Tengchen Bio Completes Tens of Millions RMB Series A Financing to Advance Clinical Application of Mass Spectrometry-Based Methylation Assays for Early Cancer Detection

Nanjing Tengchen Biotechnology Announces Completion of Tens of Millions in Series A FinancingRecently, Nanjing Tengchen Biotechnology announced the completion of its Series A financing round, raising tens of millions of RMB. The round was led by Shulan Junjie Capital, with participation from prominent individual investors, and Probes Capital served as the exclusive financial advisor. The proceeds will primarily be used to further expand the company’s biomarker patent portfolio and accumulate clinical samples, accelerate the R&D of subsequent product pipelines, prioritize the registration testing and subsequent medical device certification application for its IVD product designed to differentiate between benign and malignant pulmonary nodules, and facilitate the commercialization of its Laboratory Developed Tests (LDT) products.

Founded in 2018, Tengchen Biotechnology specializes in the research and development of nucleic acid mass spectrometry-based products for early screening and diagnosis of malignant tumors. Since its inception, the company has collaborated with top-tier hospitals in China to establish a world-class biobank for early-stage cancer samples. To date, it has accumulated over 20,000 clinical samples and developed proprietary target arrays based on real-world clinical data, securing a portfolio of molecular biomarker patents to build a robust patent moat. Furthermore, by optimizing processes around its nucleic acid mass spectrometry platform and independently developing and manufacturing core reagent kits, Tengchen Biotechnology has significantly raised product barriers while substantially reducing testing costs, thereby enhancing clinical accessibility and data stability.

The market size for early cancer screening and diagnosis has reached hundreds of billions, with the molecular diagnostics sector experiencing rapid growth in recent years. DNA methylation is considered an excellent in vitro molecular biomarker for early cancer diagnosis, enabling early detection of a range of malignant tumors, including lung cancer, breast cancer, thyroid cancer, colorectal cancer, and cervical cancer. Although several products targeting DNA methylation have already been launched (with indications including colorectal cancer and cervical cancer), most of these products are limited to cancer types where tissue samples near the tumor can be readily obtained. However, blood is the optimal medium for in vitro early diagnosis of malignant tumors, as it allows for simple sampling and is applicable to nearly all cancer types. Nevertheless, due to the weak methylation signals and strong background noise in the blood of patients with early-stage malignancies, accurately capturing the corresponding signals remains extremely challenging.

Currently, there are three primary methods for methylation detection: qPCR, next-generation sequencing (NGS), and quantitative nucleic acid mass spectrometry. Among these, qPCR is relatively simple, requires less bioinformatics analysis, and the corresponding instruments are widely available in clinical settings, with numerous precedents for IVD regulatory approvals. However, qPCR is only suitable for products targeting a limited number of loci (optimally 1–5 loci) and offers relatively low precision, making it unsuitable for testing blood samples. In contrast, NGS-based methylation detection provides higher precision and can simultaneously analyze tens of thousands of DNA loci. Nevertheless, its operation is more complex, with higher bioinformatics requirements and costs, making it more suitable for locus screening. Quantitative nucleic acid mass spectrometry is relatively easy to operate, has low bioinformatics demands, and offers high data stability. It is suitable for detecting 10–100 DNA loci, aligning well with the clinical application scenarios for blood sample testing. However, nearly all reagent kits required for each step of nucleic acid mass spectrometry must be imported. Therefore, reducing detection costs, optimizing the testing workflow, and selecting appropriate molecular biomarker panels remain key challenges that need to be addressed for the application of this technology platform.

Currently, Nanjing Tengchen Biotechnology Co., Ltd. has developed a portfolio of nearly 10 product pipelines centered around its nucleic acid mass spectrometry detection platform, covering various malignant tumors including lung cancer, breast cancer, thyroid cancer, and prostate cancer. Among these, the early lung cancer diagnostic product has completed clinical validation in over 4,000 cases (with more than 90% being Stage I lung cancer), demonstrating both sensitivity and specificity exceeding 80% for very early-stage lung cancers smaller than 2 cm. Compared to competing products, Tengchen Biotech’s early lung cancer diagnostic product, “Feijiemin,” offers advantages such as lower blood sample volume requirements, less stringent sample criteria, and reduced costs and end-user pricing. The company is currently advancing commercialization efforts and preparing to initiate the application process for In Vitro Diagnostic (IVD) certification. As the company accelerates its R&D progress and continuously injects resources, enriching its product pipeline, Tengchen Biotechnology has attracted a cohort of outstanding talents, building an exceptional team with extensive experience in R&D, production, and sales.

