# Mabwell Receives IND Clearance from NMPA for LILRB4/CD3-targeting TCE Bispecific Antibody 6MW5311

- Link: https://www.thailand-business-news.com/pr-news/mabwell-receives-ind-clearance-from-nmpa-for-lilrb4-cd3-targeting-tce-bispecific-antibody-6mw5311
- Published: 2026-06-24T07:00:00+07:00
- Author: PR Newswire

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 leukemia (AML), chronic myelomonocytic leukemia (CMML), 
and multiple myeloma (MM).

6MW5311 is the first LILRB4/CD3 targeting TCE drug candidate globally to receive
clinical trial approval. Previously, it received FDA clearance for the clinical 
trial application.

6MW5311 is developed based on Mabwell’s TCE technology platform and features a "
2+1" asymmetric molecular structure. It simultaneously targets LILRB4 and CD3, forming
an immunological synapse by bridging tumor cells and T cells, thereby activating
T cells to efficiently kill tumors. The molecule incorporates a unique steric hindrance
design. This structure significantly reduces the binding activity of the CD3 antibody
to T cells in the absence of tumor cells. T cells are specifically activated only
when tumor cells are present, which substantially enhances safety while improving
anti-tumor efficacy.

In vitro studies have demonstrated that 6MW5311 exhibits potent cytotoxic activity
across multiple tumor cell lines and patient-derived samples. In vivo pharmacodynamic
studies have shown that 6MW5311 achieves significant tumor inhibition in both LILRB4-
high and LILRB4-low expressing AML tumor models. Notably, it achieved complete tumor
clearance in high-expression models. Furthermore, 6MW5311 demonstrated a favorable
safety profile in cynomolgus monkey safety evaluation models.

As a key technological approach for directly mobilizing T cells to kill tumors, 
TCE has shown significant clinical value in various lymphoma indications, with multiple
products successfully launched. However, current treatments for AML and CMML primarily
remain primarily limited to chemotherapy, hematopoietic stem cell transplantation,
and targeted therapies for specific mutations; no TCE products have been approved
for these indications to date.

About Acute Myeloid Leukemia (AML)

AML is a group of clonal malignant disorders originating from myeloid stem cells,
characterized by high heterogeneity and mortality. Globally, approximately 172.4
thousand new cases of AML were diagnosed in 2022, with the number projected to reach
221.4 thousand by 2035, representing a compound annual growth rate (CAGR) of 1.94%.
In China, approximately 30.8 thousand new AML cases were diagnosed in 2022, accounting
for approximately 17.9% of the global total. The number is expected to reach 36.7
thousand by 2035, representing approximately 16.6% of the global total, with a CAGR
of 1.36%.

About Chronic Myelomonocytic Leukemia (CMML)

CMML is a clonal hematopoietic stem cell disorder that shares overlapping features
with both myelodysplastic syndrome (MDS) and Myeloproliferative Neoplasm (MPN). 
It is characterized by significant monocytosis in peripheral blood and carries an
inherent risk of transformation to AML (approximately 15-20% within 3-5 years). 
CMML is a rare disease with an annual incidence of approximately 3-4 per 100,000,
and currently lacks effective treatment options.

About Multiple Myeloma (MM)

MM is a clonal plasma cell malignancy characterized by the uncontrolled proliferation
of monoclonal plasma cells in the bone marrow. This leads to the overproduction 
of abnormal immunoglobulins and subsequent end-organ damage, manifested as hypercalcemia,
renal impairment, anemia, and bone lesions (collectively known as CRAB features).
Globally, MM accounts for approximately 1%-2% of all cancers and about 10% of hematologic
malignancies. The median age at diagnosis is approximately 69 years, with higher
incidence rates observed in males and individuals of African descent. Over the past
two decades, patient survival rates have significantly improved thanks to the application
of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. However,
MM remains largely incurable, and most patients experience multiple relapses during
the course of the disease.

About Mabwell

Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company 
with capabilities spanning the entire pharmaceutical value chain. The company is
committed to providing more effective and accessible therapies to meet global medical
needs, with a focus on oncology and aging-related diseases. Mabwell’s mission is"
Explore Life, Benefit Health" and its vision is "Innovation, from Ideas to Reality."
For more information, please visit [www.mabwell.com/en](http://www.mabwell.com/en).

Forward-Looking Statements

This press release contains forward-looking statements including, but not limited
to, the potential safety, efficacy, regulatory review or approval and commercial
success of our product candidates and those relating to the Company’s product development,
clinical studies, clinical and regulatory milestones and timelines, market opportunity,
competitive position, possible or assumed future results of operations, business
strategies, potential growth opportunities and other statements that are predictive
in nature. "Forward-looking statements" are statements that are not historical facts
and involve a number of risks and uncertainties, which may cause actual results 
to be materially different from any future results expressed or implied in the forward-
looking statements. These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate," "intend," "plan,""
believe," "estimate," "potential," "predict," "project," "should," "would," and 
similar expressions and the negatives of those terms.

Forward-looking statements are based on the Company’s current expectations and assumptions.
Forward-looking statements are subject to a number of risks, uncertainties, and 
other factors, many of which are beyond the Company’s control, including, but not
limited to: environment; politic; economy; society; legislation; our dependence 
on our product candidates, most of which are still in preclinical or various stages
of clinical development; our reliance on third-party vendors, such as contract research
organizations and contract manufacturing organizations; the uncertainties inherent
in clinical testing; our ability to complete required clinical trials for our product
candidates and obtain approval from regulatory authorities for our product candidates;
our ability to protect our intellectual property; the loss of any executive officers
or key personnel. In case one or more of these risks or uncertainties deteriorate,
or any assumptions are incorrect, the actual results may be seriously inconsistent
with the stated results.

The Company cautions all the persons not to place undue reliance on any such forward-
looking statements, which speaks only as of the date of this press release. The 
Company disclaims any obligation, except as specifically required by law and the
rules of the applicable Stock authority to publicly update or revise any such statements
to reflect any change in expectations or in events, conditions, or circumstances
on which any such statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the forward-looking statements.
All forward-looking descriptions, figures and assumptions in this press release 
are applicable to this statement.

 

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