Tongshu Gene Secures Hundreds of Millions in Series B Funding Led by Yuansheng Venture Capital to Advance IVD Pipeline and ctDNA-Based Precision Oncology Diagnostics

On September 22, 2020, TONGSHU GENE (Changzhou Tongshu Biotechnology Co., Ltd.) announced the completion of its Series B financing round, raising hundreds of millions of RMB. The round was led by YuanBio Venture Capital, with participation from Longma Peak Venture Capital, Xiran Capital, and Jiangsu Tuobang. The funds raised will be used to accelerate the clinical development of new IVD technology products and expand the company’s product pipeline.

TONGSHU GENE, established in November 2016, is a high-tech enterprise specializing in the research and development, production, and sales of multi-platform, innovative technologies for oncology genetic diagnostics.

As an emerging leader in the field of oncology genetic testing, TONGSHU GENE has carved out a distinct development path. First, the company has established a systematic and compliant operational framework centered on high-throughput sequencing. Its NGS-based genetic testing services have achieved “integration of three certifications,” meaning that the reagents, instruments, and bioinformatics software used are all products approved by the National Medical Products Administration (NMPA). By adopting a dual-drive strategy that combines in-hospital compliant testing with out-of-hospital Laboratory Developed Tests (LDTs), TONGSHU GENE has earned strong customer recognition amid fierce market competition. The company’s business growth has outpaced industry norms, while also achieving substantive in-hospital testing implementations in dozens of hospitals.

Since its inception, the company has been committed to building a broad product moat through the accumulation of technical know-how. Under the leadership of Dr. Cai Weijing, Chief Technology Officer, the company has developed a portfolio of multi-technology platform tumor gene testing products with domestic leading standards and significant clinical diagnostic value. These innovations have been rapidly and efficiently transformed into registrable diagnostic products. Notably, the Microsatellite Instability (MSI) Detection Kit (Multiplex Fluorescent PCR-Capillary Electrophoresis Method) is at a domestically leading stage in terms of product development progress. Clinical trials for two kits based on the MASS-PCR technology platform are being conducted simultaneously. In addition, technologies such as MASE-CE, NGS low-input library preparation, and CRIDIT-CRISPR have also advanced to the registration testing or clinical study stages.

Yan Linghua, Chief Executive Officer, and Dr. Cai Weijing, Chief Technology Officer, the two core founders of the company, both have prior clinical experience at renowned hospitals in China. Dr. Cai also possesses strong capabilities in clinical research. Their professional medical backgrounds provide the founders with a more intuitive clinical perspective, driving the practical application and systematic development of tumor gene diagnostic products.

After just over three years of development, TONGSHU GENE has experienced exponential growth in business volume, with sales ranking among the top in the industry. The completion of this round of financing marks TONGSHU GENE’s entry into a phase of leapfrog development. In the future, TONGSHU GENE will continue to uphold its mission of “Innovation, Creating Value for Cancer Patients,” dedicate itself to the field of precision medicine, and contribute to public welfare and social benefit.

Yan Linghua, CEO of TONGSHU GENE, expressed gratitude to both new and existing investors for their continued support. Over the past three years, TONGSHU GENE has adhered to a “product + service” strategy centered on hospitals, developing a series of IVD diagnostic technologies with significant technical barriers, driven by clinical needs. Notably, its NGS low-input library preparation technology secured first place in the amplicon library preparation category at the National NGS Library Preparation Competition for two consecutive editions. Additionally, its high-sensitivity MSI detection technology and MASS-PCR technology have both entered the regulatory registration phase.

Notably, TONGSHU GENE’s end-to-end ctDNA testing technology encompasses a suite of core technologies, including cfDNA extraction, cfDNA enrichment, and PRIDE-cfDNA library preparation, ensuring minimal loss of ctDNA during the detection process. We look forward to these innovative products receiving approval from the National Medical Products Administration (NMPA) in the near future, thereby benefiting patients and contributing to the advancement of precision oncology diagnosis and treatment.

Dr. Lin Yi, Managing Partner of YuanBio Venture Capital, stated, “We have consistently maintained a strong focus on advancements in the field of precision oncology diagnostics. After five to six years of market cultivation, precision oncology diagnostics has entered its 2.0 era, evolving from a phase of widespread market land-grabbing to one of intensive refinement and increasingly urgent regulatory compliance. Meanwhile, clinicians are paying growing attention to the clinical validity and cost-effectiveness of interpreting the massive amounts of data generated by high-throughput tumor sequencing. We are delighted to partner with TONGSHU GENE, marking our inaugural investment in the precision oncology diagnostics sector. TONGSHU GENE possesses a clearly defined pathway for productizing precision diagnostic solutions and demonstrates a strong capacity to translate technologies in close alignment with clinical needs. The clinical and pharmaceutical marketing backgrounds of its core team are also highly valued by us. Together with existing shareholders, we are committed to supporting TONGSHU GENE in standing out amidst intense competition and becoming an industry leader in the precision oncology diagnostics market, which still holds substantial untapped potential.”

TONGSHU GENE, established in December 2016, is a high-tech enterprise dedicated to the field of precision oncology. Its R&D headquarters is located in the Baoshan Science and Technology Innovation Park in Shanghai, with GMP-compliant production centers and internationally standardized medical laboratory testing centers established in Changzhou and Guangzhou, respectively. The company’s core business is providing a comprehensive portfolio of peri-survival companion diagnostic products for cancer patients. It has developed a precise ctDNA detection system based on high-throughput next-generation sequencing (NGS) and bioinformatics analysis, offering over 500 molecular pathology testing items. This enables non-invasive, accurate, and dynamic genetic analysis of tumors, delivering clinical consulting services for precision medication, treatment efficacy monitoring, postoperative recurrence surveillance, risk prediction, and early detection.

TONGSHU GENE’s product portfolio comprehensively meets the diverse needs of clinical and research applications, with its testing service network now covering more than 500 core hospitals across five major regions in China.

TONGSHU GENE has received numerous awards in the field of innovative oncology technologies, including First Prize in the NGS Library Preparation Competition, “2018 Best Growing Enterprise in Baoshan District,” and Vice Chairman Unit of the Gene Industry-Academia-Research-Finance Alliance. The company’s founders have individually been honored as “Changzhou Longcheng Talent,” “Changzhou Double Innovation Talent,” and recipients of the 2016 International Association for the Study of Lung Cancer (IASLC) Science Award for Developing Countries. Its research achievements have been published in high-impact SCI-indexed journals and widely recognized by authoritative international publications.

YuanBio Venture Capital is an investment firm focused on the early and growth stages of the healthcare sector, headquartered in Suzhou BioBAY with a global reach. Currently managing approximately RMB 5 billion in assets, YuanBio has invested in over 80 high-quality projects, primarily spanning new drug development, medical devices, in vitro diagnostics (IVD), and healthcare services. The firm has delivered substantial investment returns and has been repeatedly recognized as one of the Top 10 Venture Capital Funds in China’s healthcare sector and as one of the most active healthcare investment institutions in China. YuanBio brings together a team of seasoned professional investors and world-class scientific advisors, possessing extensive experience in entrepreneurship, venture capital, and corporate operations within the biopharmaceutical industry and beyond. Leveraging its specialized focus and rich industry resources, YuanBio is committed to becoming one of the most successful healthcare and pharmaceutical venture capital funds in China.