Epintek (Guiyang) Quality Technology Completes Nearly RMB 100 Million Series C2 Financing to Expand Full-Service Medical Device CRO Capabilities

VCBeat (WeChat: vcbeat) has learned that Yipin (Guiyang) Quality Technology Co., Ltd. (hereinafter referred to as “Yipin”) recently announced the successful completion of its nearly RMB 100 million Series C2 financing round. The round was led by Furong Investment, with existing investor Guiyang Venture Capital Co., Ltd. continuing to increase its investment. The proceeds will be primarily used for the construction of Yipin’s Shanghai Fengxian Experimental Center, further expansion of its clinical trial team, and continued enhancement of Yipin’s preclinical laboratory research capabilities for medical devices.

Through this round of investment and construction, EPIN will further deepen its layout in large animal testing and clinical research, significantly enhance its clinical translation capabilities, and comprehensively build a full-process, full-cycle medical device CRO service capability covering preclinical research, inspection and testing, large animal experiments, clinical trials, and regulatory registration. Relying on core laboratories located in Suzhou, Guiyang, Hefei, and Shanghai, combined with the Shandong High-Performance Medical Device Innovation Center (jointly established with Shandong Xinhua Medical to develop products such as radiological imaging equipment) and its nationwide market and technical service centers, EPIN provides comprehensive, end-to-end services for medical device enterprises, supporting their R&D innovation and commercialization.

EPIN is a medical device technology service platform with government investment backing. The company focuses on the rapidly developing medical device and biopharmaceutical industries, providing domestic and international manufacturers and research institutions with one-stop CRO services covering preclinical research, testing and inspection, large animal studies, clinical trials, and regulatory registration.

EPIN’s Operations Center is located in the Hongqiao Business District of Shanghai; its biomedical laboratories are situated in Wujiang District, Suzhou; its electrical medical and wireless communications laboratories are based in Suzhou Industrial Park; its consumables testing center, operating room and large animal center, and South China Biomedical R&D and Testing Center are located in Baiyun District, Guiyang; its Orthopedics and Implantable Device R&D and Testing Center is established in the High-Tech Zone of Hefei; and its integrated research platform for clinical translation, physician scientific research, and standardized residency training is positioned in Fengxian District, Shanghai.

EPIN Laboratories is one of the few capital-intensive laboratories in China. It currently builds and operates approximately 30,000 square meters of medical R&D outsourcing and testing laboratories across the country, having served over 4,000 clients to date. The laboratories have obtained accreditations including China CNAS and CMA, as well as U.S. A2LA and IAS, enabling them to provide rigorous, scientific data, solutions, and reports for the Chinese, U.S., and European markets. Its service capabilities cover the full spectrum of medical devices, including electronic medical devices, orthopedics, implants and interventional products, biomedical materials, sterile consumables, IVD, and software. EPIN provides comprehensive testing services such as electrical safety testing, performance testing, EMC electromagnetic compatibility, animal studies, chemical characterization, microbiological testing, biocompatibility, cleaning/disinfection/sterilization validation, packaging aging, and physicochemical property testing, thereby meeting various R&D and testing needs throughout the process from product development to clinical registration.

EPIN’s clinical trial team comprises departments specializing in medical writing, clinical monitoring, data management, statistical analysis, and quality control, enabling us to provide enterprises with comprehensive, end-to-end clinical trial services covering project initiation, protocol development, site selection, quality control, and reporting.

EPIN boasts a seasoned regulatory registration team, with core members primarily hailing from medical device manufacturing and R&D enterprises as well as international regulatory consulting firms. The team is well-versed in the regulatory requirements for medical device registration and certification, quality management systems, and testing standards in the Chinese, U.S., and European markets.

