SHANGHAI, July 16,
2024 /PRNewswire/ -- Mabwell (688062.SH), an
innovation-driven biopharmaceutical company with entire industry
chain, announced that its self-developed novel B7-H3-targeting
ADC (R&D code: 7MW3711) has been granted Orphan Drug
Designation (ODD) by the U.S. Food and Drug Administration (FDA),
for the treatment of small cell lung cancer.
The FDA grants Orphan Drug Designation to treatments for rare
diseases in the United States that
affect fewer than 200,000 patients. Orphan Drug Designation offers
policy benefits to drug developers, including as aid with
medication development, tax credits for a part of clinical trial
expenditures, and seven years of market exclusivity upon
approval.
7MW3711 is a novel B7-H3-targeting ADC developed by Mabwell's
IDDC™ platform. It is composed of innovative antibody molecule,
novel linker, and novel payload Mtoxin™ (TOP1i). When 7MW3711
enters human body, it specifically binds to antigens on the tumor
cell membrane surface, be internalized and trafficked to the
lysosome, release cytotoxic drug, and induce the apoptosis of tumor
cells.
7MW3711 is pharmaceutical characterized as stable structure,
homogeneous composition, high purity, and it is suitable for
industrial scale-up. Compared with ADCs in the same class at home
and abroad, 7MW3711 has shown better tumor killing effects in
multiple animal tumor models. In the safety evaluation model of
animals including cynomolgus monkeys, the on-target and off-target
toxicities of 7MW3711 are effectively controlled, showing its good
safety profile and pharmacokinetic properties. The above research
results indicate that 7MW3711 has clinical differentiation
characteristics and a promising future of clinical development.
About the next generation ADC platform - IDDC™
IDDC™ is a next generation ADC site-specific conjugation
technology platform independently developed by Mabwell, consisting
of multiple systematic core patented technologies including the
site-specific conjugation process DARfinity™, the site-specific
linker IDconnect™, the novel payload Mtoxin™, and the conditional
release structure LysOnly™. The next generation ADCs developed
based on the above systematic patented technologies have better
structural uniformity, quality stability, efficacy, and
tolerability. The novel payload Mtoxin™ (MF6) demonstrates
good pharmacodynamics, bystander killing efficacy, and
anti-multidrug resistance.
The IDDC™ platform has been validated in multiple drug
candidates under development. Mabwell currently has several ADCs in
clinical development stages. Among them, the novel
Nectin-4-targeting ADC, 9MW2821, is in Phase III clinical trial for
the indication of urothelial carcinoma. The novel B7-H3-targeting
ADC, 7MW3711, and Trop-2-targeting ADC, 9MW2921, are both in
clinical trial stages.
About Mabwell
Mabwell (688062.SH) is an innovation-driven biopharmaceutical
company with the entire value chain of the pharmaceutical industry.
We provide more effective and accessible therapy and innovative
medicines to fulfill global medical needs. Since 2017, an advanced
R&D system which covers target discovery, early discovery,
druggability, preclinical, clinical research and manufacturing
transformation was established. Mabwell has 14 pipeline products in
different stages based on a world-class and state-of-the-art
R&D engine, including 10 novel drug candidates and 4
biosimilars. We focus on the therapeutic areas of oncology,
auto-immune diseases, metabolic disorders, ophthalmologic diseases
and infectious diseases, etc. Of these, 3 products have been
approved and commercialized, 1 product has been filed for MA
approval, 3 products are in pivotal trials. We have also undertaken
1 national major scientific and technological special project for
"Significant New Drugs Development", 2 projects for National Key
R&D Programmes, and multiple provincial and municipal science
and technological innovation projects. Mabwell's Taizhou factory
possesses robust in-house manufacturing capability compliant with
international GMP standards regulated by the NMPA, FDA and EMA, and
has passed the EU QP Audit. The large-scale manufacturing base in
Shanghai and the ADC
commercialized manufacturing base in Taizhou are under
construction. Our mission is "Explore Life, Benefit Health" and our
vision is "Innovation, from ideas to reality". For more
information, please visit 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
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which may cause actual results to be materially different from any
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expectations and assumptions. Forward-looking statements are
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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 potential
impact of COVID-19; 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.
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SOURCE Mabwell