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
08
2024
/
07
Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) reported positive results from its Phase II clinical trial of VC005 tablets, a second-generation selective JAK1 inhibitor, for the treatment of ankylosing spondylitis (AS).
02
2024
/
07
Jiangsu Vcare and Geneseeq Form Strategic Partnership for NTRK Companion Diagnostics
On July 2, 2024, Jiangsu Vcare and Geneseeq signed a strategic cooperation agreement in Nanjing’s Jiangbei New District. The collaboration will focus on the joint development and future commercialization of a companion diagnostic kit for the NTRK inhibitor VC004.
07
2024
/
06
Jiangsu Vcare Unveils Phase I Clinical Trial Results of TRK Inhibitor VC004 at 2024 ASCO
On June 2, 2024,Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) unveiled the Phase I clinical trial results of its self-developed next-generation TRK inhibitor, VC004, for the treatment of locally advanced/metastatic solid tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
28
2024
/
04
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of participants enrollment in its Phase I clinical trial for VC005, a second-generation selective JAK1 inhibitor developed as a topical gel formulation for the treatment of mild-to-moderate atopic dermatitis (AD). The trial included four cohorts of healthy volunteers and three cohorts of patients. The blinded analysis demonstrated promising efficacy and safety profiles for the drug.
20
2024
/
03
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of Phase II clinical enrollment for its self-developed second-generation selective JAK1 inhibitor VC005 tablets in the treatment of moderate-to-severe atopic dermatitis (AD). Preliminary blinded analysis from the clinical trial demonstrated promising efficacy and safety profiles for VC005.
07
2024
/
02
I. Important Progress in Innovative Drug R&D ① Submitted NDA to US FDA for anti-platelet drug Vicagrel: If approved, it may benefit ~27.6M US patients with coronary heart disease/stroke. ② Completed 1st patient enrollment in China’s Phase II trial for anti-resistant TRK inhibitor VC004: Phase I data showed ORR of 80%-90% in NTRK fusion+ solid tumors and DOR up to 24 months. ③ Completed Phase II enrollment for 2nd-gen selective JAK1 inhibitor VC005 in ankylosing spondylitis: Preliminary blinded analysis showed favorable efficacy/safety. Additionally: VC004 gel approved for clinical trials; VC005 gel initiated China Phase I for atopic dermatitis; Multiple preclinical projects advanced in cardio-cerebrovascular, oncology, and autoimmune fields.