MedLinkage Completes RMB 100 Million Series B Financing Led by Qingke Asset Management to Advance IVD Innovation
VCBeat has learned that on June 23,Beijing Sophonix Biotechnology Co., Ltd. (hereinafter referred to as “Sophonix”) recently completed a RMB 100 million Series B financing round, led by Zero2IPO Asset Management, with participation from Delian Capital,Anlong Capital,Guotai Venture Capital and Mingshi Investment participated as co-investors, while existing shareholder ETP continued to increase its stake. Yijun Capital served as the financial advisor for this financing round. This transaction represents one of the largest single funding rounds in China’s POCT chemiluminescence sector to date. Following this round, Sophonix Co., Ltd. will accelerate product development and upgrades, drive the construction, enhancement, and refinement of its marketing system, further strengthen its localization strategy, advance the development of middle-office capabilities in logistics and warehousing, after-sales service, and marketing, continuously expand its product portfolio coverage, and further explore expansion into specialized niche markets and overseas markets.。
Sophonix Co., Ltd. was established in July 2017, with dual R&D centers in California, USA, and Beijing, China, and a total workforce of over 190 employees. The company has established a 6,000-square-meter production facility for in vitro diagnostic (IVD) instruments and reagents in the Beijing Economic-Technological Development Area, which complies with the Good Manufacturing Practice (GMP) for Medical Devices. The company has passed the quality management system assessment conducted by the National Medical Products Administration (NMPA) of China, based on the GMP for Medical Devices and the YY/T 0287-2017 idt ISO 13485:2016 standards, covering Class I, II, and III medical devices. Furthermore, it has successfully undergone the CE certification on-site audit by TÜV SÜD and obtained CE certification in compliance with the ISO 13485:2016 standard.
Sophonix Co., Ltd. is dedicated to the research and development, manufacturing, sales, and service of in vitro diagnostic instruments and reagents. Centered on point-of-care testing (POCT) scenarios and leveraging advanced detection technology platforms, the company provides comprehensive, highly reproducible, and accurate precision POCT solutions. Currently, the company offers two product lines—pathological diagnosis and immunodiagnostics—with a molecular diagnostics product line under development.
The immunodiagnostic product line consists of the MS-Fast series instruments and supporting magnetic microparticle chemiluminescence assay kits. The testing menu covers areas such as cardiac markers, inflammation, hormones, maternal and child health, diabetes, brain injury, and infectious diseases. The single-test chemiluminescence products combine the high sensitivity and accuracy of magnetic microparticle chemiluminescence with the ease of operation and rapid turnaround time characteristic of POCT products. This enables the diagnostic capabilities typically available in central laboratories of tertiary hospitals to be extended to emergency departments, ICUs, and primary healthcare settings, while ensuring precision. Notably, the traumatic brain injury (TBI) biomarkers are exclusive products of Sophonix Co., Ltd. These products have completed large-scale, multi-center clinical trials in the United States and Europe, with a sample size approaching 2,000 cases. In February 2018, they received FDA market approval through the Breakthrough Devices Program, becoming the first FDA-approved blood-based ancillary diagnostic test for traumatic brain injury in adults. Leveraging the MS-Fast single-test chemiluminescence platform and the latest blood biomarkers for brain injury, the system achieves rapid detection of traumatic brain injury within 30 minutes, offering clear clinical application scenarios.
MS-Fast Series Instruments and Reagent Kits
The pathology diagnostics product line comprises the Ultra 60 and Ultra 30 fully automated immunohistochemistry (IHC) stainers, which perform fully automated IHC procedures. These systems provide robust support for ensuring the accuracy of pathological diagnoses and are widely applicable to pathology departments in major hospitals and independent clinical laboratories. The Ultra 60 has been successfully deployed in numerous top-tier tertiary hospitals and specialized oncology hospitals across China, receiving widespread acclaim.
Ultra 60 and Ultra 30 Fully Automated Immunohistochemistry Stainers
With the growing trend of domestication in China’s medical device industry and the continuous advancement of primary healthcare, Sophonix Co., Ltd. will continue to deepen its engagement in the field of in vitro diagnostics, ensuring that its fully automated single-test chemiluminescence products, pathological diagnosis products, and molecular diagnosis products better align with market trends and industry development directions. Committed to precision medicine, Sophonix strives to enable more people to enjoy healthier lives.
Li Feng, General Manager of Sophonix Co., Ltd., stated: “The completion of our Series B financing and the continued support from numerous renowned investment institutions demonstrate their recognition of Sophonix’s product quality and market prospects. The year 2020 is a pivotal year for Sophonix’s development. Receiving strong capital support at this critical juncture has provided powerful momentum for the company’s market expansion and strategic layout.”
