Mabwell (Shanghai) Bioscience Co., Ltd. has announced that it has received a Clinical Study May Proceed notice from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug application for 6MW5311 for injection.

The application, for the treatment of hematologic malignancies including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM), has now been formally permitted to proceed to clinical trials by the FDA.

Additionally, the clinical trial application for 6MW5311 has been accepted for review by the National Medical Products Administration in China.

6MW5311 represents the world's first T-cell engager (TCE) therapy targeting LILRB4/CD3 to receive approval to commence clinical trials.