Kunyu Gene Secures Nearly RMB 1 Billion in Series B Financing to Advance Cancer Early Screening R&D and Commercialization
VCBeat (WeChat ID: vcbeat) has learned that on December 15, 2020, Singlera GENOMICS (SHANGHAI) Ltd. (hereinafter referred to as “Singlera Genomics”) announced the completion of its Series B financing round, raising nearly RMB 1 billion. The round was co-led by the CICC Qide Innovative Biopharmaceutical Fund under CICC Capital, Detong Capital, and Furong Investment. It was followed by investments from renowned venture capital firms and industry funds, including Huamei International, Lingdao Capital, Wuxi Financial Investment Group, FutureX Capital, and the Shanghai Free Trade Zone Fund. Existing shareholders, including Shunwei Capital, Jingxu Venture Capital, and Proxima Ventures, also continued their participation in this round.
It is understood that this round of financing will be primarily used to expand the company’s R&D pipeline for early cancer screening products, with a focus on advancing the regulatory approval, manufacturing, and commercialization of various products, as well as conducting expanded prospective validation of pan-cancer early screening products.
Singlera GENOMICS was established in 2014, dedicated to the research and development and clinical application of next-generation genetic testing and molecular diagnostic technologies. Focusing on tumor prevention, onset, and progression, the company develops a series of solutions, particularly for the development and application of non-invasive early screening and diagnostic technologies for cancer based on its patented methylation detection platform.
Previously, Singlera GENOMICS secured RMB 120 million in Series A financing in August 2016, led by Lilly Asia Ventures. In March 2018, the company raised RMB 350 million in Series A+ financing, led by Sinopharm Capital and Jingxu Venture Capital. This latest Series B round has once again attracted top-tier professional investors, underscoring widespread recognition of Singlera GENOMICS’ strong capabilities in original technology R&D and its promising commercialization prospects.
So-called early cancer screening refers to the auxiliary diagnosis of early-stage cancers and precancerous lesions in target populations who appear healthy and have not yet exhibited obvious abnormal symptoms. Unlike cancer companion diagnostics, which aim at clinical evaluation, diagnosis, and grading of cancer, the majority of individuals yield negative results in early cancer screening tests. Early cancer screening is crucial for early diagnosis and treatment, helping to alleviate patient suffering, improve prognosis, and increase cure rates.
Schematic Diagram of Tumor Development, Screening, and Diagnosis
Based on estimates of the target population size, the demand for early cancer screening far exceeds that for companion diagnostics. Mr. Zhang Jiangli, CEO of Singlera GENOMICS, told VCBeat that, ideally, application scenarios for early cancer screening would include testing services provided by healthcare institutions and third-party medical laboratories, direct screening of high-risk populations, and convenient at-home testing for general consumers. At present, the business model for early cancer screening products primarily targets hospital patients and high-risk individuals undergoing health check-ups at examination centers.
Methods employed for early cancer screening primarily fall into two categories: conventional testing and liquid biopsy. Conventional testing methods mainly include tumor marker assays, medical imaging examinations, and endoscopy. Liquid biopsy, a concept complementary to tissue biopsy, involves sampling non-solid biological specimens to analyze tumor-related analytes, such as circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA).
In the field of early cancer screening, liquid biopsy offers numerous advantages over traditional testing methods.
First, liquid biopsy utilizes liquid samples such as blood, urine, or stool, offering simple sampling procedures that significantly reduce costs and minimize patient trauma and risk. Second, unlike medical imaging and endoscopy, which can only examine tumor lesions at specific sites per session, liquid biopsy facilitates simultaneous coverage of multiple tumor types. Third, liquid biopsy is straightforward to perform and provides rapid detection results, allowing for repeated sample collection and high-frequency monitoring. Finally, since malignant tumors are heterogeneous diseases, liquid biopsy can reflect the comprehensive genomic profile of the tumor, thereby reducing diagnostic bias caused by tumor heterogeneity while promptly capturing the dynamic changes in tumor progression.
