On January 21, 2021, Shanghai Longyao received the approval notice from the State Drug Administration for the approval of the clinical trial of Shanghai Longyao's cell injection named LY007 ("LY007 Cell Injection"), which is registered as a Class I new drug.
LY007 cell injection is a chimeric antigen receptor T cell (CAR-T) injection, mainly used for the treatment of relapsed and refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and transformed follicular lymphoma. LY007 cell injection is independently developed by Shanghai Longyao and adopts the OX40 co-stimulatory signal design with independent intellectual property rights of Longyao. Experiments show that the design improves the efficacy of the product on the premise of ensuring safety. LY007 cell injection is currently the first and only CD20-targeted CAR-T product approved for registration clinical application in China. According to the application for clinical trial of LY007 cell injection, Shanghai Longyao will carry out a phase I clinical trial and research on LY007 cell injection according to the submitted protocol.
The State Drug Administration approved the clinical trial application of Shanghai Longyao's LY007 cell injection, which reflects Shanghai Longyao's research and development capabilities in the field of immune cell drugs.