Nantong University Affiliated Hospital Announces Licensing of a Novel Hydrogel Technology for Atopic Dermatitis Treatment

Recently, the Affiliated Hospital of Nantong University released a public notice on patent licensing, indicating that the hospital intends toAn Invention Patent for the Treatment of Atopic Dermatitis, licensed to industry partners on a non-exclusive basis, with the licensing transaction amount being RMB50,000 yuan. The inventor of this patented technology is the Affiliated Hospital of Nantong UniversityProfessor Ren Xuqi and His Team。

The invention patent technology proposed for transfer in this instance involvesA Novel Hydrogel Dressing for the Treatment of Atopic Dermatitis (AD). This hydrogel possessesAntibacterial, anti-inflammatory, and repair-promotingmultiple efficacies: Experiments have demonstrated that it can effectively inhibit common pathogens such as Staphylococcus aureus, with low cytotoxicity and favorable biosafety. In animal experimental models, this material significantly alleviated skin inflammation and improved skin lesions in mice with atopic dermatitis (AD), while promoting wound healing by creating a moist wound environment. This scientific achievement provides a novel topical therapeutic strategy for the clinical treatment of AD.

Atopic Dermatitis (AD), also known as atopic eczema or hereditary allergic dermatitis, is a chronic, relapsing inflammatory skin disease with high prevalence in childhood. In recent years, the global incidence of this condition has continued to rise, affecting approximately 15–20% of children and 6–10% of adults, with about 20% of cases being moderate to severe. Although the characteristics of skin lesions vary across different age groups, intense pruritus remains a universal core symptom.

The severity of pruritus is closely correlated with disease severity, while repetitive scratching further compromises the skin barrier, exacerbating inflammation and pruritus, thereby creating a vicious cycle of “itch–scratch–worsening itch.” This not only significantly impairs patients’ sleep quality and daily functioning but may also precipitate psychological disorders such as anxiety and depression, and even elevate the risk of suicide. Furthermore, atopic dermatitis (AD) frequently coexists with other allergic conditions, including asthma and allergic rhinitis. Consequently, AD not only markedly diminishes patients’ quality of life but also imposes a substantial economic burden on families and society.

The pathogenesis of AD is associated with the interaction of multiple complex factors, among whichImpaired Skin Barrier Functionis one of the key etiologies. The skin barrier acts as the body's "outer wall"; once its structure is compromised, external pathogenic microorganisms are more likely to colonize and invade. Studies have shown that Staphylococcus aureus colonization on the skin surface of patients with atopic dermatitis (AD) is significantly increased, leading to dysbiosis.

These bacteria can secrete various virulence factors, such as superantigens and cytotoxins, thereby compromising the integrity of the skin barrier and perpetuating local inflammatory responses. Therefore, effectively reducing inflammation and facilitating skin barrier repair are key therapeutic strategies for managing atopic dermatitis (AD) lesions.

Currently,The treatment of atopic dermatitis (AD) is mainly based on topical medications,Commonly used medications include topical corticosteroids (TCS), calcineurin inhibitors (TCI), and phosphodiesterase-4 (PDE-4) inhibitors. Among these, TCS are currently the most widely used topical anti-inflammatory agents. They work by suppressing the activity of various immune cells, such as macrophages and monocytes, thereby rapidly alleviating inflammation and pruritus. However, long-term or extensive application of TCS may lead to adverse effects, including skin atrophy, telangiectasia, and dyspigmentation, and may even compromise the skin barrier.

Topical calcineurin inhibitors (TCIs, such as tacrolimus and pimecrolimus) are often recommended for the treatment of areas with thinner skin, such as the face and neck, as well as special sites like the perianal region, due to their minimal impairment of the skin barrier during long-term use. They are also suitable for long-term maintenance therapy after disease remission.

Furthermore, as the first PDE-4 inhibitor currently in clinical use, crisaborole ointment reduces the production of pro-inflammatory cytokines by inhibiting intracellular phosphodiesterase-4 (PDE-4) activity and has been approved for patients aged 3 months and older with mild-to-moderate atopic dermatitis (AD). Although topical calcineurin inhibitors (TCIs) and PDE-4 inhibitors are relatively gentle on the skin barrier, they often cause local adverse reactions such as burning, pruritus, or stinging at the application site during the initial phase of treatment.