Therefore, liquid biopsy has consistently been a focal point for research and commercial development in genetic testing, both domestically and internationally. According to incomplete statistics from VCBeat, there are currently dozens of companies in China engaged in the development of tumor liquid biopsy products. Companies with relatively rapid clinical progress include Singlera GENOMICS, Berry Genomics, Burning Rock Biotech, and Genetron Health. Among these, Singlera GENOMICS’ colorectal cancer early screening product and Huirui Gene’s hepatocellular carcinoma early screening product completed development and launched their services in 2018 and 2020, respectively.
Liquid biopsy has also become a favorite in the capital market. From around 2015 to the present, genetic testing companies in China that have laid out this pipeline have collectively attracted billions of yuan in funding. Berry Genomics, Burning Rock Biotech, and Genetron Health have successively entered the capital market, while Singlera GENOMICS has recently secured the largest single-round financing for a project in this field in China to date.
Unlike many genetic testing companies that have incorporated early cancer screening as just one expansion direction in their product pipelines, Singlera GENOMICS has remained deeply committed to early cancer screening, progressively achieving the translation of scientific research outcomes into clinical products.
In 2017, Professor Kun Zhang published a paper on methylation haplotype analysis in the journal Nature Genetics, marking the first international demonstration that methylation detection methods can capture trace amounts of cancer signals in ctDNA, enabling early cancer screening and tissue-of-origin identification. Building on this foundation, Singlera GENOMICS developed ColonES® (Changlesi®) and ColonAiQ™ (Changaikè™), early screening and diagnostic products for colorectal cancer, based on large-scale clinical studies conducted both domestically and internationally. These products are designed for the detection of colorectal cancer and advanced colorectal adenomas (precancerous lesions) in the general population.
“High detection accuracy, ease of use, and strong stability are the lifeblood of early cancer screening products,” said Mr. Zhang Jiangli. “Due to established operational habits and the need for unified testing standards, end-users exhibit a low willingness to actively switch to alternative solutions. Therefore, early screening products that enter the market first will gain a significant first-mover advantage.”
It is understood that Singlera GENOMICS is actively preparing the FDA submission for Changlesi and completed the second round of pre-review in May this year. Upon completion of clinical trials and subsequent FDA approval for market launch, Changlesi will be the only non-invasive liquid biopsy technology based on blood testing for advanced adenomas and early-stage colorectal cancer (Exact Sciences’ Cologuard is based on stool testing).
In November, Singlera GENOMICS officially launched a sub-project under the National Key R&D Program titled “Research and Evaluation of Technologies for Screening and Early Diagnosis of Common Malignant Tumors Based on Liquid Biopsy (Lung Cancer Special Project),” serving as a key collaborator and lead unit for this technical sub-project. This marks the first time that early screening and diagnosis of lung cancer have been included in a national-level key R&D program in China.
Mr. Zhang Jiangli stated that this study aims to identify suitable technologies for the widespread adoption of early lung cancer screening. Specifically, the researchers conducted a large-scale, multicenter, real-world study to apply ctDNA methylation detection, an advanced liquid biopsy technology, to the differential diagnosis of pulmonary nodules and early lung cancer screening. The study sought to validate the feasibility of a molecular subtyping system model for early lung cancer screening and diagnosis, and to develop such a system.
In addition to its commercially launched colorectal cancer early screening products, Singlera GENOMICS’ multi-cancer early detection technology, PanSeer®, has also achieved milestone data results. A large-scale natural population cohort study published in the prestigious international journal Nature Communications in July 2020 demonstrated that the PanSeer® assay can detect trace ctDNA methylation signals associated with five types of cancer up to four years earlier than clinical diagnosis.
With this, Singlera GENOMICS has become the third company globally, following GRAIL and Thrive Earlier Detection, to release large-scale clinical data on multi-cancer early detection. The five cancer types included in PanSeer®—lung, liver, gastric, esophageal, and colorectal cancers—cover the five malignancies with the highest incidence and mortality rates among the Chinese population.
