CARsgen Appoints Yong Fan as Senior Vice President of Global Regulatory Affairs

CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, today announced appointment of Yong Fan, MD, as Senior Vice President, Global Regulatory Affairs. Dr. Fan, will be responsible for CARsgen global regulatory strategy, leading U.S. and China regulatory affairs team, working closely with clinical, medical and process development team, striving to achieve CARsgen global strategic objectives for immunotherapies.

"Dr. Fan's insights and rich experiences of regulatory strategy consulting, FDA review and regulatory inspection, cell and gene therapy research & development, and related policy implementation is a precious asset as CARsgen is developing its global strategy," said Dr. Zonghai Li, Founder and CEO of CARsgen. "In the near future, CARsgen aims to submit several INDs, BLAs to US FDA, China NMPA and other regulatory agencies for our advanced CAR-T cell programs. We are delighted to have Dr. Fan joined, together with more and more global top talents to deliver our commitment to cancer patients".

Prior to join CARsgen, Dr. Fan served as A2Z Reg Solutions Senior Consultant and owner, Member of ISCT Legal and Regulatory Affairs North America Committee, Senior Reviewer in the FDA Office of Tissues and Advanced Therapies (OTAT/Previous OCTGT), Center for Biologics Evaluation and Research (CBER), mainly responsible for review, evaluation and inspection for cellular and gene therapies' pre-IND, IND and BLA. Prior to FDA career, she served several roles as Staff Scientist at the Cell Processing Section of National Institute of Health, Laboratory Supervisor of Cellular Activities in the Gene Transfer Core Facility at the Memorial Sloan-Kettering Cancer Center, Cell Processing Laboratory Supervisor for New York Presbyterian Hospital-University Hospital of Columbia and Weill Cornell.

Dr. Fan earned her Bachelor of Medicine (equivalent to US Medical Doctor) from Jilin Medical College in Jilin, China, and Master of Medicine from the Academy of Military Medical Sciences in Beijing, China. She completed her post-doctoral training in cancer immunotherapy, hematopoietic stem cell transplantation at The New York Blood Center. Dr. Fan is based in Fredrick, Maryland.

About CARsgen Therapeutics, Inc.

CARsgen Therapeutics is a clinical-stage immune-oncology company committed to the development and commercialization of CAR-T and monoclonal antibody therapeutics for unmet medical needs. The company has collaborated with top hospitals in China to launch several First-in-Human studies such as CAR-GPC3-T for hepatocellular carcinoma and squamous lung cancer, CAR-EGFR/EGFRvIII-T for glioblastoma multiforme and CAR-Claudin18.2-T for gastric and pancreatic cancer.

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