Jiangsu Vcare's Second-Generation Selective JAK1 Inhibitor VC005 Gel Approved for Clinical Study in Mild-to-Moderate Atopic Dermatitis

　　Recently, the second-generation selective JAK1 inhibitor VC005 Gel, independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare), received approval from the NMPAto conduct clinical trials. The target indication is mild-to-moderate atopic dermatitis (AD). Related Phase I clinical trial work is scheduled to commence shortly.

　　This approval of the topical formulation VC005 marks another significant milestone in the development of VC005, following the approval of the oral tablet formulation for indications including inflammatory bowel disease (IBD), moderate-to-severe atopic dermatitis, ankylosing spondylitis (AS), and rheumatoid arthritis (RA). Currently, multiple Phase II clinical studies for the VC005 tablet have already been initiated.

　　About VC005

　　VC005 is a novel, highly potent, and selective second-generation JAK1 inhibitor independently developed by Jiangsu Vcare. By selectively inhibiting JAK1, the drug reduces inflammatory responses and immune cell activation, thereby achieving therapeutic effects in inflammatory and autoimmune diseases. Compared to Upadacitinib(a currently marketed JAK inhibitor), VC005 exhibits lower JAK2 inhibitory activity(based on in vitro kinase assays), which may mitigate safety concerns associated with excessive JAK2 inhibition. The drug is currently being developed in two formulations: oral tablets and topical gel.

　　About JAK1

　　The JAK/STAT signaling pathway, mediated by JAK family kinases and downstream STAT transcription factors, plays a critical regulatory role in inflammatory and autoimmune diseases such as AS and AD. Current first-generation pan-JAK inhibitors non-selectively inhibit multiple JAK subtypes (e.g., JAK1, JAK2,  TYK2) at similar potency levels. Excessive JAK2 inhibition is associated with severe adverse events, prompting the U.S. FDA to issue black box warnings for these agents. Consequently, second-generation selective JAK1 inhibitors like VC005, designed for enhanced safety and efficacy, represent a necessary evolution in therapy.

　　About AD

　　AD is a chronic, recurrent, inflammatory skin disease characterized by dry skin, intense pruritus, and eczematous lesions, significantly impairing patients’ quality of life. Epidemiological data indicate that AD affects up to 230 million individuals globally, including 70 million in China, with two-thirds classified as mild and one-third as moderate-to-severe. Prevalence continues to rise globally.

　　Traditional therapies such as glucocorticoids are limited by adverse effects and poor long-term outcomes, while treatment options for moderate-to-severe patients remain insufficient, leaving many without stable disease control. VC005’s development holds promise for bridging this gap.