Fubio (Suzhou) Biopharmaceutical Technology Co., Ltd. Files for IPO: A Leading Player in Viral and Virus-Like Gene Delivery Vectors

Recently, the FDA approved two gene therapies—Casgevy and Lyfgenia. Among them, Lyfgenia delivers a functional copy of the β-globin gene into patients’ hematopoietic stem cells via a lentiviral vector to produce normal hemoglobin.

The mechanism of Lyfgenia relies on gene delivery, a key foundational technology in the research, development, and manufacturing of genetic medicines. Gene delivery is a technique that uses biological, chemical, or physical methods to encapsulate exogenous genetic material (typically recombinant DNA or RNA) into gene vectors for delivery into target cells, where it is subsequently expressed.

Among these, gene delivery vectors are broadly categorized into two major classes: viral vectors and non-viral vectors. Common viral vectors include lentivirus (LV), adeno-associated virus (AAV), and adenovirus (AdV). Leveraging the inherent biological properties of natural viruses, viral vectors offer high gene delivery efficiency and are the vector type employed in the majority of cell and gene therapy projects. According to statistics from a review article by Samantha L. Ginn, clinical trials using viral vectors accounted for 67.3% of all gene therapy clinical trials conducted between 1989 and 2017.

Liu Jun, co-founder of Fubaiao (Suzhou) Biomedical Technology Co., Ltd. (“Fubaiao Bio”) and a participant in the Fosun Star Future Entrepreneurship Camp, stated, “Gene delivery technology is a core challenge that needs to be addressed in the future of biomedicine.”

To promote industry development and overcome technical challenges, Liu Jun and his team established Fubaiao Biomedical in 2017.Fubaiao Biologics is a platform company focused on providing R&D and CRO services for viral and virus-like vector products, and it is one of the few technology companies in China offering end-to-end services for oncolytic virus product development.

Liu Jun graduated from the School of Life Sciences at Fudan University and has previously worked at the Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, as well as GeneChem Co., Ltd. He possesses over 10 years of experience in the research, development, and industrialization of viral products.

It was also in 2017 that the U.S. FDA approved Luxturna, the first AAV-based product in the United States. This milestone breakthrough marked the dawn of the era of in vivo gene therapy. Drawing on market conditions and his personal experience, Liu Jun recognized that gene delivery holds immense potential for growth within the cell and gene therapy (CGT) sector. In particular, viral vectors, as a hot segment in the gene delivery landscape, have attracted significant attention. “Thus, I aimed to establish a company dedicated to viral and virus-like vector products and technical services,” said Liu Jun.

Driven by the vision of founding a company, Liu Jun joined forces with Dr. Xiao Qian and others, who also came from technical backgrounds. Dr. Xiao had previously conducted related research at the Institute of Biochemistry and Cell Biology of the Chinese Academy of Sciences, completed her postdoctoral research at Yale University in the United States, and served as an Assistant Professor at Rutgers University. With over ten years of experience in oncology and immunology research, she has undertaken four projects funded by the U.S. National Institutes of Health (NIH) and participated in the preclinical development and clinical trials of cell therapy projects for multiple pharmaceutical companies.Ⅰ/Phase II Trial.

Liu Jun’s philosophy aligned with that of Dr. Xiao Qian and others, leading to the formation of the company’s core team. The company promptly assembled a team of technical personnel and expert advisors, establishing a specialized “Viral Vector Engineering Expert” team. This team has cumulatively mastered the engineering technologies and manufacturing capabilities for more than 30 viral vectors, including adenovirus (Adv), adeno-associated virus (AAV), human papillomavirus (HPV), human immunodeficiency virus (HIV), rabies virus, and Newcastle disease virus.

When discussing the original intention behind the establishment of Fubaiao Biologics, Liu Jun stated, “We aspire to become the ‘SF Express’ of the gene therapy sector. By continuously advancing our technology and processes, we aim to develop highly efficient and safe delivery vectors that leverage the inherent properties of viruses, ensuring that the genetic ‘package’ is delivered accurately and safely into the body.”

Over the past two years, Fubaiao Biopharma, leveraging its founding team’s deep understanding of viral vector engineering technologies and extensive research experience,Rapidly completed site construction and established a modular viral vector preparation technology platform, obtained seven granted patents, and completed BSL-2 biological laboratory filing as well as ISO 9001 system certification.

Meanwhile, the company's product pipeline covers multiple key areas and has gradually formed six core product categories, including “Oncolytic viruses, tool viruses, specialized functional viruses, pseudoviruses for viral drug/vaccine evaluation, nucleic acid testing quality control materials, and cell lines for drug screening.The company’s business encompasses two models: standard viral products and CRO services. It provides viral vector products, testing quality control materials, virus and cell line products for drug screening, and viral vector process development services to new drug R&D and in vitro diagnostic (IVD) companies.

