Pregene

Shenzhen Pregene Biopharma Co., Ltd. was established in 2012 as a national high-tech enterprise, the Guangdong Provincial Cell and Gene Therapy Innovative Drug Engineering Technology Research Center, and a Shenzhen specialized, refined, distinctive, and innovative enterprise. The company positions itself as a leading enterprise in cell-based innovative drugs with industrialized core technologies. Its investors include enterprises funded by the National SME Development Fund, Guoke Jiahé Fund under the Chinese Academy of Sciences, Haier Capital, and others. After years of dedication to the field of cell therapy drugs, its product pipeline includes CAR-T, TCR-T, CAR-NK drugs, and more, covering indications such as hematological tumors, solid tumors, and autoimmune diseases across multiple therapeutic areas. It is currently the only leading innovative cell drug enterprise in the industry that has achieved multi-regional global licensing for CAR-T cell drugs. Pregene adheres to the development strategy and path of independent research and development, industrialization, and internationalization of innovative cell drugs. After years of investment and development, it has built a complete cell drug research and production quality management system, successfully establishing innovative and industrialized core technology platforms for nanobody screening, immune cell drug discovery, plasmid/viral vector process development and production, and cell drug process development and production. The company has passed ISO9001 quality management system certification. Focused on cell drug research and development, the company has achieved phased R&D results. Its BCMA-targeted CAR-T cell drug for treating multiple myeloma obtained clinical approval from the NMPA in March 2020, marking the first CAR-T cell drug clinical approval in South China, demonstrating excellent safety and efficacy based on clinical trial results. The TCR-T drug project, "TCR-T Cell Injection Targeting HLA-A*02:01/NY-ESO-1," received NMPA approval for clinical trials in December 2022. The company’s various product pipelines are developing in a stepped manner, with abundant reserve technologies and broad development prospects. Looking ahead, the company will take the mission of developing affordable biologics for Chinese patients, centering on industrialized technology platforms for nucleic acids, gene vectors, and cell engineering. It will further strengthen original R&D, apply for, and own a batch of high-value international patents, maintain and expand its leading edge in the industry, seize the commanding heights of global biopharmaceutical technology, and become a world-class new biopharmaceutical company.