
Monoclonal Antibody and Diagnostic Reagent Raw Material R&D, Manufacturer
Recently, Zhejiang Zhengxi Bio-Technology Co., Ltd. (hereinafter referred to as “Zhengxi Bio”) announced the completion of a new round of financing amounting to tens of millions of yuan. This round was led by Orient Gene Investment, with Qushi Capital and Xuyi Capital serving as financial advisors.
Zhengxi Bio is an innovative high-tech company built upon four core technology platforms: high-throughput cell culture, antibody preparation, antibody purification, and antibody conjugation.Focusing on flow cytometry fluorescence detection, immunohistochemistry detection, and multi-omics detectionContinuously expanding the layout of clinical products and upstream reagent raw materials, having completed the filing and strategic layout of over 30 core technology patents.
The domestic market for biological reagents has long suffered from a reliance on imported products. The importance of supply chain localization has become increasingly prominent during the pandemic. With product performance comparable to that of imported brands, Zhengxi Bio is poised to accelerate the process of import substitution in this field and reshape the competitive landscape. The company’s core product, membrane surface flow fluorescence antibodies, has overcome critical technological bottlenecks in the upstream segment of the IVD industry chain, presenting clear market demand and opportunities for domestic substitution.
Dr. Yang Zhang, Founderstated, “We are deeply grateful for Oriental Gene’s trust and support.” Zhengxi Bio specializes in the production of high-quality, cost-effective monoclonal antibodies, as well as the research, development, and manufacturing of premium flow fluorescence antibody reagents for research and diagnostic applications based on its proprietary antibodies. The proceeds from this financing round will be primarily allocated to channel development, new product R&D, capacity expansion, and daily operations.
Zhang Xue, Head of Investment at Oriental GeneIt was stated that flow cytometry technology has extremely broad applications in disease detection, drug development, cell therapy, and other fields. Leveraging its proprietary protein expression and labeling technologies, Zhengxi Bio holds significant advantages in multiple key indicators, including product stability, purity, potency, yield, and cost efficiency. The founding team possesses extensive industry experience, with profound technical expertise and a strong track record in product commercialization. Oriental Gene will continue to closely monitor the Zhengxi team and provide support for the company’s development.
Zhang Junqi, Partner and Head of Healthcare at Qushi CapitalZhengxi Bio has established a leading domestic platform in the field of flow cytometry antibodies, overcoming technical barriers in the production of antibodies targeting core membrane surface proteins. The company possesses foundational technological platforms for antibody R&D, preparation, production, and labeling, enabling the gradual construction of multi-omics antibody panels. These products are poised to penetrate upstream raw material supply and clinical testing sectors for emerging multi-omics applications, including mass cytometry, immunohistochemistry, single-cell sequencing, proteomics, and spatial omics. Furthermore, the management team brings extensive experience in the clinical commercialization of flow cytometry solutions. By collaborating with international brands, Zhengxi Bio is accelerating the adoption and promotion of its independently developed flow cytometry reagents in both clinical and life science fields.
With the rise and growing prominence of immunotherapy, flow fluorescence detection platforms, as a critical analytical tool in this field, are involved in the entire process of immunotherapy—from R&D, manufacturing, and characterization to efficacy prediction and post-treatment monitoring.
Taking CAR-T as an example, during CAR-T preparation, flow cytometry can be used to assess CAR transduction efficiency, purity, specificity, cell subsets, co-stimulatory molecules, and target cell sorting. During treatment, the detection of relevant pro-tumor and anti-tumor factors can serve as a companion diagnostic for predicting the efficacy of immunotherapy in cancer patients. After administration, the measurement of related cytokines enables real-time monitoring of the immune status and adverse effects in cancer patients, such as cytokine release syndrome (CRS).
To support the research applications and clinical implementation of flow cytometry, the company has establishedWith Years of R&D and Commercialization Experience**Core Team:** Founder Dr. Zhang Yang studied under Professor Jason Cyster, a renowned immunologist, member of the U.S. National Academy of Sciences, and investigator at the Howard Hughes Medical Institute. Dr. Zhang is the first immunology Ph.D. graduate from the University of California, San Francisco (UCSF), a top-tier global medical school, to hail from mainland China. Through years of systematic efforts, the founding team led by Dr. Zhang has established an integrated technology platform for the high-throughput development, production, and application of flow cytometry antibodies. The company’s Chief Operating Officer has previously served as the Head of Flow Cytometry Business or Clinical Flow Cytometry Business in China for two major international corporations, bringing deep industry insights and extensive experience that support optimistic projections for the company’s overall business development and operations. The Chief Medical Officer possesses extensive expertise in pathological research, having formerly served as a Director of Pathology, with decades of deep engagement in the pathology testing industry. The team’s rich experience and diverse composition constitute a critical foundation for the project’s rapid growth.
Antibodies constitute the upstream segment of the in vitro diagnostics (IVD) industry chain and represent a critical bottleneck in the localization of domestic production. Flow cytometry antibodies, which recognize cell surface antigens, present high technical barriers and are challenging to develop; however, future emerging multi-omics applications heavily rely on the advancement of such antibodies. BioLegend, a leading global player in this field, has consistently provided high-quality reagents for various immunodiagnostic applications, including flow cytometry, enabling the detection of diverse targets such as stem cells, cytokines, and recombinant proteins. In 2021, BioLegend was acquired by PerkinElmer for $5.25 billion.
