IASO Biotherapeutics, a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products announced that the company’s commercial manufacturing facility in Nanjing successfully passed a comprehensive inspection by the Medical Products Administration of Province Jiangsu (JSMPA) and was granted a drug manufacturing license.
The cell production workshop, as a core facility area, is designed in the form of a workstation according to the cGMP requirements and NMPA/EMA/FDA regulations with the capacity of producing 3000 batches of CAR-T cell products per year. The approval of the drug manufacturing license for IASO Bio’s Nanjing commercial manufacturing facility marks a solid step of transition from clinical development to commercialization.
Dr. David He, Chief Technology Officer and Executive Vice President of IASO Bio said:
The approval of the drug manufacturing license is a milestone before the launch of the new drug. It is of great significance for the launch of the first chimeric antigen receptor (CAR)-T cell therapy drug developed by IASO Bio. It marks that IASO Bio has the full in-house capabilities to manufacture GMP compliant Plasmids, Lentiviral vectors, and CAR-T cell therapy products. We will take it as a new starting point to bring our first CAR-T product for the treatment of Multiple myeloma to the market, and provide patients with safe, effective, and reliable cell immunotherapy as soon as possible, and strive to bring hope to patients.
About IASO Biotherapeutics
IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully-human antibody discovery platform (IMARS), high-throughput CAR T drug priority platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR T and biologics product candidates. This includes a diversified portfolio of 10 novel pipeline products, including IASO’s leading asset, CT103A, an innovative anti-BCMA CAR T cell therapy under pivotal study for relapsed/refractory multiple myeloma (RRMM). CT103A received Breakthrough Therapeutic Designation by China’s National Medical Products Administration (NMPA) in February 2021 and it was granted Orphan Drug Designation (ODD) by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment of R/R MM. In addition, the company’s in-house developed fully-human CD19/CD22 dual-targeted chimeric antigen receptor (CAR) T cell therapy has entered phase I/II registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r B-NHL). It was also granted Orphan Drug Designation by the U.S. Food and Drug Administration in October 2021.