Shares of MABWELL-B (02493) rose more than 6% in morning trading. At the time of writing, the stock was up 6.22% to HK$26.66, with a turnover of HK$12.56 million.

The price movement follows a company announcement that its U.S. subsidiary, MABWELL (Shanghai) Bio-technology Co., Ltd., has received a "Study May Proceed" notification from the U.S. Food and Drug Administration (FDA). This notification grants formal permission to proceed with the clinical trial application for its investigational drug, 6MW5311 for injection.

The trial will target hematologic malignancies, including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM).

In addition to the FDA clearance, the clinical trial application for 6MW5311 has also been accepted for review by China's National Medical Products Administration.

The drug candidate utilizes a novel "2+1" asymmetric molecular structure designed to simultaneously target LILRB4 and CD3. This mechanism bridges tumor cells and T cells to form an immune synapse, activating T cells to efficiently kill tumors.

A key feature of the molecule is the incorporation of a unique steric hindrance design. This design significantly reduces the binding activity of the CD3 antibody to T cells in the absence of tumor cells, allowing for specific T cell activation only when tumor cells are present. This approach aims to enhance anti-tumor efficacy while substantially improving the drug's safety profile.