Zhengxi Bio leverages its inherent advantages and deep insights into clinical and market demands to establish a high-barrier technology platform for flow cytometry antibody preparation. Based on three core standards—antibody titer, purity, and concentration—and utilizing standardized cell banks and human tissue specimen libraries, the company conducts antigen identification, screens for high-quality antigens, and performs animal immunization with qualified candidates. As industry regulations are expected to extend further upstream to raw materials in the future, traditional ascites-based production systems will face increasing scrutiny regarding antibody purity, subtype homogeneity, stability, and ethical concerns. In contrast, the novel in vitro production system adopted by Zhengxi Bio offers high purity, superior accuracy, and excellent batch-to-batch consistency, making it more conducive to expansion into clinical applications.
The company has mastered composite dye labeling processes, patented technologies for the directed conjugation of antibodies and fluorescent proteins, and Fc-terminal directed conjugation technology based on antibody glycosylation sites, enabling efficient fluorescent labeling of antibodies.
Zhengxi Bio currently conducts GMP-compliant large-scale production of over 100 monoclonal antibodies, having completed more than 200 batches at the gram scale. For each product, multiple fluorescent dye-labeled and conjugated variants are available. The traceability system aligns with the quality management requirements for in vitro diagnostic reagent manufacturers and complies with international export regulations, thereby supporting the company’s steady growth.
Zhengxi Bio’s flow cytometry reagents have undergone head-to-head comparisons with products from international manufacturers, demonstrating quality that is consistent with or superior to overseas brands. The products exhibit stable signal performance across batches, are independently manufactured, feature short supply lead times, and achieve production costs reduced by more than an order of magnitude, thereby offering significant competitive advantages over international brands. Currently, these products have gained clinical recognition at benchmark hospitals such as Peking University People’s Hospital and Beijing Jingdu Children’s Hospital. Research-grade flow cytometry antibodies have been sold to prestigious universities including Fudan University, Zhejiang University, Sun Yat-sen University, Nanjing Medical University, Soochow University, and Shanghai Jiao Tong University, with product quality receiving high acclaim from university laboratories.
The Chinese market for emerging multi-omics applications, including fluorescence flow cytometry, full-spectrum flow cytometry, mass cytometry, immunohistochemistry, single-cell analysis, proteomics, and spatial omics, is characterized by its large scale, rapid growth, and high potential.Zhengxi Bio will leverage its core capabilities in underlying flow cytometry antibodies and labeling technologies to gradually expand into upstream raw materials for emerging multi-omics applications and their clinical implementation.
About Oriental Gene
Zhejiang Orient Gene Biotech Co., Ltd. (“Orient Gene”), established in 2005, was listed on the STAR Market of the Shanghai Stock Exchange on February 5, 2020 (stock abbreviation: Orient Bio; stock code: 688298). It is a publicly listed company specializing in the research and development, manufacturing, and sales of in vitro diagnostic (IVD) products. Its main products are point-of-care testing (POCT) reagents, primarily applied in infectious disease detection (including COVID-19 testing), drug abuse and food safety testing, and tumor marker detection. Since its listing on the STAR Market in February 2020, the company has achieved dozens-fold growth in overall operating performance and asset scale over the subsequent two-plus years. In 2021, the company recorded operating revenue of RMB 10.169 billion and net profit of RMB 4.920 billion. In 2021, the company ranked among the top A-share listed companies in China across multiple indicators: its basic earnings per share ranked first in the healthcare sector, the IVD industry, and the STAR Market, and second among all A-share listed companies in China; its net profit ranked first in the A-share IVD industry and third on the STAR Market.
About Qushi Capital
Qushi Capital, a subsidiary of Qushi Holdings Group, serves as the group’s boutique investment banking arm. It has provided services to dozens of top-tier enterprises, including Haijieya, Suizhen Bio, Sose Medical, Gewu Zhihe, Jinshi Technology, Leiao Science, Xiaoliang Medicine, Taoxuan Science, Pulimon, Yunyi Medical, Delaisen, Qichen Medical, Ruijing Bio, Xinyi Bio, Huxiu Technology, Leyan Technology, and 36Kr Jingzhun, facilitating billions in financing from renowned domestic and international funds. Investors include China Reform Holdings, Hillhouse Capital, Sequoia China, Yunfeng Capital, Huachuang Capital, Ascent Capital, CMB International, Sinopharm Capital, Boyuan Capital, Lilly Asia Ventures, and Yuanhe Holdings.
Qushi Holdings Group is committed to becoming a premier research-driven holding group. The company’s business portfolio includes boutique investment banking services (Qushi Capital), primary equity investments (Qushi Growth Fund), secondary equity investments (Hongzhou Capital), research services (Qushi Research Institute), and real economy and industrial incubation (Qushi Industrial). The company positions itself as a comprehensive service platform behind China’s top entrepreneurs.