Kuoran Genomics Completes Tens of Millions RMB Pre-A Financing to Accelerate Commercialization of Next-Generation Pathology Technologies

Recently, Kuoran Biomedical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Kuoran Genomics”) announced the completion of its Pre-A financing round, raising tens of millions of RMB. The round was led by Guosheng Furui, with Jinyun Shanghui serving as the financial advisor. The funds will be used to further advance the company’s layout in regulatory filing and registration reserves for its Next-Generation Pathology (NGP) technology and IVD products, thereby accelerating their market launch.

Kuoran Biomedical Technology (Shanghai) Co., Ltd. is a leading enterprise with in-depth deployment in next-generation pathological diagnostics, as well as in vitro diagnostic (IVD) products for central nervous system tumors and hepatobiliary tumors. The company currently offers more than 48 testing products, has prepared regulatory registration submissions for six IVD products, and operates two CAP-accredited independent clinical laboratories across China. It provides precise testing solutions for early cancer screening, auxiliary diagnosis, intraoperative predictive monitoring, and postoperative recurrence risk assessment, and has established collaborations with over 500 medical institutions.

Bu Lingbin, founder of Kuoran Biomedical Technology (Shanghai) Co., Ltd. (Kuoran Genomics), stated: “Kuoran Genomics aligns its R&D initiatives and marketing strategies with clinical needs, achieving cost controllability and garnering support from numerous senior clinical experts. The company has established a strong presence in specialized fields such as brain tumors and hepatobiliary malignancies, backed by robust technical barriers and forward-looking vision. By proposing technological innovations that integrate Next-Generation Pathology (NGP) with Next-Generation Sequencing (NGS), Kuoran Genomics demonstrates significant potential for future growth. More importantly, the company has deployed multiple technology platforms, including multiplex immunohistochemistry (mIHC), NGS, and mass spectrometry, thereby fostering strong scalability and brand effect.”

Zhang Shouzhong, General Manager of Guosheng Furui, stated: “Kuoran Genomics focuses on the translational research and application of precision medicine, dedicated to providing one-stop molecular diagnostic solutions for multiple application scenarios. First, leveraging innovative technologies across diversified platforms as its operational foundation, the company establishes innovative Laboratory Developed Tests (LDTs) that meet clinical and research needs, thereby expanding application areas for clinical testing and scientific research while paving sales channels for In Vitro Diagnostic (IVD) products. Second, through deep collaboration with universities, enterprises, research institutions, and Grade A tertiary hospitals, it facilitates the translation and implementation of various achievements, offering high-margin IVD reagent products and profits to further support R&D. Meanwhile, it strategically deploys next-generation pathological diagnostics based on multiplex fluorescent immunohistochemistry technology platforms to achieve commercialization. This fully aligns with the entrepreneurial philosophy and methodology of ‘Trend, Market, and Execution,’ namely: identifying trends to determine strategic direction; pinpointing the market to define niche segments; and executing tasks to perfection to implement all plans.”

The founding team of Kuoran Gene has over a decade of experience in the healthcare sector, possessing inherent advantages in sales network deployment, process management, and cost control. In terms of business layout, Kuoran Gene has established a unique model characterized by “LDT + IVD” and “NGP + NGS.”

In its “LDT+IVD” business layout, Kuoran Genomics has engaged in extensive discussions with clinical experts and deployed dozens of testing products through the Laboratory Developed Tests (LDT) model. This strategy has not only generated stable revenue but also established distribution channels for In Vitro Diagnostic (IVD) products. Building on its LDT offerings, the company selected products with broad market potential and strong commercialization prospects for regulatory registration. Currently, it has a pipeline of six IVD product registrations, including the HCC7S “Kit for Auxiliary Diagnosis of Liver Cancer via Detection of 7 microRNAs” and the HCC5R “Kit for Risk Assessment of Postoperative Metastasis and Recurrence of Liver Cancer,” thereby establishing technical barriers in IVD products for brain tumors and hepatobiliary cancers.

Furthermore, Kuoran GenomicsPioneered Novel Clinical Applications of NGP and NGS, laying out next-generation pathology technologies. Kuoran Biomedical was among the early entrants into the NGS market, with applications in solid tumors such as brain tumors. As competition in the NGS market intensifies and the focus of oncologic diagnostic pathology shifts from targeted therapy to research on the tumor immune microenvironment, the limitations of NGS are increasingly becoming apparent.

