Shenzhen Pregene Biopharma Co., Ltd., a national high-tech enterprise, is one of the founders of the Guangdong Research Center for Innovative Drug Engineering Technology of Cell and Gene Therapy, and one of Shenzhen Specialized and Sophisticated Enterprises. The investors and shareholders include the National Small and Medium-sized Enterprise Development Fund, CAS Jiahe Fund under the Chinese Academy of Sciences, Haier Capital, Shenzhen Capital Group, Huapont Life Sciences (002004), etc. It has been deeply involved in the field of cell and gene therapy drugs for many years. Its product pipelines include CAR-T and CAR-NK drugs with multiple targets, with indications covering multiple therapeutic fields such as hematological tumors, solid tumors, and autoimmune diseases. Pregene adheres to the development strategies and paths of independent R&D and technology platformization, platform productization, product commercialization and commercial internationalization, and is currently the leading innovative cell therapy enterprise in the industry that takes the lead in realizing the global multi-regional authorization of CAR-T cell agents. After many years of investment and development, Pregene has established a complete quality management system for the R&D and production of cell agents, successfully built a core technology platform for innovation and industrialization of nanobody screening, immune cell agent discovery, plasmid/viral vector process development and production, cell process development and production, and obtained the ISO9001 quality management system certification.

Pregene participated in the preparation of the national drug standard Points to Consider on Quality Control Testing Research and Nonclinical Research on CAR-T Cell Therapy Products issued by the National Institutes for Food and Drug Control in 2018; participated in the discussion of CDE cell agent review criteria from 2018 to 2020; and participated in the discussion and suggestions of legislation of the Regulations of Shenzhen Special Economic Zone on the Promotion of Cell and Gene Industry in 2022.

Pregene focuses on the R&D of cell and gene therapy drugs and has achieved phased R&D results. For BCMA-targeted CAR-T cell agent for the treatment of multiple myeloma, the Company obtained an NMPA clinical approval letter in March 2020, which is the first clinical approval letter for CAR-T cell agents in the south China area. The clinical trial results showed excellent safety and efficacy.

The product pipelines of the Pregene have developed in steps, with rich technology reserves and broad development prospects. In the future, the Company will shoulder the development of urgently needed cell and gene drugs for clinical treatment as its responsibility, be centered on nucleic acids, gene vectors and cell engineering industrialization technology platform, further strengthen innovative R&D, apply for and own a number of high-value international patents, maintain and expand the leading advantages in the industry, seize the commanding height of biomedical technology in the world, and strive to build itself a world’s first-class new biopharmaceutical company.