Comparison of Pan-Cancer Early Screening Products from Singlera GENOMICS, GRAIL, and Thrive Earlier Detection
Unlike the fervent product development and strategic deployment seen in single-cancer early screening, multi-cancer early detection (MCED) products, despite garnering significant attention, have experienced relatively slow R&D progress. However, with GRAIL’s marketing application, MCED has once again been thrust into the spotlight. In its prospectus, GRAIL listed nine global competitors, including Singlera GENOMICS. GRAIL even asserted that few companies would actually conduct large-scale clinical trials to develop MCED products capable of rivaling its own.
Mr. Zhang Jiangli pointed out that Singlera GENOMICS’ pan-cancer early screening product has previously undergone rigorous validation in large-scale natural population cohorts, and the company will subsequently advance expanded prospective clinical studies involving tens of thousands of participants. “This will require substantial capital investment and serve as a test of the team’s comprehensive capabilities.”
Regarding this financing round, Mr. Zhang Jiangli stated, “We are grateful to our investors for their trust and support. We are honored that Singlera GENOMICS’ capabilities in innovative R&D, clinical translation, and commercialization have been recognized by top-tier investors. This round of financing will help us further expand our product portfolio and strengthen Singlera’s strategic advantages and marketing capabilities in the fields of early cancer screening and liquid biopsy. Cancer has become a major disease burdening China and the world at large. Since its founding six years ago, Singlera GENOMICS has been committed to overcoming the challenges of early cancer screening and diagnosis. Today, we have achieved a series of significant breakthroughs in technologies for early cancer detection and diagnosis. We will accelerate the commercialization of our products, ensuring that these innovative achievements can be applied at an early stage to cancer prevention and control for hundreds of millions of people across China.”
Professor Gao Yuan, Co-founder and Scientific Advisor of Singlera GENOMICS, stated: “Singlera has been committed to building an open and diverse collaborative innovation ecosystem integrating industry, academia, research, and clinical practice. Over the past few years, we have established extensive collaborations with dozens of domestic and international research institutions, hospitals, and pharmaceutical companies, which has laid a substantial foundation for our advantages in basic research and the translation of application outcomes in early cancer screening and liquid biopsy. Singlera GENOMICS has developed early cancer screening and diagnostic technologies and products covering common cancers, including pan-cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer, esophageal cancer, pancreatic cancer, and thyroid cancer. This round of financing will help us further conduct large-scale clinical trials and prospective healthy cohort validation.”
Dr. Han Tao, Executive General Manager of CICC Capital, stated: “Singlera GENOMICS is a globally leading enterprise in early cancer screening and diagnosis, possessing a rare, independently developed patent portfolio and top-tier original technology platforms in China. Against the backdrop of rapidly increasing global awareness of cancer prevention and the widespread adoption of screening and diagnostic services, significant public health needs and market potential are calling for ‘Made in China’ solutions. As the lead investor in this round, we firmly believe in Singlera’s outstanding scientific research foundation, mature operational management, and robust commercialization pathway. CICC has already begun to empower Singlera through both capital and industrial resources, and will work together with existing and new shareholders to help Singlera achieve rapid growth and sustain long-term success.”
Mr. Shao Jun, Founding Partner and Chairman of Detong Capital, stated that the application of new technologies such as DNA methylation testing has led to breakthrough progress in early screening and diagnosis of tumors. Singlera GENOMICS boasts an internationally renowned team of scientist-entrepreneurs and globally leading foundational technologies in the field of DNA methylation detection. By selecting blood samples, which are conducive to multi-cancer screening, as the test material, the company has expanded its product portfolio from single-cancer to pan-cancer detection. This approach genuinely addresses the practical needs of health screenings for the general population and clinical diagnostics. In the emerging and vast market of early tumor screening and diagnosis, Singlera GENOMICS is poised to become a global leader rather than an imitator or follower.
