AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of JAK1 Inhibitor Ivarmacitinib in Combination with Topical Corticosteroids in the Treatment of Moderate-to-Severe Chronic Hand Eczema (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The First Hospital of Hebei Medical University; The First Hospital of Hebei Medical University

New P4 trial • Atopic Dermatitis • Contact Dermatitis • Dermatology • Immunology

Efficacy and Safety of Ivarmacitinib Sulfate Tablets in the Treatment of SAPHO Syndrome: A Single-Arm, Single-Center, Open-Label Clinical Trial (ChiCTR) - P4 | N=20 | Not yet recruiting | Sponsor: The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University

New P4 trial • Acne Vulgaris • Immunology

Ivarmacitinib for the Treatment of Sjögren’s Syndrome (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University o

New P4 trial

Effect of Ivarmacitinib on Joint Swelling and Tenderness in Patients with Moderate-to-severe Rheumatoid Arthritis: A Post-hoc Study of a Phase III Clinical Trial (ACR Convergence 2025) - P3 | "Ivarmacitinib significantly improves joint swelling and tenderness in patients with moderate-to-severe RA. Moreover, ivarmacitinib 8 mg provides superior long-term benefits in improving tenderness of small joints than large joints."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy of Ivarmacitinib in Patients with Moderate-to-severe Rheumatoid Arthritis Stratified by Baseline Characteristics: A Post-hoc Study of a Phase III Clinical Trial (ACR Convergence 2025) - P3 | "Ivarmacitinib provides consistent efficacy across various subgroups in patient with moderate-to-severe RA."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers. (PubMed, Drug Des Devel Ther) - "In healthy Chinese male volunteers, the bioavailability of the SHR0302 oral solution was comparable to that of the SHR0302 tablet. The drug was safe and well tolerated following a single dose."

Clinical • Journal • P1 data • PK/PD data

Determination of 13 janus kinase inhibitors in anti-alopecia cosmetics by ultra-high performance liquid chromatography-tandem triple quadrupole composite linear ion trap mass spectrometry (PubMed, Se Pu) - "Anti-alopecia cosmetics are often found to contain illegal additions of prohibited drugs such as minoxidil， finasteride and other substances...An ultra-high performance liquid chromatography-multiple reaction monitoring-information dependent acquisition-enhanced production scanning （UHPLC-MRM-IDA-EPI） method was developed to determine 13 JAK inhibitors in anti-alopecia cosmetics， including baricitinib， tofacitinib， ritlecitinib， peficitinib， abrocitinib， upadacitinib， ivarmacitinib， fedratinib， filgotinib， ruxolitinib， momelotinib， pacritinib and bozitinib...Recoveries of the 13 JAK inhibitors ranged from 94.7% to 102.2% for the water-soluble matrix and from 92.4% to 99.2% for the cream matrix， with relative standard deviations （RSDs） ≤8.8%. This method is characterized by high efficiency， rapidity， accuracy， sensitivity and simplicity， making it a powerful tool for rapid risk screening and simultaneous quantitative analysis of JAK inhibitors in anti-alopecia cosmetics."

Journal • Alopecia • Immunology

Ivarmacitinib for the Treatment of Adults with Severe Alopecia Areata: Results from a Phase 3 Trial. (PubMed, J Am Acad Dermatol) - "Once-daily ivarmacitinib 4 mg or 8 mg resulted in meaningful hair regrowth and demonstrated an acceptable safety profile in patients with severe AA."

Clinical • Journal • P3 data • Alopecia • Cardiovascular • Immunology • JAK1

A Multi-Cohort, Phase II Study of SHR0302 Combined With PD-1/PD-L1 Inhibitior for Treatment Naïve or Acquired Resistant to Immunology NSCLC (IASLC-WCLC 2025) - "Cohort 2 enrolled NSCLC whose disease progressed due to acquired resistance to first-line PD-1 inhibitor, and they will be administered with a combination of Adebrelimab (PD-L1 inhibitor) and SHR0302. Both cohorts will be treated until patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint of this trial is progression - free survival (PFS), while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety."

P2 data • Ankylosing Spondylitis • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Inflammatory Arthritis • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Rheumatology • Seronegative Spondyloarthropathies • Solid Tumor • IFNG

Biologics and Small Molecules for Psoriasis in China: Global Integration and Domestic Innovation (EADV 2025) - " Biosimilars: Domestic TNF-α inhibitors (e.g., Yisaipu) reduced costs by 50–60%, increasing systemic therapy uptake. Innovative Biologics: IL-17A inhibitors (frunevetmab, sailizumab [Phase III PASI75: 90.7%]) and IL-23- targeted piconchizumab (NDA 2024) demonstrated non-inferiority to global counterparts (secukinumab, guselkumab). Small Molecules: Local JAK1 (ivarmacitinib [NDA filed]) and TYK2 inhibitors (D-2570 [Phase II]) showed comparable efficacy/safety to upadacitinib and deucravacitinib. Emerging Therapies: Bispecifics (XKH004 [IL-17A/F]), IL-36R mAb HB0034 (GPP-focused), CRISPR-edited IL- 23/Th17 modulators, and engineered MSCs entered late-stage development... China's psoriasis therapeutics have transitioned from import dependency to globally competitive innovation. Domestic biosimilars and novel agents now challenge foreign dominance, while cost-reduction strategies improve accessibility for 6–8 million patients. With 15+ candidates in global trials, China..."

