IASO BIO’s Nanjing production base obtained the "Drug Production License" for CAR-T cell therapy products

On March 2, IASO BIO, an enterprise in NJBPV, an innovative biopharmaceutical company in the clinical stage dedicated to the development and industrialization of cell therapy and antibody drugs, announced that the company's commercial production base in Nanjing has successfully passed through Jiangsu Province. Comprehensive review by the Drug Administration (JSMPA), and was granted the "Drug Manufacturing License".

IASO BIO's Nanjing production base was put into use in November 2020. It is located in NJBPV, with a total area of nearly 10,000 square meters. It has complete plasmid, lentiviral vector and CAR-T cell production capacity, as well as ensure the quality control ability of the corresponding products. As the core facility area, the cell production workshop is designed in the form of workstations in accordance with Chinese GMP standards and with reference to EU GMP and FDA cGMP. The designed production capacity can achieve an annual production of 3,000 CAR-T cells. Obtaining the "Drug Production License" marks a further step in IASO BIO's road to industrialization of cellular immunotherapy and benefiting tumor patients.

About IASO BIO

IASO BIO is an innovative biopharmaceutical company focusing on the development and industrialization of cell therapy and antibody drugs. The company takes the development of hematological tumor cell-based drugs and antibody drugs as the cornerstone of innovation, and expands to solid tumors and autoimmune diseases. It has a complete full-process platform capability from early discovery, registration application, clinical development to commercial production, including a fully human antibody discovery platform, a high-throughput CAR-T drug optimization platform, a general CAR technology platform, a production technology platform, Multiple technology platforms, including clinical translational research platforms.At present, 10 products under research are in different stages of research and development. Among them, the most rapidly progressing product CT103A (full human BCMA chimeric antigen receptor autologous T cell injection) is in the late stage of clinical development, and has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to be included in the "Breakthrough Therapy Drug" category, in February 2021, and in February 2022, it was granted "Orphan Drug" designation by the U.S. Food and Drug Administration (FDA);The innovative product CT120 (full human CD19/CD22 dual-target CAR-T cell injection) independently developed by the company has entered the clinical research stage, and the indications are CD19/CD22 positive relapsed/refractory B cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory B-lymphocytic leukemia (B-ALL), and has been granted FDA Orphan Drug Designation (ODD).

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