XUANZHUBIO-B (02575) announced that NG-350A, a product licensed from clinical-stage oncology company Akamis Bio Ltd. (Akamis), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR). The group holds exclusive rights for the development, production, and commercialization of NG-350A in Greater China.

The FDA Fast Track designation is a process designed to expedite the development and review of potential drugs. Drugs granted this designation are intended to treat serious conditions and address unmet medical needs, either as the first therapy for a specific disease, offering significant clinical advantages over existing treatments, or improving the safety profile of current therapies.