Jiangsu Vcare Announces First Patient Enrollment in Phase Ⅱ Clinical Trial of VC005 Tablets, a Second-Generation Highly Selective JAK1 Inhibitor, for Oral Treatment of Vitiligo

　　Recently, Jiangsu Vcare PharmaTech Co.,Ltd. (Jiangsu Vcare) announced the completion of first patient enrollment in the Phase Ⅱ clinical trial of VC005 Tablets. This independently developed next-generation highly selective JAK1 inhibitor is being evaluated for the oral treatment of non-segmental vitiligo (NSV). The trial aims to assess the efficacy, safety, and PK profile of VC005 Tablets in Chinese adult NSV patients, providing a basis for the selection of dosage in subsequent clinical studies.

　　VC005 Tablets reduces inflammatory responses and immune cell activation through selective inhibition of JAK1. Compared with traditional therapies, it offers advantages such as high compliance, convenient administration, and good accessibility. In vitiligo patients, VC005 Tablets exerts effects via dual pathways: on one hand, it blocks keratinocytes from releasing chemokines that recruit more CD8+ T cells by inhibiting the IFN-γ - JAK1/2 - STAT1 signaling pathway; on the other hand, it suppresses the activation of Trm cells through inhibiting the IL-15 - JAK1/3 - STAT3/5 signaling pathway. This dual mechanism holding promise for delaying disease recurrence.

　　VC005 Tablets has demonstrated therapeutic effect in various autoimmune diseases. Currently, clinical studies are underway for multiple autoimmune conditions, including moderate-to-severe atopic dermatitis (Phase Ⅲ enrollment completed), ankylosing spondylitis (Phase Ⅲ initiated), and vitiligo (first patient enrolled in Phase Ⅱ). Meanwhile, VC005 Topical Gel, developed for mild-to-moderate atopic dermatitis, has successfully completed Phase Ⅱ clinical enrollment. Both oral and topical formulations of the project have shown favorable efficacy and safety profiles.

　　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 partnership 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 molecule 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, chronic depigmenting skin disorder. Currently, it is believed 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, vary in sizes and shapes. Most patients with vitiligo are asymptomatic, and spontaneous remission of the disease is rare. The pathological features of vitiligo include melanocyte death and CD8+ T cell infiltration, with CD8+ T cells preferentially localized in melanocytes at the lesional borders. Disease reversal 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) play a key role in the recurrence of vitiligo.