(Hangzhou, China,
November 29, 2025) – Immorna
Biotechnology, a biotechnology company focused on mRNA technology platforms,
today announced that its investigational bivalent therapeutic mRNA vaccine
candidate, JCXH-401, for the treatment of acne vulgaris, has received clearance
from the United States Food and Drug Administration (FDA) for its
Investigational New Drug (IND) application to initiate a Phase 1/2 clinical
trial.
Acne vulgaris is a highly prevalent skin
disease among adolescents and young adults. A key driver of acne is a bacterium
called Cutibacterium acnes (C. acnes). Existing treatments often
lead to disease recurrence and are associated with significant side effects,
such as teratogenic risks.
JCXH-401 is designed to induce specific
antibody responses in the body that precisely target inflammatory mediators
produced by pathogenic subtypes of C. acnes, while not
disrupting the skin's normal microflora composition. This innovative mechanism
is expected to minimize the risk of side effects such as antibiotic resistance,
excessive skin dryness, and irritation, offering patients a safer and more
targeted treatment option.
Globally, only two mRNA candidate vaccines for
acne vulgaris are currently under development, including Immorna's JCXH-401 and
another candidate from Sanofi. According to the plan, the Phase 1/2 clinical
trial for JCXH-401 will first focus on adult patients with moderate to severe
acne.
Dr. Yuanqing Liu, Chief Scientific Officer of
Immorna, stated, "The FDA's IND clearance for JCXH-401 is a significant
milestone for our company in the field of dermatology therapeutics. If the
clinical trials are successful, JCXH-401 has the potential to provide a novel
treatment option for this significant unmet medical need, offering hope to
millions of acne patients."
About Immorna
Biotechnology:
Immorna Biotechnology is a global biotechnology company dedicated to developing
and commercializing innovative therapies and vaccines using its proprietary
mRNA technology platform. The company focuses on delivering breakthrough
treatment options for patients in areas such as oncology, infectious diseases,
and rare diseases.
Media Contact:
BD@immorna.com
Forward-Looking Statements:
This press release contains forward-looking statements about future events.
These statements are based on current expectations and assumptions and are
subject to risks and uncertainties. Actual results may differ materially from
those described in the forward-looking statements due to various factors.