6 Core Product Categories

Image source: Provided by the interviewee

Notably, the HPV neutralizing antibody pseudoviruses developed by Fubaiao Biologics can be used for HPV vaccine antibody testing in China and comply with the gold standard method recommended by the World Health Organization for detecting virus-neutralizing antibodies—the Pseudovirus-Based Neutralization Assay (PBNA). This assay enables simple and rapid detection of neutralizing antibodies with immunoprotective effects across various antibody types. Furthermore, these neutralizing antibody pseudoviruses possess only single-round infectivity, ensuring a high safety profile and mitigating biosafety risks associated with researching highly pathogenic and highly transmissible viruses.

In addition to HPV, the company also provides pseudotyped viruses bearing neutralizing antibodies for highly infectious, non-replicating pathogens such as rabies and HIV. Vaccine evaluation assays using these pseudoviruses can be conducted in laboratories not requiring Biosafety Level 3 (P3) containment, while addressing the issue where post-vaccination seropositivity does not confer protective immunity.

Leveraging its comprehensive technology platform and the professional expertise of its team, Fubaiao Biomedical has shortened the virus preparation cycle to one-quarter to one-sixth of the original duration, with the ability to deliver target virus products in as little as seven days. To date, the company has established over 1,000 collaborative research projects with approximately 200 universities and research institutes, as well as 300 hospitals and enterprises.

Construction of gene delivery vectors is a process with high technical barriers. Its main workflow includes vector system selection, vector system design, and target gene screening, each step presenting distinct technical challenges.

To overcome technical barriers and tackle key challenges, Fubaiao Biomedical has established BSL-2-certified cell and virus laboratories, along with a modular viral vector preparation technology platform, based on its R&D of virus-based gene delivery vectors.

This integrated platform enables arbitrary segmentation of viral genomic nucleic acid sequences based on functional architecture, facilitating the separate construction of modular expression plasmids. It allows for the assembly of viral and non-viral particles with diverse functions and applications according to customer requirements, ultimately yielding targeted viral gene delivery vectors characterized by low immunogenicity, high payload capacity, and enhanced safety. Furthermore, the viral and cellular products manufactured by this platform comply with the ISO 9001:2015 Quality Management System certification requirements.

Viral Product Preparation Process

Image source: Provided by the interviewee

To meet the process requirements of diverse projects, the company has successfully established a one-stop virus construction platform, leveraging its advanced virus preparation technology and robust product R&D capabilities. This platform encompasses an oncolytic virus engineering platform, a quality control material development platform, a vaccine evaluation product platform, a tool virus production platform, and a cell-based product service platform.

Leveraging five major technology platforms, Fubaiao has built a diversified and comprehensive viral product library, with products covering multiple virus types and vector systems, includingPseudoviruses such as AdV, AAV, HPV, rabies virus, Newcastle disease virus, HIV, and HBV, along with more than 10 pseudovirus vector systems including bacteriophages and lentiviruses, and over 500 types of in-stock viral quality control materials.

The company’s viral product portfolio covers a broad range of applications, providing critical support and solutions for scientific research, drug development, and the advancement of diagnostic technologies.

In April 2023, Fubaiao (Suzhou) Biomedical Technology Co., Ltd. completed a Pre-A financing round of tens of millions of RMB, jointly invested by Jiale Capital and Suzhou Industrial Park Leading Venture Capital. This round of financing facilitated the expansion of the company’s Phase II laboratory, covering approximately 3,500 square meters, and the establishment of a research and development platform for novel viral and virus-like particle (VLP) vectors.

Fubaiao Bio has established a comprehensive product portfolio and commercial network. Moving forward, the company will continue to focus on cutting-edge research in the field of virology, expand innovative applications of viruses in new scenarios within biopharmaceuticals, and prioritize its strategic transition from a traditional “CRO” to an “R&D-focused CRO.” Meanwhile, it will further expand production capacity to foster the development of industries such as oncolytic viruses and recombinant viral tools, thereby accelerating the localization of virus-based gene delivery vectors in China.

Liu Jun stated, “Over the next three years, the company will further advance the development of novel viral vector products with clinical value, building on its existing products and services, to address more pain points for customers in downstream application areas such as IVD, CGT, and drug screening.”

To accelerate the company’s future growth, Fubaiao Biologics is planning its next round of financing to increase investment in the research and development of novel viruses and virus-like particle (VLP) vectors, as well as in team optimization. The new financing round is expected to commence in the first half of 2024.

Fosun · Star Future Institute, established by Fosun Group in partnership with Fosun Pharma, aggregates industrial resources across Fosun’s biomedical, medical device and diagnostics, healthcare services, health insurance, and elderly care sectors. It serves as a platform for entrepreneurs and business leaders in the healthcare and life sciences industry, operating under an “investment + mentoring + incubation” model. The institute features instruction from industry luminaries, provides direct access to Fosun’s various business units and supply chains, and is backed by substantial industrial capital from numerous Fosun funds and strategic business development initiatives, enabling early identification and investment in future unicorns.

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