Efficient Progress! Jiangsu Vcare Completed Patient Enrollment in Phase II Clinical Trial of VC005 Tablets, a Second-Generation Highly Selective JAK1 Inhibitor for Vitiligo

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) has successfully completed patient enrollment in a Phase II clinical trial of VC005 Tablets, an independently developed second-generation highly selective JAK1 inhibitor, for the oral administration of non-segmental vitiligo (NSV).

　　This multicenter, randomized, double-blind, placebo-controlled parallel trial aims to systematically evaluate the efficacy, safety, and PK profile of VC005 Tablets in Chinese adult subjects with NSV. The primary endpoint is the percentage change from baseline in the Vitiligo Area Scoring Index (VASI) at Week 24, which will provide key evidence for subsequent registration clinical studies and dose selection.

　　As a novel, potent, and highly selective second-generation JAK1 inhibitor, VC005 Tablets address the therapeutic challenges of vitiligo through a precise targeted mechanism. Its core advantage lies in dual-pathway synergistic action: On one hand, it inhibits the IFN-γ-mediated activation of the JAK/STAT signaling pathway, blocking the release of chemokines from keratinocytes, reducing the recruitment of CD8+ T cells to skin lesions, and preventing continuous damage to melanocytes. On the other hand, it suppresses the IL-15-mediated activation of the JAK/STAT signaling pathway and inhibits the activation of tissue-resident memory T (Trm) cells, thereby reducing the risk of disease recurrence at the fundamentally.

　　While retaining the activity JAK1 inhibition, VC005 Tablets significantly reduce the inhibition of JAK2, which is expected lower underlying safety risk from such as anemia and thrombocytopenia, etc, making it more suitable for the long-term vitiligo treatment.

　　The completion of Phase II patient enrollment marks an important milestone in the clinical development of VC005 Tablets for the systemic treatment of vitiligo. As a core product in Jiangsu Vcare’s autoimmune disease pipeline, VC005 is being developed across multiple high-unmet-need indications: Phase III clinical trials for moderate-to-severe atopic dermatitis have completed enrollment; Phase III trials for ankylosing spondylitis are ongoing; IND application for alopecia areata has been approved; A Phase III clinical trial of the topical gel formulation for mild-to-moderate atopic dermatitis is in preparation.

　　The multi-formulation strategy (oral and topical) and parallel advancement across multiple indications fully validate the broad application potential of VC005 in inflammatory and autoimmune diseases, whose favorable efficacy and safety profiles have been preliminarily demonstrated in earlier clinical studies.

　　About VC005

　　VC005 Tablets is a novel, potent, and highly selective second-generation JAK1 inhibitor, for which Jiangsu Vcare holds independent intellectual property rights. In August 2025, Jiangsu Vcare entered into an exclusive strategic cooperation with Huadong Medicine regarding the commercialization rights of VC005 Tablets in Mainland China. By selectively inhibiting JAK1, VC005 Tablets reduces inflammatory responses and the activation of immune cells. Currently, the compound has been developed for multiple autoimmune diseases such as moderate-to-severe atopic dermatitis, ankylosing spondylitis, rheumatoid arthritis, and vitiligo, with two dosage forms under development: oral tablets and topical gel. While maintaining strong JAK1 inhibitory activity, VC005 Tablets further reduces JAK2 inhibitory activity in a selective manner (based on in vitro kinase assay results), which is expected to alleviate safety issues caused by excessive JAK2 inhibition in clinical practice.

　　About Vitiligo

　　Vitiligo is an acquired depigmenting skin disorder. Currently, it is considered that the occurrence of depigmentation in the skin, mucous membranes, or hair is mainly caused by the specific destruction of local melanocytes by autoreactive T cells. The global incidence of vitiligo is approximately 0.5%-2%. Clinically, it is characterized by hypopigmented or depigmented macules, usually milky white in color, with clear boundaries, varying in sizes and shapes. Most patients are asymptomatic, with low propensity for spontaneous resolution.. The pathological features of vitiligo include melanocyte loss and CD8+ T cell infiltration, with CD8+ T cells preferentially localized in melanocytes at the lesional margins. The reversal of the disease can be achieved through immunosuppression and melanocyte regeneration. The function and continuous recruitment of CD8+ T cells are crucial for the progression of vitiligo. The cytokine IFN-γ produced by CD8+ T cells is the core cytokine triggering vitiligo, and autoreactive resident memory T cells (Trm cells) is critical in the recurrence of vitiligo.