China Biotechnology Service (08037) announced that Shanghai Longyao Biotechnology Co., Ltd. (Shanghai Longyao, a non-wholly-owned subsidiary of the company) has applied to the Drug Evaluation Center of the State Drug Administration for the registration of clinical trials for domestically produced drugs , the product name is LY007 cell injection.
The product application has been reviewed and accepted in accordance with Article 32 of the Administrative License Law of the People's Republic of China. Within 60 days from the date of acceptance, if no negative or questioning opinion is received from the Center for Drug Evaluation, Shanghai Longyao can conduct clinical trials of the product according to the submitted plan.
The product is a chimeric antigen receptor T-cell (CAR-T) injection, which is mainly used for the treatment of relapsed and refractory CD20-positive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and transformed type of follicular lymphoma. This product is designed by Shanghai Longyao independently developed and has intellectual property rights of OX40 co-stimulatory signal design. Experiments have shown that the design improves the efficacy of the product on the premise of ensuring safety. This product is currently the first and only CAR-T product for the CD20 target in China that has received a clinical application for registration.