Crystal Sun | CEO Assistant & Director, Regulatory & Government Affairs
Fosun Kite Biotechnology | China

Crystal Sun, CEO Assistant & Director, Regulatory & Government Affairs, Fosun Kite Biotechnology

Crystal Sun, Master Degree of Tumor Pharmacology, graduated from Tsinghua University. She has more than 8 years drug registration, regulatory affair and project management experience, in charge of registration of chemical drugs, traditional Chinese medicines and biologics. 

Crystal Sun joined Fosun Kite biotechnology company in early 2017, served as CEO assistant and director of regulatory affairs and government affair. She assisted CEO in establishment and operation of the company. After consultation and communication meeting with CFDA/CDE, Fosun Kite gets a clear idea of the strategy to commercialize the first CAR-T product Yescarta in China which has been approved by FDA in US under her effort. Fosun Kite promotes the establishment of Development and Review Guideline of CAR-T cell Therapy in China and makes great effort to standardize commercialization of CAR-T cell-therapy product, following the pathway of drug registration.

Prior to join Fosun Kite, from 2013 to 2016, she was in charge of the department of drug registration in Shanghai Henlius Biotech, Inc, registered 10 IND projects in China and 2 projects both in China and Europe. These projects are all been approved for clinical trial. Since 2013,Crystal Sun has been dedicated to promoting establishment of Biosimilar Guideline in China. Anti-CD20 mAb, Rituximab of Henlius, has been submitted NDA as a first Biosimilar in China.

Appearances:



Phar-East Day 2 @ 14:30

CAR-T therapy regulation requirement in China

last published: 26/Sep/18 02:35 GMT

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