Dr. Sun Pengjun, Founding Partner and Chairman of Furong Investment, stated that Singlera GENOMICS possesses unparalleled advantages in both the depth of its proprietary technologies and the breadth of its product pipeline. Against the backdrop of the “Healthy China—Cancer Prevention and Control Action,” Singlera’s innovative technologies facilitate the earlier implementation of cancer screening, optimize the allocation of medical resources, and further promote the development of China’s tiered diagnosis and treatment system, thereby meeting the growing healthcare needs of the general public.
Mr. Luo Fei, Founding Partner, Chairman, and General Manager of Sinopharm Capital, representing existing shareholders and co-investors in this financing round, stated: “As steadfast supporters of Singlera GENOMICS, we have stood by the company throughout its journey. We are delighted to have witnessed a series of significant advancements in its scientific research, clinical applications, and commercialization, as well as its strong strategic focus and business resilience amid intense market competition. Singlera GENOMICS is a company driven by a profound sense of mission and is destined to become an enterprise with substantial impact.”
CICC Qide (Xiamen) Innovative Biopharmaceutical Equity Investment Fund (hereinafter referred to as the “CICC Qide Fund”) is an equity investment fund under CICC Capital Management Co., Ltd. (hereinafter referred to as “CICC Capital”) that focuses on innovative pharmaceuticals and biotechnology. It is a biopharmaceutical equity fund managed by CICC Capital, with professional expertise, scale, and brand influence all at leading market levels, and it is also the first equity fund launched by a Chinese securities company to focus on innovative pharmaceuticals.
DT Capital Partners is a leading professional private equity fund management firm in China, with assets under management nearing RMB 20 billion. In recent years, it has nurtured six listed companies and a cohort of early-stage enterprises with significant technological breakthroughs in the healthcare sector, including Chipscreen Biosciences, the first innovative drug company to list on the STAR Market. DT Capital Partners is also among the earliest investment institutions to establish strategic partnerships with multiple local governments and prominent industrial groups, providing comprehensive services and support to its portfolio companies.
Furong Investment is a specialized investment fund focused on the industrialization of scientific and technological achievements, established by Shanghai Furong Investment Co., Ltd. Shanghai Furong Investment Co., Ltd. is a technology finance and innovation & entrepreneurship platform initiated by Fudan University Ningbo Institute, which fully leverages Fudan University’s robust resources in talent, scientific research, academia, and clinical practice to promote the industrialization of related scientific and technological achievements and support high-level talent in innovation and entrepreneurship, thereby serving the national strategy of innovation-driven development and Shanghai’s initiative to build a globally influential science and technology innovation center.
Since its establishment in 2014, Singlera Genomics has been dedicated to advancing early cancer screening and diagnosis. Leveraging molecular diagnostic technologies, the company has developed a series of genetic testing solutions for tumors and hereditary diseases. As a pioneer and promoter of methylation detection technology, Singlera Genomics provides full-cycle services, including risk assessment, early screening, medication guidance, and postoperative monitoring for high-incidence cancers. The company boasts a robust product pipeline covering pan-cancer screening as well as specific cancers such as lung, colorectal, liver, gastric, esophageal, pancreatic, and thyroid cancers. By continuously accumulating large-scale samples and big data, Singlera Genomics has emerged as a global leader in the fields of liquid biopsy and early cancer screening.
Singlera GENOMICS is committed to building an open and diversified collaborative innovation ecosystem integrating industry, academia, research, and healthcare. The company has undertaken major national-level scientific research projects, led the drafting of multiple key industry standards, and engaged in extensive collaborations with top academic institutions, hospitals, and pharmaceutical companies both domestically and internationally, thereby advancing scientific research, clinical practice, and translational applications in the fields of liquid biopsy and early cancer screening. Singlera GENOMICS has assembled a multidisciplinary team of experts across various fields, currently holds nearly 100 international and domestic patents, and has published numerous papers in prestigious international academic journals. The company operates R&D centers in Shanghai and San Diego, USA; production bases in Shanghai and Yangzhou; and medical testing laboratories in Shanghai, Taizhou, and San Diego, USA.