RealBio Secures Strategic Investment from Zhangjiang Hi-Tech and Additional Funding from Luxin Venture Capital to Accelerate National Rollout of Colorectal Cancer Screening and Clinical Certification of Pathogen Detection Products

Shanghai Realbio Technology Co., Ltd, a leading enterprise dedicated to the commercialization of scientific and technological achievements in the field of the human microbiome, has recently secured strategic investment from Shanghai Haocheng Venture Investment Co., Ltd., an investment platform under Shanghai Zhangjiang Hi-Tech Park Development Co., Ltd. (Stock Code: 600895, abbreviated as “Zhangjiang Hi-Tech”). Luxin Venture Capital Group Co., Ltd. (Stock Code: 600783, abbreviated as “Luxin Venture Capital”), an existing shareholder, continued to increase its investment in Realbio through its fund, Qingdao Chuangxin Marine Economy Venture Investment Fund Center (Limited Partnership). Previously, in April 2019, Realbio disclosed that it had completed a financing round of nearly RMB 100 million, with investors including Luxin Venture Capital, Wuxi Financial Investment, and Yuanyi Capital.

Zhangjiang High-Tech, the lead investor in this round, is the primary force behind the development and construction of Zhangjiang Science City. Zhangjiang Haocheng is an industrial investment platform under Zhangjiang High-Tech. The Qingdao Chuangxin Marine Economy Venture Capital Fund Center (Limited Partnership) was jointly established by Luxin Venture Capital Group Co., Ltd., a company listed on the A-share market, and the Qingdao Municipal Venture Capital Guidance Fund Management Center, among others, and is managed by Luxin Chicheng, a subsidiary of Luxin Venture Capital. The joint investment by existing and new shareholders will further support Realbio’s nationwide layout and its future IPO plans.

Dr. Qin Nan, founder of Realbio, stated that the proceeds from this financing round will be primarily used to further strengthen the national sales network for its core product, the colorectal cancer early screening test “Changyishu®,” and to advance the clinical registration and market promotion of new pathogen detection products based on high-throughput sequencing technology, namely “Ruimingwei™ (RealPathogen),” as well as its PCR series products.

Realbio's Business Layout

With the development and advancement of sequencing technologies, scientists have begun to conduct more comprehensive and in-depth studies on the role microbes play in our lives. Over the past decade, there has been an abundance of research findings related to microbes. Beyond inflammation, neurological disorders, metabolic diseases, and even cancer have all been found to be influenced by microbes.

Based on these associations, scientists have begun to explore the use of microbes for diagnosing and even treating certain diseases, including inflammatory bowel disease, diabetes, autism, HIV/AIDS, and cancer. In recent years, research findings on the human microbiome have frequently graced the covers of major international top-tier journals. With the explosive growth in scientific achievements, the market size of the microbiome industry has continued to expand accordingly.

As a leading enterprise in the translation of scientific and technological achievements in the field of human microbiome in China, Shanghai Realbio Technology Co., Ltd. has been deeply engaged in human microbiome research since its establishment in 2014. The company owns multiple high-throughput sequencing platforms and has established in-depth cooperative relationships with more than 300 large hospitals and research institutes. Its core team has published numerous articles in top international journals such as Nature, Science, Nature Genetics, and Genome Biology. In recent years, the cumulative impact factor of its publications in the microbiome field ranks among the top of Chinese enterprises, demonstrating its industry leadership in the industrialization of the microbiome sector.

Shanghai Realbio Technology Co., Ltd. has long been deeply engaged in the field of human microbiome research and has accumulated extensive experience in fecal DNA processing. Based on a large number of clinical trials, the company independently developed a non-invasive early screening technology for colorectal cancer and successfully launched the Changyishu® Fecal Human SFRP2 and SDC2 Dual-Gene Methylation Combined Detection Kit. The novel dual-gene methylation combined detection technology targeting SFRP2 and SDC2 used in this kit, with high-level research results demonstrating a sensitivity of 97.73% and a specificity of 94.24%, was included in the "Expert Consensus on Early Colorectal Cancer Screening Process in China (2019, Shanghai)," published in the Chinese Medical Journal in October 2019.

“Expert Consensus on the Screening Process for Early Colorectal Cancer in China (2019, Shanghai)”

Diagnosis of infectious diseases represents another critical scenario for the industrial application of microbiomics. In 2014, The New England Journal of Medicine (NEJM) published a paper that first reported the use of metagenomic next-generation sequencing (mNGS) to diagnose nervous system infections, ushering in an era of precision diagnosis and treatment for infectious diseases. Since 2018, the application of mNGS technology in the field of infection has been gradually implemented in clinical practice in China. Over the past five years, Realbio Technology has remained dedicated to human microbiome research, accumulating extensive expertise in pre-processing techniques for various complex sample types, as well as efficient and low-input library preparation technologies. Furthermore, Realbio Technology’s microbial genome database has grown to include over 100,000 entries, balancing comprehensive scientific research needs with clinical practicality. The Ruimingwei™ product, developed by Realbio Technology, enables the unbiased and precise detection of the full microbial spectrum—including bacteria, fungi, viruses, and other suspected pathogens—from a single sample without the need for culture. With just one test, it comprehensively identifies potential pathogens, thereby assisting in the precise diagnosis and treatment of clinical infectious diseases.

