Xinyuan Biotech Completes Strategic Financing to Accelerate Lung Cancer Pipeline Development

VCBeat has learned exclusively that Nanjing Xinyuan Biotechnology Co., Ltd. (“Xinyuan Biotech”) has announced the completion of a strategic financing round, with investment coming from a well-established listed company in China’s in vitro diagnostic (IVD) reagent industry and a leading enterprise in the IVD sector. The funds raised will be primarily used to build the company’s commercialization team, accelerate the research and development of its lung cancer pipeline products, and create an innovative portfolio of autoantibody-based diagnostic products for lung cancer.

Lung cancer, as the malignant tumor with the highest incidence and mortality rates worldwide, presents a significant challenge in early diagnosis and treatment. With population aging, changes in lifestyle, and worsening environmental issues, the incidence of lung cancer continues to rise. From the perspective of disease prevention and management, the importance of early diagnosis is self-evident. Existing early diagnostic techniques for lung cancer, including imaging, sputum cytology, tissue biopsy, and tumor marker detection, all have certain limitations and challenges.

In response, autoantibody diagnostic technology has demonstrated its potential for the early diagnosis of lung cancer, leveraging its unique advantages. By detecting autoantibodies against lung cancer antigens in patients’ bodies and utilizing the principle of specific antigen-antibody binding, this technique enables highly specific and sensitive early diagnosis of lung cancer. Furthermore, autoantibody diagnostic technology offers additional benefits, including being non-invasive, easy to perform, and highly reproducible. It has been recommended as a valuable technique for early lung cancer screening by the Chinese Expert Consensus on Lung Cancer Screening and Management and the Clinical Diagnosis and Treatment Guidelines for Oncology issued by the Chinese Medical Association.

Against this backdrop, Nanjing Xinyuan Biotechnology Co., Ltd. has actively responded to clinical needs by establishing in-depth industry-academia-research collaborations with the CDI Laboratory at Johns Hopkins University School of Medicine, a globally leading institution, and major tertiary hospitals in China. These efforts are dedicated to identifying earlier and more sensitive biomarkers for lung cancer diagnosis. Through an exclusive strategic R&D partnership with the CDI Lab—co-founded by Professor Jef Boeke, a pioneer in synthetic biology and member of both U.S. National Academies, along with several professors and researchers from Johns Hopkins University School of Medicine—Nanjing Xinyuan Biotechnology has conducted in-depth research on early diagnostic biomarkers for lung cancer using the “HuProt” high-throughput protein microarray platform. This platform enables the simultaneous detection of over 21,000 human recombinant proteins, covering 81% of the open reading frame (ORF) regions of the human genome, with 89% of these proteins being full-length. It is currently the internationally leading platform tool in scientific research for systematic studies of serum antibody profiles, boasting the highest protein throughput and citation impact worldwide, thereby significantly advancing the progress of antibody screening research related to lung cancer.

Currently, Xinyuan Biotechnology has successfully established a patent barrier pool for lung cancer autoantibody diagnostics, covering more than 80 innovative targets. Among these, the invention patent titled “Protein Composition for Detecting Serum Antibodies and Its Applications,” jointly held by Xinyuan Biotechnology and CDI LAB, includes an antigen target combination featuring multiple promising targets such as TP53, NSG1, MAGEC2, SULT2B1, DDX53, and CEACAM5. With a specificity of 90%, this combination achieves a sensitivity approaching 90%, demonstrating significant clinical innovation potential for the early diagnosis of lung cancer. Building on this foundation, Xinyuan Biotechnology is committed to developing proprietary patented biomarker products for lung cancer autoantibody diagnostics, based on high-throughput proteomic target screening and large-sample validation in Chinese populations. These products will be applied to the differential assessment of benign and malignant pulmonary nodules, thereby facilitating the early diagnosis of lung cancer.

