. Fortunately, since its establishment in 2009, Hebei Technology has been committed to providing comprehensive scientific research services. In this process,The company not only regards clinicians as service recipients, but also as close collaborative partners.. By deeply understanding and addressing the pain points encountered by clinicians in clinical practice, Hebei TechnologyGradually established a vast network of clinical experts。Hebei Technology has established an expert resource pool comprising over 6,000 clinicians. When complex experiments arise that the animal center cannot resolve independently, Hebei Technology can rapidly collaborate with these experts to devise solutions.。

As most experiments closely simulate the clinical use of medical devices, it is necessary to verify their safety and efficacy in animal subjects before proceeding to human trials, a process that bears a high degree of similarity to clinical surgical procedures. Therefore, Hebei Technology’s expert pool and the solutions provided by its collaborative experts exemplify the company’s advantage in resource integration. In recent years, with the rising trend of domestic substitution for medical devices in China, Hebei Technology has timely expanded its service portfolio to include safety and efficacy evaluation of medical devices. Currently, this segment accounts for approximately 70% of the company’s business, becoming its core operation.

In this regard, Chen Danfeng, Deputy General Manager of Hebei Technology, summarized: “We did not rush into the fierce competition of new drug efficacy evaluation when our foundation was weak. Instead, we first accumulated experience through scientific research services, and then gradually transitioned toward efficacy evaluation and medical device services. This strategy has allowed us to maintain competitiveness in the market and successfully seize opportunities for industry development.”

Hebei Technology’s core strategic layout began with the establishment of its Animal Experimentation Center, a module regarded as the cornerstone of its entire service system. The Animal Experimentation Center is not only a critical component for evaluating drug efficacy and verifying the safety and effectiveness of new drugs and medical devices, but also an indispensable foundation for scientific research services. Meanwhile, in the medical device CRO industry, a comprehensive system encompassing animal experimentation, pathology, and biochemical testing is essential to ensure the accuracy of experimental results—a capability that many small and medium-sized CRO companies currently lack.

To this end,Hebei Technology integrates pathology laboratories with multiple imaging platforms., these platforms are all supported by senior technical experts from Zhejiang University, ensuring the comprehensiveness and reliability of experimental data.

With the rise of combination products integrating drugs and medical devices,Based on its extensive experience in securing regulatory approvals for multiple drug-device combination products, Hebei Technology has accordingly adjusted its strategic layout.. Leveraging its accumulated expertise in pharmacodynamics and medical devices, the company has developedSpecialized Services for Drug-Device Combination Products, such as through fluorescence labeling, biotin labeling, and isotope labeling, to conduct in-depth studies on the degradation, distribution, and metabolism of the product in vivo.This initiative not only targets the industry's pain points but also propels Hebei Technology headfirst into the innovative sector of passive material science products.。

Hebei Technology’s Six Major Service Platforms. Image source: Hebei Technology

In addition, Hebei Technology alsoEmphasize the establishment of interdisciplinary platforms, such as the development of a cell biology platform., to meet the demand for mechanistic research on energy-based medical devices at the cellular level. This comprehensive service platform model has enabled Hebei Technology to expand its business collaborations in the two major sectors of active energy-based products and medical aesthetics devices.

In the field of active medical devices, Hebei Technology has assisted numerous domestic medical device manufacturers in achieving FDA approval for animal studies with zero deficiency letters. For energy-based products, including ablation devices, pulsed-field systems, and microwave ablation instruments, Hebei Technology provides comprehensive service solutions by integrating animal experiments, imaging observations, and histopathological analysis to thoroughly evaluate ablation efficacy and in vivo tissue damage. These successful collaborative projects have effectively consolidated its industry presence and attracted peer enterprises to seek partnership for verification services.

