Zhiying Huizhong Medical Submits IPO Prospectus Highlighting 'Innovation + Entrepreneurship + Venture Capital' Model

“I find it truly rewarding to continuously help my clients and entrepreneurial founders achieve project success, as well as connect them with resources to ensure their projects reach fruition,” Zhou Gui, founder of Zhiying Huizhong, told VCBeat.

Zhiying Huizhong was established in Beijing in 2018. As a CRO service provider, Zhiying Huizhong initially focused on regulatory consulting during its early stages and is now committed to providing medical device manufacturers with comprehensive technical and investment-financing services spanning the entire process from research and development to product commercialization.

Over the past two years,Zhiying Huizhong has partnered with more than 50 companies, including six or seven publicly listed ones. This year alone, approximately six of its Class III medical device products have entered the clinical trial phase.Zhiying Huizhong is now like a thriving tree, gradually sprouting new buds and bearing abundant fruit.

The origins of Zhiying Huizhong can be traced back more than a decade. In 2006, China’s medical device industry was in its nascent stage, with regulatory frameworks for medical devices still underdeveloped. As the industry evolved, medical device manufacturers urgently required specialized professionals to provide regulatory compliance consulting.

At the time, Zhou Gui, then a university lecturer, resolutely resigned from his academic position to join the corporate sector, focusing on testing and certification of medical devices. He subsequently worked on regulatory registration for medical devices at SGS and Jietong Consulting, the latter of which was renowned at the time as the “Whampoa Military Academy” for medical device regulatory affairs. After Jietong Consulting was merged into Tigermed, Zhou Gui became the Technical Director for Medical Devices at Tigermed.

In the realm of medical regulations, Zhou Gui has been engaged for approximately six years, with his experience spanning over a decade when including his student days. Throughout this long journey, he has witnessed the entire process of changes and reforms in China’s medical device regulations.

“In fact, the majority of medical device manufacturers in our country are severely lacking in foundational knowledge of technical regulations for medical devices.The entire industrial chain is dominated by Class II medical devices, with only about 2,000 certificates issued for domestically produced Class III medical devices.“This figure still does not exclude the number of certificates for discontinued medical devices,” Zhou Gui stated truthfully.

Under such circumstances, medical device manufacturers urgently require professional Contract Research Organization (CRO) services to address regulatory registration and certification challenges. However, establishing a technically proficient CRO is no easy feat, as it demands professionals with extensive industry experience. Meanwhile, this trend brings about another shift: highly skilled talents with rich practical experience must be matched with a corresponding service value system.

Some companies have recognized the issue of underpriced CRO services and aim to elevate their pricing structures. However, alongside price increases, these companies must also deliver more valuable services. “Rather than dismantling an entrenched legacy system, it is better to start afresh by establishing a new company,” said Zhou Gui. This was the inspiration behind founding Beijing Zhiying Huizhong Medical Technology Co., Ltd.

The four characters in “Zhiying Huizhong” embody the founder’s vision. “Zhiying” refers to assisting medical device manufacturers in addressing regulatory submission challenges and helping scientists translate R&D products into commercial reality. By tackling the most critical issues, such as registration strategic planning and implementation of major projects, we help clients resolve practical challenges during the pre-market phase and achieve sustainable long-term market growth.

The so-called “Huizhong.” Zhou Gui believes that the company is engaged in an endeavor that benefits people’s livelihoods and hopes to continue doing so. This is also related to the first investment Zhou Gui received: “I still remember what I said during my first meeting with my investor: ‘I hope that in the future, I can proudly tell my friends and family that the medical devices they have used were developed and registered with our company’s participation, ensuring product quality and safety.’”

To realize the company’s vision, Beijing Zhiying Huizhong Medical Technology Co., Ltd. provides professional one-stop CRO services to clients such as medical device manufacturers, university professors, and hospital directors. Its scope of services covers product research and design, quality oversight, clinical trials, regulatory registration and filing, and technology transfer.