Compared with traditional pathogen detection methods, mNGS technology not only features a broad detection spectrum, high throughput, and high positivity rate, but also offers unique advantages in detecting co-infections and emerging pathogens. The recent outbreak of novel coronavirus infection was initially identified through mNGS testing; subsequent bioinformatic analysis deciphered the viral nucleic acid sequence, leading to its official designation as Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by the International Committee on Taxonomy of Viruses (ICTV).

As a participant in the field of pathogen infection detection, Realbio Technology responded swiftly by leveraging viral nucleic acid information to design and launch two types of nucleic acid testing kits and viral sampling sets that are rapid, accurate, efficient, and suitable for various scenarios. The company donated nearly 10,000 units free of charge to medical institutions to support the detection of the novel coronavirus. Currently, Qingdao Realbio Medical Laboratory, a subsidiary of Realbio Technology, has successfully achieved a perfect score in the external quality assessment for novel coronavirus nucleic acid testing organized by the Shanghai Center for Clinical Laboratory (CNAS PT0025) and the Shanghai Clinical Laboratory Quality Control Center.

Meanwhile, Realbio joined forces with more than 50 enterprises to launch the “Joint Initiative for Epidemic Control and Virus Elimination,” providing disease control agencies with free access to testing facilities, instruments, and test kits, thereby effectively integrating resources to combat the epidemic. In the aftermath of this public health crisis, Realbio will further upgrade and optimize its Ruimingwei™ product line. Complementing a diverse portfolio of PCR-based pathogen detection solutions, these offerings enable precise pathogen typing while simultaneously assessing phenotypic characteristics such as drug resistance and virulence, specifically addressing emerging, sudden, and complex infections to effectively meet clinical needs.

Wang Fahua, Investment Director at Zhangjiang High-Tech, stated, “We are delighted to participate in the investment in Realbio. As a leading domestic enterprise in the field of human microbiome testing, Realbio has achieved outstanding results in translating cutting-edge technologies into practical applications. Its core product for early screening of colorectal cancer rivals top international standards, while its pathogenic microorganism testing products further meet clinical needs for infection diagnosis, providing patients with more precise diagnostic solutions. We remain bullish on the future industrial development of the human microbiome sector and look forward to seeing Realbio bring more microbiome-based new products to clinical practice.”

Wang Kuiqi, General Manager of Luxin Chicheng, stated, “We firmly believe that a number of outstanding technology-driven innovative enterprises benefiting the public will emerge in China, and Realbio is one of them. Colorectal cancer has consistently maintained high incidence and mortality rates in our country. As one of the cancers most amenable to early prevention and control, with a disease progression period of approximately ten years, early screening offers a significant opportunity to substantially reduce colorectal cancer mortality in China. Realbio’s colorectal cancer screening technology, a core part of its business, holds exceptional significance for the prevention and treatment of colorectal cancer. Furthermore, pathogen metagenomic testing has demonstrated greater potential than traditional diagnostic techniques in the clinical diagnosis of infectious diseases, and an increasing number of patients are expected to benefit from this technology in the future.”

Shanghai Zhangjiang Hi-Tech Park Development Co., Ltd. was officially listed on the Shanghai Stock Exchange in April 1996 (Stock Code: 600895). As a main force in the construction of Zhangjiang Science City, Zhangjiang Hi-Tech gathers multi-party resources to create a harmonious and symbiotic ecosystem for technological innovation, empowering and leading the development of China’s sci-tech innovation industry, and co-creating scientific and technological innovation capabilities. As the investment platform under Zhangjiang Hi-Tech, Zhangjiang Haocheng invests in projects at early, growth, and pre-IPO stages, covering key technological fields prioritized within Zhangjiang Science City, including biopharmaceuticals and medical devices, integrated circuits, information technology, and intelligent manufacturing.

Luxin Venture Capital Group Co., Ltd. is the largest professional venture capital firm in Shandong Province and one with significant influence nationwide, controlled by Shandong Luxin Investment Holding Group Co., Ltd. Luxin Venture Capital serves as a co-chair unit of the Venture Capital Professional Committee of the Investment Association of China, the secretary-general unit of the Shandong Venture Capital Association, and the chairman unit of the Talent Venture Capital Alliance under the Shandong High-Level Talent Development Promotion Association. In January 2010, the company’s venture capital business was successfully listed through a reverse merger, becoming the first listed venture capital firm in China’s capital market (stock code: 600783.SH). The funds managed and operated by Luxin Venture Capital include government-entrusted investment funds and market-oriented self-operated investment funds, totaling more than 40 funds across various categories such as industrial investment funds, regional investment funds, specialized investment funds, and platform investment funds.

Shanghai Realbio Technology Co., Ltd. was established in 2014, focusing on the translational application of cutting-edge technologies and research findings in the human microbiome field to medicine, particularly in precision medicine areas such as early cancer screening and diagnosis, and pathogenic microorganism diagnostics. Headquartered in Shanghai, Realbio operates a standard GMP-compliant facility spanning over 2,000 square meters in the Pujiang High-Tech Park of Minhang District, Shanghai. Additionally, the company has established an R&D center in Hangzhou and a wholly-owned third-party medical testing laboratory in Qingdao. Realbio has been honored with titles including “National High-Tech Enterprise,” “Top Ten Emerging Tech Entrepreneurs in Minhang, Shanghai,” and “Top 50 Most Investable Startups in Shanghai.” The company has currently forged in-depth collaborations with more than 300 research institutions and hospitals across China.