Vcare PharmaTech Completes Full Participant Enrollment in Phase III Clinical Trial of VC005 Tablets, a New‑Generation Balanced High‑Selectivity JAK1 Inhibitor, for Ankylosing Spondylitis

　　Recently, the Phase III clinical trial of VC005 Tablets, a next‑generation balanced high‑selectivity JAK1 inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Vcare PharmaTech), for the oral treatment of ankylosing spondylitis (AS), has successfully completed enrollment of all participants.

　　Featuring high selectivity and a differentiated target‑inhibition strategy, VC005 Tablets potently inhibit JAK1 and moderately inhibit TYK2 in a synergistic manner, while markedly reducing inhibition against JAK2 and JAK3. While maintaining anti‑inflammatory efficacy, the drug significantly mitigates safety risks associated with pan‑JAK inhibition, achieving an improved clinical balance between maximized therapeutic efficacy and tolerable safety profile, and demonstrating promising clinical application potential. Its efficacy, safety and tolerability in patients with active AS have been preliminarily validated in the preceding Phase II clinical trial.

　　This ongoing multicenter, randomized, double‑blind, placebo‑controlled Phase III trial will further confirm the efficacy and safety of VC005 Tablets in patients with active AS in a larger patient cohort, generating core evidence‑based medical data to support subsequent new‑drug registration and filing.

　　Vcare PharmaTech will fully advance subsequent development of the project, striving to deliver a safer, better‑quality and more accessible new oral therapeutic option for patients with AS at an early date.

　　About VC005

　　VC005 Tablets represent a next‑generation balanced highly‑selective JAK1 inhibitor. It combines potent JAK1 inhibition with moderate TYK2 suppression to cover the Th2/Th1/Th17 inflammatory axes for optimized disease control. Meanwhile, its deliberately reduced affinity for JAK2 and JAK3 effectively mitigates risks of myelosuppression and opportunistic infections. It achieves a refined, superior clinical balance between maximized efficacy and tolerable safety, offering a viable therapeutic option to address the long‑standing trade‑off dilemma between efficacy and safety in autoimmune disease management. In August 2025, Vcare PharmaTech entered into an exclusive strategic cooperation with Huadong Medicine for the commercialization rights of VC005 Tablets in mainland China.

　　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 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.

　　Disclaimer

　　1.This press release shares cutting‑edge R&D progress of the Company for informational purposes only and is not intended for advertising. Information herein is not directed at patients and is for reference by healthcare professionals only.

　　2.Nothing in this press release constitutes a recommendation for any medicinal product and/or indication.

　　3.All information contained herein is for reference only. Company press releases and announcements shall in no way substitute for professional medical advice and shall not be construed as medical guidance. Please consult physicians or other qualified healthcare professionals for disease‑specific diagnosis and treatment advice.

　　4.As of the release date of this document, VC005 Tablets have not obtained marketing approval from the NMPA.

　　5.This press release may contain certain forward‑looking statements. Such statements inherently carry substantial risks and uncertainties. Words including “anticipate”, “believe”, “forecast”, “expect”, “intend” and other similar expressions in connection with the Company constitute forward‑looking statements. The Company assumes no obligation to update such predictive statements on an ongoing basis.

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