Shots:

• The US FDA’s OOPD has granted orphan drug designation (ODD) to fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy, CT103A/IBI326, for relapsed and/or refractory multiple myeloma (R/R MM)
• The ODD will accelerate drug development and registration action of CT103A in the US. CT103A will be eligible for development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a 7yrs. US market exclusivity granted upon product approval
• The companies are planning to launch CT103A both in China and the US. In Feb’2021, NMPA has granted BTD to CT103A for RRMM

 Ref: PR Newswire | Image: Newsbreak