Gnovo Biotech Files IPO Prospectus: Pioneering China's High-End Medical Device CDMO with 400 Innovations and 200 Top PIs
Clinical demand is the lifeblood of medical devices. For device innovation, clinical needs and physicians’ user experience are paramount. Since 2015, China has successively introduced a series of macro-level policies and supporting documents to encourage healthcare institutions to translate scientific and technological achievements into practical applications, explicitly incorporating metrics for such translation into the performance evaluations of public hospitals.
Driven by policy incentives, medical institutions and clinicians have continued to achieve new breakthroughs in the translation of scientific and technological achievements. According to data from the Medical Innovation Alliance, the volume of patent transfers at Grade A tertiary hospitals across China has grown steadily over the past decade. In 2023, the total number of patents commercialized by these hospitals reached nearly 2,000, representing a year-on-year increase of 28%. Among these, 1,455 patents were assigned, up 17% year on year, while 511 patents were licensed, marking a significant 69% year-on-year increase.
As conversion rates accelerate, the critical role played by healthcare institutions and physicians in the process of medical innovation is being increasingly validated and reinforced. In particular, when examining the multifaceted roles of physicians, they serve not only as identifiers of clinical needs, inventors of product innovations, and collaborators in product development, but also as executors of clinical trials and end-users of the final innovative products.
Once the conversion metrics of healthcare institutions and physicians’ awareness of commercialization have improved in tandem, the implementation capabilities of engineering technologies and the ability to integrate various resources become the key bottlenecks constraining the realization of clinical innovations.
Driven by market demand, the founding team, with backgrounds in clinical medicine, jointly established Wuhan Greenovo Biotechnology Co., Ltd. (hereinafter referred to as “Greenovo”) in 2012. Seizing the wave of rapid development in the medical device industry, Greenovo has adopted a patient-centric approach. By connecting with clinical experts at hospitals to continuously explore innovative clinical treatment technologies on one end, and leveraging its engineering technical team to realize medical device products through breakthroughs in process technology on the other, Greenovo integrates medicine with engineering. In doing so, it has gradually built a leading domestic CDMO platform for innovative medical devices.
The medical device industry is a high-tech sector characterized by knowledge intensity, capital concentration, and multidisciplinary integration; consequently, the innovation translation chain in medicine is particularly lengthy. Generally, it takes 2–3 years for Class II medical devices to go from research and development to market launch, whereas Class III clinical medical devices require 5–7 years. This timeline can be even longer for physicians who lack relevant experience and resources. Therefore, systematic support and one-stop services are crucial forces in accelerating the translation of clinical innovations from within hospitals to external application scenarios.
“Integrating medicine with engineering technology to create medical devices and improve the quality of human life” is the vision of Greenovo. To achieve this goal, Greenovo has establishedMedical-Engineering Integration Center, Pilot Scale-up and Maturation Center, Mass Production and Intelligent Manufacturing Center, Key Materials Research Center, Innovation Translation CenterFive Functional Modules.
Greenovo's Five Major Centers
The primary responsibility of the Medical-Engineering Integration Center is to identify unique and innovative medical technologies derived from clinical practice, while establishing preclinical research, surgical simulations, and academic training programs to support the exchange and promotion of innovative medical technologies.
“Identifying and screening clinical needs is the cornerstone of the entire medical device innovation process. In addition to collaborating with physicians on the R&D of innovative medical devices, Greenovo has established in-depth partnerships with hospitals. By selecting and evaluating intellectual property rights derived from source innovations, we identify innovative solutions that offer genuine clinical value and broad commercial prospects,” said Zhu Xiangtao, General Manager of the Public Affairs Center at Wuhan Greenovo Biotechnology Co., Ltd.
To date, Wuhan Greenovo Biotechnology Co., Ltd. has established strategic partnerships with over 100 large tertiary teaching hospitals (Grade A), and more than 200 top medical experts across China have joined its platform.By deeply integrating clinical resources, the company’s team systematically analyzes clinical needs and collaborates with medical institutions and physicians to translate clinical insights into innovative therapeutic technologies.
From the perspective of service domains, Greenovo focuses on the field of advanced precision surgical instruments. It has established common design capabilities in product categories such as surgical operating instruments, cardiovascular and cerebrovascular interventional devices, implantable devices, and energy-based equipment. Meanwhile, it has built multiple general process platforms and specialized process platforms, thereby providing strong support for product research and development and production.
In China alone, the number of patients with cardiovascular and cerebrovascular diseases has reached 330 million, with mortality rates continuing to rise and no inflection point in sight, creating an urgent need for innovative products and therapies. However, innovative medical devices entail extremely high technical complexity and involve multidisciplinary integration, requiring the combination of knowledge and technologies from various fields, including engineering, medicine, and biology.
In response, Wuhan Greenovo Biotechnology Co., Ltd. has established a new interdisciplinary R&D team of over 300 members, spanning multiple disciplines including medicine, electronics, mechanics, industrial design, materials science, and computer science. The company has accumulated experience in the design and development of nearly 400 innovative medical device products and has secured more than 400 PCT international patents and national patents.
“Pilot-scale trials” play a pivotal role in the research and development, manufacturing, and market launch of medical devices. Through pilot-scale trials, we can not only verify whether the design of medical devices meets predetermined technical requirements and performance specifications, but also optimize production processes, thereby enhancing production efficiency and reducing manufacturing costs.
One of the Five Major CentersPilot Scale-up and Maturation CenterLeveraging the company’s interdisciplinary R&D team and its medical-engineering collaborative development model, we transform clinically translatable innovative medical technologies into novel medical device products, rapidly achieving small-batch production to facilitate the critical leap of clinical innovations from hospital settings to the broader market.
