Junshan Bio Enters High-Growth Phase with Integrated Pathology Lab Solutions and Cancer Early Screening Innovations

The Department of Pathology is an essential department in hospitals and one of the cornerstone departments supporting surgical operations. Its primary role is to provide pathological diagnosis during medical care. Pathological diagnosis refers to the process of determining the etiology and pathogenesis of diseases through methods such as biopsy, cytological examination, intraoperative frozen section analysis, immunohistochemistry, and fluorescence in situ hybridization (FISH), thereby providing evidence for clinical diagnosis, treatment, and prognosis. Therefore,Pathological diagnosis is also known as the gold standard for clinical diagnosis, and the importance of the pathology department in hospitals is self-evident.

However, in stark contrast to the critical role of pathology departments, they remain in a disadvantaged position in China’s secondary hospitals due to their limited economic profitability. They are often merged with clinical laboratory departments and receive insufficient attention in terms of equipment investment, personnel training, and talent acquisition.

In recent years, with the implementation of tiered diagnosis and treatment, policies encouraging private healthcare provision, and the adoption of Diagnosis-Related Groups (DRGs) for health insurance payment, the demand for and advantages of pathological diagnosis have become increasingly prominent, prompting hospitals at all levels to prioritize the development of their pathology departments.

“Pathology departments are required to treat exhaust gases generated from the volatilization of toluene, xylene, and other substances, as well as waste liquids such as formalin. Their construction requirements are far higher than those for departments such as clinical laboratories. Moreover, given that there are currently only over 20,000 registered pathologists in China, resulting in a significant talent shortage, hospitals find it difficult to independently plan and establish pathology departments,” said Zhang Feng, founder and general manager of Hangzhou Junshan Biotechnology Co., Ltd. (hereinafter referred to as “Junshan Biotech”).

Junshan Biotech is committed to providing hospitals with comprehensive solutions for pathology departments, offering full-process product configuration and technical support required for planning, construction, and subsequent operations. Currently, the company is assisting more than 10 centers and hospitals in establishing their pathology departments.

Junshan Biotech, established in June 2017, is committed to becoming a leading provider of comprehensive pathology solutions, with its business spanning molecular pathology, immunohistochemistry, routine histopathology, medical laboratory testing, and genetic testing.

The company is anchored by overseas PhD graduates from prestigious institutions such as the University of California, Berkeley, and the University of California, San Francisco School of Medicine. Its founding team comprises diverse talents with many years of experience in the R&D, production, and sales of medical devices and reagents, as well as extensive expertise in pathology, genetic testing, and cytology.

The Chief Consultant of Junshan Biotech is a nationally renowned expert in pathology department design, with over 30 years of experience in pathological technology. Under his guidance, Junshan Biotech’s comprehensive solutions for pathology departments integrate environmental protection, safety, and human-centric considerations. These solutions assist hospitals in establishing pathology departments from the ground up, providing supporting equipment and technical support throughout all stages—from design and planning to renovation and construction, as well as subsequent operations.

Currently, Junshan Biology has developed a series of proprietary and patented products for hospital pathology departments, covering equipment and supporting reagents required for the entire pathological diagnosis workflow, including grossing, embedding, sectioning, flotation and baking, staining, slide review, and storage of paraffin blocks., such as fully automated classic tissue stainers, fully automated immunohistochemistry (IHC) stainers, and intelligent paraffin block management systems. The end-to-end digital management from surgical specimens to pathological paraffin blocks enables traceability of pathological tissues. Among these, the fully automated IHC stainer and the intelligent paraffin block management system are among the company’s flagship products.

Pathology paraffin blocks carry patients’ disease information, enabling physicians to make rapid and precise cancer diagnoses and providing a basis for formulating personalized treatment plans. Moreover, the information contained in each block is non-replicable, rendering every block particularly valuable. Consequently, countries have established corresponding regulations for the preservation of paraffin blocks, requiring retention periods ranging from at least 10 to 30 years.

Zhang Feng stated, “With the rising incidence of cancer, the emergence of targeted therapies, and the advent of novel diagnostic technologies such as IHC, PCR, and NGS, hospitals have raised their standards for the management and storage of paraffin blocks.”

Previously, pathological paraffin blocks in hospitals across China were mostly managed manually, resulting in low efficiency and a high susceptibility to errors.The intelligent paraffin block management system developed by Junshan Biotech accurately records information such as location changes, usage, handlers, and borrowing duration of paraffin blocks, and generates historical archives in real time through scan verification.Enable efficient and precise management of every paraffin block within the department, address the pain points associated with manual management, prevent loss of paraffin blocks, and truly facilitate the standardization of pathology archive management while serving as a platform for scientific research and education.

