Significant Efficacy! Jiangsu Vcare’s VC005 Tablets Achieve Positive Topline Results in Phase III Clinical Trial for Moderate-to-Severe AD

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced a major milestone breakthrough in the Phase III clinical study of VC005 Tablets, its independently developed second-generation highly selective JAK1 inhibitor for the oral treatment of moderate-to-severe AD, achieved positive topline results for the primary endpoint. This key milestone marks a decisive step forward for VC005 Tablets toward market launch and provides new therapeutic hope for numerous patients with moderate-to-severe AD.

　　The Phase III clinical trial of VC005 Tablets is a multicenter, randomized, double-blind, placebo-controlled confirmatory clinical trial designed to further validate the efficacy and safety of the drug in adult patients with moderate-to-severe AD.

　　Outstanding Efficacy and Impressive Results

　　Preliminary statistical results showed that both dose groups successfully met the primary efficacy endpoint at Week 16, with extremely significant statistical and clinical relevance (all p-values < 0.0001). The proportion of patients achieving EASI-75 and IGA responses in both dose groups were comparable to the best-in-class drugs targeting the same pathway, and was significantly higher than that in the placebo group. VC005 also showed rapid pruritus relief. Notably, at Week 16, the proportion of patients achieving WI-NRS4 response in the high-dose group was even superior to the best-in-class drugs of the same target class and significantly higher than the placebo group.(All comparative data above are based on non-head-to-head comparisons in Phase III trials.)

　　Favorable Safety Profile with No New Signals Identified

　　In terms of safety, VC005 Tablets demonstrated excellent overall tolerability. During the study, most TEAEs were mild to moderate (Grade 1–2), and no new safety signals were detected. This safety profile is consistent with previous studies, further confirming the safety advantages of VC005 Tablets as a highly selective JAK1 inhibitor in the treatment of autoimmune diseases.

　　These results not only confirm the positive topline data of VC005 Tablets in patients with moderate-to-severe AD, but also fully demonstrate the R&D strength and competitive advantages of domestically developed innovative drugs in the autoimmune field. In the future, the drug is expected to break the monopoly of imported originator drugs in the targeted therapy of moderate-to-severe AD, providing a strong impetus for the development of domestic innovative therapeutics.

　　In-Depth Pipeline Layout with Broad Prospects

　　As a core product in Jiangsu Vcare’s pipeline for autoimmune diseases, Jiangsu Vcare has entered into an exclusive commercialization cooperation for VC005 Tablets in Chinese mainland with Huadong Medicine. The positive results of the primary endpoint in this Phase III trial thereby established a solid foundation for the joint efforts to accelerate patient access to the product.

　　Beyond the major breakthrough in moderate-to-severe AD, VC005 Tablets are also under rapid advancement in multiple clinical programs: a Phase III trial for AS, a Phase II trial for NSV, and a planned Phase II trial for AA, demonstrating the drug’s broad application potential in the autoimmune field. Jiangsu Vcare is committed to providing precise and efficient treatment options for more patients with autoimmune diseases and elevating the standard of care for autoimmune disease in China

　　Remarks from Experts and Executives

　　Professor Lu Qianjin, Principal Investigator of the Phase III trial from the Institute of Dermatology, Chinese Academy of Medical Sciences, stated: “The clinical treatment of moderate-to-severe AD has long faced challenges with substantial unmet medical needs. VC005 Tablets demonstrated clinically meaningful efficacy and an acceptable safety profile in this Phase III study. With a mechanism of action that precisely targets the key pathogenic pathways of AD, the drug showed favorable clinical benefits in onset speed, skin lesion clearance, and pruritus relief. This study fully illustrates the continuous progress of China’s innovative drug R&D in the field of dermatological diseases. We look forward to VC005 Tablets providing a new treatment option for patients with moderate-to-severe AD upon completion of subsequent regulatory approval processes.”

　　Dr. Gong Yanchun, Co-Founder, Chairman and General Manager of Jiangsu Vcare, commented: “The achievement of the primary endpoint in the Phase III clinical trial of VC005 Tablets represents another major breakthrough for Jiangsu Vcare in innovative drug R&D, embodying the relentless efforts of our R&D team and the strong support from all collaborative partners. We adhere to differentiated innovation and strive to develop globally leading highly selective JAK1 inhibitors. The outstanding performance of VC005 Tablets strengthens our resolve to deepen the autoimmune field and develop more high-quality innovative drugs. Moving forward, we will accelerate the marketing application process of VC005 Tablets, while continuously advancing its clinical development for other autoimmune indications, and further optimize our product portfolio in the autoimmune sector. We will live up to patients’ expectations and partners’ trust, and deliver safer and more effective new clinical treatment solutions at an early date.”

　　About VC005

　　VC005 Tablets are a novel, potent and highly selective second-generation JAK1 inhibitor with independent intellectual property rights owned by Jiangsu Vcare. In August 2025, Jiangsu Vcare entered into an exclusive strategic cooperation with Huadong Medicine for the commercialization rights of VC005 Tablets in mainland China.

　　By selectively inhibiting JAK1, VC005 Tablets reduce inflammatory responses and the activation of immune cells, and are clinically developed for the treatment of inflammatory and autoimmune diseases. Currently, it is under development for multiple autoimmune indications including moderate-to-severe atopic dermatitis, ankylosing spondylitis and vitiligo, with two formulations: oral tablets and topical gel. While retaining potent JAK1 inhibition, VC005 Tablets exhibit further reduced selective inhibitory activity against JAK2 (based on in vitro kinase assay results), which is clinically expected to mitigate safety issues associated with excessive JAK2 inhibition.

　　About Atopic Dermatitis

　　AD is a chronic, recurrent and inflammatory skin disease characterized mainly by dry skin, severe pruritus and eczematous lesions, which severely impairs patients’ quality of life. Epidemiologically, approximately 230 million people worldwide are affected by AD, with over 70 million patients in China. The prevalence of adult AD ranges from 2% to 8%, and 33% of patients suffer from moderate-to-severe disease, with a rising patient population trend.

　　Current therapeutic options for AD are limited: traditional oral therapies are associated with numerous adverse reactions and suboptimal efficacy, failing to achieve effective and stable disease control. In contrast, second-generation highly selective oral small-molecule JAK1 inhibitors offer effective disease control with rapid onset and durable long-term responses alongside favorable safety profiles, providing superior treatment options for patients with moderate-to-severe AD.