However, the transition from pilot-scale trials to final commercialization and large-scale production remains fraught with challenges. These include ensuring the stable scale-up of manufacturing process parameters, establishing a robust industrial ecosystem and supply chain, and achieving effective quality and cost control during mass production. In particular, the fabrication materials often incorporate cutting-edge technologies, necessitating advanced manufacturing craftsmanship for high-precision fabrication and assembly.
Company-builtMass Production and Intelligent Manufacturing Center, it has established a GMP shared manufacturing center for holders of medical device registration certificates, providing mass production and OEM services for incubated innovative medical devices. In terms of process technology, Wuhan Greenovo Biotechnology Co., Ltd. currently possesses over 300 advanced pieces of equipment for high-precision machining, micro-nano forming, precision stamping, cleanroom injection molding, and intelligent inspection. With capabilities in more than 50 processing techniques and a maximum machining precision of up to 0.0001 mm, the company can meet customers' diverse needs for the custom production of precision components for medical devices.
Mass Production and Intelligent Manufacturing Center
“A nine-story terrace begins with a pile of earth. To address upstream raw material issues, the company has focused on the research and development, processing, and improvement of ‘chokepoint’ raw materials, thereby breaking free from dependence on imported suppliers for key core materials,” said Zhu Xiangtao.
To this end, Greenovo has establishedKey Materials Research Center, and strengthen scientific and technological breakthroughs in key raw materials. For instance, raw materials such as artificial blood vessels and porous PEEK have long been monopolized by foreign suppliers. The company’s interdisciplinary team collaborated with university experts to conduct research, developed proprietary process equipment, broke through foreign technological blockades, resolved critical “chokepoint” challenges, and has become a raw material supplier for multiple listed companies.
Innovation Transformation Center
As one of the five major centers of Wuhan Greenovo Biotechnology Co., Ltd., the Innovation Transformation Center aims to establish a highland for the transformation of innovative medical devices in central China and across the country. By integrating advantageous resources in clinical practice, R&D, technology, capital, and operations, it has further streamlined the entire chain for transforming achievements in innovative medical devices. To date, it has cumulatively introduced and incubated more than 50 innovative enterprises.
Through its five major centers, Greenovo has established an innovative full-industry-chain system spanning raw materials, R&D, pilot-scale testing, and mass production. Leveraging rapid product realization capabilities, customized mass production capacity, and a strictly compliant quality management system, Greenovo provides customers with one-stop, full-lifecycle professional services, including medical device design and development (CDO), new product introduction (NPI), validation and regulatory registration (CRO), and large-scale contract manufacturing (ODM).
“With the support of Greenovo’s five major modules, the time and cost required for an innovative medical device to go from R&D to market approval can be significantly reduced,” said Zhu Xiangtao. To date, the company has served nearly 400 products, many of which have successfully entered the National Special Examination Procedure for Innovative Medical Devices.
For example, based on the clinical needs and conceptual prototypes identified at Tongji Hospital of Huazhong University of Science and Technology, the company collaboratively developed the world’s first breakthrough technology—the Hypertrophic Cardiomyopathy Resection System. This system significantly reduces surgical complexity, shortens operative time, and steepens the learning curve for physicians, thereby increasing the adoption rate of the procedure. This achievement has resolved the global challenge of resecting hypertrophic myocardium without thoracotomy or cardiac arrest, garnering widespread attention and numerous accolades both domestically and internationally.
CCTV News Channel’s “24 Hours” Report on the Hypertrophic Cardiomyopathy Resection System
After twelve years of dedicated development, as a leading Chinese CDMO in high-end medical devices, Wuhan Greenovo Biotechnology Co., Ltd. has long adhered to the integration of medicine and engineering to promote the transformation of scientific and technological achievements, continuously breaking through critical bottlenecks that constrain medical device R&D. Meanwhile, the company aims to support the development of China’s high-end medical device industry through diverse channels, fostering independent, self-reliant, and robust growth.
Regarding the issue of homogeneous competition currently prevalent in the CDMO industry, Zhu Xiangtao stated, “The Marketing Authorization Holder (MAH) system introduced in 2019 enabled many CRO companies to identify a strategic opportunity, gradually transitioning into and entering the CDMO sector. However, whether through regulatory filing services or assembly-based contract manufacturing, this business model rarely penetrates core R&D and supply chain operations. Consequently, these firms are unable to collaborate closely with upstream partners to drive product development guided by clinical needs, inevitably trapping them in a vortex of price wars.”
“Greenovo’s differentiated advantage lies in directly uncovering innovative therapeutic technologies from clinical practice, aggregating innovation resources through the integration of medicine and engineering as well as by connecting upstream and downstream segments of the value chain. Ultimately, it provides patients and healthcare institutions with minimally invasive, high-safety new products and innovative medical solutions that improve clinical outcomes via one-stop services, while simultaneously shaping an industrial innovation ecosystem to advance the industrialization of China’s medical device sector,” Zhu Xiangtao continued.
Wuhan Greenovo Biotechnology Co., Ltd. also co-established“Hubei Institute for Innovative Translational Medicine”, the first in Central ChinaLarge Animal Experiment CenterPut into operation at the end of 2022, it specializes in comprehensive preclinical large-animal experimental studies for high-risk medical devices. Adhering to a service philosophy of scientific rigor and objectivity, it is committed to evaluating the safety and efficacy of medical devices.
Large Animal Experimental Center
In the future, Wuhan Greenovo Biotechnology Co., Ltd. will continue to adhere to a clinical needs-oriented approach, actively promote the translation of clinical innovations, and help more ideas be realized and applied in clinical practice to achieve an effective cycle. Meanwhile, it will drive Chinese clinical innovations originating from Chinese doctors to go global, leveraging its “global first-in-class” capabilities to benefit more patients.