The Department of Pathology is a major pillar of the hospital, and Zhang Feng remains optimistic about the future prospects of pathology.

Zhang Feng noted, “In recent years, the government has vigorously implemented measures to control healthcare insurance expenditures, leading to reduced fees for various diagnostic tests. However, pathology testing fees have risen contrary to this trend. For example, in 2019, the cost of immunohistochemistry testing in Beijing increased from 80 yuan to 150 yuan, and pathology department charges in Zhejiang Province rose by 15%.”

It is evident that both the government and hospitals have recognized the importance of pathology departments. In the future, pathology departments will become key foundational support units within hospitals, and Junshan Biotech’s comprehensive solutions for pathology departments are poised to reach a tipping point for business growth.

In addition to assisting hospitals in planning their pathology departments, Junshan Biology also provides pathological testing services to hospitals without established pathology departments by taking equity stakes in or controlling third-party pathology centers. Currently, the company has successfully acquired an equity stake in one third-party pathology center.

At the end of 2016, the General Office of the National Health and Family Planning Commission issued the “Notice on Printing and Distributing the Basic Standards and Management Specifications for Pathology Diagnosis Centers (Trial),” explicitly stating that pathology diagnosis centers are independently established medical institutions and encouraging their development toward chain and group-based models. From a policy perspective, third-party pathology centers are likely to become a future trend.

Junshan Biotechnology’s other business line focuses on early cancer screening. Zhang Feng stated, “Early screening is the most effective method for the prevention and treatment of malignant tumors.” Junshan Biotechnology has successfully developed a comprehensive solution for cytological screening of gynecological cancers, as well as products for early colorectal cancer screening.

Gynecological cancers have emerged as a major threat to women’s health worldwide in recent years, with cervical cancer and endometrial cancer ranking among the most prevalent malignancies in Chinese women.

Junshan Biotech’s gynecological cancer cytology screening solution includes an automated liquid-based cytology slide preparation and staining system, a fully automated P16 immunohistochemistry staining system, a microfluidic fully automated nucleic acid detection system, Li-Shi pathological liquid-based thin-layer cell tissue embedding, and the Li-Shi endometrial cancer screening system. This integrated approach meets the need for mutual validation between histology and cytology by combining morphological observation with immunohistochemical testing, thereby improving diagnostic accuracy and reducing rates of missed and misdiagnoses.

It is worth noting that,Junshan Biotechnology’s microfluidic fully automated nucleic acid detection system, jointly developed by Chinese and American teams, is the world’s first microfluidic fully automated nucleic acid detection system capable of multi-subtype HPV testing. Li-Shi Pathology’s liquid-based thin-layer cell tissue embedding technology represents China’s first proprietary integrated cell and tissue pathology system. The Li-Shi endometrial cancer screening system addresses the challenge of difficult sample collection; clinical validation has demonstrated the effectiveness of the uterine cavity sampler in clinical practice. This system achieves a sensitivity of 90% and a specificity of 98.15% for endometrial cancer screening, with a false negative rate of 1.85% and a false positive rate of 10%.

Colorectal cancer is also one of the most prevalent cancers in China. Over 90% of colorectal cancers develop from adenomas, and the progression from adenoma to early-stage colorectal cancer typically takes 5 to 10 years. Timely detection and removal can prevent 75% of colorectal cancers.

Junshan Biotech’s “Junshan No. 1” is an at-home early detection product for colorectal cancer. By analyzing a 5-gram stool sample from the subject for multiple free-floating tumor methylation markers, it can detect adenomas larger than 1 centimeter and early-stage colorectal cancer.This product can detect colorectal cancer five years in advance, with a sensitivity of up to 70% for advanced adenomas, up to 93% for early-stage colorectal cancer (Stage I–II), and a specificity of up to 90%.

According to Zhang Feng: “Since October 2019, Junshan Biotech has focused on the scaled-up production and sales of its mature and registered products.”

Zhang Feng previously served as the Sales Director for Abbott’s Greater China region, bringing extensive sales experience and a robust professional network. Junshan Bio boasts an extensive sales channel network. Zhang Feng stated, ““The company’s sales have exceeded RMB 80 million from 2019 to the present. Annual sales are projected to surpass RMB 100 million.”

Going forward, in addition to optimizing existing products, Junshan Biotech will continue to develop new products and projects, such as liquid-based HER2 testing, liquid biopsy assays for efficacy evaluation and monitoring in lung and gastric cancers, and quantitative pathological tissue testing.