New Expansion in Topical Pipeline! Jiangsu Vcare’s VC005 Topical Gel Granted China IND Approval for New Indication of Vitiligo

　　Recently, VC005 Topical Gel, a second-generation highly selective JAK1 inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare), has officially obtained the IND approval from the CDE of the NMPA. The product is intended for the topical treatment of non-segmental vitiligo.

　　This marks another key strategic expansion of VC005 in the topical preparation sector, following its layout for mild-to-moderate atopic dermatitis (AD). Meanwhile, VC005 has previously established a robust clinical evidence and pipeline portfolio across multiple autoimmune disease therapeutic fields including vitiligo. The approval of this new indication is expected to further meet the diverse treatment requirement of vitiligo patients and open a new chapter for targeted topical therapy of vitiligo.

　　Vitiligo is a common acquired depigmentary skin disorder affecting over tens of millions of people worldwide with urgent unmet clinical needs. Current topical therapeutic drugs generally are limited by suboptimal efficacy, inadequate safety profiles and high recurrence rates, failing to satisfy patients’ long-term treatment demands. There is an urgent clinical need for novel topical therapies with high efficacy, favorable safety and low recurrence risk.

　　Leveraging its core strength of targeted JAK1 inhibition, VC005 Topical Gel can precisely block key immune inflammatory signaling pathways underlying the pathogenesis of vitiligo, effectively inhibit melanocyte damage and promote repigmentation of the skin. It not only provides a new safe and effective topical treatment option for vitiligo patients but also improves medication adherence due to its superior product properties, expected to fill the unmet clinical treatment gap in this therapeutic field of domestic population.

　　As a core innovative product independently developed by Jiangsu Vcare, VC005 is a second-generation highly selective JAK1 inhibitor. It demonstrates unique advantages in the treatment of inflammatory and autoimmune diseases by virtue of precise target selectivity and potent inhibitory activity. At present, both oral and topical formulations with multiple specifications have been successfully developed, forming a product portfolio covering a wide range of indications. This fully meets the differentiated medication needs of diverse disease types and patient populations, delivering diversified and personalized therapeutic regimens for clinical diagnosis and treatment.

　　Among them, VC005 Topical Gel is a novel locally exposed topical gel targeting JAK1 specifically developed for skin diseases. It has previously successfully completed the Phase II clinical trial for mild-to-moderate atopic dermatitis, delivering outstanding efficacy and safety profile and highlighting its leading potential among peer products. The IND approval for the new vitiligo indication further expands the clinical application scope of VC005 Topical Gel and underscores Jiangsu Vcare’s strong R&D innovation strength and clinical transformation capability in the field of JAK inhibitors.

　　Currently, preparations are in full swing for the Phase III clinical trial of VC005 Topical Gel for the indication of mild-to-moderate atopic dermatitis. Its 1% strength formulation entered a strategic R&D cooperation with Beijing Sun-Novo Pharmaceutical Research Co., Ltd. in February 2026. The IND approval for the vitiligo indication signifies the official expansion of VC005 Topical Gel’s indication landscape from atopic dermatitis to vitiligo, which will further enhance the clinical value and commercial potential of the product in the field of autoimmune dermatoses.

　　About VC005 Topical Gel

　　VC005 is a novel, potent, and highly selective second-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 improving 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 address better 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 Vitiligo

　　Vitiligo is a localized or generalized depigmentary disorder caused by a reduction or disappearance of tyrosinase activity in melanocytes within the skin and hair follicles, resulting in decreased or loss of melanin granule production. It is characterized by complete loss of skin and mucous membrane pigmentation in a localized or generalized manner. It can occur in any part of the body, commonly on the back of the fingers, wrists, forearms, face, neck, etc.

　　The worldwide lifetime prevalence was estimated at 0.36% in the general population, affecting an estimated 28.5 million people worldwide.

　　The target mechanism of VC005 is well-defined. In patients with vitiligo, it can achieve disease reversal and recurrence delay through two pathways:

　　By inhibiting the IFN-γ - JAK1/2 - STAT1 signaling pathway, it blocks keratinocytes from releasing chemokines that recruit more CD8+ T cells.

　　By inhibiting the IL-15 - JAK1/3 - STAT3/5 signaling pathway, it suppresses the activation of Trm cells.

Vitiligo Pathogenesis and Therapeutic Mechanisms

Citing from Frisoli, et al, Vitiligo: Mechanisms of Pathogenesis and Treatment,2020

Immunological Mechanisms of Vitiligo Progression and Maintenance

Citing from Frisoli, et al, Vitiligo: Mechanisms of Pathogenesis and Treatment,2020