On June 10, 2026, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) announced that it has accepted the clinical trial application for a recombinant anti-CD19m-CD3 antibody injection (Acceptance No. CXSL2600625) submitted by ITAbMed Ltd. The product is classified as a Class 1 innovative drug.

Competition in China's CD19/CD3 bispecific antibody field has intensified. Several candidates targeting the same pathway, including those developed by Antengene and Keymed Biosciences, have already entered clinical development.

ITAbMed's candidate is differentiated in two key areas.

Improved safety profile. The antibody incorporates a CD19 mutant (CD19m) design to reduce excessive depletion of normal B cells. It is also intended to limit excessive T-cell activation and cytokine release, potentially lowering the risk of severe adverse events and improving patient tolerability.

Expanded therapeutic potential. In addition to hematologic malignancies such as relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) and acute lymphoblastic leukemia (ALL), the candidate is also being developed for autoimmune diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). This broader development strategy could expand the application of bispecific antibodies beyond oncology.

ITAbMed is a China-based biotechnology company focused on bispecific antibody technologies. The CDE acceptance marks an important milestone in advancing the company's T-cell engager (TCE) bispecific antibody pipeline.

In recent years, Chinese developers of bispecific antibodies have gained increasing international recognition through differentiated technology platforms. Companies such as Keymed Biosciences and AIMM Therapeutics have expanded their global presence through overseas licensing agreements and competitive clinical data. The acceptance of ITAbMed's CD19m-CD3 candidate also reflects a broader shift in China's innovative drug sector—from follow-on innovation toward first-in-class and differentiated drug discovery.