Legend Biotech

Legend Biotech, a subsidiary of Genscript, was founded in 2014 as a developer of tumor cell immunotherapy. It has developed CAR-T therapies targeting CD38 and BCMA for the treatment of multiple myeloma. These therapies utilize the patient's own immune cells, which are genetically modified in vitro and then reinfused into the patient’s body. The enhanced immune cells precisely target and destroy tumor cells, primarily used to treat blood cancers and lymphomas. In December 2017, Legend Biotech made a sudden move by being the first in China to file for a CAR-T clinical trial, immediately entering the priority review list. The leading product co-developed by Legend Biotech and Janssen, LCAR-B38M / JNJ4528, completed U.S. patient enrollment for its phase 1b/2 pivotal clinical trial (CARTITUDE-1) by the end of 2019. Preliminary results from the phase 1 clinical trial were reported at the American Society of Hematology Annual Meeting in December 2019. Additionally, Legend Biotech and Janssen are rapidly advancing the clinical development of LCAR-B38M / JNJ-4528. JNJ-4528 is the name used for this experimental product in clinical trials in the U.S., Europe, and Japan; LCAR-B38M is the name used for the same experimental cell therapy in clinical trials in China. It is reported that LCAR-B38M received FDA IND approval in May 2018, orphan drug designation from the FDA in February 2019, and PRIME designation from the European Medicines Agency (EMA) in April 2019, making it the first CAR-T product from China to receive this certification.