Jiangsu Vcare's Class 1 Innovative Drug VC005 Tablets Receives Clinical Trial Approval

　　In August 2021, VC005 tablets, an innovative drug developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare), received clinical trial approval from the NMPA for the indication of inflammatory bowel disease (IBD), with clinical trials set to begin shortly.

　　VC005 tablets is a novel, highly selective JAK1 inhibitor independently developed by Jiangsu Vcare. It effectively inhibits inflammatory targets such as TYK2 while simultaneously suppressing immune cell-mediated cytotoxicity and immune responses. It exhibits weaker inhibitory activity against JAK2 and JAK3, demonstrating favorable compound selectivity.

　　The JAK-STAT signaling pathway plays a crucial role in the pathogenesis of diseases like IBD. Marketed oral JAK inhibitors, due to their lower selectivity, inhibit JAK1 while also affecting targets like JAK2 and JAK3. This has led to the clinical manifestation of severe adverse reactions, including anemia, infections, dyslipidemia, and malignancies, prompting the FDA to issue boxed warnings. As safety concerns regarding JAK inhibitors have been frequently reported, regulatory agencies have become increasingly cautious regarding the expansion of indications and the review of new drug applications for this class. Since the first half of 2021, the FDA has repeatedly delayed review decisions for JAK inhibitors, drawing significant attention from the biopharmaceutical industry.

　　The development of VC005 tablets is based on a differentiated strategy, specifically addressing the above-mentioned issues from the initiation and design stages of the project. Preclinical studies have confirmed that compared to drugs targeting the same pathway, VC005 exhibits a lower effective dose, higher tolerated dose, and fewer side effects in animal models, suggesting potential dual advantages in both safety and efficacy. It holds promise to become a globally leading therapeutic option for autoimmune and inflammatory diseases.