Crack the Challenge of Alopecia！Jiangsu Vcare Secures IND Approval in China for VC005 Tablets, a Next-Generation Selective JAK1 Inhibitor, in Alopecia Areata

　　Recently, a major R&D milestone has been achieved for VC005 Tablets, a second-generation highly selective JAK1 inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare). The project has officially obtained IND approval from the CDE of the NMPA of China, which is intended for the oral treatment of alopecia areata, bringing a brand-new therapeutic hope to patients suffering from hair loss.

　　VC005 Tablets exhibit potent pM-level targeted inhibitory activity against JAK1 kinase, enabling precise and efficient blocking of the JAK/STAT signaling pathway associated with the immune mechanism underlying alopecia areata pathogenesis. It effectively inhibits the excessive activation and proliferation of CD8+ NKG2D+ T cells that induce inflammatory damage at the hair follicle level, thereby suppressing the occurrence and progression of alopecia areata at its root. In the completed preclinical efficacy models, VC005 at low, medium, and high dose groups all significantly improved hair loss in animals, with excellent tolerability observed across all groups, laying a solid foundation for subsequent clinical development.

　　To date, oral VC005 Tablets have launched systematic clinical research in multiple autoimmune disease areas. Specifically, clinical studies for moderate-to-severe atopic dermatitis and ankylosing spondylitis have both entered Phase III, while the study for vitiligo has progressed to Phase II. Meanwhile, the concurrently developed topical VC005 Gel for the treatment of mild-to-moderate atopic dermatitis is scheduled to initiate Phase III clinical trials shortly. The approval of the IND for the alopecia areata indication marks another critical strategic layout of VC005 in the field of autoimmune diseases, following its advancement in atopic dermatitis, ankylosing spondylitis, and vitiligo.

　　About VC005

　　VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor. In August 2025, Jiangsu Vcare entered into an exclusive strategic cooperation with Huadong Medicine for the commercialization rights of VC005 Tablets in Mainland China (click for details). By highly selectively inhibiting JAK1 to reduce inflammatory responses and immune cell activation, VC005 is clinically being developed for the treatment of inflammatory and autoimmune diseases. Its oral tablet formulation is under development for multiple autoimmune indications, including moderate-to-severe atopic dermatitis (Phase III enrollment completed), ankylosing spondylitis (Phase III enrollment ongoing), vitiligo (Phase II enrollment ongoing), and alopecia areata (IND approved). The topical gel formulation is being developed for mild-to-moderate atopic dermatitis (Phase III to be initiated soon). While retaining potent JAK1 inhibitory activity, VC005 further selectively reduces JAK2 inhibitory activity (based on in vitro kinase assay results), which is expected to clinically mitigate safety concerns associated with excessive JAK2 inhibition.

　　About Alopecia Areata

　　Alopecia areata（AA） is a chronic inflammatory disorder characterized by the sudden onset of circular or oval patches of hair loss. It can occur at any age in both males and females, with a global incidence of approximately 0.1% to 0.2%. The scalp is the most common site of involvement; 5% to 10% of cases may progress rapidly after onset, leading to total alopecia (complete hair loss) within days or months. The specific attack on hair follicles by autoreactive T cells is the key driver of hair follicle damage and subsequent hair loss. The JAK/STAT signaling pathway plays a pivotal role in the immunopathogenesis of AA, particularly as cytokines such as IFN-γ and IL-15 activate and sustain the autoimmune response against hair follicles through this pathway.

　　Currently, clinical treatment options for AA mainly include topical medications, systemic glucocorticoids, and traditional immunosuppressants. Among these, topical treatments are only suitable for patients with small-area AA, while traditional systemic therapies are associated with limitations such as numerous adverse reactions and high recurrence rates. By highly selectively inhibiting JAK1 to precisely target the key inflammatory pathways linked to AA, VC005 Tablets are expected to provide patients with a new and superior therapeutic option, facilitating hair regrowth and maintaining long-term efficacy.