Graduated from Shenyang Pharmaceutical University with a major in pharmacy, with over 15 years of experience in drug registration and application, deeply involved in the fields of biological products and cell and gene therapy (CGT). I have previously worked for large domestic pharmaceutical companies such as FedEx and Livzon monoclonal antibody. I joined Shengji Pharmaceutical in 2019 and worked as a CMC registration affairs specialist, responsible for the CMC registration strategy and regulatory requirements for CGT products. I am familiar with the CMC regulatory system for drugs at all stages from research and development to market launch, and have accumulated rich experience in CMC technology control and registration path planning for CGT products. At the same time, I have a deep understanding and practical experience in the management system and registration path of clinical trials (IITs) initiated by researchers, and have led and successfully completed registration applications for multiple IND projects, two BLA projects, and multiple IIT projects.