Xunjia Tech CDMO Integrated Platform Files IPO Prospectus: Four Core Advantages Driving the Medical Device Registrant System
According to the "Innovation Report on the Medical Device R&D Outsourcing Services Industry" released by VCBeat, the medical device CRO/CDMO industry has become an important strategic choice for medical device R&D entities to reduce upfront investment, accelerate registration and approval processes, and mitigate product launch risks after its initial development phase. In 2019, the market size of China's medical device CRO/CDMO industry reached RMB 10 billion, with a projected compound annual growth rate exceeding 20% in the coming years.
The journey of medical devices from R&D to market launch is fraught with challenges. CRO/CDMO services for medical devices can assist developers in reducing investment costs and accelerating time-to-market. With the pilot implementation of the Marketing Authorization Holder (MAH) system for medical devices in multiple regions and government encouragement of innovation, the medical device CRO/CDMO industry is poised for significant growth opportunities.
Amidst the national implementation of the Medical Device Registrant System and Hunan Province’s encouragement of innovative development in the medical device industry, Xunjia Technology was founded by a group of senior professionals from the healthcare sector. Its integrated CDMO platform (CDO+CRO+CMO+CSO), established in Xiangtan, Hunan, is the first such platform in Hunan Province under the guidance of the Hunan Provincial Food and Drug Administration to operate under the Medical Device Registrant System, and it serves as the exclusive integrated CDMO platform within the Xiangtan Hunan Medical Device Industrial Park.
According to Hu Hongping, co-founder of Xunjia Technology, “Leveraging Hunan Province’s pilot policies for medical device innovation and the Marketing Authorization Holder (MAH) system, Xunjia Technology has built an integrated CDMO platform for medical devices. This platform connects all key elements of the medical device industry ecosystem—including government, industry, academia, research, healthcare, and finance—and provides a full-process service model covering patent incubation, design and R&D, testing and registration, contracted manufacturing, and channel sales.”
Due to the prosperity of the medical industry in economically developed regions, where medical resources are relatively concentrated and there is greater access to cutting-edge market intelligence and customer bases, Xunjia Technology currently primarily conducts its business in the Yangtze River Delta, Hunan Province and Central China, the Pearl River Delta, and the Beijing-Tianjin-Hebei region.
From research and development to market launch, medical devices must undergo multiple stages, including proof of concept, product development, animal testing, production line setup, quality management system establishment, raw material screening, process validation, supply chain management, sample production, registration testing, clinical evaluation, and regulatory approval application.
Each stage involves a certain degree of uncertainty and risk, such as compliance of manufacturing facilities, stability of raw materials, whether samples can pass registration testing, and whether clinical trial outcomes meet the intended design specifications. For medical device companies, every new product treads on thin ice at each step from research and development through production to sales.
Small and medium-sized enterprises in the healthcare sector typically face “six major challenges”: difficulties in financing, R&D, commercialization, manufacturing, sales, and regulatory compliance. Healthcare companies also encounter “three high barriers”: high R&D thresholds, high market access thresholds, and high thresholds for product sales channels.To this end, Xunjia Technology has built an integrated CDMO platform that connects all key elements of the healthcare industry ecosystem—including government, industry, academia, research, clinical practice, end-users, finance, intermediaries, trade, and media—providing new methods and pathways for the healthcare sector and enterprises to overcome the “six major difficulties and three high barriers.”
Xunjia Technology's Integrated CDMO Platform
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By leveraging platforms for medical achievement transformation, technological innovation design, centralized contract manufacturing, product testing and inspection, global certification and registration, product sales channels, marketing and promotion partnerships, and investment and financing services, Xunjia Technology connects renowned international and domestic medical industry experts, research institutions, universities, associations, enterprises, and capital entities. This integrated approach addresses key challenges faced by medical device companies in scientific achievement translation, R&D, production, regulatory certification, sales channel development, and financing.
Xunjia Technology's Eight Major Industrial Service Platforms
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Xunjia Technology provides full lifecycle services, focusing on three key areas: products, enterprises, and capital. For the product full lifecycle, Xunjia Technology leverages its integrated CDMO platform to assist companies in obtaining regulatory certifications quickly, cost-effectively, and in full compliance with laws and regulations, thereby enabling them to realize economic benefits at an earlier stage. Meanwhile, Xunjia Technology aims to help medical device companies reduce the complexity of product R&D and production costs, minimizing upfront investments.
Throughout the entire corporate lifecycle, Xunjia Technology leverages its professional medical industry management team to provide service support in finance, talent acquisition, and local policy navigation. Following product certification and commencement of production, the company rapidly captures market share and generates revenue through its established sales alliance. Meanwhile, Xunjia Technology is committed to helping innovative enterprises secure financing and accelerate their growth.
Throughout the entire capital lifecycle, Xunjia Technology leverages its professional investment management team to match suitable projects for investment institutions. Furthermore, Xunjia Technology assists portfolio companies in obtaining medical device registration certificates at an early stage, thereby ensuring project return on investment (ROI) and facilitating smooth capital exit.
