The National Medical Products Administration (NMPA) of China accepted the investigational New Drug application for the immunotherapy 6MW5311, a LILRB4/CD3 T-cell engager bispecific antibody, to treat patients with acute myeloid leukemia, chronic myelomonocytic leukemia, and multiple myeloma.
6MW5311 simultaneously targets LILRB4 and CD3 to bridge tumor cells and T cells, activating T cells only when tumor cells are present to enhance safety while improving antitumor efficacy, according to the press release by Mabwell, the therapy’s manufacturer. In the release, Mabwell reported that 6MW5311 demonstrated a favorable safety profile in animal models and achieved complete tumor clearance.
The drug candidate is the first LILRB4/CD3 TCE bispecific antibody to reach the clinical trial application stage globally. Plans are underway to formally submit an IND application to the Food and Drug Administration in the second quarter of 2026.
