Mabwell-B (02493.HK): 6MW5311 Injection Receives FDA Clinical Trial Approval as World’s First LILRB4/CD3-Targeted TCE Innovative Drug
NewTimeSpaceNews: Mabwell (Shanghai) Bioscience Co., Ltd. (02493.HK) issued a voluntary announcement on 13 June 2026, stating that the company has received a Study May Proceed Notification from the U.S. Food and Drug Administration (FDA). The IND application for 6MW5311 Injection for hematologic malignancies (acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM)) has been formally approved by the FDA. Additionally, the IND application for 6MW5311 has been accepted by the National Medical Products Administration (NMPA) of China.
6MW5311 is a bispecific antibody targeting LILRB4/CD3 developed based on the company’s proprietary T Cell Engager (TCE) platform. It adopts a "2+1" asymmetric molecular structure with a unique steric hindrance design, which significantly reduces the binding affinity of the CD3 antibody to T cells in the absence of tumor cells. The molecule specifically activates T cells only in the presence of tumor cells, thereby enhancing anti-tumor efficacy while substantially improving safety.
According to the announcement, there were approximately 172,400 new AML cases globally in 2022, with the figure projected to rise to 221,400 by 2035. CMML is a rare disease with an annual incidence of 3–4 per 100,000 people and lacks effective treatments. MM accounts for 1%–2% of all cancers and remains largely incurable. As the world’s first TCE innovative drug approved for clinical trials targeting LILRB4/CD3, 6MW5311 holds broad clinical development prospects and significant market potential.
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