Xunjia Technology Full Lifecycle Services
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According to Hu Hongping, as of June 30, 2020, dozens of medical device companies had joined the integrated CDMO platform, with an expected 200 various registration certificates to be obtained this year. This achievement is inseparable from the uniqueness of Xunjia Technology’s CDMO platform.
Hardware Advantages:Xunjia Technology’s integrated CDMO platform comprises a medical innovation hub and a centralized contract manufacturing platform that complies with the requirements of the Medical Device Registrant System. The innovation hub features shared activity areas, exhibition spaces, a fitness center, a pitch hall, and private office spaces for enterprises, while providing professional services to support companies in business registration, finance, talent acquisition, policy compliance, and other areas.Phase I of the Centralized Contract Manufacturing Platform covers a total area of 9,500 square meters. It has established sterile and non-sterile production platforms, as well as an in vitro diagnostic (IVD) product production platform, that comply with the requirements of the Medical Device Registrant System. The facility also features shared resources, including public laboratories, public cold storage, a hazardous materials warehouse, and a sterilization center, enabling shared manufacturing capabilities. Upon settling into the platform, enterprises can rapidly obtain registration certificates and pass quality management system audits to secure production licenses, thereby accelerating the market launch of their products.
Service Advantages:Xunjia Technology provides one-stop services, including patent incubation, design and R&D, medical-engineering translation, testing and inspection, registration and certification, contract manufacturing, product sales, channel development, investment and financing, as well as the formulation of and consulting on industrial policies. The company offers flexible cooperation models, allowing clients to choose from CRO, CRO+CMO, or CDO+CRO+CMO arrangements.Xunjia Technology provides customized services tailored to different customer segments. For out-of-province enterprises requiring rapid relocation and centralized production, Xunjia Technology offers contract manufacturing and registration filing services. For manufacturers with new products pending registration, the company provides testing and inspection, clinical trials, registration filing, and contract manufacturing services. For research institutions, innovative enterprises, and distributors undergoing business transformation, Xunjia Technology delivers end-to-end services covering product R&D and beyond.
Xunjia Technology Cooperation Model
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Team Advantages:To date, Xunjia Technology has recruited more than 50 specialized professionals in the healthcare sector, including 15 R&D specialists, 12 regulatory affairs experts, and 10 interdisciplinary talents. The core management team members each boast over 20 years of industry experience, having accumulated extensive resources and managerial expertise in the medical device field.The core founding team possesses extensive experience across the entire healthcare spectrum, including medical-engineering translation and manufacturing of medical devices, sales through medical channels, and investment in the healthcare industry. Notably, Du Xiaodong, Chairman of Xunjia Technology, has been a key driver in implementing Hunan’s innovative policies for medical devices. The core management team brings rich expertise in medical regulations and registration, software and hardware R&D for medical devices, industrial product design, production, and supply chain management. This enables them to provide comprehensive services to platform enterprises, helping them overcome the “three high barriers.”Meanwhile, the company has established a comprehensive talent development system and succession planning framework, complemented by corresponding incentive programs to ensure talent retention.
Policy Support:On August 1, 2019, the National Medical Products Administration (NMPA) issued the "Notice of the NMPA on Expanding the Pilot Program for the Medical Device Registrant System," encouraging 21 provinces (autonomous regions or municipalities directly under the Central Government), including Hunan Province, to carry out pilot programs for the medical device registrant system. On October 10, 2019, the Hunan Provincial Medical Products Administration released the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in Hunan Province."The Hunan pilot program states that medical device registrants in Hunan Province adopting the entrusted production model may entrust their products forHunan Medical Device Industrial Park, Xiangtan Cityand by other qualified medical device manufacturers within the province. Enterprises in Hunan Province may be commissioned to manufacture medical devices for registrants from the other 20 pilot provinces (municipalities).
In summary, the highlights of Hunan Province’s implementation of the Medical Device Registrant System include: prioritized review for Class II medical device registration certificates already obtained in other provinces; expanded pathways for registration testing by permitting third-party testing; and measures to encourage innovation by reducing timeframes and procedural steps, simplifying documentation requirements, and optimizing clinical evaluations.
Hu Hongping stated: “In the Hunan Medical Device Industrial Park in Xiangtan, Xunjia Technology is the exclusive CDMO platform.“Leveraging Hunan Province’s innovative development policies for medical devices, the Xiangtan Hunan Medical Device Industrial Park’s strategically accessible location, and its concentration of high-quality medical industry resources, Xunjia Technology helps companies that already hold Class II medical device registration certificates to obtain certifications rapidly; assists companies seeking medical device registration in shortening their certification timelines; and supports companies requiring mass production of medical devices in manufacturing their products. This significantly reduces corporate investment costs, accelerates the compliant market launch of medical device products, and enables companies to achieve economic benefits quickly.”
Finally, Hu Hongping told VCBeat: “Xunjia Technology’s vision is to gather high-quality resources from the international and domestic medical industries, collaborate to build a specialized technological innovation platform, empower medical technology innovation, construct an ecosystem with extended value chains, and drive innovative development in the medical device industry. All members of the company will strive tirelessly to realize this vision.”