In such cases, the use of conventional topical medications is somewhat limited when there is significant skin barrier disruption or concurrent bacterial infection. Therefore, there is an urgent clinical need to develop a novel topical therapy that offers anti-inflammatory effects, promotes skin barrier repair, demonstrates a favorable safety profile, and is suitable for application on compromised skin, thereby addressing the limitations of existing treatment regimens.

The team has developed a hydrogel for the treatment of atopic dermatitis (AD), with its key advantage lying inAn Integrated Therapeutic Strategy Combining “Repair, Anti-Inflammation, and Antibacterial” Effects. From an innovative perspective that integrates materials science with pharmacology, this hydrogel overcomes the limitations of existing clinical topical treatment regimens. Traditional medications, such as glucocorticoids, although possessing potent anti-inflammatory effects, can impair the skin barrier with long-term use and are not suitable for application on damaged skin.

This patent ingeniously selectsSodium Alginate (SA) HydrogelAs a functional substrate, it not only serves as a carrier but also creates a critically important environment for the wound itself.“Moist Wound Healing Environment”. This moist microenvironment has been validated by modern wound care science, capable of significantly accelerating epithelial cell migration and promoting tissue regeneration while alleviating pain during dressing changes, thereby laying the physical foundation for repairing the compromised skin barrier in atopic dermatitis (AD).

In terms of pharmacological activity, the invention does not employ a single chemically synthesized drug, but instead innovativelyA composite of two natural active ingredients extracted from the traditional herbal medicine licorice, namely glycyrrhizin G2 (L-G2) and flavonoid A (FLA).These two components exert synergistic anti-inflammatory effects through distinct molecular pathways. As a saponin compound, L-G2 effectively inhibits the release of key pro-inflammatory mediators by immune cells, including nitric oxide (NO), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6).

More critically, it blocks the arachidonic acid metabolic pathway at the upstream level by inhibiting the activity of phospholipase A2 (PLA2) and the expression of cyclooxygenase-2 (COX-2), thereby reducing the synthesis of pro-inflammatory mediators such as prostaglandin E2 (PGE2) and achieving fundamental anti-inflammatory regulation.

Meanwhile, as a flavonoid, FLA not only exhibits anti-inflammatory properties but also possesses potent antibacterial activity, precisely targeting the key secondary issue of dysbiosis (particularly Staphylococcus aureus overcolonization) induced by skin barrier defects in patients with atopic dermatitis (AD). Studies have shown that FLA can effectively inhibit the formation of S. aureus biofilms.

Biofilms are mucus-like substances secreted by bacteria for self-protection, helping them resist attacks from the immune system and antibiotics. Their formation is considered a key factor in persistent infections. FLA can disrupt this protective layer while inhibiting the production of virulence factors such as staphyloxanthin, thereby achieving efficient bacteriostatic effects. In vitro zone-of-inhibition assays clearly demonstrated that SA hydrogels co-loaded with L-G2 and FLA exhibited significantly stronger inhibitory effects against Staphylococcus aureus and Escherichia coli compared to hydrogels loaded with a single component, showcasing a synergistic antibacterial effect where “1 + 1 > 2.”

The advanced nature of this invention is strongly supported by rigorous preclinical experimental data. In terms of safety, in vitro cytotoxicity assays demonstrated that even under high-concentration conditions, cell viability remained maintained after co-culturing the hydrogel with murine and human-derived cells.Over 80%, live/dead cell staining results also indicated that the vast majority of cells were in good condition, providing primary assurance for their biosafety. In terms of therapeutic efficacy, animal studies conducted using a dinitrochlorobenzene (DNCB)-induced atopic dermatitis (AD) mouse model provided multi-level evidence from macroscopic to microscopic perspectives.

From a macro perspective,In the treatment group, skin lesions such as erythema, edema, and crusting on the dorsal side of mice showed significant improvement within a short period, with a rapid decrease in SCORAD (Scoring Atopic Dermatitis) scores.Meanwhile, microscopic histopathological analysis reveals the underlying mechanisms of improvement:In the skin of mice treated with this hydrogel, the originally abnormally thickened epidermis (acanthosis) was significantly alleviated; the disordered and fragmented collagen fibers in the dermis were realigned in an orderly and dense manner, and the number of hair follicles was also markedly restored. These findings provide direct morphological evidence of inflammation resolution and tissue repair.

Further immunofluorescence molecular assays were conducted to elucidate the mechanism of action from the perspective of cytokines. In post-treatment skin tissues, the expression levels of the key pro-inflammatory cytokine TNF-α were significantly downregulated, and the levels of the anti-inflammatory cytokine IL-10, secreted as a compensatory response, were correspondingly reduced. Together, these findings substantiate that the local inflammatory response was substantially alleviated.

