Nanjing legend biology: China's first car-t submitted clinical application

Source: on December 11, 2017, Sina Pharmaceutical News, Nanjing legend Biotechnology Co., Ltd (hereinafter referred to as "Nanjing legend") submitted car-t therapy China clinical application (cxsl1700201) and received formal acceptance by CDE The drug that legend biology submitted the application for this time is "lcar-b38m car-t cell autotransfusion preparation (referred to as lcar-b38m cell preparation)", which is applied for registration according to class 1 biological products (biological products not marketed at home and abroad) Lcar-b38m is a car-t therapy targeting B cell mature antigen (BCMA) developed by Nanjing legend BCMA exists on the surface of mature B cells and belongs to the TNF receptor family It is a very important biomarker of B cells BCMA RNA is almost always found in multiple myeloma cells, and the protein is also found on the surface of malignant plasma cells in multiple myeloma patients, so it is an important potential therapeutic target At the 2017 annual meeting of the American Society of Clinical Oncology, Nanjing legend became "big black horse" with its breakthrough in the field of car-t According to the study of lcar-b38m in Nanjing legend, 33 (94%) of the 35 patients with multiple myeloma relapsed after previous treatment received clinical remission 2 months after the treatment of experimental anti BCMA car-t cells (lcar-b38m), showing significant clinical remission (complete response or very good partial response) of myeloma, and the objective remission rate reached 100% Founded in 2014, Nanjing legend is a wholly-owned subsidiary of Nanjing Kingsway Biotechnology Co., Ltd., which focuses on the research and development of car-t immunotherapy, and has shown great achievements in the treatment of multiple myeloma At present, there are two car-t products approved for market in the world, namely kymriah (tisagenlecleucel) from Novartis and yescarta (kte-c19) from kite pharmaceutical Kymriah was approved for the treatment of acute lymphoblastic leukemia (all) in children and young adults (2-25 years old) at a price of $475000; yescarta was approved for the treatment of certain types of large B-cell lymphoma at a price of $373000.