Yongming Chengdao Medical Technology Files IPO Prospectus: A Leading CRO Specializing in Interventional Cardiology with Partnerships Across 300+ Clinical Research Centers
CRO (Contract Research Organization) 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 clients are mainly pharmaceutical and medical device companies, for which it provides services such as clinical trials and medical statistics.
Innovation-driven development has become the prevailing trend in the pharmaceutical and medical device industries. As companies continuously increase their R&D investment, their reliance on Contract Research Organizations (CROs) is growing stronger. The high cost-effectiveness of the CRO industry has made it an indispensable link in the R&D supply chain for pharmaceuticals and medical devices in a short period. Consequently, the global CRO market continues to maintain robust growth.
Currently, domestic CRO companies are mainly concentrated in pharmaceutical research, with few firms specializing in the medical device sector. However, a series of policies introduced by industry regulatory authorities—including the Special Examination and Approval Procedure for Innovative Medical Devices, the Selection Catalog for Domestically Produced Medical Equipment, and the Priority Review and Approval Procedure for Medical Devices—have explicitly called for accelerating the development of national brands and the industrialization of domestically produced medical devices, as well as speeding up the substitution of imported devices with domestic alternatives. These developments have brought significant benefits to China’s medical device industry.
The "Research Report on the Prospects and Investment Opportunities of China's Medical Device Industry from 2019 to 2024," released by China Business Industry Research Institute, shows that China's medical device market maintained a high growth rate from 2014 to 2018. In 2017, the market size reached RMB 445 billion, with a growth rate of 20.3%, and exceeded RMB 500 billion in 2018. The cost of CRO services for domestic medical devices before listing accounts for about 3% of their market sales. Based on the 2018 market size of RMB 500 billion, the MA (Marketing Authorization) market size for medical devices could reach RMB 15 billion.
CCRF (Beijing) Inc. (hereinafter referred to as “CCRF”) is a medical device CRO company distinguished by its specialized focus on cardiovascular disciplines and exceptional professional expertise. The company is committed to providing comprehensive solutions in regulatory consulting and registration, clinical trial management, data management, core laboratory services, biostatistical analysis, IT innovation, and medical media communication, delivering high-quality and efficient professional services to clients both domestically and internationally. Since its establishment in 2009, the company has engaged in extensive and in-depth business collaborations with more than 300 clinical research centers across China, established partnerships and collaborative mechanisms with over 20 research organizations domestically and abroad, and built relationships with nearly 100 industry experts worldwide, thereby accumulating rich experience in clinical project management.
At the beginning of this century, China's cardiac interventional technology witnessed rapid advancement, with the volume of cardiac interventional procedures and the surgical proficiency of cardiologists gradually aligning with those in developed countries.
Discussing the evolution of the industry, Gu Xi, General Manager of CCRF (Beijing) Inc., told VCBeat: “At that time, the concept of ‘evidence-based medicine’ was highly popular in China. Many interventional cardiologists kept abreast of the latest advances in cardiac intervention through international academic exchanges. Authoritative international clinical research data continuously reshaped cardiologists’ understanding of procedural techniques, products, and treatments. Some experienced and forward-thinking cardiologists began to reflect on the discrepancies between their own clinical experience and published data, examine the similarities and differences between China and other countries, and question why similar research findings had not been derived from Chinese data. This professional inquiry shifted more physicians’ focus from the quantity and quality of surgical procedures to clinical research.”
Subsequently, physicians quickly recognized that clinical research is a multidisciplinary endeavor characterized by intricate and cumbersome processes. Tasks such as regulatory management, protection of patient rights, trial design, statistical considerations, data management, and product management cannot be accomplished by physicians alone; instead, they require collaborative efforts among professionals from diverse disciplines. Any oversight in any single link may lead to the failure of the entire undertaking. The founding of CCRF (Beijing) Inc. was driven by its founder’s long-cherished aspiration to “integrate industry talent, leverage systemic advantages, support clinical scientific research in China, amplify China’s voice on the international stage, and ultimately benefit patients both domestically and abroad.”
