BRL Medicine Appoints Li Fuying as VP & Head of Regulatory Affairs

SHANGHAI, Sept. 6, 2021 /PRNewswire/ -- On Sept. 6, 2021, a research and development company focused on gene therapy and cell therapeutics -- BRL Medicine Inc. announced the appointment ofMs. Li Fuying is the Vice President of the Company (VP）& Regulatory Affairs Team (Regulatory Affairs) Person in Charge， will be fully responsible for the domestic and international registration affairs of BRL Medicine's R&D pipeline products.

Ms. Fuying Li

Li Fuying graduated from Peking University Health Science Center in 2003, successively earning a Bachelor’s degree in Clinical Medicine and a Master’s degree in Biochemistry and Molecular Biology (with her master’s research focusing on gene therapy for cancer). After graduation, she worked in innovative drug R&D for five years before joining the regulatory affairs team of a multinational pharmaceutical company. She subsequently worked at Pfizer China for four years and at Eli Lilly China’s regulatory affairs team for nine years, progressing through various roles within the regulatory department to ultimately serve as Regulatory Director. Prior to joining BRL Medicine, Li Fuying comprehensively managed regulatory affairs in China for neurological disorders, autoimmune diseases, and Eli Lilly’s future gene therapy products as part of the Eli Lilly China regulatory team. Her responsibilities encompassed formulating regulatory strategies, preparing and submitting regulatory filings, interacting with regulatory authorities, obtaining approval documents from drug regulatory agencies, and conducting post-approval regulatory maintenance for marketed drugs.

CEOMr. Zaixi Xi stated：“Fu Ying brings extensive experience in drug R&D and registration from multiple renowned multinational pharmaceutical companies, coupled with a profound understanding and insight into the evolution of China’s pharmaceutical regulatory environment. She possesses substantial expertise in registration pathways for various types of innovative drugs, encompassing diverse expedited review and approval channels and their applicable criteria. Over the years, she has actively participated in policy advisory initiatives to provide recommendations on government regulatory frameworks (serving as Chair of the Regulatory Information Working Group for the multinational pharmaceutical industry association from 2015 to 2017). She holds unique perspectives on how the industry and government can collaborate synergistically to optimize China’s regulatory landscape, and excels at integrating existing resources while developing new ones to address evolving challenges. We are delighted to welcome Fu Ying to the team! We look forward to working together to drive the company’s rapid growth, enabling BRL Medicine’s innovative therapeutics to reach patients in need more swiftly, and ultimately realizing the vision of harnessing gene technology to benefit humanity.”

Ms. Li Fuying stated“It is a great honor to join the BRL Medicine family. BRL Medicine boasts a globally leading technology platform and a robust R&D pipeline, with multiple investigator-initiated trials (IITs) delivering exciting results. I am proud of BRL Medicine’s recent achievements, as I have witnessed how emerging technologies can treat or even cure diseases, thereby benefiting individual patients and their families and enabling every person to live with greater dignity. I am committed to fully leveraging my extensive experience in R&D and regulatory affairs to help advance BRL Medicine’s goal of becoming a world-leading gene and cell therapy company.”