Junyue Medical Completes Tens of Millions of RMB Series A Financing to Deepen Its CRO Services in Interventional Medical Devices

VCBeat has learned that Junyue Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as“Junyue Medical” recently completed its tens-of-millions-of-yuan Series A financing round, led by Hygeia Capital, with participation from Shanghai Bestar and Shanghai Nabotong. The funds raised in this round will be used to expand its specialized SMO (Site Management Organization) network and build core laboratories.

Junyue Medical is a medical device CRO company featuring a full-process service platform, differentiated service platforms, and specialized SMO and Core-Lab capabilities. Deeply rooted in the field of interventional medical devices, the company boasts an extensive network of core experts, rich experience in interventional medical device CRO projects, a robust management system, and strong project execution capabilities.

Prior to this financing round, Junyue Medical underwent an asset restructuring by integrating two other medical device CRO companies with strong synergies into its main entity. Guo Gongjian, Chairman of Junyue Medical, stated, “The founders of the other two CRO companies have accumulated extensive resources. With shared values and complementary personalities, the integration of resources will strengthen Junyue Medical and its management team, achieving a synergistic effect where 1+1+1 is greater than 3.”

Through asset restructuring, Junyue Medical will provide full-chain medical device CRO services covering the entire lifecycle of medical devices. Guo Gongjian stated, “Junyue Medical will provide device companies withEstablishment of production quality systems, animal testing services, medical writing, clinical trial planning and implementation, data management and statistical analysis, imaging core laboratoryand other services. Our project management adheres to the ISO 9001 and ISO 13485 quality management systems, and we have helped numerous partners obtain product registration certificates.

The development of medical device CROs is dependent on the medical device industry. Guo Gongjian stated, “The next decade will be a golden period for the booming development of China’s domestic medical device sector. Compared with developed countries in Europe and the United States, the ratio of medical device to pharmaceutical usage in China remains relatively low, indicating substantial room for growth. Furthermore, changes in the international landscape have heightened national awareness of the importance of core technologies; therefore, innovation in medical devices will be the central theme over the coming decade.”

“Blue Book of Medical Devices: Report on the Development of China’s Medical Device Industry (2019)” corroborates Guo Gongjian’s view: As of 2018, China had become the world’s second-largest medical device market, and over the next decade, the industry is projected to maintain an average annual growth rate of more than 10%.

Currently, Junyue Medical Technology (Shanghai) Co., Ltd. is undertaking clinical trials for a variety of innovative medical devices, with the scope of such projects showing an upward trend. It is foreseeable that the development of the medical device sector will significantly boost demand for Contract Research Organization (CRO) services in this field, while also raising the bar for professional expertise and service quality.

In 2020, the State Council executive meeting approved the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)" and pointed out: It is necessary to strengthen the responsibility of enterprises and research and development institutions for the safety and effectiveness of medical devices, clarify approval and filing procedures, enrich regulatory means, add regulatory measures such as unique device identification traceability and extended inspections, and increase penalties for illegal acts...Regulatory policies for medical devices are becoming increasingly stringent, reinforcing the compliance requirements for medical device companies across all stages—including R&D, production, and quality management systems—while also boosting demand for CRO services in the medical device sector. Furthermore, the nationwide rollout of the Medical Device Registrant System will encourage research institutions, universities, and other innovative entities and teams to engage in medical device innovation, significantly promoting the integration of medicine and engineering as well as the translation of scientific achievements into clinical applications.

In light of the aforementioned factors, it is evident that the medical device CRO industry is on the verge of explosive growth, presenting development opportunities for all companies within the sector.

Junyue Medical has chosen to specialize in interventional devices due to the substantial demand for clinical trial services in this sector, which imposes higher requirements on the resource integration capabilities and service proficiency of device CRO teams. Junyue Medical holds significant advantages in regulatory affairs, manufacturing, quality systems, project management, and access to clinical expert resources.

