New Progress in Autoimmune Disease Pipeline! Vcare PharmaTech's VC005 Topical Gel Secures China IND Approval for Plaque Psoriasis

　　Recently, VC005 topical gel, a new-generation highly selective JAK1 inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Vcare PharmaTech), has officially obtained the IND approval from the CDE for the topical treatment of plaque psoriasis.

　　Following its layouts for mild-to-moderate atopic dermatitis (AD) and non-segmental vitiligo (NSV), this approval marks another key strategic expansion of VC005 topical gel in the topical administration. It further consolidates the Company’s leading R&D position in the field of autoimmune dermatoses.

　　Accounting for 80% to 90% of all psoriasis cases, plaque psoriasis is a chronic, recurrent inflammatory skin disorder. Lesions commonly appear on the scalp, back and extensor sides of limbs, presenting as well-demarcated dark red plaques or infiltrative erythema covered with white or silvery scales. Beyond cutaneous manifestations, psoriasis is often accompanied by other systemic diseases.

　　Currently available conventional topical therapies such as glucocorticoids and vitamin D3 derivatives have notable limitations, including modest efficacy, frequent drug resistance, suboptimal safety profiles and high recurrence rates. Long-term use may also trigger adverse reactions like skin atrophy and telangiectasia, failing to meet patients’ demands for long-term and safe treatment. There is an urgent clinical need for novel targeted topical agents with high efficacy, favorable safety and low recurrence risk.

　　As a new-generation highly selective JAK1 inhibitor, VC005 topical gel precisely blocks the IL23-JAK-STAT inflammatory signaling pathway, a key driver of plaque psoriasis. It effectively suppresses the release of pro-inflammatory factors, inhibits excessive proliferation of keratinocytes and inflammatory infiltration, curbs lesion progression at the source and facilitates skin barrier repair. In preclinical animal models, VC005 topical gel has demonstrated therapeutic potency comparable to oral TYK2 inhibitors, holding promise to deliver superior treatment options for patients.

　　As a core product in Vcare Pharma’s topical pipeline, VC005 topical gel is now fully enrolling patients for the Phase III clinical trial for atopic dermatitis. Its Phase II study has yielded outstanding efficacy and safety results. The extremely low systemic exposure of the drug is expected to resolve the black box warning concerns associated with peer agents. Clinical trials for non-segmental vitiligo are also in preparation.

　　The new IND approval for plaque psoriasis further broadens the clinical application scope of VC005 topical gel and enhances its clinical value and commercial potential in autoimmune dermatoses. This milestone signifies that the Company’s R&D layout for topical autoimmune dermatoses has entered a new phase with coordinated advancement across multiple indications, and fully demonstrates Vcare PharmaTech’s robust innovation capability and efficient clinical translation in the development of JAK inhibitors.

　　About VC005 Topical Gel

　　VC005 is a novel, potent, and highly selective new-generation JAK1 inhibitor. Both oral and topical formulations with multiple specifications have been developed, forming a product matrix covering multiple therapeutic areas.

　　As a novel JAK1-targeted topical gel for skin exposure, VC005 Topical Gel utilizes a unique pharmaceutical dosage form matrix. While achieving high drug loading, it also features excellent stability, safety, non-irritation, and a refreshing gel texture, greatly optimizing patient medication compliance.

　　In the completed Phase II clinical trial for mild-to-moderate atopic dermatitis, VC005 Topical Gel demonstrated significant anti-pruritic effects and skin lesion recovery early in treatment: pruritus relief was observed on the first day, with the average Numeric Rating Scale (NRS) for pruritus decreasing by approximately 14% within 12 hours. After one week of administration, at least a 50% improvement in skin lesions (EASI-50 response) was achieved in about 30% of patients, significantly improve their quality of life.

　　In terms of safety, the incidence of treatment-related adverse events (TRAE) was lower than that in the vehicle group, with no serious adverse reactions (SAR) reported, indicating favorable patient tolerability. Regarding metabolism, plasma exposure is extremely low, especially in adolescents, with no drug accumulation. It is expected to address the black box warning issues of marketed topical drugs targeting the same receptor.

　　About Plaque Psoriasis

　　Psoriasis is an immune-mediated chronic, recurrent inflammatory systemic disease triggered by a combination of genetic and environmental factors. Its clinical subtypes include vulgaris psoriasis, pustular psoriasis, erythrodermic psoriasis, psoriatic arthritis and other special types.

　　Plaque psoriasis accounts for 80% to 90% of all psoriasis cases. Characterized as a papulosquamous disorder, it presents as dark red plaques or infiltrative erythema covered with white or silvery scales, accompanied by typical manifestations such as wax-like scaling, thin film phenomenon and pinpoint bleeding.

　　Apart from skin lesions, psoriasis is frequently complicated by comorbidities, mainly including cardiovascular and metabolic diseases, mental disorders, chronic kidney diseases and other autoimmune disorders.

　　The core pathogenesis lies in the abnormal activation of the IL-23/Th17 axis. Genetic and environmental factors disrupt immune homeostasis and cause excessive activation of Th17 cells, which secrete abundant pro-inflammatory factors. These factors activate the JAK-STAT signaling pathway, leading to excessive proliferation of keratinocytes and inflammatory cell infiltration, and eventually forming typical erythema and scaly lesions. Meanwhile, impaired skin barrier function and persistent inflammatory microenvironment contribute to prolonged disease course and high recurrence rate.