Vcare PharmaTech’s VC005 Tablets, a New‑Generation Balanced Highly‑Selective JAK1 Inhibitor, Achieves Positive Top‑line Results in Phase II Clinical Trial for Vitiligo

　　Jiangsu Vcare PharmaTech Co., Ltd. (Vcare PharmaTech) recently announced positive top‑line results from its multi‑center, randomized, double‑blind, placebo‑controlled Phase II clinical study evaluating orally‑administered VC005 Tablets, a self‑developed next‑generation balanced highly‑selective JAK1 inhibitor, in adult patients with non‑segmental vitiligo (NSV). This marks another positive top‑line outcome for VC005 Tablets in dermatological indications, following its Phase III program for moderate‑to‑severe atopic dermatitis (AD).

　　Efficacy results demonstrated that at Week 24 of VC005 Tablets treatment, patients achieved approximately 43% improvement from baseline in F‑VASI, showing a highly statistically significant clinical difference versus the placebo group (P<0.001). The F‑VASI 75 response rate reached around 24%. More than half of patients attained ≥50% facial lesion repigmentation at Week 24, confirming tangible and meaningful repigmentation benefits with VC005 Tablets. The overall safety profile was favorable with no new safety signals identified, strongly supporting advancement into subsequent Phase III clinical trials.

　　As a next‑generation balanced highly‑selective JAK1 inhibitor, VC005 Tablets exert potent JAK1 inhibitory activity to modulate immune cells, protect melanocytes and reduce relapse risk. Meanwhile, substantially reduced inhibition against JAK2 and JAK3 lowers risks of myelosuppression and opportunistic infections, making it well‑suited for long‑term treatment of vitiligo patients. Different from mainstream topical therapeutic regimens for vitiligo, VC005 Tablets are orally administered twice daily, delivering stable and controllable plasma drug concentrations with systemic sustained action. It largely addresses unmet medical needs for patients with generalized vitiligo, eliminates the burden of large‑area topical application, and improves treatment adherence.

　　A core asset in Vcare PharmaTech’s auto‑immune pipeline, VC005 Tablets has previously secured an exclusive commercialization partnership with Huadong Medicine for mainland China. Multiple indications are advancing steadily across the VC005 pipeline: the Phase III trial for moderate‑to‑severe AD has met its primary endpoint; patient enrollment for the Phase III trial of ankylosing spondylitis is nearing completion; a Phase II clinical trial for alopecia areata is about to initiate; and enrollment for the topical gel’s Phase III trial in mild‑to‑moderate AD is more than halfway done. The R&D strategy of multi‑formulation coverage from oral to topical and simultaneous development across multiple indications continues to validate VC005’s broad therapeutic potential in inflammatory and autoimmune diseases. Prior clinical studies have preliminarily proven its robust efficacy and favorable safety profile.

　　About VC005

　　VC005 Tablets represent a new‑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 Vitiligo

　　Vitiligo is an acquired depigmenting skin disorder. Its cutaneous, mucosal or hair depigmentation is primarily driven by autoreactive T‑cell‑mediated specific destruction of local melanocytes. With a global prevalence of 0.5%‑2%, vitiligo clinically manifests as well‑demarcated milky‑white hypopigmented or depigmented macules of variable sizes and shapes, usually without subjective symptoms and rarely undergoing spontaneous repigmentation. Pathologically, vitiligo is characterized by melanocyte death and CD8⁺ T‑cell infiltration; CD8⁺ T cells preferentially target melanocytes at lesion borders. Disease reversal can be achieved via immunosuppression and melanocyte regeneration. Function and sustained recruitment of CD8⁺ T cells are critical to vitiligo progression. Interferon‑γ (IFN‑γ) produced by these cells serves as a core pathogenic cytokine for vitiligo, and autoreactive tissue‑resident memory T cells (Trm cells) play a pivotal role in disease relapse.

　　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.

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