Shengen (Beijing) Medical Technology Co., Ltd. Files IPO Prospectus as a Leading CRO Specializing in Medical Device Regulatory Consulting and Clinical Trials

In recent years, China's medical device market has developed rapidly.

According to statistical data from the “Analysis Report on the Competitive Landscape and Leading Enterprises of China’s Medical Device Industry” released by Qianzhan Industry Research Institute, the market size of China’s medical device industry reached RMB 212 billion in 2013, grew to RMB 445 billion in 2017, and exceeded RMB 500 billion in 2018, representing a compound annual growth rate (CAGR) of 20% from 2013 to 2018. Key development areas in the medical device sector, such as diagnostic reagents, imaging equipment, and high-value consumables, are becoming priority industries for rapid strategic deployment by local governments.

The booming market has attracted more companies to enter the field, bringing greater opportunities to both upstream and downstream sectors of the industry. For instance, with the implementation of a series of policies—such as the approval process for innovative medical devices, the selection catalog for domestically produced medical equipment, and guidelines promoting the healthy development of the pharmaceutical industry—alongside enterprises’ increasing investment in R&D costs, medical device companies are becoming increasingly reliant on CROs (Contract Research Organizations).

CRO is a highly specialized outsourcing service that primarily includes clinical trial protocol design, clinical trial monitoring, project management, data management, and statistical analysis. Its target market mainly consists of pharmaceutical and medical device companies, to which it provides clinical trial and medical statistics services for drugs and medical devices.

VCBeat recently connected with Shengen (Beijing) Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Shengen Pharma”), a leading CRO company specializing in regulatory consulting and clinical trial services. To date, the company has completed dozens of clinical trial projects and successfully obtained registration certificates, boasting extensive experience particularly in the fields of cardiovascular, peripheral vascular, orthopedics, neurointervention, gastroenterology, respiratory medicine, and plastic and cosmetic surgery.

“We define our company as a professional research institution,” Li Chengli, General Manager of Shengen Pharmaceutical, told VCBeat. In serving clients, Shengen Pharmaceutical strives to minimize the influence of commercial factors, focusing instead on resolving technical issues and executing clinical research projects, approaching each project with rigor.

To this end, in building its team, Shengen Pharmaceutical ensures that all project managers have more than five years of clinical trial experience and are capable of independently writing clinical trial protocols. “We firmly believe that a clinical trial project manager who lacks the ability to write clinical trial protocols cannot manage trial projects with high quality, nor can they engage in in-depth communication with investigators.” In Li Chengli’s view, experienced and adept project managers are the key to success.

Li Chengli, General Manager of Shengen Pharmaceutical

Taking the clinical services team as an example, Shengen Pharmaceutical’s Clinical Division comprises several departments, including the Clinical Project Department, Medical Affairs Department, Quality Assurance/Quality Control (QA/QC) Department, Data Management and Biostatistics Department, Regulatory Affairs Department, and Clinical Support Department. Leveraging extensive experience in clinical research and consolidating high-quality clinical resources, this team provides domestic and international clients with professional project management and monitoring services for medical device clinical trials, medical monitoring and medical writing services, preparation of regulatory submission documents (clinical sections) and registration services, third-party audits, SOP development and training, as well as technical services such as data management and statistical analysis.

To date, the Clinical Business Division has established close collaborative relationships with numerous research institutions, pharmaceutical companies, healthcare facilities, as well as industry experts and scholars. Its professional coverage spans multiple disciplines, including cardiovascular and cerebrovascular diseases, peripheral vascular diseases, neurology, endocrinology, gynecology, urology, general surgery, orthopedics, dermatology, hematology, stomatology, oncology, and neuroscience.

To strengthen the team’s professional capabilities, Shengen Pharmaceutical has established an internal learning mechanism that includes not only basic onboarding training but also specialized technical training, scenario simulations, and interest groups. Furthermore, Shengen Pharmaceutical places significant emphasis on external academic activities, seizing opportunities to engage in exchanges and learning with industry experts.

As a CRO for clinical trials, Shengen Pharmaceutical places great emphasis on professional expertise and service quality in its business operations.

How, then, can service levels be measured against expected benchmarks? Li Chengli believes that two factors are particularly critical for Shengen Pharmaceutical. First, customer satisfaction reaches 98%, and subsequent customer satisfaction evaluations remain at this level, indicating that the service quality has attained a high standard.

The second key point is that 80% of projects were completed ahead of the scheduled trial plan within a year, indicating significant effectiveness in internal process optimization and widespread recognition and trust in the collaboration model between the team and clients.

In terms of professionalism, as a third-party service provider, Shengen Pharmaceutical focuses more on the clinical trial services themselves, avoiding business activities beyond its scope. It continues to deepen its expertise in advantageous fields such as cardiovascular, peripheral vascular, orthopedics, dentistry, and plastic surgery, thereby accumulating richer industry project experience.

The results are evident. One piece of supporting evidence is that a cardiovascular project conducted by Shengen Pharmaceutical in 2019 shortened the entire clinical trial execution cycle by nearly eight months compared to similar products in the industry, setting a new record in the field of clinical trials for cardiovascular medical devices in terms of execution progress.

Why is such high efficiency achievable? Li Chengli believes it is mainly due to three aspects.

First, early-stage planning and preparation are crucial. As the saying goes, “Sharpening the axe will not delay the job of cutting wood.” For every project, we have conducted thorough research and made adequate preparations during the project initiation phase.

Second, emphasis is placed on collaboration with partners. When working with sponsors, Shengen Pharmaceutical establishes agreed-upon cooperation models and communication mechanisms in advance, particularly by implementing risk management and preventive measures for key issues.

Third, throughout the entire process, team members remained focused on the smooth execution of the project. “Regardless of the issues encountered, the primary consideration should be how to resolve them, rather than assigning blame. For the team, the key priority is to keep the project moving forward; determining accountability for issues that arise during the process is a task reserved for the final review.”

It is precisely based on its professional capabilities and high-quality team that Shengen Pharmaceutical has earned the trust and consistent acclaim of its clients.

Looking ahead, Shengen Pharmaceutical will continue to strengthen its internal capabilities by focusing on team development and service optimization. The company will remain dedicated to the medical device sector, with continued in-depth expansion in its areas of strength, including cardiovascular and cerebrovascular diseases, peripheral vascular conditions, orthopedics, dentistry, and medical aesthetics.

“Although many clients have praised our achievements, we are well aware that there is still much work to be done on our journey toward becoming China’s most respected medical technology services company,” said Li Chengli.