Mabwell Receives IND Clearance From NMPA for LILRB4/CD3-Targeting TCE Bispecific Antibody 6MW5311
The candidate is the first LILRB4/CD3-targeting TCE to win trial approval worldwide, with preclinical studies showing strong tumor killing and a favorable safety profile.
- On Wednesday, June 24, 2026, China's National Medical Products Administration cleared the clinical trial application for Mabwell's 6MW5311, an innovative LILRB4/CD3 targeting T Cell Engager for treating Acute Myeloid Leukemia , Chronic Myelomonocytic Leukemia , and Multiple Myeloma .
- Utilizing an asymmetric "2+1" molecular structure, 6MW5311 bridges tumor cells and T cells to form an immunological synapse. This design ensures T cells activate only when tumor cells are present, substantially enhancing safety while improving anti-tumor efficacy.
- Current treatments for AML and CMML remain limited to chemotherapy and stem cell transplantation. No TCE products have been approved for these indications to date, representing a significant unmet medical need.
- 6MW5311 marks the first LILRB4/CD3 targeting TCE candidate globally to receive clinical trial approval. Previously, the drug received FDA clearance for clinical trial applications, advancing its development across major regulatory markets.
- Mabwell, guided by its mission to "Explore Life, Benefit Health," develops therapies focused on oncology and aging-related diseases. The company aims to provide more effective and accessible treatments to meet global medical needs.
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LoudounTimes.com
Mabwell Receives IND Clearance from NMPA for LILRB4/CD3-targeting TCE Bispecific Antibody 6MW5311
SHANGHAI, June 23, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the National Medical Products Administration (NMPA) of China has cleared the clinical trial application for its innovative LILRB4/CD3 targeting…
China's NMPA clears Mabwell's bispecific antibody 6MW5311 for clinical trials
SHANGHAI, June 24, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the National Medical Products Administration (NMPA) of China has cleared the clinical trial application for its innovative LILRB4/CD3 targeting T Cell Engager (TCE) bispecific antibody (R&D code: 6MW5311), for the treatment of hematologic malignancies, including acute myeloid…
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