Janssen Biotech has entered into a worldwide collaboration and license agreement with Legend, a subsidary of Genscript Biotech Corporation. The partnership is to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen (BCMA). 

LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the United States for multiple myeloma.

“Despite significant advances, multiple myeloma remains an incurable disease for most patients, creating the need for additional, highly active options. LCAR-B38M provides an innovative approach with the potential to transform the treatment of myeloma,” said Peter F. Lebowitz, M.D., Ph.D., global therapeutic area head of Oncology at Janssen. 

LCAR-B38M is the first CAR-T therapy accepted for review by the CFDA. Under the agreement, Legend will grant Janssen a worldwide license to jointly develop and commercialize LCAR-B38M in multiple myeloma with the Legend team of experts. Janssen will record worldwide net trade sales, except for sales made in Greater China. The companies have entered into a 50/50 percent cost-sharing/profit-split arrangement, except in Greater China, where Janssen and Legend have a 30/70 percent cost-sharing/profit-split arrangement. Janssen will make an upfront payment of $350 million that will be recorded in the fourth quarter and additional payments based upon the achievement of certain development, regulatory and sales milestones.