News Update Immorna Biotechnology’s Acne Therapeutic mRNA Vaccine JCXH-401 Receives US FDA Clearance to Initiate Clinical Trial
Release time:
2025-12-02
(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.
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