Notably, EPIN has entered into a strategic partnership with Oriental Beauty Valley Enterprise Group and plans to establish its presence in the Fengxian Cannova Oriental Beauty Valley Life and Health Industrial Park by founding Shanghai EPIN Pharmaceutical Technology Co., Ltd. This project focuses on high-performance medical devices in areas such as cardiovascular care, surgical robots, and ultrasound therapy. It aims to build an integrated research platform encompassing large-animal centers, clinical trials, and scientific research and standardized training for hospital physicians, thereby effectively connecting innovative medical device companies with hospitals and doctors while integrating preclinical research, clinical studies, and academic research. With strong technological attributes, the project is eligible to apply for initiatives and programs such as municipal and district-level Medical Device Innovation Centers, national and local key laboratories, Small and Medium-sized Enterprise Service Centers, Advanced Service Industry Centers, and Medical Device Research Institutes. The project plans a cumulative investment of RMB 100 million, requiring substantial investment in facilities and hardware. It will be constructed to high specifications and with large capacity to meet the innovative needs of high-quality clients, research-oriented hospitals, and physicians.

Yu Rui, Chairman of EPIN“The recognition from Furong Investment and Fengxian Oriental Beauty Valley Group is greatly appreciated. The empowerment from Fudan University and Fengxian Beauty Valley will propel EPIN to achieve steady and long-term progress in its development as a research-oriented CRO. We also extend our gratitude to Guiyang Venture Capital for its continued support; the steadfast backing of existing shareholders serves as the cornerstone of EPIN’s sustained and robust growth. EPIN will remain committed to its strategy of building a capital-intensive, research-oriented CRO, providing compliant data and solutions to support clients’ R&D and innovation, thereby enhancing product innovation efficiency.””

Dr. Sun Pengjun, Chairman of Furong InvestmentIt stated: “With the rapid development of China’s domestic medical device industry and the implementation of the new Regulations on the Supervision and Administration of Medical Devices, the third-party testing market for medical devices is undergoing significant restructuring. As a leading enterprise in China with substantial asset investment in third-party medical device testing laboratories, EPIN boasts comprehensive CRO service capabilities covering the entire process from preclinical research, inspection and testing, large animal studies, and regulatory registration to clinical trials. Furthermore, its accreditations by CNAS and CMA have established strong industry barriers. We remain firmly optimistic about third-party professional medical device inspection and testing institutions that possess key qualifications. Upon the completion of this round of investment and EPIN’s subsequent establishment in Oriental Beauty Valley, Furong Investment will actively assist EPIN in further connecting with the abundant top-tier medical research resources within the Fudan University system to expand its business scope. We believe that EPIN’s experienced team will emerge as a leader in China’s third-party testing sector.””

EPIN is a medical device technology service platform with government investment backing. The company focuses on the rapidly developing medical device and biopharmaceutical industries, providing integrated one-stop services—including preclinical research, testing and inspection, regulatory registration, and clinical trial CRO—to domestic and international manufacturers as well as research institutions.

EPIN Laboratories have obtained CNAS and CMA accreditations in China, as well as A2LA and IAS accreditations in the United States, enabling them to provide rigorous and scientifically sound R&D outsourcing services and testing reports for the Chinese, U.S., and European markets. The laboratory’s service capabilities cover all categories of medical devices, meeting enterprises’ various R&D and testing needs throughout the entire process from research and development to clinical registration. EPIN’s clinical trial team offers end-to-end, full-cycle clinical trial services, including project initiation, protocol development, site selection, quality control, and reporting. Furthermore, leveraging EPIN’s experienced regulatory registration team, the company can meet the needs of medical device manufacturers and R&D enterprises for registration, certification, regulatory compliance, quality systems, and testing services in the Chinese, U.S., and European markets.

Furong Investment, established in 2014, is a specialized innovation investment and services firm focused on early- to mid-stage projects in life and health, semiconductors, new energy materials, and other fields. Adhering long-term to the principles of “research-driven” and “early-stage, specialized investing,” it is committed to promoting the industrialization of scientific and technological achievements and fostering innovation and entrepreneurship among high-level talents. It actively supports national innovation-driven development strategies, including the integrated development of the Yangtze River Delta region and Shanghai’s initiative to build a globally influential science and technology innovation hub.

Guiyang Venture Capital, established in 2010, is a government-backed professional investment institution. It primarily supports the rapid growth of small and medium-sized enterprises (SMEs) with unique advantages during their start-up and expansion stages. The firm focuses its investments on sectors such as biopharmaceuticals, medical devices, big data, and high-end manufacturing. Currently, it manages 13 funds with assets under management exceeding RMB 15 billion. It has cumulatively invested in over 100 projects, five of which have successfully achieved initial public offerings (IPOs).