Mabwell-B (02493.HK)： 6MW5311 Clinical Trial Application Approved by NMPA

Mabwell (Shanghai) Bioscience Co., Ltd. (2493.HK) announced on June 24, 2026, that the Company received the Drug Clinical Trial Approval Notification issued by the National Medical Products Administration. The clinical trial application for 6MW5311 for injection for hematologic tumor indications (acute myeloid leukemia ("AML"), chronic myelomonocytic leukemia ("CMML") and multiple myeloma ("MM")) has been approved. Previously, the clinical trial application for 6MW5311 had been permitted by the U.S. Food and Drug Administration (FDA). 6MW5311 is the world's first TCE innovative drug targeting LILRB4/CD3 approved for clinical trials.

Pursuant to the Drug Administration Law of the People's Republic of China and relevant regulations, upon review, the clinical trial application for 6MW5311 for injection accepted on April 14, 2026, meets the relevant requirements for drug registration, and the single-agent clinical trial in relapsed/refractory hematologic tumors (AML, CMML and MM) is approved.

6MW5311 is a bispecific antibody targeting LILRB4/CD3 developed based on the Company's T Cell Engager ("TCE") technology platform, with proposed indications for hematologic tumors (AML, CMML and MM). 6MW5311 adopts a "2+1" asymmetric molecular structure, simultaneously targeting LILRB4 and CD3, bridging tumor cells and T cells to form immune synapses, activating T cells and efficiently killing tumors. Through unique steric hindrance structural design, the molecule significantly reduces the binding activity of the CD3 antibody to T cells in the absence of tumor cells, specifically activating T cells only when tumor cells are present, thereby greatly enhancing safety while improving anti-tumor efficacy.

In vitro studies showed that 6MW5311 demonstrated potent killing activity against multiple tumor cell lines and patient-derived samples. In vivo pharmacodynamic studies indicated that 6MW5311 showed clear tumor suppressive effects in both LILRB4 high-expression and low-expression AML tumor models, achieving complete tumor clearance particularly in the high-expression model. In addition, 6MW5311 demonstrated favorable safety characteristics in the cynomolgus monkey safety evaluation model.

TCE, as a key technical means to directly mobilize T cells for efficient tumor killing, has demonstrated significant clinical value in various lymphoma indications, with multiple products successfully launched. However, current treatments for AML and CMML remain primarily chemotherapy, hematopoietic stem cell transplantation, and targeted drugs for specific mutations, with no TCE product approved. As the world's first TCE innovative drug targeting LILRB4/CD3 approved for clinical trials, 6MW5311 possesses broad clinical development prospects and market potential.

As pharmaceutical products are characterized by high technology, high risk and high added value, the cycle from clinical trials to approval to production is long with many steps, and is susceptible to various uncertainties. The Company cannot guarantee that 6MW5311 will ultimately be successfully developed and marketed.

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