In the field of medical aesthetics devices, Chen Danfeng noted, “Medical aesthetic products are inherently devices; however, the involvement of pharmaceutical companies has intensified competition and led to a convergence of drugs and devices.” As domestic pharmaceutical enterprises have increasingly entered the medical aesthetics market and invested in the emerging biomanufacturing industry, Hebei Technology has rapidly adapted to this new trend of integrating medical aesthetic devices with pharmaceuticals, leveraging its accumulated expertise in drug efficacy evaluation. Currently, Hebei Technology provides one-stop preclinical services—ranging from product design to clinical validation—for numerous well-known pharmaceutical companies and medical aesthetics brands, and has successfully facilitated market access approval for multiple medical aesthetic products.

In the current highly competitive market for medical device CROs, particularly within animal testing centers, although industry demand has not seen significant growth, the number of laboratory facilities on the supply side has increased substantially. This has further intensified market competition, leading to a trend of involution.

In response, Hebei Technology has adopted a differentiated competitive strategy by focusing on assisting manufacturers of active medical devices in formulating overseas expansion strategies to address the challenges of intense domestic competition, thereby helping Chinese enterprises enter the international market. Although Hebei Technology does not directly participate in the operation of overseas animal testing centers, it leverages its domestic animal testing capabilities through collaborations with international clinical CROs. This approach attracts medical device manufacturers located in Europe who face difficulties in conducting experiments due to animal ethics restrictions.

Furthermore, in the field of medical aesthetics products, Hebei Technology has chosen to focus on research into the in vivo degradation of such products. By employing advanced techniques such as fluorescent labeling, biotin labeling, and isotope labeling, the company is able to provide its partners with more precise solutions.

Chen Danfeng pointed out that in the highly competitive fields of animal experimentation platforms and medical device CROs, the key to Hebei Technology’s sustained competitiveness lies in its differentiated business strategy. She emphasized that given the wide variety and complexity of medical device sub-sectors, breakthroughs in a single core technology often fail to drive significant market growth. In contrast, transitioning from a CRO to a CDMO business model can more effectively facilitate scale expansion. Furthermore, Hebei Technology has clearly defined areas it will not enter as part of its strategic planning; for instance, the company has proactively avoided sectors such as cardiac stents and other cardiac-related segments involving DIC equipment.

Chen Danfeng summarized the market attractiveness of Hebei Technology into several points:

First, Hebei TechnologyPossess a Solid Foundation, in addition to the approved establishment of an SPF animal experimental center, the company also participated in establishing a quality management system compliant with ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories” and obtained CNAS accreditation, which constituteFundamental Guarantee of Experimental Quality。

Secondly, Hebei Technology has been deeply rooted in the Jiangsu-Zhejiang-Shanghai region for many years,Successfully established a vast resource network comprising 6,000 cliniciansThis characteristic enables Hebei to engage in in-depth communication with clinicians, accurately grasp product features, and proactively identify and address potential issues through comprehensive evaluations and expert reviews by clinical specialists during real-world applications, thereby effectively mitigating risks associated with the clinical trial phase.

Furthermore, Hebei TechnologyAccumulated extensive experience in differentiated competitive products, particularly in the market launch of multiple medical aesthetic products and the FDA animal study validation of active energy-based devices.This specialized service capability enables Hebei to precisely match the needs of different medical device R&D enterprises, provide customized solutions, help companies quickly replicate successful experiences, and accelerate the product launch process.

Furthermore, for customers in the Jiangsu-Zhejiang-Shanghai region, Hebei Technology, as part of Zhejiang Province’s science and technology innovation platform, alsoBenefited from the government's innovation voucher subsidy policy.. This policy has delivered tangible economic benefits to clients, enabling contract amounts for collaborative projects to receive subsidies ranging from 30% to 50%. Coincidentally, amid changes in the capital market environment and intensified anti-corruption efforts in recent years, this subsidy has garnered increasing attention from clients, thereby evolving into a distinct competitive advantage.

When discussing the company’s future development plans, Chen Danfeng pointed out that Hebei Technology will focus on pragmatic and grounded strategies in the short term, namely continuing to deepen its preclinical animal testing services for medical devices, thereby helping more medical device products obtain certification and successfully enter overseas markets. Meanwhile, the company plans to increase its involvement in research on the application of materials science in medical devices, such as validation studies on material safety, in vivo degradation, and metabolism, so as to promote innovation and development in the field of medical devices.