Mr. Ji Ao, founder of Nanjing Xinyuan Biotechnology Co., Ltd., statedAs a young entrepreneur within the Johns Hopkins University entrepreneurship community, I am deeply honored to have received cutting-edge technical support from my alma mater’s laboratories. Upon returning to China, I founded Nanjing Xinyuan Biotechnology Co., Ltd. (Xinyuan Bio) to conduct research and commercialization efforts focused on high-throughput proteomics for tumor marker screening, identification of high-risk populations, and cancer staging and subtyping.The introduction of strategic investment from a publicly listed company in this funding round marks a significant milestone in the commercial translation of our laboratory’s innovative technologies. This listed partner possesses an internationally advanced platform for the production of in vitro diagnostic (IVD) reagents and a comprehensive quality control system, laying a solid foundation for the successful development and stable manufacturing of new products.Leveraging collaborations with the Johns Hopkins CDI Lab and top-tier domestic clinical centers, and by introducing industrial investment to support technological R&D and production, Xinyuan Bio has established a commercialization pathway that integrates international medical translation, target validation in Chinese populations, laboratory research, and OEM transfer to listed manufacturing enterprises. By integrating premier clinical resources from leading medical institutions both domestically and abroad, and relying on our advantages in high-throughput proteomics, we aim to discover more innovative cancer diagnostic biomarkers, build a mature and stable library of recombinant protein raw materials, and continuously combine these with established IVD technology platforms—such as enzyme immunoassay, chemiluminescence, and flow cytometry—to commercialize biomarkers with significant clinical innovation value, thereby contributing our modest efforts to the cause of human health.

Zhang Xin, General Manager of Xingang High-Tech Investment, stated: Warm congratulations to Nanjing Xinyuan Biotechnology Co., Ltd. on the successful completion of this round of strategic financing. The Park Fund is delighted to have served as the seed-round investor for Xinyuan, an outstanding startup founded by overseas talent returning to China. As the wholly-owned fund manager of the Xin’gang High-Tech Park under the Nanjing Economic and Technological Development Zone, Xin’gang Gao Tou will continue to leverage park resources to empower the development of Nanjing Xinyuan Biotechnology Co., Ltd. and support its growth and expansion. Meanwhile, adhering to the principle of investing early, investing in small enterprises, and investing in technology, we will continue to identify and invest in high-quality early-stage projects like Nanjing Xinyuan Biotechnology Co., Ltd.

As a well-established listed enterprise in China’s in vitro diagnostics (IVD) industry, the company integrates research and development, manufacturing, and sales, boasting extensive production experience and a comprehensive portfolio of medical diagnostic products. Its self-developed product lineup focuses on four core segments: immunodiagnostics, clinical chemistry diagnostics, molecular diagnostics, and point-of-care testing (POCT), covering multiple therapeutic areas including oncology, infectious diseases, endocrinology, autoimmune disorders, and genetic metabolic diseases. The company has obtained numerous authoritative certifications and registrations both domestically and internationally.

Xinyuan Biotechnology is an innovative proteomics company that has established R&D centers and commercialization teams for Class III innovative medical devices in Nanjing and Jiaxing. With the corporate vision of “achieving precision medicine and making cancer preventable and treatable,” the company focuses on the development of diagnostic products based on disease-specific autoantibodies. Xinyuan Biotechnology has entered into an international strategic cooperation agreement with the CDI Laboratory at Johns Hopkins University School of Medicine. Leveraging the CDI Laboratory’s cutting-edge high-throughput human whole-proteome microarray platform technology, the company is developing innovative diagnostic biomarkers across multiple disease pipelines. With advancements in bioinformatics and “modern multi-omics analysis,” high-throughput proteomics holds significant promise for elucidating molecular mechanisms of diseases and discovering novel biomarkers. Xinyuan Biotechnology will collaborate with world-leading proteomics experts to advance the R&D, regulatory registration, and commercialization of innovative in vitro diagnostic (IVD) products, striving continuously to break through boundaries and improve human health.