6MW5311 / Mabwell (Shanghai) Biosci - LARVOL DELTA

Mabwell (Shanghai) Bioscience…has received the Study May Proceed Notification issued by the U.S. Food and Drug Administration (’FDA’) (HKEXnews) - "The clinical trial application for 6MW5311 for Injection targeting indications of hematological malignancies, including acute myeloid leukemia ('AML'), chronic myelomonocytic leukemia ('CMML') and multiple myeloma ('MM'), has been officially cleared by the FDA. In addition, the clinical trial application for 6MW5311 has been accepted for review by the National Medical Products Administration ('NMPA')."

New trial • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Multiple Myeloma

Global First | NMPA Accepts IND Application for Mabwell's Innovative LILRB4/CD3 TCE Bispecific Antibody 6MW5311 (The Manila Times) - "The drug candidate is being developed for hematologic malignancies, specifically Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Multiple Myeloma (MM)...The U.S. IND application is currently in the pre-IND phase, with plans to formally submit it to the FDA in the second quarter of 2026...In vivo pharmacodynamic studies have shown that 6MW5311 achieves significant tumor inhibition in both LILRB4-high and LILRB4-low expressing AML tumor models."

IND • New trial • Preclinical • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Multiple Myeloma