Jiangsu Vcare Launches Phase III Clinical Trial of VC005, a Highly Selective JAK1 Inhibitor, for Ankylosing Spondylitis
Published Time:
2025-09-15 17:19
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Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the official initiation of the Phase III clinical trial of VC005 Tablets—a self-developed second-generation highly selective JAK1 inhibitor—for the oral treatment of ankylosing spondylitis (AS). This marks the second Phase III clinical trial of VC005 Tablets, following the one for oral treatment of moderate-to-severe atopic dermatitis (AD), signifying that the AS indication has entered the confirmatory clinical research stage.
Results from the previously Phase II clinical trial have preliminarily demonstrated the efficacy, safety, and tolerability of VC005 Tablets in patients with active AS. The newly launched study is a multicenter, randomized, double-blind, placebo-controlled pivotal Phase III clinical trial. Its aim is to further confirm the efficacy and safety of VC005 Tablets in treating active AS in a larger patient population, thereby providing critical evidence for subsequent registration filings.
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 strategic cooperation 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 Ankylosing Spondylitis
AS is a chronic inflammatory disease that primarily affects the sacroiliac joints, spine, paravertebral soft tissues, and peripheral joints. It may be accompanied by extra-articular manifestations, and in severe cases, can lead to spinal deformity and ankylosis. Epidemiologically, the prevalence of AS in China is approximately 0.36%, affecting over 5 million people. The disease has a higher incidence in males, and the age of onset ranges from 15 to 40 years, commonly affecting young people under 35. The etiology of AS is associated with genetic, infectious, environmental, and immunological factors. The disease progresses progressively over time, often causing irreversible structural damage; in severe cases, it can result in disability and deformity. Currently, there is no cure for AS, and timely disease control is essential. In terms of therapeutic drugs, traditional treatment methods such as non-steroidal anti-inflammatory drugs can only relieve symptoms, while highly selective small-molecule JAK1 targeted inhibitors can effectively control the progression of AS and achieve favorable clinical therapeutic effects.
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