This multifunctional integrated design, which features potent inhibition of core pro-inflammatory pathways, targeted elimination of opportunistic pathogens, and the creation of an ideal physical environment for tissue repair, represents a significant advantage of the present invention over existing topical drugs with single mechanisms. It provides a novel, safe, and efficient local treatment strategy and product development pathway to address the clinical challenge in atopic dermatitis (AD) management of simultaneously achieving anti-inflammation, infection prevention, and promotion of repair.

In the aforementioned AD treatment,"Effective Anti-Inflammation," "Avoiding Barrier Damage," and "Infection Control"To address this core clinical challenge, innovative pharmaceutical companies both in China and abroad are actively exploring novel topical therapies through diverse technological approaches, aiming to provide patients with superior treatment options.

In the international market,Alphyn BiologicsDedicated to the research and development of first-in-class multi-target therapeutics for severe skin diseases. The company’s core product is indicated for the treatment of atopic dermatitis.Topical Hydrogel Formulation: Zabalafin Hydrogel(Development Code AB-101a). This medication is a first-in-class, plant-derived combination topical formulation designed to simultaneously address the three core issues of atopic dermatitis—intense pruritus, immune-mediated inflammation, and cutaneous microbiome dysbiosis (particularly the impact of Staphylococcus aureus)—with a single agent, thereby achieving comprehensive disease management.

To date, the product has achieved several key milestones. First, its Investigational New Drug (IND) application for the treatment of mild-to-moderate atopic dermatitis was approved by the U.S. Food and Drug Administration (FDA) in February 2025, thereby removing regulatory hurdles for subsequent clinical trials. Second, two completed Phase 2a clinical trials successfully met all primary and secondary endpoints. The data demonstrated that the drug significantly alleviates pruritus, improves patients’ quality-of-life metrics, and exhibits a favorable safety and tolerability profile. For instance, interim data from an early-phase study showed that 80% of participants achieved a clinically meaningful improvement in pruritus scores after eight weeks of treatment. Furthermore, the core formulation and indications of the drug are protected by U.S. patents, with protection lasting until 2042, providing long-term intellectual property security.

Currently, the drug’s development is in the Phase 2b clinical trial stage. According to the company’s plan, the global Phase 2b trial was initiated in 2025, with final data expected in the first half of 2026, and Phase 3 trials are scheduled to commence in 2026.

Jiangsu Kanion Pharmaceutical Co., Ltd.Its predecessor was the Lianyungang Traditional Chinese Medicine Factory. It has now developed into a national demonstration enterprise for the modernization of traditional Chinese medicine and a national key high-tech enterprise. Under the guidance of this strategy, one achievement made by Kangyuan Pharmaceutical is its independently developedClass 1 Novel Chemical Drug KYS2301 Gel. This drug is a novel chemokine receptor 8 (CCR8)-specific inhibitor, belonging to the class of peptide molecules with entirely new amino acid sequences. Its significant importance lies in the fact that KYS2301 is the world’s first peptide inhibitor targeting CCR8, and also the world’s first peptide drug whose design was completed using artificial intelligence technology and has entered clinical trials. Compared with traditional research and development methods, the R&D cycle has been shortened by>60%. This gel formulation (available in 1%, 3%, and 5% strengths) is indicated for atopic dermatitis. It is designed for topical application to ensure therapeutic efficacy while minimizing systemic adverse reactions, thereby enhancing patient convenience and adherence.

As of now, the cumulative R&D investment in this project has reached approximately RMB 44.93 million. Currently, KYS2301 gel officially obtained the "Notice of Approval for Drug Clinical Trials" issued by the National Medical Products Administration (NMPA) in July 2025, approving the conduct of clinical trials for atopic dermatitis.

In terms of the future development of the industry, advances in topical therapies for atopic dermatitis (AD) may focus more on the organic integration of innovative drug mechanisms of action and improved formulations. As a carrier that creates a moist healing environment and enhances the medication experience, the value of hydrogels is being confirmed by an increasing number of R&D projects.

Future competition and collaboration may center on building product advantages through more precise targeted therapies, more comprehensive symptom management (such as simultaneously relieving pruritus, reducing inflammation, and modulating the microbiota), and superior topical delivery systems. The technological maturity and market translation effectiveness across the field still require thorough validation by subsequent clinical data.