Zhiying Huizhong Service Model (Compiled)

In terms of service model,Beijing Zhiying Huizhong Medical Technology Co., Ltd. prefers an “end-to-end” approach, guiding clients from factory construction through product R&D, production standardization, and validation reporting, all the way to final implementation.This model can streamline the project’s R&D process and reduce the client’s upfront investment.

During the clinical trial phase of the project, Beijing Zhiying Huizhong Medical Technology Co., Ltd. primarily collaborates with hospital-based trial sites, leveraging its existing service portfolio that includes collaborative projects with hospitals.

During the technology transfer phase, the company adopts a “recommendation” approach. Beijing Zhiying Huizhong Medical Technology Co., Ltd. believes that collaboration between clients and industrial parks is a process of mutual selection. At this stage, the company informs partners about the characteristics and policy frameworks of the industrial parks, with the final decision resting in the hands of the founders. The company solely provides recommendations and facilitates connections between partners and the industrial parks.

The company’s service model can be summarized in six Chinese characters as the “Three Innovations” model: “Innovation + Entrepreneurship + Venture Capital.”

“Innovation”: The company has been relentlessly pursuing innovative service models, with the ultimate goal of addressing customer needs, encompassing innovations in both service and business models.

Innovation in Service Model: Beijing Zhiying Huizhong Medical Technology Co., Ltd. believes that the company should strive to meet any customer needs.

Innovation in the business model: When Beijing Zhiying Huizhong Medical Technology Co., Ltd. was first established, it primarily provided consulting services. It later shifted its focus to contract development projects, and has now evolved into a business model that offers comprehensive validation solutions and product development. For instance, Zhiying Huizhong is about to collaborate with a company in Nanjing, where it will engage from the front end to assist the enterprise with contract development and other related processes.

“Entrepreneurship”: Innovative enterprises, entrepreneurial companies and entrepreneurs, distributors deciding to start businesses, and even researchers enter into service partnerships with Beijing Zhiying Huizhong Medical Technology Co., Ltd., which assists clients in incubating their projects. Meanwhile, the company also helps its clients connect with business financing opportunities to support its partners in achieving success.

“Venture capital? When I founded my company, I brought my own capital,” Zhou Gui told VCBeat. He helps connect some investment firms—including an investment fund established by his former boss at Jietong—with potential investment projects, as these firms also have such needs.

The journey from research and development to commercialization is a lengthy process, with the clinical trial phase being particularly capital-intensive and time-consuming. Encountering funding obstacles during trials can result in significant losses. Beijing Zhiying Huizhong Medical Technology Co., Ltd. helps its clients reduce upfront investments, accelerate the regulatory submission process, and overcome funding barriers.

Based on this innovative “Three-Creation” model, Beijing Zhiying Huizhong Medical Technology Co., Ltd. assisted Beijing Galaxy Bama Biotechnology Co., Ltd. in obtaining the Class III implant approval for its “dural repair material” in April this year; additionally, in July this year, the company facilitated the successful renewal of the registration certificate for “dialysis powder.”

Beijing Zhiying Huizhong Medical Technology Co., Ltd. strives to provide customers with the best services through its proprietary "Three Innovations" model. It is this commitment that has driven continuous growth in its client base, rather than relying solely on projects from existing customers.Currently, the company’s customer base is primarily divided into two categories: one comprises enterprises, and the other includes university professors, hospital directors, and scientific researchers.

In its early startup phase, Beijing Zhiying Huizhong Medical Technology Co., Ltd. had a limited customer base, primarily constrained by its target audience reach and market recognition. Initial clients were mainly those whom the founder, Zhou Gui, had connected with in his previous work. These clients accounted for all of the company’s business activities and revenue during the first six months after its establishment.

With the success of its projects, Zhiying Huizhong’s professionalism has gained industry recognition. Existing clients are willing to refer new clients to Zhiying Huizhong, including university professors and scientific researchers.

