Jiangsu Vcare Completes Phase III Enrollment of VC005, a Next-Generation High-Selective JAK1 Inhibitor for Moderate-to-Severe Atopic Dermatitis
Published Time:
2025-09-29 17:15
Source:
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) has achieved a major milestone in the Phase Ⅲ clinical trial of VC005 Tablets – the company's independently developed second-generation highly selective JAK1 inhibitor for oral treatment of moderate-to-severe atopic dermatitis (AD) – with the successful completion of full patients enrollment. This multicenter, randomized, double-blind, placebo-controlled pivotal Phase Ⅲ study aims to further validate the efficacy and safety of VC005 Tablets in adult patients with moderate-to-severe AD. The smooth completion of enrollment marks a crucial step forward for this innovative drug towards clinical application.
In the completed Phase Ⅱ clinical trial for moderate-to-severe AD, VC005 Tablets demonstrated significant efficacy across multiple key endpoints including EASI-75, EASI-90, and IGA 0/1. It showed immediate pruritus relief on the first day of administration, with overall good safety and tolerability. Beyond moderate-to-severe AD, clinical research on VC005 Tablets for other indications is also progressing smoothly. Recently, the company has officially initiated the Phase Ⅲ clinical study for ankylosing spondylitis (AS) and the Phase Ⅱ clinical trial for non-segmental vitiligo (NSV), gradually building a comprehensive layout in the field of autoimmune diseases.
In August 2025, Jiangsu Vcare entered into an exclusive commercialization cooperation agreement with Huadong Medicine for VC005 Tablets, further highlighting the market potential of the project.
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 Atopic Dermatitis
Atopic Dermatitis (AD) is a chronic, recurrent, inflammatory skin disease, mainly characterized by dry skin, intense pruritus, and eczematous rashes, which severely affects patients' quality of life. In terms of epidemiology, the total number of patients worldwide is approximately 230 million. The prevalence of AD among adults in China is about 2% to 8%, with the number of patients exceeding 70 million. Among them, moderate to severe cases account for 33%, and the patient population shows a continuous upward trend. Currently, in terms of therapeutic drugs, traditional oral medications for AD have many adverse reactions and poor efficacy, making it difficult to achieve effective and stable control of the disease. In contrast, the second-generation highly selective oral JAK1 small-molecule targeted inhibitors can not only control the condition effectively but also take effect quickly, achieve long-term patient response, and have good safety, thus providing a better medication option for patients with moderate to severe AD.
Related News
03
2025
/
07
Recently, the NDA for Eratrectinib (VC004) capsules, a next-generation anti-resistance TRK inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) has been officially accepted by China's NMPA. Previously granted priority review designation, the drug holds promise as a new treatment option for patients with advanced solid tumors.
30
2025
/
05
Recently, Eratrectinib (VC004) capsules, a self-developed next-generation anti-resistant TRK inhibitor by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare), were included in the priority review list by the NMPA, through public notice. This milestone positions the drug within the first tier of next-generation anti-resistant products targeting the same mechanism in China.
21
2025
/
05
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of patient enrollment for its self-developed Class 1 innovative antiplatelet drug, Vicagrel Capsules, in a Phase III clinical trial conducted in China. This study evaluates the efficacy and safety of Vicagrel compared to Clopidogrel in patients with acute coronary syndrome (ACS). The milestone marks a critical step toward Vicagrel’s potential market approval.
09
2025
/
05
On May 8, 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) achieved another major milestone in its self-developed second-generation highly selective JAK1 inhibitor, VC005 tablets. The project, intended for the oral treatment of non-segmental vitiligo received official IND approval from the NMPA (Application No.: CXHL2500200).
28
2025
/
04
Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced the successful enrollment of the first participant in its Phase II clinical trial for VC005 topical gel, a self-developed next-generation highly selective JAK1 inhibitor, for the treatment of mild-to-moderate atopic dermatitis (AD). The trial aims to evaluate the efficacy of VC005 gel in adult patients with mild-to-moderate AD, providing a critical data for dose selection in future clinical studies and further assesses the drug's safety profile.
11
2025
/
04
Recently, following joint review by Nanjing Jiangbei New Area Sci-Tech Bureau and Nanjing Municipal Science and Technology Bureau, the"Nanjing Key Laboratory for Artificial Intelligence (AI) Drug Design"established byJiangsu Vcare Pharmatech Co., Ltd.(Jiangsu Vcare) was approved as a 2025 Nanjing Key Laboratory. This marks authoritative recognition of Jiangsu Vcare’s scientific capabilities, with the Lab having achieved significant progress in drug design and molecular discovery.