Therefore, Kuoran Genomics has begun to deploy next-generation pathology (NGP) technologies, represented by multiplex fluorescent immunohistochemistry, to address challenges in tumor immune microenvironment research. This has led to a parallel development strategy of NGP and NGS. By integrating NGS with NGP technologies, the company enables more accurate, comprehensive, and efficient assessment of the tumor immune microenvironment, thereby guiding clinical diagnosis and treatment, as well as evaluating the efficacy and prognosis of immunotherapy.

LDTs and IVDs, along with NGP and NGS, complement each other, enabling Kuoran Biomedical to establish a differentiated market position in an increasingly competitive landscape. Currently, Kuoran Biomedical has established collaborations with over 500 medical institutions, including Fudan University Shanghai Cancer Center, Huashan Hospital Affiliated to Fudan University, Shanghai Eastern Hepatobiliary Surgery Hospital, Beijing Tiantan Hospital, and Xuanwu Hospital Capital Medical University.

Leveraging multiplex fluorescence immunohistochemistry technology, Kuoran Genomics is strategically focusing on the pathology diagnostics market.

According to the 2020 World Pathology Congress report, the global pathology market size is projected to grow from RMB 191.3 billion in 2019 to RMB 255 billion in 2024, representing a compound annual growth rate (CAGR) of 6.1% from 2019 to 2024. According to forecasts by Western Securities, the potential market for China’s pathology industry exceeds RMB 40 billion.

However, data indicate that China currently has fewer than 20,000 practicing pathologists. Based on the National Health Commission’s staffing requirement of one to two pathologists per 100 hospital beds, the shortfall exceeds 90,000 pathologists. Uneven distribution of pathological resources, prolonged diagnostic turnaround times, low efficiency, and excessive workloads are among the major pain points facing the pathology diagnostics industry.

Pain points signify opportunities. From H&E staining to FISH and then to immunohistochemistry, pathological diagnostic technologies have yet to achieve a disruptive breakthrough. Bu Lingbin believes:“Pathological diagnosis will expand from qPCR and NGS to next-generation pathological technologies, represented by multiplex fluorescent immunohistochemistry.”

Notably, qPCR has already seen some application in pathology departments. However, NGS kits do not yet offer comprehensive coverage, the launch of in-hospital instruments requires large panels, and there is no standardized pricing model within hospitals, indicating that its use is still in the early stages.Multiplex fluorescence immunohistochemistry aligns with the emerging needs of tumor immune microenvironment research. With registered test kits available and established reimbursement models, it addresses multiple pain points associated with the hospital adoption of NGS, holding promise for rapid implementation in pathology departments.

Multiplex fluorescent immunohistochemistry can be regarded as a technology specifically developed for research on the tumor immune microenvironment. Existing studies have demonstrated that this technique significantly enhances detection sensitivity, enabling the analysis of low-abundance samples and facilitating comprehensive and objective assessment of patients’ tumor immune subtypes. Detection of the tumor microenvironment based on multiplex fluorescent immunohistochemistry allows for a deeper understanding of tumorigenesis mechanisms, improves the prediction of tumor response to immunotherapy, and enables precise identification of patients likely to benefit from immunotherapy.

At the current stage, multiplex fluorescence immunohistochemistry technology is generally in the research phase.Kuoran Genomics is poised to become the first company in China to achieve commercial implementation of multiplex fluorescent immunohistochemistry technology., has integrated the upstream and downstream sectors of the industry, and established a comprehensive multiplex fluorescent immunohistochemistry technology platform, including Opal™ multi-label staining technology and PhenoImager™ HT (formerly Vectra^®Polaris® multispectral imaging system and InForm™ image analysis system, and developed seven diagnostic products.

Next, Kuoran Genomics will proceed with the PhenoImager™ HT (formerly Vectra^®Polaris) multispectral imaging system registration and certification, further optimize the InForm™ image analysis system, while outputting solutions for different diseases, accelerating the implementation of multiplex fluorescence immunohistochemistry technology in pathology departments.

Guosheng Group was established in August 2018. Affiliated with the State-owned Assets Supervision and Administration Commission of Xuzhou Municipality, it has a registered capital of RMB 5 billion. It is a local financial holding platform consolidatedly built by the Municipal Party Committee and the Municipal People’s Government through resource integration. Its predecessor was Guosheng Company, which was restructured from Xuzhou Fiscal Securities Company in 2001.

Jinyun Shanghui, founded by the founder of Yunbai Capital, is a boutique investment bank headquartered in Hong Kong, dedicated to serving technology and innovation in the new digital era and connecting China with the world. Jinyun Shanghui is committed to assisting China’s innovation and change leaders in overseas financing and cross-border mergers and acquisitions, promoting collaborative value creation among major global industries, economies, and capital markets.