As a company that has focused on the field of cardiovascular intervention since its inception, CCRF (Beijing) Inc. has established long-term and stable cooperative relationships with numerous experts in the cardiovascular field over the past decade. “In the process of collaborating with industry experts, we continuously accumulate experience and make improvements, incorporating lessons learned from each project into updates of our company’s Standard Operating Procedures (SOPs), thereby making subsequent collaborations smoother and more efficient,” said Gu Xi. In light of the specific characteristics of medical devices in the cardiovascular sector, CCRF (Beijing) Inc. has been constantly refining high-quality operational standards for clinical trials. It has established specialized entities such as an imaging core laboratory and a safety analysis team, both featuring distinct subspecialty expertise, ensuring that every step of complex clinical trial processes is conducted in accordance with well-defined protocols.
With the support and guidance of industry experts both domestically and internationally, CCRF’s core laboratory has established a set of internationally recognized analytical standards and management systems. Its service scope has gradually expanded from initial qualitative and quantitative coronary angiography image analysis (QCA) and intravascular imaging analysis (IVUS/OCT) to imaging- and function-based assessments utilizing ultrasound, CT, angiography, and other modalities. Through numerous domestic and international clinical research projects, the laboratory has completed analyses of tens of thousands of cases to date, accumulating extensive experience.
Clinical Trial Safety Management Services Provided by CCRFThe clinical trial safety management services offered by CCRF encompass multiple aspects, including the Clinical Endpoint Committee (CEC), Data and Safety Monitoring Board (DSMB), adverse event/serious adverse event (AE/SAE) management, and the management and coordination of clinical event adjudication. By adhering to high-standard, professional standard operating procedures (SOPs), we ensure that the adjudication results for clinical endpoint events are objective and accurate. To date, these services have covered numerous pre- and post-marketing clinical research projects both domestically and internationally, cumulatively completing nearly 10,000 CEC adjudications, managing over 5,000 AE/SAE cases, and providing DSMB support for multiple clinical research projects.
“As is well known, medical specialties are relatively specialized, with data in each discipline possessing distinct characteristics and forming independent systems. A thorough understanding of the unique features and significance of data within each field’s research enables more effective and efficient execution of clinical trials.” According to Gu Xi, CCRF (Beijing) Inc has avoided many potential detours and even errors during the early stages of trials through its continuous, in-depth exploration of specific domains.
CCRF has always maintained a prudent attitude toward exploring new business areas. However, leveraging its deep expertise in the interventional field and the industry’s inherent connection to cardiac interventions, CCRF has successfully expanded into neurointervention, peripheral intervention, structural heart disease, medical imaging, and electrophysiology. Meanwhile, it has bolstered its capabilities in R&D, investment, distribution, and marketing, with its services rapidly gaining recognition from industry clients. Guo Xi stated, “Fully integrate multi-party resources and continuously leverage corporate advantages.”
Clinical trials for medical devices are highly specialized, and the entry barriers for contract research organizations (CROs) in this field have risen accordingly. The core competencies of medical device CROs are primarily reflected in the professionalism and experience of their personnel, access to expert resources, and communication channels.
“Imaging analysts with specialized skills, project managers, regulatory affairs specialists, and data managers with extensive experience in complex project management, as well as statisticians and medical professionals with outstanding expertise, are CCRF’s most valuable assets.” In Gu Xi’s view, this high-caliber research services team of over 100 professionals, operating at an international standard, is the fundamental reason why CCRF is highly regarded by its industry clients.
Notably, all imaging analysts at CCRF (Beijing) Inc. hold degrees in biomedical engineering or clinical disciplines and have received systematic training in cardiovascular imaging at leading hospitals in China. The safety management team members all possess clinical medicine backgrounds and relevant experience in cardiovascular clinical trials.
Regarding the future development of the medical device CRO industry, Gu Xi indicated that there are two trends worth noting.
First is the extension of the industrial chain. “China has many highly successful CRO companies, such as WuXi AppTec and Tigermed, with clinical trial services occupying a strategic position within their corporate strategies. From this service segment, operations can extend upstream into R&D and investment, and downstream into sales and marketing services. By integrating the entire industry chain, these companies can maximize the strategic impact of clinical services, thereby driving healthy and rapid corporate growth.”
Second, scientific management. Currently, the threshold for early-stage development in the industry is relatively low, leading to intense competition. As regulatory oversight becomes increasingly stringent, how to leverage scientific management to enhance CRO efficiency and improve customer satisfaction will become a key factor in the industry’s development.