PaiZhi Biotech Files IPO Prospectus: Specializing in Cell Line Development with 50% Faster Timelines, 70% Lower Costs, and 5x Higher Success Rates

Currently, virtually all pharmaceuticals utilize cell models to varying degrees during the drug development process. In 2012, CRISPR technology achieved gene editing in mammalian cells for the first time. Since then, this “genetic scissors” has ushered in a new era for the application of cell models, leveraging advantages such as precision, high efficiency, and operational simplicity. Beyond basic research and new drug development, gene editing in cells is also involved in fields such as in vitro diagnostics and biomanufacturing. The overall market size exceeds RMB 100 billion, with a compound annual growth rate (CAGR) of 12%.

For pharmaceutical companies and research institutions, gene-edited cells can play a significant role in the early stages of innovative drug discovery, particularly in target identification, drug screening, and validation. According to a survey report by Synthego, taking the construction of a single gene-knockout cell line as an example, researchers who develop gene-edited cell lines in-house face an average development cycle of three months, require an investment of approximately $20,000, and achieve a success rate of only 14%.

For researchers, having to invest significant time and effort in developing such tools before initiating a project would clearly undermine overall research efficiency. The substantial unmet needs have created a vast market, which continues to expand alongside the growing precision medicine sector.

Leave specialized tasks to specialized teams.Compared with in-house development by researchers, outsourcing the construction of gene-edited cell lines to third-party companies can effectively reduce the turnaround time by half and costs by nearly 70%, while increasing the success rate by approximately fivefold. Even when benchmarked against the industry’s overall success rate, this approach achieves an improvement of about 50%.

The significant improvement in the source and quality of this data stems from the optimization of core technologies and the establishment of a standardized system by Shanghai Pregen Biotechnology Co., Ltd. (hereinafter referred to as “Pregen”). Through automated solutions, Pregen has further increased the throughput of cell line construction and reduced costs, enabling researchers to focus more efficiently on new drug development.

Pregen, founded in 2016, specializes in the development of CRISPR gene-editing technologies and cell lines, as well as their application in innovative drug R&D. Positioning itself to address the market gap for gene-edited cell banks in China, the company boasts two core technological platforms: standardized cell line construction and high-throughput CRISPR screening.

Pregen’s core technology team is composed of PhDs and postdoctoral researchers from the Chinese Academy of Sciences. The founder has extensive R&D experience in cell biology and gene editing, and has been honored with titles such as “Shanghai Young Entrepreneurial Talent” and “High-Level Talent in Jiading District.” Additionally, the founder has achieved notable success in entrepreneurship competitions including “Entrepreneurship China,” “Maker China,” and the “Taihu Cup.”

Based on the self-developed Quick-KO^®、Quick-KI^®Leveraging these technologies, pregen has successfully established a gene-edited cell library covering more than 20 diseases, including lung cancer, liver cancer, and colorectal cancer, providing targeted cell line development and target screening services to over one hundred clients, such as universities, hospitals, pharmaceutical companies, IVD companies, and biotechnology firms.

Cells are the core materials in biomedical research and development. However, due to their high heterogeneity, cell contamination is widespread and often undetectable in laboratories worldwide, leading to a large number of irreproducible research results. According to documented reports, the misuse of two cell lines, HEp-2 and INT407, due to neglected quality control, resulted in losses of up to $4.2 billion in research funding.

Pregen attaches great importance to cell quality control, strictly adhering to the standards of international cell banks such as ATCC, DSMZ, and JCRB. Rigorous quality control is performed on every cell line, covering cell identity (STR profiling/karyotyping/morphology), contamination (pathogens/xenogeneic cells), and viability. The company employs an electronic laboratory notebook system compliant with NMPA and FDA regulatory requirements to ensure cell traceability and data reproducibility. Furthermore, Pregen has established a feasibility assessment system for gene editing, including target genotyping, transfection/infection efficiency, monoclonal formation rate, and drug sensitivity testing, to ensure high success rates in gene editing.

Leveraging its core platform and years of R&D and project experience, Pregen provides customers with diverse gene-edited cell solutions tailored to market demands.

In terms of productsPregen adopts optimal gRNA design and validation strategies to develop ready-to-use gene editing kits. Even researchers without prior experience in gene editing can efficiently construct gene-edited cell lines under the guidance of the instructions, significantly reducing the costs associated with preliminary exploration and trial-and-error. Furthermore, the company offers related products such as nucleic acid and protein reference materials based on gene-edited cells, as well as CRISPR libraries (standard/customized), catering to the diverse application scenarios of various clients including enterprises, research institutions, and hospitals.

In terms of servicePregen boasts a comprehensive suite of gene-editing cell line development solutions, encompassing technical approaches such as gene knockout, knock-in, mutation, endogenous activation and inhibition, site-specific methylation and demethylation, and RNA editing; gene delivery methods including chemical transfection, electroporation, and viral transduction; and characterization assays for genotyping, RNA expression, protein expression, and off-target effect detection.Leveraging its two core platforms—cell line development and CRISPR screening—the company also provides services such as primary cell immortalization and CRISPR library screening.

Currently, pregen’s clients include top-tier (Grade 3A) hospitals such as Ruijin Hospital, Huashan Hospital, and Changzheng Hospital, as well as Southwest Hospital and Xinqiao Hospital; universities and research institutions including Fudan University, Shanghai Jiao Tong University, the Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Army Medical University, and Southwest University; and companies such as GeneChem, Bioss, Puzhong Discovery, and LDT Bioscience.

Currently, the procurement of technical services from abroad still suffers from communication and logistics delays. Moreover, prices are significantly higher than domestic rates due to the high labor costs of European and American companies. As innovative drug R&D in China continues to advance, local CROs such as pregen are poised for rapid growth.

However, the emergence of new fields is inevitably accompanied by growing pains. Unlike other materials, cells, particularly those of human origin, are subject to strict legal regulations during commercialization. Currently, domestic pharmaceutical companies, biotech firms, and research institutions still need to import various cell lines annually from cell banks in the United States, Europe, Japan, and other regions. However, due to ethnic differences, there are obvious variations in the genetic backgrounds of these cells. This raises a critical question: Are studies based on these imported cell lines merely paving the way for other countries?

Regarding its development vision, pregen stated: “We aim not only to establish a gene-edited cell bank, but also to build this bank using cells derived from the Chinese population. Furthermore, we will make it accessible to all domestic researchers within the framework permitted by law.”

“However, this is no easy task. First, given the vast number of cells and genes, selecting an appropriate construction strategy is crucial. Second, the value of a cell bank must be built upon rigorous quality control, systematic characterization, and a robust management system, all of which require substantial investment. Fortunately, drawing on hundreds of previous projects, Pregen has accumulated extensive experience in standardized cell line development and quality control, laying a solid foundation for the next step: large-scale cell bank construction.”

“With advances in gene editing, multi-omics, artificial intelligence, and 3D cell culture technologies, cell models will play an increasingly important role in new drug development. We hope that in the near future, cells—a core raw material in biomedical R&D—will also achieve ‘domestic substitution’ with Chinese-made alternatives.”