VC005 / Jiangsu Vcare Pharma, Huadong Medicine - LARVOL DELTA

Jiangsu Vcare PharmaTech Co., Ltd. announced a partnership with Beijing Sun-Novo Pharmaceutical Research…to advance VC005 topical gel (1%), a second‑generation highly selective JAK1 inhibitor, for the treatment of mild to moderate atopic dermatitis (AD) (flcube.com) - "Sun-Novo will receive a revenue share in mainland China and collaborate on Phase III trials and market launch....Next Steps: Phase III trial initiation expected Q2 2026; NDA submission targeted for 2028."

Filing • Licensing / partnership • New P3 trial • Atopic Dermatitis

A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of VC005 tablets in subjects with non-segmental vitiligo (ChiCTR) - P2 | N=120 | Not yet recruiting | Sponsor: Peking University People's Hospital; Peking University People's Hospital

New P2 trial • Dermatology • Immunology • Vitiligo

Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VC005 in Adolescent Subjects With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Vitiligo

Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis. (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy and Safety Phase II Study of VC005 Tablets in Subjects With Non-segmental Vitiligo (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P2 trial • Dermatology • Immunology • Vitiligo

Efficacy and Safety Phase III Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis. (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P3 trial • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Vcare Enters into Exclusive Partnership with Huadong Medicine to Commercialize its second-generation JAK1 inhibitor, VC005 tablets, in China (PRNewswire) - "Under the agreement, Jiangsu Vcare will remain the marketing authorization holder (MAH) and retain responsibility for R&D, registration, manufacturing, and supply of VC005 tablets. Jiangsu Vcare will receive an upfront payment of RMB 50 million and registration milestone payments of up to RMB 180 million. Huadong Medicine will take charge of commercialization and market promotion across mainland China."

Licensing / partnership • Ankylosing Spondylitis • Atopic Dermatitis • Immunology • Vitiligo

The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult Subjects With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Jiangsu Weikaier VC005 topical treatment of mild to moderate atopic dermatitis Phase II clinical trial officially launched [Google translation] (zhihu.com) - "At the end of March 2025, Jiangsu Weikai Pharmaceutical Technology Co., Ltd. (referred to as 'Jiangsu Weikai') officially launched Phase II clinical trials for the topical treatment of mild to moderate atopic dermatitis with VC005 gel , a new generation of highly selective JAK1 inhibitors independently developed by the company. The enrollment of relevant subjects is in progress."

Trial status • Atopic Dermatitis

Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult Subjects With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase III Clinical Study of VC005 Tablets in Adult Patients with Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase III Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=480 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis. (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ May 2024 | Trial primary completion date: Apr 2026 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2024 | Trial primary completion date: Dec 2024 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=149 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Recruiting ➔ Completed | Trial completion date: Aug 2026 ➔ Jul 2024 | Trial primary completion date: Aug 2026 ➔ Jul 2024

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis. (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Oct 2023 | Trial primary completion date: Jun 2026 ➔ Oct 2023

Trial completion • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=152 | Not yet recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis. (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis. (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology