Gracell Biotechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for GC012F, Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma. The long-term follow-up data for GC012F was presented in June at the ASCO 2021 Annual Meeting and the EHA 2021 Congress. GC012F is currently being evaluated in investigator-initiated trials in China, including in newly diagnosed Multiple Myeloma patients. The tech transfer to Lonza to support manufacturing of GC012F in the U.S. is currently ongoing, with U.S. IND filing targeting the first half of 2022. Granted by the U.S. FDA, Orphan Drug Designation incentivizes the development of innovative drugs and biologics for the safe and effective treatment of rare diseases and conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation qualifies the sponsor of the therapy for certain development incentives, including up to seven years of market exclusivity upon regulatory approval, as well as tax credits for clinical testing and reduction of or exemption from prescription drug user fees.