For instance, the core management team of Junyue Medical all possess over 10 years of industry and managerial experience. The company’s team has extensive expertise in clinical trial services for innovative medical devices, having conducted clinical trials for multiple medical device products that were first-of-their-kind in China. Junyue Medical assisted Professor Liu Jianmin’s team at Changhai Hospital in conducting the DIRECT-MT study, the results of which were published in The New England Journal of Medicine in May 2020. This study was ranked second among the “Top Ten Medical Science and Technology News Stories in China for 2020,” selected by Health News Press, trailing only the isolation and identification of the novel coronavirus, and it garnered significant attention within the industry. Currently, Junyue Medical has assembled a competitive network of clinical experts, including several academicians, chairpersons of medical associations, more than 100 cardiovascular specialists, and over 50 neuro-interventional experts.

What sets Junyue Medical apart from other medical device CRO companies is its strategy of capturing market share through differentiated services. Specifically, leveraging advantages such as a full-process service model for interventional devices, an extensive network of core key opinion leaders (KOLs), rich experience in providing CRO services for interventional devices, an excellent management system and project execution capability, and strong brand recognition, Junyue Medical will deepen its presence in the interventional field. It provides integrated, end-to-end CRO services for devices used in cardiac intervention, neurointervention, and peripheral intervention.

Additionally, Junyue Medical will co-establish a clinical research quality system with medical institutions to create a distinctive SMO service collaboration model; introduce new technologies to enhance the efficiency of real-world clinical research data collection; jointly establish follow-up centers, data centers, and imaging evaluation centers with medical institutions to accumulate clinical imaging data; and set up on-site offices at medical institutions to provide professional technical support.

Guo Gongjian stated, “In the future, Junyue Medical will continue to deepen its presence in the field of vascular intervention. With CRO as our core, we will develop, establish, and expand full-process services for medical devices, providing customers with end-to-end solutions and positioning Junyue as the premier choice for CRO services among medical device companies. Our team will engage in continuous learning and innovation, striving to become the largest, most comprehensive, and most professional contract research organization in China’s medical device sector.”

Hygeia Capital stated, “We are honored that Hygeia Yingtai has led this round of financing for Junyue Medical. Hygeia Yingtai is primarily positioned to invest in start-ups in the field of interventional and implantable medical devices, adhering to a core investment logic centered on industrial synergy, capital empowerment, and ecosystem building. Junyue Medical aligns closely with Hygeia Yingtai’s investment thesis. We also believe that, under the leadership of its three founders, Junyue Medical will grow into a leading domestic clinical CRO enterprise in the medical device sector within the next three to five years through this restructuring and financing.”

Hygeia Capital is a private equity investment fund focused on the healthcare and wellness industry, driven by a dual strategy of “active investing” and “in-depth investment banking services.” Its management team possesses extensive background in the healthcare sector and rich experience in equity investment. The fund’s portfolio includes numerous high-quality companies such as Kindly Medical Devices (1501.HK) [interventional medical devices], Cofoe Medical [home-use medical devices], Bestar [clinical CRO], Baishan Pharmaceutical [new drug R&D], Weilizhibo [new drug R&D], Zhidao Biology [protein engineering], Zhongyi Anke [vaccine R&D], Respry [new drug R&D], Huajian Future [new drug R&D], Junyue Medical [device CRO], and Xinuo Medicine [animal testing].

Shanghai Bestar Medical Technology Co., Ltd., established in 2010, is an international clinical development organization for innovative drugs, with a wholly-owned subsidiary (Shangrui) and controlled subsidiaries in the United States and Australia. Headquartered in Shanghai, China, the company collaborates on projects with over 300 hospitals across 76 cities in 30 provinces. It maintains close partnerships with experts in various therapeutic areas in China, has passed audits by more than 30 internationally renowned pharmaceutical companies, and has participated in the regulatory submission, clinical design, and project management of over 80 new drugs, undertaking more than 200 Phase I–III registrational clinical study projects. The company’s clinical research services span pharmaceuticals, medical devices, and biological products, providing clients with specialized technical solutions and services. In November 2017, the company was recognized as a High-Tech Enterprise by the Shanghai Municipal Science and Technology Commission.