Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with IASO Biotherapeutics (IASO Bio) jointly announced that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) has formally granted Orphan Drug Designation (ODD) to their co-developed fully-human B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM).
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ODD will accelerate drug development and registration action in the United States. IBI326 will be eligible for certain development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a seven-year U.S. market exclusivity granted upon product approval. In February 2021, IBI326 was granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for the treatment of R/R MM.
“This ODD of IBI326 is a milestone recognizing our effort to develop a novel anti-BCMA CAR with better efficacy and persistence,” said Dr. Hui Zhou, Senior Vice President of Innovent, “It underscores the importance of bringing this therapeutic option to patients with multiple myeloma, and strongly motivates us to expedite the clinical development of IBI326. We hope to launch IBI326 as soon as possible which will bring hope to patients with multiple myeloma.”
“FDA approval of ODD to CT103A is of great significance to patients with multiple myeloma and represents the FDA’s recognition of CT103A and the clinical data provided by IASO Bio”, said Dr. Wen Wang, Chief Executive Officer and Chief Medical Officer of IASO Bio. “Currently, our team is advancing the clinical development of CT103A to the four dimensions of strategy including frontline therapy, combination therapies, indication expansion, and ex-China development. We are looking forward to the launch of CT103A both in China and US as soon as possible to offer living-saving treatment option to more patients.”