Jiangsu Vcare Completes Pre-IND Submission for VC005, a Highly Selective JAK1 Inhibitor New Drug

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) successfully submitted a Pre-IND application to the NMPA for its VC005 tablets. VC005 is a highly selective JAK1 inhibitor independently designed by Jiangsu Vcare. It is intended for the clinical treatment of inflammatory bowel disease (IBD), an intestinal autoimmune disorder.

　　IBD encompasses chronic, non-specific inflammatory conditions of the gut, primarily ulcerative colitis (UC) and Crohn's disease (CD). Clinical manifestations include diarrhea, abdominal pain, and even bloody stools. UC can occur at any age, with peaks between 15-30 and 50-70 years old. It primarily affects the rectum and sigmoid colon, exhibiting diffuse distribution. CD can also occur at any age but is most common in adolescence. Lesions can affect the entire gastrointestinal tract from mouth to anus, characterized by segmental and skip lesions, most frequently involving the terminal ileum, colon, or both the small and large intestine. Both UC and CD are chronic inflammatory diseases currently without a cure, requiring lifelong medication management. Often termed "incurable intestinal disorders," they carry high relapse rates of 70–90%. The incidence of IBD in China is steadily increasing, establishing it as a common and challenging condition within the digestive system. It represents a key focus and significant challenge in both basic research and clinical diagnosis/treatment of digestive diseases.

　　Janus kinases (JAKs) comprise a family of tyrosine kinases, consisting of four members: JAK1, JAK2, JAK3, and TYK2. JAKs play crucial roles in signal transduction for numerous cytokines. Together with their downstream effectors, Signal Transducers and Activators of Transcription (STATs), they mediate cytokine receptor regulation of nuclear gene transcription and expression. Dysfunction of the JAK-STAT signaling pathway is closely associated with the pathogenesis of hematological diseases such as polycythemia vera, thrombocythemia, leukemia, and myelofibrosis, as well as autoimmune disorders including rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE), IBD, and atopic dermatitis. Consequently, the JAK kinase family has emerged as a critical therapeutic target for these conditions.

　　About VC005

　　VC005 is a novel, potent, gut-restricted selective JAK1 inhibitor independently developed by Jiangsu Vcare. It features controllable systemic exposure coupled with high intestinal exposure. Preclinical studies have demonstrated that VC005 exhibits a low effective dose, high tolerated dose, and minimal side effects in animal models, offering dual advantages of safety and efficacy. It holds promise as a potential globally leading gut-selective anti-inflammatory drug.