Haihe Biomedical, a Leading China-based Medical Device CXO, Files IPO Prospectus After Five Consecutive Years of High Growth

In 2023, various industries in China erupted like long-dormant volcanoes. This was particularly evident in the medical device sector, where government agencies joined forces with enterprises to secure overseas orders, industrial parks engaged in fierce talent wars, and a cohort of scientists in the field committed to full-time entrepreneurship.

Amid the booming medical device industry, the device CXO sector has also begun to accelerate its development. For instance, Haihe Bio, a leading enterprise in China’s device CXO field, has achieved high-speed growth for five consecutive years.

According to reports, Haihe Bio is a platform-based company that specializes in providing full lifecycle services for products to research institutions, R&D and manufacturing enterprises, and regulatory authorities related to medical devices and pharmaceuticals. It holds a prominent industry position in the biomedical CRO sector, with its business covering full product lifecycle services, service-oriented manufacturing, intelligent creation, and third-party testing and certification.

Since its establishment, Haihe Biologics has not only served highly demanding multinational medical device companies such as Johnson & Johnson, Medtronic, Philips, and Siemens, but also leading domestic enterprises including Mindray, Weigao, United Imaging, Xinwei Medical, and Double Medical, thereby accumulating extensive experience. Meanwhile, Haihe Biologics also serves numerous other innovative medical device companies that pursue higher standards in product quality and technology and aspire to expand their products into overseas markets.

In 2022, Haihe Biology was honored with the “Deloitte China Technology Fast 50 Rising Stars 2022” title and was selected for inclusion in the Demonstration Platform for Industrial and Information Technology Service Manufacturing, the Jiangsu Province Science and Technology Innovation Voucher Service Provider Registry, and the List of National Public Service Demonstration Platforms for Small and Medium-sized Enterprises (SMEs) for 2022. Additionally, Haihe Biology’s integrated toxicology and biology evaluation platform received support from the Central Government’s Special Fund for Guiding Local Scientific and Technological Development.

Why Has Haihe Biology Gained Recognition and Favor from Renowned Domestic and International Medical Device Companies and Governments at All Levels? A Multi-Dimensional Analysis Based on Its Business, Team, Achievements, and Reputation.

Currently, Haihe Biologics' business is primarily divided into three major segments: testing and inspection, regulatory consulting, and CDMO.

Among these services, testing and inspection provide compliance testing and inspection services for medical devices, pharmaceuticals, and pharmaceutical packaging materials in accordance with Chinese and international requirements, as well as preclinical animal studies for medical device products. This business covers all medical device products, including active, passive, implantable, and interventional devices, excluding in vitro diagnostic reagents.

In China, third-party testing and inspection of medical devices remains an emerging market. It was only in 2021, with the issuance of the new Regulations on the Supervision and Administration of Medical Devices by the state, that medical device manufacturers were permitted to commission third-party testing and inspection agencies for such services. Previously, domestic medical device testing could only be conducted by testing institutions designated by the National Medical Products Administration (NMPA).

In 2022, the state issued detailed regulations clarifying that medical device testing and inspection institutions with China Metrology Accreditation (CMA) qualifications are permitted to conduct testing and inspection services for medical devices, and that the National Medical Products Administration (NMPA) recognizes third-party test reports issued by such CMA-accredited institutions, thereby truly opening the door to rapid development for the third-party testing and inspection industry.

Currently, Haihe Biologics has procured internationally advanced hardware equipment and established a joint laboratory in collaboration with Shimadzu Corporation (Japan). This enables the company to deliver rigorous testing results that meet high requirements and stringent standards. In accordance with advanced domestic and international testing standards, Haihe Biologics conducts animal studies involving rats, mice, guinea pigs, rabbits, dogs, sheep, and pigs, and provides services including biocompatibility testing, microbiological testing, process validation, and preclinical animal trials.

In terms of the team, Haihe Bio’s members span multiple disciplines, including chemical analysis, mechanical properties, veterinary medicine, and pathology. With extensive professional experience, the team is well-equipped to meet clients’ specialized needs.

Leveraging hardware and software advantages,Haihe Biologics’ testing and inspection services not only hold national-level CMA and CNAS accreditations, meeting domestic requirements, but have also obtained recognition from the American National Accreditation Board (ANAB), the U.S. FDA Good Laboratory Practice (GLP) program, OECD GLP, and the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), ensuring broad acceptance of its reports.。

Hong Xiaoming, Chairman of Haihe Biology, stated: “Over the years, we have been continuously applying for certifications in countries around the world. By 2022, our reports finally achievedGlobally Recognized. Meanwhile, we have assisted clients in various regions with submitting test reports and completing their registrations.”

Compared with other testing and inspection institutions, Haihe Biotechnology leverages its advantages in talent and technical expertise to provide testing solutions for innovative medical devices and other medical devices that lack established testing standards or guidelines. Furthermore, as the entire experimental process is conducted within its own laboratories, Haihe Biotechnology can better ensure the quality of its experiments.

To date, Haihe Biologics’ testing and inspection services have served thousands of clients. In 2022 alone, the company provided testing services to hundreds of medical device manufacturers, issued over ten thousand test reports, and earned high recognition from its clients.

Today, Haihe Biology has been selected for inclusion in the MIIT’s List of Demonstration Platforms for Service-Oriented Manufacturing and recognized as a Tianjin Public Service Platform for Industrial Technology Foundations. It is expected to deliver high-quality services to a broader range of medical device enterprises.