Dr. Yang Rongxi, Founder and CEO of Tengchen Biotechnology, stated, “We are delighted to have continuously received recognition and support from renowned professional funds and investors. With over a decade of technological accumulation, Tengchen Biotechnology possesses internationally leading capabilities in continuous original research and development. We are committed to developing highly efficient, stable, and cost-effective molecular biomarkers for early cancer screening and diagnosis, along with the underlying technologies and testing systems. After four years of growth, our team has been progressively strengthened, clinical data has been rapidly accumulated, and market sales initiatives are being rolled out. Moving forward, we will work hand in hand with our partners to advance R&D and regulatory submissions, providing high-quality products and services for early cancer screening and diagnosis to clinicians and patients.”

Xu Dilong, Founding Partner of Shulan Junjie Capital, stated: “We are delighted to participate as the lead investor in Tengchen Biotechnology’s Series A financing round. Rooted in the industry and deeply engaged in healthcare investments, Shulan Junjie Medical Capital has maintained a pragmatic focus on the early cancer screening and diagnosis sector in recent years, seeking projects with entrepreneurial spirit, sustained original R&D capabilities, and strong potential for commercial implementation. With over a decade of commitment to original research, Tengchen Biotechnology has accumulated more than 30 invention patents, thousands of clinical cases, and proprietary process technologies, thereby establishing significant technical barriers. The application of its nucleic acid mass spectrometry platform has not only substantially improved data precision and stability but also greatly reduced costs and enhanced operational efficiency. We look forward to Tengchen Biotechnology’s future development with great anticipation.”

Yang Danning, Partner at Tan Capital, stated: “Tengchen Biotechnology possesses first-class R&D and commercialization capabilities for IVD products. The company has rapidly deployed multiple product pipelines centered on nucleic acid mass spectrometry, while establishing its own molecular biomarker arrays and proprietary reagent patent barriers. In developing IVD products with high differentiation, precision, and specificity, Tengchen further reduces testing costs and enhances result stability, thereby better aligning with application scenarios for early disease screening and diagnosis. Since its inception, the company has collaborated with numerous renowned hospitals in China to jointly advance project implementation, and we are confident that it will achieve explosive growth in the future. We are honored to participate in Tengchen Biotechnology’s current financing round and look forward to the company, under the leadership of its CEO, further strengthening its R&D barriers and refining its product pipeline to contribute to the industry’s robust development.”

Nanjing Tengchen Biotechnology Co., Ltd. is located in the "Nanjing Bio-medicine Valley" of the Nanjing Jiangbei New Area. It is a high-tech biotechnology enterprise founded by a Ph.D. holder who returned to China after studying in Germany, dedicated to developing next-generation in vitro early diagnostic technologies and products for major diseases such as cancer and cardiovascular and cerebrovascular disorders. The company possesses leading proprietary technologies in early disease diagnosis, prognosis assessment, treatment efficacy evaluation, and recurrence monitoring, and has secured investment from multiple top-tier domestic venture capital firms. The company has established collaborations with numerous Grade III Class A hospitals in China and is actively establishing an R&D base for in vitro tumor diagnostics to further enhance its R&D innovation capabilities, enrich its big data accumulation, and optimize its intellectual property layout. The founder previously served as a researcher at the German Cancer Research Center (DKFZ) and the Medical Faculty of Heidelberg University, which is ranked first in Germany. His research achievements were awarded the Breast Cancer Research Contribution Award by the renowned Claudia von Schilling Foundation in Europe in 2016. With extensive entrepreneurial experience in Germany and multiple awards, the in vitro tumor diagnostic system he founded successively received the High-Tech Transfer Award from the German Federal Ministry for Economic Affairs and Energy and the First Prize in the Biotechnology Category of the EU Start-up Competition.

Shulan Junjie Capital was jointly established by early investors and the founding team of Shulan Medical Group. It serves the translation of medical technology innovations into industry applications by leveraging clinical resources on a global scale. Through the establishment of a science and technology investment fund, the SATOL Life Sciences Accelerator, and the SATOL Global Medical Innovation and Entrepreneurship Center, as well as by hosting the World Life Sciences Conference and the Global Medical Innovation and Entrepreneurship Competition, it promotes the integrated development of clinical practice, scientific research, and industry via three core businesses: community services, fund investment, and research incubation. It supports the innovation and entrepreneurship of medical science and technology talents and has invested in a portfolio of outstanding technology enterprises in fields such as digital diagnostics and treatment, biotechnology, and innovative therapies.

Probe Capital was founded in 2017 as a boutique investment bank specializing in healthcare and life sciences. Its business lines encompass financial advisory, direct investment, industry consulting, and innovation incubation. The founding team hails from leading private equity firms, financial advisory institutions, management consulting companies, and healthcare-focused media outlets. Since its inception, Probe Capital has consistently completed double-digit private financing and M&A transactions annually, with cumulative transaction values approaching RMB 10 billion. In terms of value-added services for portfolio companies, the Probe Capital team boasts extensive and mature industry expertise. In 2020, Probe New Healthcare Fund was established and has since invested in more than ten leading companies in the sector.