Geneshine Biotech Files for IPO: Pioneering Picogram-Level Liquid Biopsy for Early Cancer Detection

Cancer has become one of the leading diseases threatening human health. According to data from the International Agency for Research on Cancer (IARC) of the World Health Organization, in 2020, there were 4.57 million new cancer cases in China, accounting for 23.7% of the global total; cancer-related deaths in China reached 3 million, representing 30% of the global total. Furthermore, according to the latest data published in CA: A Cancer Journal for Clinicians, malignant neoplasms have risen to the top position among the leading causes of death in China in 2020.

As a critical approach for the early detection of cancer and precancerous lesions, cancer early screening plays a vital role in cancer prevention and control.Extensive research and clinical practice have demonstrated that early screening and diagnosis of cancer, combined with timely treatment, can significantly improve patient survival rates and prolong survival. Taking colorectal cancer as an example, the 5-year survival rate for early-stage adenomas approaches 100%, whereas it is only 10.8% for Stage IV disease. In the United States, screening programs have reduced the incidence of colorectal cancer by approximately 30% over a decade.

Furthermore, the cost of treating advanced-stage cancer is significantly higher than that of early detection and timely intervention. Therefore, early screening and diagnosis not only improve patients’ quality of life but also reduce overall cancer-related healthcare expenditures, thereby alleviating the national healthcare burden.

Driven by the substantial social and economic value of early cancer screening, China’s early cancer screening market has experienced rapid growth in recent years. The capital market for early cancer screening has witnessed numerous high-profile transactions; key players strategically focused on this sector, including Burning Rock Biotech, Genetron Health, and New Horizon Health, have successively gone public; notably, New Horizon Health obtained China’s first Class III medical device registration certificate for an early cancer screening product.

Thus, it is evident that the field of early cancer screening has become a focal point in the industry, with an increasing number of biotechnology companies entering this space. Among them, Jingshan Biotech has emerged as a standout player due to its advanced technological advantages.

Jingshan Bio was founded by Dr. Li Xuhui’s team.

Speaking of his entrepreneurial journey, he described it as a natural progression.

During his doctoral studies at Tsinghua University, Dr. Li focused primarily on biochemistry and enzymology; at Harvard Medical School, he mainly conducted research on the pathological mechanisms of tumors and diagnostic technologies.

Drawing on years of accumulated research insights and recognizing the limitations of existing cancer early screening methods as well as emerging market opportunities, Dr. Li founded Jingshan Biotechnology in 2015, a biotech company dedicated to early cancer detection. The company has now been incubated at the Peking University Health Science Center for Technology Transfer and Innovation & Entrepreneurship (hereinafter referred to as “PKU HSC Innovation Center”).

Peking University Medical Science and Innovation Center is a technology transfer and innovation-entrepreneurship platform established by Peking University Health Science Center to provide comprehensive services for medical technological innovation. Since its establishment, the Center has incubated dozens of high-quality medical startup projects across China and successfully attracted more than ten top-tier medical startups to settle in, continuously empowering these ventures to embark on new journeys.

Conventional methods for early cancer screening mainly include endoscopy, imaging tests, and tissue biopsy, all of which have certain limitations. Endoscopic screening has a limited detection range, is expensive, causes discomfort to patients, and may lead to cross-infection. Imaging tests can only detect tumors once they reach a certain size, resulting in significant delays; furthermore, these methods involve radiation exposure, cannot be used for real-time monitoring, and frequent examinations carry a certain risk of carcinogenesis. Tissue biopsy is challenging due to difficult sampling, and tumor heterogeneity often leads to incomplete sampling, which hinders diagnostic subtyping and increases the risk of complications. Additionally, both false-positive and false-negative rates are relatively high.

Therefore, it is urgent to develop novel cancer screening methods that are safer, more accurate, and more convenient.

Liquid biopsy is an emerging method for cancer detection that assesses tumor progression by analyzing circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and exosomes released into the bloodstream by primary tumors or their metastases.Compared with traditional early screening methods, liquid biopsy has four major advantages: first, it is non-invasive and can significantly reduce the risk of trauma to patients; second, it can achieve pan-cancer detection; third, it is easy to operate and allows for repeated sampling; fourth, it can effectively address tumor heterogeneity.

According to CB Insights data, among all segmented application areas of liquid biopsy, early cancer screening is the fastest-growing segment, with its market size expected to reach $344 million in 2023, at a compound annual growth rate (CAGR) of 71.8%.

Jingshan Bio primarily focuses on a niche technology within liquid biopsy: DNA methylation.

In the human genome, approximately 3%–6% of cytosine (C) residues are covalently bonded to methyl groups at the C5 position within CpG dinucleotides under the action of DNA methyltransferases. CpG dinucleotides often exist in dense clusters of 300–3,000 base pairs (bp) in length, known as CpG islands, which are typically located near the transcription start sites of genes and play a role in regulating gene expression.

Following DNA methylation, the binding of transcription factors to DNA is inhibited, leading to gene silencing and a corresponding decrease in protein levels. In cancer cells, which differ significantly from normal cells, the promoter regions of tumor suppressor genes are typically highly methylated. This results in the shutdown of tumor suppressor genes, thereby allowing uncontrolled cancer cell growth. Consequently, assessing DNA methylation levels in patients' peripheral blood can provide insights into tumor growth status, facilitating early screening and diagnosis of cancer.

Jingshan Biotech’s DNA methylation detection platform integrates its proprietary circulating tumor DNA (ctDNA) isolation and enrichment technology with ultra-sensitive DNA methylation molecular detection, enabling the precise identification of picogram-level (one trillionth of a gram) trace amounts of tumor biomarkers in blood.

Dr. Li explained, “The lower the quantity of detectable targets, the earlier tumors can be detected.”“Laboratory results indicate that we can detect samples at a maximum sensitivity of 50 picograms per target, which represents a high level of performance.” He stated that compared with foreign companies, Jingshan Bio has overall reached an advanced technological level, including in metrics such as stability and sensitivity.

Leveraging its proprietary DNA methylation detection platform, Jingshan Biotech has developed a cervical cancer detection kit, with detection kits for other cancers currently under development.

Among these, the cervical cancer methylation detection kit covers over 99% of HPV types associated with cervical carcinogenesis, achieves a sensitivity as high as 90%, and has an extremely low missed diagnosis rate. It requires only a small amount of cervical smear sample, causing no invasive injury or radiation damage.

Currently, Jingshan Bio has engaged in multiple research and clinical collaborations with renowned scientific research institutions and medical organizations, including the Zhejiang Yakangbo Medical Research Institute, the Yangtze Delta Region Institute of Tsinghua University, Peking University First Hospital, and Shanghai First Maternity and Infant Hospital, to jointly advance product development and validation.

It is reported that Jingshan Biotech is launching a new round of financing, with the proceeds to be primarily used for product registration and filing, new product research and development, market promotion, and daily operations.

“In the near term, we will continue to focus on early cancer detection and sequentially develop new early cancer screening products based on our proprietary technology platform.” Dr. Li further stated that, building upon the first-generation technology employing real-time quantitative PCR (qPCR), the team is currently developing second-generation technological reserves, which are expected to reduce testing costs and enable multiplex detection.