Research & Development
QureBio's Q-1802 receives US FDA Investigational New Drug application approval
2 March 2021 -

QureBio Ltd, in partnership with CMAB Biopharma (Suzhou) Inc, has received approval for an Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) for its innovative drug Q-1802, it was reported on Tuesday.

The product is the lead candidate in the company's range and is the first bispecific antibody against PD-L1 and Claudin18.2 to be studied in a United States clinical trial.

Under the collaboration, CMAB provided integrated CDMO services for the Q-1802 program, using its antibody production platform. Services included CMC development activities and successful production of drug substance and drug product batches in only 9 months.