At this point, Zhou Gui shared a brief anecdote. On one occasion, while finalizing a contract with a long-standing client in Jiangsu Province, the client voluntarily increased the service fee. This gesture stemmed from their recognition of Beijing Zhiying Huizhong Medical Technology Co., Ltd.’s technology and their high level of satisfaction with the services provided. “I was responsible for all five Class III medical device registrations handled by their company, so they have great trust in me.”

However, the service model cannot constitute a company’s core competitiveness; for technology-driven service companies, the core competitiveness lies in talent. “When I founded this company, I always believed that talent is the primary competitive advantage in the industry,” Zhou Gui told VCBeat.

The medical device outsourcing services industry has high demands for specialized talent. The scarcity of such professionals has long been a pain point in this sector, primarily due to the substantial demand for talent coupled with the lengthy training cycle required to cultivate them.The medical device R&D outsourcing industry is a high-tech sector characterized by multidisciplinary integration and knowledge intensity, making it difficult for typical university graduates to meet corporate requirements. Meanwhile, there is strong demand for such talent among medical device companies, investment firms, and pharmaceutical enterprises.

Regarding talent, Beijing Zhiying Huizhong Medical Technology Co., Ltd. has been considering how to build a strong professional team since its inception,Currently, the company's employees are predominantly engineers with R&D backgrounds.To build a strong team, the company can provide various resources and conditions to its members.“My current compensation is lower than that of many managers at our company. For the sake of the company, I am willing to make significant sacrifices.”

In terms of hiring criteria, Beijing Zhiying Huizhong Medical Technology Co., Ltd. has a unique requirement: all candidates must submit their graduation theses. The company also shows a preference for engineers with R&D backgrounds. “Graduation theses allow us to assess not only the volume of a candidate’s research but also their writing proficiency. Therefore, we prioritize candidates with strong writing skills and experience in research projects,” said Zhou Gui with a smile.

Furthermore, to enable the team to accumulate experience and foster a sense of accomplishment, Beijing Zhiying Huizhong Medical Technology Co., Ltd. has been continuously exploring various fields, with the aim of establishing the company as a technology-driven R&D center.Amid the impact of the pandemic this year, the state has significantly increased investment in research projects for medical enterprises. Beijing Zhiying Huizhong Medical Technology Co., Ltd. has also collaborated with several universities to apply for national-level research grants, aiming to enhance its team’s R&D capabilities.Beijing Zhiying Huizhong Medical Technology Co., Ltd. believes that only through extensive participation in scientific research can employees significantly enhance their knowledge frameworks.

Meticulously cultivating the team, from selecting members to providing opportunities for their growth, all these efforts are aimed at strengthening the core competitiveness of Zhiying Huizhong—talent.

At each stage, Beijing Zhiying Huizhong Medical Technology Co., Ltd. formulates a three-year short-term development goal, which is primarily divided into internal and external objectives.

Internally, the primary objective for Beijing Zhiying Huizhong Medical Technology Co., Ltd. this year is to establish a modern management system. During its startup phase, the company was centrally managed by its founder, Zhou Guitong; however, as the company has grown, this model has become misaligned with its current needs. Meanwhile, the company aims to build a platform that supports the continuous professional development of its employees. Given the rapid expansion of its business scale, it is imperative to significantly increase talent acquisition and strengthen training initiatives.

“Externally, our original three-year target was a growth rate of no less than 50%. It now appears that this goal was somewhat conservative, so I have raised this year’s target to 100%.” As he spoke, Zhou Gui could hardly conceal his joy.

In addition, Beijing Zhiying Huizhong Medical Technology Co., Ltd. plans to carry out construction centered around the Review Center of the Medical Device Incubator Research Institute.This is aligned with the company’s long-term development strategy, which aims to provide medical device manufacturers with an integrated platform spanning design verification, clinical trials, and manufacturing, thereby addressing key pain points in medical device R&D and refinement. This objective is scheduled to be implemented within one to two years.