Clinical • Dermatology • Immunology • Psoriasis • IL17A • IL23A • JAK1 • TYK2

New molecules in the therapy of chronic graft-versus-host disease. (PubMed, Curr Opin Hematol) - "Expanding therapeutic options in cGvHD require decision-making based on organ involvement, prior therapy, and tolerability. Emerging compounds offer the potential to modulate chronic inflammation and fibrosis more precisely, supporting a move toward personalized and combinatorial approaches in advanced-line settings."

Journal • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Inflammation • Transplantation

A prospective clinical study on advanced or metastatic non-small cell lung cancer in the first-line treatment of adebelimab combined with emacetinib +/- chemotherapy (ChiCTR) - P4 | N=68 | Not yet recruiting | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Early itch relief with ivarmacitinib improves quality of life, working productivity, and sleep quality in patients with moderate-to-severe atopic dermatitis: a post hoc analysis of a phase III trial. (PubMed, J Dermatolog Treat) - P3 | "Sleep disturbance due to itch was also significantly improved in the EIR group from week 4 to week 40, though the difference at week 52 was not statistically significant. Early itch relief with ivarmacitinib showed significant improvements in QoL, sleep, and work productivity in patients with moderate-to-severe AD."

Clinical • HEOR • Journal • P3 data • Retrospective data • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Sleep Disorder

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Anesthesia

JAK1 inhibitor combined with Camrelizumab as first-line therapy for PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Efficacy and Safety of Ivarmacitinib in Patients with Polymyalgia Rheumatica: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

New P4 trial • Giant Cell Arteritis • Immunology • Musculoskeletal Pain • Pain • Rheumatology

A Multi-Center, Randomized, Controlled Trial of Ivarmacitinib in IgG4-Related Disease (ChiCTR) - P4 | N=88 | Not yet recruiting | Sponsor: Beijing Friendship Hospital Affiliated to Capital Medical University; Beijing Friendship Hospital Affiliated to Capital Medical University

New P4 trial • Inflammation

A prospective phase II clinical trial evaluating the efficacy and safety of chemotherapy combined with immune checkpoint inhibitors and ivarmacitinib in first-line treatment of extensive stage small cell lung cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

Checkpoint inhibition • New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Prospective, Multicenter Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate-to-Severe Active Rheumatoid Arthritis(IMPROVE-RA) (ChiCTR) - P4 | N=1000 | Not yet recruiting | Sponsor: Nanjing DrumTower Hospital of Nanjing University Medical School; Nanjing DrumTower Hospital of Nanjing University Medical School

New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Ivarmacitinib Sulfate: First Approval. (PubMed, Drugs) - "In April 2025, ivarmacitinib was approved in China for use in adult patients with moderate to severe atopic dermatitis (AD) who have had an inadequate response or intolerance to topical or other systemic treatments. This article summarizes the milestones in the development of ivarmacitinib leading to this first approval for the treatment of adult patients with active AS."

Journal • Ankylosing Spondylitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • JAK1

EFFICACY OF IVARMACITINIB IN BIOLOGICAL DMARDS-NAÏVE RHEUMATOID ARTHRITIS PATIENTS: A POST-HOC ANALYSIS FROM A PHASE III TRIAL (EULAR 2025) - P3 | "Ivarmacitinib effectively reduces disease activity and improves health-related quality of life in bDMARDs-naïve RA patients."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Ivarmacitinib improves different dimensions of patient-reported outcomes in patients with active ankylosing spondylitis: a post-hoc analysis of a phase II/III trial (EULAR 2025) - P2/3 | "Ivarmacitinib significantly enhances multiple dimensions of PROs in active AS patients, supporting its utility in managing PROs in AS. Switching to Ivarmacitinib also provides substantial benefits, ensuring that patients who delay initiation of Ivarmacitinib also experience meaningful improvements in PROs."

Clinical • P2/3 data • Patient reported outcomes • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies

Efficacy of Ivarmacitinib in patients with active ankylosing spondylitis stratified by baseline characteristics: a post-hoc analysis of a phase II/III trial (EULAR 2025) - P2/3 | "Ivarmacitinib significantly improves treatment response in active AS across subgroups, especially in those with younger age, lower BMI, shorter disease duration, and without a history of biological/JAK inhibitors."

Clinical • P2/3 data • Retrospective data • Ankylosing Spondylitis • Back Pain • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Pain • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Ivarmacitinib reduces the need for concomitant medication in moderate-to-severe rheumatoid arthritis patients: a post-hoc analysis from a phase III trial (EULAR 2025) - P3 | "Ivarmacitinib reduces the need for additional RA medications, thereby decreasing treatment burden."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Effect of Ivarmacitinib on patient-reported outcomes in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: a post hoc analysis of a phase III trial (EULAR 2025) - P3 | "Ivarmacitinib significantly and sustained improves patient-reported outcomes in patients with moderate-to-severe RA who have not responded well to csDMARDs."

Clinical • P3 data • Patient reported outcomes • Retrospective data • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology