Maiwei Biological-B (02493): The clinical trial application for injection 6MW5311 has been approved by the National Medical Products Administration.

MW Bioscience-B (02493) announced that the company has received the Drug Clinical Trial Approval Notification issued by the National Medical Products Administration for the clinical trial application of injection 6MW5311 for the indications of hematologic malignancies (acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM)). Previously, the clinical trial application for 6MW5311 has been approved by the Food and Drug Administration (FDA) in the United States. 6MW5311 is the world's first targeted LILRB4/CD3 TCE innovative drug approved for clinical trials, developed using the company's T Cell Engager (TCE) technology platform. Due to the long clinical trial period of the drug and the multiple approval processes involved, it may be susceptible to uncertainties. Investors are advised to make decisions cautiously and be aware of investment risks. 6MW5311 is a bispecific antibody targeting LILRB4/CD3 developed based on the company's TCE technology platform. It is intended to be developed for hematologic malignancies (AML, CMML, and MM). AML is a group of malignant clonal diseases derived from hematopoietic stem cells, with high heterogeneity and death rates. The global number of new AML cases in 2022 was approximately 172,400, and it is estimated to increase to 221,400 by 2035, with a compound annual growth rate (CAGR) of 1.94%. In China, there were approximately 30,800 new AML cases in 2022, accounting for about 17.9% of global new cases. It is estimated that there will be 36,700 new cases by 2035, accounting for about 16.6% of global new cases, with a CAGR of 1.36%. CMML is a clonal hematopoietic stem cell disorder with overlapping features of myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN), characterized by a significant increase in monocytes in peripheral blood and having an inherent risk of transformation to AML (approximately 15-20% within 3-5 years). CMML is a rare disease with an annual incidence of (3-4) per 100,000 and lacks effective treatment. MM is a clonal plasma cell malignant tumor characterized by uncontrolled proliferation of monoclonal plasma cells in the bone marrow, leading to excess production of abnormal immunoglobulins and causing damage to end organs, manifested as hypercalcemia, renal dysfunction, anemia, and bone lesions (CRAB features). MM accounts for 1%-2% of all cancers globally, about 10% of malignant tumors of the hematopoietic system, with a median age of diagnosis around 69 years, and higher incidence rates in males and African Americans. Over the past twenty years, the survival rates for patients have significantly improved due to the use of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, but MM is still largely incurable, and most patients experience multiple relapses during the course of the disease, hence the anticipated market potential for 6MW5311. 6MW5311 adopts a "2+1" asymmetric molecular structure, simultaneously targeting LILRB4 and CD3, forming an immune synapse by bridging tumor cells and T cells to activate T cells and efficiently kill tumors. By introducing a unique spatial steric hindrance design, the binding activity of CD3 antibodies to T cells in the absence of tumor cells is significantly reduced, specifically activating T cells only when tumor cells are present, thus enhancing anti-tumor efficacy while greatly improving safety. In vitro study results show that 6MW5311 exhibits potent killing activity against various tumor cell lines and samples from patients. Pharmacological studies in vivo have shown that in AML tumor models with high and low expression of LILRB4, 6MW5311 demonstrated clear tumor inhibition, especially achieving complete tumor clearance in high-expression models. Furthermore, in a safety evaluation model in crab-eating macaques, 6MW5311 also showed favorable safety characteristics. As a key technology for directly mobilizing T cells to efficiently kill tumors, TCE has demonstrated significant clinical value in various lymphoma indications, with several products successfully launched. However, current treatments for AML and CMML mainly consist of chemotherapy, hematopoietic stem cell transplantation, and targeted drugs for specific mutations, and there are no approved TCE products. 6MW5311 is the world's first targeted LILRB4/CD3 TCE innovative drug approved for clinical trials, with broad clinical development prospects and market potential.