“China’s POCT industry has approached a total market size of RMB 10 billion, maintaining rapid growth. The introduction and implementation of policies such as tiered diagnosis and treatment, chest pain centers, and stroke centers have also brought significant benefits to the industry’s development. China has more than 2,800 counties, over 41,000 townships, and more than 600,000 villages, with substantial disparities in medical capabilities across different regions. As the state vigorously promotes the upgrading of primary healthcare, we hope to provide a precise and rapid immunoassay system for primary hospitals serving 800 million people, enabling more individuals to enjoy diagnostic services as accurate as those offered by tertiary A-level hospitals right at their doorstep,” said Li Feng.
ThisLead Investor of the RoundZero2IPO Asset ManagementWe believe that the in vitro diagnostics (IVD) sector remains a promising area for investment within the broader healthcare industry, although homogenization among domestic products has led to intense competition. The core team at Sophonix Co., Ltd. comprises seasoned industry veterans who have undergone long-term collaboration and refinement, bringing extensive experience and sophisticated operational strategies. On one hand, the company has established dual R&D headquarters in China and the United States to guide strategic direction with an international perspective; on the other hand, it accurately identifies pain points in the domestic market, enabling precise, pragmatic, and effective market entry. We highly endorse the company’s product pipeline design philosophy, its R&D capabilities in magnetic particle chemiluminescence platforms, and the clinical value of its POCT products in primary care settings. We are pleased to join both new and existing shareholders in supporting Sophonix’s rapid growth and look forward to the swift launch of its valuable new products.
Delian Capital and Xiao PengIt stated: “China’s POCT sector has become the fastest-growing segment within the IVD industry. After evolving from scratch, POCT applications are now subject to increasingly stringent requirements for accuracy, reliability, and ease of use. As a provider of solutions and products for POCT settings, Sophonix Co., Ltd. offers a single-test chemiluminescence platform featuring superior CV values and a more user-friendly operational experience, along with exclusive assays in its testing menu. Notably, its brain injury biomarkers represent the first FDA-approved blood-based diagnostic test for brain injury. The Sophonix team combines strong capabilities in international collaborative development with efficient local implementation. We look forward to the company continuing to embrace advanced technologies, designing and producing more competitive products tailored to the Chinese POCT market, and emerging as a leader in this field.”
Wu Yuepeng, Managing Partner of Anlong Fund ManagementWe believe that China’s POCT industry has reached an overall scale of nearly RMB 10 billion and is maintaining rapid growth. Recently, multiple companies in the IVD sector have gone public or are preparing for IPOs on the A-share market, demonstrating strong performance in the capital markets. The capital market prospects for Sophonix Co., Ltd. are promising. The company’s in vitro diagnostic products can meet the clinical requirements of hospitals at various levels, offering broad application potential. Sophonix’s single-test chemiluminescence platform, pathological diagnosis platform, and molecular diagnosis platform possess core technological advantages and hold significant application potential in niche markets. We are optimistic about the execution capabilities of the Sophonix team and believe that its products will surely meet the demand for precision medicine products across hospitals at all levels, continue to improve, and benefit the general public.
Partner, Guotai Venture CapitalIt is believed that China’s IVD industry has entered a phase of rapid growth, which is expected to sustain over the long term as advanced medical testing becomes increasingly widespread. In the POCT sector, alongside market expansion, healthcare institutions have raised higher demands for the precision of testing technical indicators, product reliability, and operational convenience. In response to the structural adjustments in Chinese market needs, Sophonix Co., Ltd. has successfully developed high-sensitivity and high-reliability POCT solutions by leveraging its global perspective and precise understanding of the Chinese market. The company’s products feature full automation, diverse sample type compatibility, support for eight different test items, and minimal cross-contamination, earning strong market recognition. Guotai Venture Capital values the Sophonix team’s proven track record of long-term dedication to the IVD market. With R&D capabilities in both diagnostic instruments and reagents, the team will ensure rapid technological and product iteration, maintain competitive advantages, and provide cost-effective products and services for POCT applications in China.
ETP FundSophonix Co., Ltd. is an innovative enterprise deeply rooted in the field of in vitro diagnostics (IVD). We have witnessed and been deeply involved in its transformation from scratch. We are very optimistic about this team. We continue to increase our investment in this round, looking forward to the company's series of rapid and accurate diagnostic products, represented by POCT, benefiting more primary healthcare institutions in China and expanding into international markets.