SHANGHAI, June 23, 2026
Mabwell announced that China’s National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) clearance for 6MW5311, the company’s innovative LILRB4/CD3-targeting T Cell Engager (TCE) bispecific antibody, for the treatment of hematologic malignancies, including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM). The regulatory approval marks an important milestone as 6MW5311 becomes the first LILRB4/CD3-targeting T Cell Engager globally to receive clinical trial authorization. The candidate had previously received U.S. FDA IND clearance, positioning Mabwell to advance clinical development in both China and the United States. The latest approval further strengthens the company’s oncology pipeline and highlights growing international interest in next-generation bispecific antibody therapies for difficult-to-treat blood cancers.
Novel Bispecific Antibody Designed to Enhance Anti-Tumor Activity
6MW5311 was developed using Mabwell’s proprietary T Cell Engager (TCE) technology platform and features a unique “2+1” asymmetric molecular structure that simultaneously targets LILRB4 on tumor cells and CD3 on T cells. By bridging immune cells directly to cancer cells, the therapy forms an immunological synapse that activates T cells to selectively destroy malignant cells. The molecule also incorporates an innovative steric hindrance design that minimizes unnecessary CD3 activation when tumor cells are absent, reducing the potential for off-target immune activation while improving overall safety. This targeted mechanism is intended to maximize anti-tumor efficacy while lowering the risk of excessive immune responses commonly associated with T cell-engaging therapies, making 6MW5311 a promising candidate for treating aggressive hematologic cancers.
Preclinical Studies Demonstrated Strong Efficacy and Safety
Preclinical research demonstrated encouraging anti-cancer activity across multiple laboratory and animal models. In vitro studies showed that 6MW5311 produced potent cytotoxic effects against multiple tumor cell lines and patient-derived cancer samples. In vivo pharmacodynamic studies further demonstrated significant tumor inhibition in both high and low LILRB4-expressing AML models, with the therapy achieving complete tumor clearance in high-expression models. Safety evaluations conducted in cynomolgus monkeys also indicated a favorable tolerability profile, supporting progression into human clinical trials. These findings suggest that 6MW5311 has the potential to become an important new immunotherapy for hematologic malignancies where treatment options remain limited despite advances in targeted therapies and stem cell transplantation.
Advertisement
Mabwell Expands Its Oncology Pipeline with First-in-Class Innovation
The approval represents another important achievement for Mabwell’s expanding immuno-oncology portfolio, particularly in diseases such as AML, CMML, and multiple myeloma, where significant unmet medical needs continue to exist. While T Cell Engager therapies have already demonstrated clinical success in several lymphoma indications, no approved TCE therapies currently target AML or CMML, creating an opportunity for 6MW5311 to establish a new treatment approach if future clinical trials confirm its safety and efficacy. By advancing the first globally approved LILRB4/CD3-targeting bispecific antibody into clinical development, Mabwell strengthens its position in the competitive biopharmaceutical industry while reinforcing its commitment to developing innovative cancer immunotherapies capable of improving outcomes for patients with difficult-to-treat hematologic malignancies.
Source: Mabwell press release
