Clinical Trial Application of LILRB4/CD3-Targeting TCE Bispecific Antibody Innovative Drug 6MW5311 Accepted by NMPA

2026-04-20

In April 2026, Mabwell (688062.SH) announced NMPA’s acceptance of its world’s first LILRB4/CD3-targeting TCE bispecific antibody (6MW5311) for clinical trials, intended for hematological malignancies including AML, CMML and multiple myeloma.

Based on the TCE platform, the drug features a "2+1" asymmetric structure. Its unique steric hindrance design specifically activates T cells only with tumor cells, boosting efficacy and safety while addressing traditional TCE safety issues.

Preclinical studies confirm 6MW5311’s potent tumor-killing ability and good safety. Its US clinical application is in pre-IND stage, to be submitted to the FDA in Q2 2026.

With no approved TCE products for AML and CMML yet, 6MW5311 will fill the clinical gap, strengthening Mabwell’s oncology pipeline and R&D strength.

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Clinical Trial Application of LILRB4/CD3-Targeting TCE Bispecific Antibody Innovative Drug 6MW5311 Accepted by NMPA

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Clinical Trial Application of LILRB4/CD3-Targeting TCE Bispecific Antibody Innovative Drug 6MW5311 Accepted by NMPA

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