Medical devices are high-tech, high-barrier products with highly complex manufacturing processes. Moreover, they are almost invariably the product of multidisciplinary integration, involving an extremely vast and diverse body of knowledge.

Based on this, regulations, guidelines, and registration guidance principles issued by regulatory authorities worldwide—such as China’s NMPA, the U.S. FDA, and the EU’s CE marking framework—are often abstract and difficult to concretize. Consequently, companies must further interpret the relevant provisions in light of their product-specific characteristics when submitting registration applications.

However, during this process, medical device companies are highly likely to deviate from regulatory requirements and considerations, thereby affecting product registration progress and approval timelines.

Moreover, medical device regulations in major countries worldwide are continuously evolving. Given their R&D cycles and registration frequencies, medical device companies often struggle to keep pace with regulatory changes and review trends. In contrast, medical device CXO firms maintain ongoing interactions with regulatory authorities across various countries, making them more attuned to shifts in regulations and review patterns. As such, they can provide medical device companies with advice that aligns more closely with regulatory requirements during product development.

On the other hand, scientific development always outpaces regulation. For instance, innovative medical devices such as medical AI, digital therapeutics, and brain-computer interfaces lacked a regulatory basis and corresponding testing standards during their early stages of development. Consequently, it is more challenging for these pioneering innovative medical devices to demonstrate their safety and efficacy to regulatory authorities during global registration and filing processes.

To address the mandatory registration requirements and aforementioned pain points of medical device enterprises, Haihe Biologics provides a comprehensive suite of services covering the entire lifecycle of all medical devices. These services include regulatory consulting, quality management system establishment, product registration and certification consulting for major global markets, as well as post-market adverse event handling and product recalls.

In the field of regulatory registration, Haihe Bio has built a multidisciplinary team with diverse backgrounds based on 18 years of experience. The team includes professionals in regulatory affairs, quality management, testing and inspection, and manufacturing, covering specialties such as software, hardware, mechanics, chemistry, and animal toxicology.

Meanwhile, the team comprises members with diverse backgrounds—some specialize in testing and inspection, others are well-versed in domestic registration, some focus on U.S. regulations, and others have an in-depth understanding of EU requirements. This multidisciplinary team delivers tailored services to clients as needed.

It is worth noting that in the field of innovative medical devices, due to their cutting-edge nature, verifying product safety and efficacy presents certain challenges, necessitating the integration of frontier international scientific research. This, in turn, requires regulatory affairs professionals to possess enhanced professional competencies, enabling them to comprehend the technical background and principles underlying these innovative products.

Furthermore, the verification of the safety and efficacy of innovative medical devices requires more advanced testing and inspection equipment. In this regard, Haihe Biologics is also continuously increasing its investment and procuring relevant equipment.

To date, Haihe Bio has assisted clients in securing over 1,000 medical device registration certificates both domestically and internationally. Notably, it helped a Chinese medical device company become the first to obtain U.S. FDA approval for orthopedic implants, facilitating the company’s entry into the U.S. market and accelerating the global expansion of China’s orthopedic industry.

In addition to testing and inspection, and regulatory consulting services,Haihe Bio has also expanded into the CDMO business.According to reports, Haihe Bio is currently building production lines for in vitro diagnostic reagents, passive implantable and interventional products, and active medical devices, and will provide contract development and manufacturing services to its customers. By offering regulatory consulting, testing and inspection, and CDMO services, Haihe Bio will deliver comprehensive solutions that guide clients from research achievements to final products.

Today, a large number of enterprises in China have entered the medical device CXO sector, resulting in a mixed landscape with varying levels of quality and professionalism.

In the view of Haihe Biotech, the core competitiveness in the medical device CXO sector lies in technology and professional ethics.

From a technical perspective, medical device CXO companies need to leverage their technological capabilities to address the shortcomings of medical device manufacturers, helping them reduce costs while ensuring high-quality and compliant understanding of regulations, completion of testing and inspection, acquisition of registration certificates, and efficient product manufacturing. Only by providing valuable value-added services based on technological advantages can medical device CXO companies and the industry gain greater recognition from more medical device manufacturers, thereby accelerating development.

In terms of professional ethics, reputation serves as a prized hallmark for medical device companies and a powerful tool for medical device CXO firms to acquire clients. However, building such a reputation typically requires years of accumulation and sustained commitment. In this regard, Haihe Biologics has established a strong reputation since it began serving medical device companies in 2005, earning recognition from both clients and the market.

In addition, Haihe Biologics has accumulated a substantial number of successful registration cases in various countries and regions, including China, the United States, the European Union, and Canada. These achievements serve as valuable references for future clients and demonstrate the strength of Haihe Biologics.

Having secured a leading position in the domestic market, Haihe Biologics is not resting on its laurels; instead, it plans to actively expand its overseas resources to become an international CXO enterprise and compete with global peers. Meanwhile, Haihe Biologics also intends to continuously enhance its testing capabilities to serve a broader range of enterprises.

In the CDMO sector, Haihe Bio will further build an ecosystem by introducing more high-quality partners to provide better services and meet customers’ end-to-end needs from laboratory-scale development to large-scale manufacturing.

Finally, to promote the high-quality development of China’s medical device industry, Haihe Biotechnology, in collaboration with the Third-Party Testing Branch of the China Medical Devices Industry Association and other stakeholders, will host the “Forum on Compliance and Strategic New Developments for China’s Medical Device Industry under the Dual Circulation Paradigm” in Tianjin on March 24, 2023, to discuss the future of the sector.

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