Beijing-based Immunochina Pharmaceuticals has obtained a Drug Production License for its chimeric antigen receptor (CAR) T-cell therapies, making it the first company in Beijing and one of a few nationally to receive the certification as a gene therapy firm.
Approval Significance
The license confirms that Immunochina’s facilities comply with quality regulations, enabling the company to support New Drug Application (NDA) filings and commercialization.
Product Pipeline
Immunochina is focused on its first in-house CAR-T therapy, anti-CD19 IM19, currently in regulatory studies for relapsed or refractory aggressive non-Hodgkin lymphoma (r/r NHL), acute B lymphocytic leukemia (r/r B-ALL), and mantle cell lymphoma (r/r MCL).
Company Profile
Founded in 2015, Immunochina has an independent gene cell drug R&D and industrialization platform, with capabilities in large-scale plasmid preparation, lentiviral vector preparation, and primary immune cell preparation. Its pipeline covers hematological tumors (lymphoma, leukemia, myeloma) and solid tumors (liver, colorectal, gastric, pancreatic cancers).-Fineline Info & Tech
